Myleran

Pronunciation: byoo-SUL-fan
Generic Name: Busulfan
Brand Name: Myleran

Myleran may cause severe bone marrow depression, which can reduce the body's ability to fight infection or cancer. Lab tests will be required to monitor therapy. Myleran may also increase the risk of developing a second cancer.

Myleran is used for:

Treating the symptoms of chronic myelogenous leukemia.

Myleran is an alkylating agent. It works by slowing down reproduction and growth of certain white blood cells, which helps the body fight leukemia.

Do NOT use Myleran if:

• you are allergic to any ingredient in Myleran


• you are also taking metronidazole or have recently been vaccinated with a live vaccine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Myleran:

Some medical conditions may interact with Myleran. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have bone marrow depression, blood problems (eg, porphyria, thalassemia), a head injury, or a history of seizures (eg, epilepsy)


• if you have undergone chemotherapy or radiation or have previously or are currently taking any other medicines for cancer


• if you are overweight

Some MEDICINES MAY INTERACT with Myleran. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Metronidazole, acetaminophen, or itraconazole because the toxic side effects of Myleran may be increased


• Cyclophosphamide because the risk of serious heart side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Myleran may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Myleran:

Use Myleran as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Myleran may be taken with or without food. If nausea or vomiting occurs, it may help to take Myleran on an empty stomach.


• Myleran works best if it is taken at the same time each day.


• Drinking extra fluids while you are taking Myleran is recommended. Check with your doctor or nurse for instructions.


• If you miss a dose of Myleran, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Myleran.

Important safety information:

• Myleran may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Myleran. Using Myleran alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Myleran may lower your resistance to infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first.


• Myleran may reduce the number of certain blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur.


• Check with your doctor before having vaccinations while you are using Myleran.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Myleran.


• Myleran increases the risk of a second cancer in future years. If you have questions about this risk, talk with your doctor.


• The use of birth control is recommended while you are taking Myleran.


• Myleran may cause infertility. Talk with your doctor if you have any questions or concerns.


• LAB TESTS, including liver function tests, blood cell counts, and bone marrow tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• PREGNANCY and BREAST-FEEDING: Myleran has been shown to cause harm to the fetus. Avoid becoming pregnant while you are taking Myleran. If you suspect you may be pregnant, discuss with your doctor the benefits and risks of using Myleran during pregnancy. It is unknown if Myleran is excreted in breast milk. Do not breast-feed while taking Myleran.

Possible side effects of Myleran:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Darkening of the skin; diarrhea; dizziness; dry mouth, nose, and throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abrupt weakness; chest pain; confusion; congestion; decreased ability to fight infection; fever, chills, or sore throat; infertility; loss of appetite; missed menstrual period; nausea; persistent cough; seizures; shortness of breath; stomach or joint pain; unusual bruising or bleeding; unusual tiredness or fatigue; vision changes; vomiting; weight loss; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Myleran side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Myleran:

Store Myleran at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Myleran out of the reach of children and away from pets.

General information:

• If you have any questions about Myleran, please talk with your doctor, pharmacist, or other health care provider.


• Myleran is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Myleran. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Myleran resources

• Myleran Side Effects (in more detail)
• Myleran Dosage
• Myleran Use in Pregnancy & Breastfeeding
• Myleran Drug Interactions
• Myleran Support Group
• 1 Review for Myleran - Add your own review/rating

• Myleran Prescribing Information (FDA)


• Myleran Concise Consumer Information (Cerner Multum)


• Busulfan Monograph (AHFS DI)


• Busulfan Professional Patient Advice (Wolters Kluwer)


• busulfan Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Busulfex Prescribing Information (FDA)

Compare Myleran with other medications

• Bone Marrow Transplantation
• Chronic Myelogenous Leukemia
• Thrombocythemia

Myobloc

Generic Name: Botulinum Toxin Type B
Class: Other Miscellaneous Therapeutic Agents
VA Class: MS900

Special Alerts:

[UPDATED 08/03/2009] FDA notified healthcare professionals of changes to the established drug names for botulinum toxin Type A (Botox/Botox Cosmetic, Dysport) and botulinum toxin Type B (Myobloc) to reinforce individual potencies and prevent medication errors, and provided recommendations for healthcare professionals to consider, plus information for patients, family members, and caregivers. For more information visit the FDA website at: and .

[Posted 04/30/2009] FDA notified healthcare professionals that after an ongoing safety review initiated in February 2008, the manufacturers of licensed botulinum toxin products [botulinum toxin Type A (Botox and Botox Cosmetic) and botulinum toxin Type B (Myobloc)] will be required by FDA to strengthen warnings in product labeling and add a boxed warning regarding the risk of adverse events when the effects of the toxin spread beyond the site where it was injected.

FDA will also require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers. FDA is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

FDA’s evaluation of the data continues to support the recommendations made in the 2008 Early Communication. For more information visit the FDA website at: , and .

REMS:

FDA approved a REMS for rimabotulinumtoxinb (formerly botulinum toxin b) to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of rimabotulinumtoxinb (formerly botulinum toxin b) and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Neurotoxin produced by Clostridium botulinum;^{1 2 3 5 31 37 70 73 79} 7 structurally similar but antigenically and serologically distinct botulinum toxin serotypes (A, B, C, D, E, F, and G) exist.^{2 3 31 32 37 70 73 75 79}

Botulinum toxin disrupts neurotransmission by inhibiting release of acetylcholine at cholinergic nerve terminals of the peripheral nervous system and at ganglionic nerve terminals of the autonomic nervous system, inducing a chemical denervation and flaccid paralysis and inhibiting glandular secretion.^{2 3 31 32 37 43 72 73 75 194}

Uses for Myobloc

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Botulinum toxin type B (Myobloc) and type A (Botox, Botox Cosmetic) currently are the only botulinum toxin serotypes commercially available in the US;^{1 2 5} types C and F reportedly under clinical investigation in other countries.⁴

Cervical Dystonia

Management of cervical dystonia (also referred to as spasmodic torticollis) to decrease severity of associated abnormal head position and neck pain;^{2 3 4 9 14 16 29 30 32 35 37 40 54 65 69 81 85 95 96 122 123} designated an orphan drug by US FDA for this use.⁸¹

Considered first-line therapy for cervical dystonia because of efficacy, relatively low incidence of adverse effects, and temporary dose-related therapeutic effects (compared with surgery).^{3 15 30 33 34 35 54 83 86 90 296 297}

Also considered an effective and safe treatment for cervical dystonia in patients who are not responsive to therapy with botulinum toxin type A.^{3 14 15 16 17 32 35 41 42 60 64 65 79 137 348 350 354 355}

Comparative safety and efficacy of botulinum toxin types A and B in cervical dystonia have not been established;^{14 69} botulinum toxin type B appears to be effective in patients who develop tolerance to type A as well as in those who are responsive to botulinum toxin type A.^{2 14 17 42 69 123 297 345}

Very limited experience in patients not previously treated with botulinum toxin type A.^{2 296 297 298}

Cosmesis

Has been used for temporary improvement in the appearance of facial wrinkles associated with hyperactivity of the orbiculus oculi muscle† (lateral canthal wrinkles†, also known as “crow’s feet”†) in a limited number of individuals.^{152 156 310 337 338}

Myobloc Dosage and Administration

General

• 
  

  Adjust dosage carefully according to response and particular condition treated.^{4 120}

  
  


• 
  

  Generally, the effective IM dose depends on muscle mass; the larger the muscle, the higher the required dose.^{4 120}

  
  


• 
  

  Individual susceptibility to the toxin varies;⁴ optimal dosages for a number of conditions have not been fully elucidated.^{37 133 138 142 156 218 219 238 243 301 302 313 321 337 338}

  
  


• 
  

  Lower doses may be required in patients with preexisting weakness or when there is concern about weakness, in those with milder disease severity, and in women and patients with lower body weights.⁴

  
  


• 
  

  Patients with cervical dystonia who have not previously received botulinum toxin should receive a lower initial dose; very limited experience in patients who have not received prior therapy with botulinum toxin type A.^{2 296 297}

  
  


• 
  

  If a patient fails to respond, consider possibility of an inadequate drug dose, improperly stored drug solution, and/or misinjection.^{65 296 348}

  
  


• 
  

  Carefully dispose of all used vials, including expired vials and/or equipment used in preparation and administration, as medical waste.²

  
  

Administration

Administer by IM injection into affected muscles.^{2 3 4 120}

Has been administered intradermally†^{30 35 60 67 79 85 123 157 158 160 170 259} , intracutaneously†,^{60 157 163 164 165 296 297} sub-Q†,^{60 157 163 164 165 296 297} or directly into affected glands†.^{4 320}

IM Administration

Administer by IM injection into affected muscles.^{2 3 4 120}

Dilution

Commercially available as a sterile solution containing 5000 units of botulinum toxin type B per mL.² Do not shake vial.²

Commercially available vials of botulinum toxin type B (Myobloc) are overfilled to ensure delivery of the labeled volume of drug: the vial labeled as containing 2500 units in 0.5 mL actually contains approximately 4100 units in 0.82 mL, the vial labeled as containing 5000 units in 1 mL actually contains approximately 6800 units in 1.36 mL, and the vial labeled as containing 10,000 units in 2 mL actually contains approximately 12,650 units in 2.53 mL.^{2 156 297 338} Drug solutions should not be diluted in the vial since this may result in a solution with a higher concentration than expected due to overfill.^{297 338}

Allow stopper of the vial to dry thoroughly after cleansing with alcohol before entering vial with a needle to prevent toxin inactivation.^{121 142 296 297}

May be diluted with 0.9% sodium chloride injection to obtain desired concentration; however, since the drug solution does not contain a preservative, use diluted solutions within 4 hours of preparation.^{2 296 297} Diluted solutions reportedly stable for at least 24 hours at 25°C.^{157 172}

Some clinicians suggest that injection pain (possibly due to acidity of the solution)^{152 157 286} may be decreased by adding a small amount of sodium bicarbonate to the injection solution†.^{152 157} However, the compatibility and stability of such solutions remain to be fully elucidated.^{157 296 297}

IM Injection Techniques

Targeting the injection to the appropriate muscle(s) may be facilitated by active electromyography (EMG), ultrasonography, palpation of muscle belly, and/or use of anatomic landmarks (e.g., evidence of muscular hypertrophy, stiffness, tenderness, visible abnormal muscular activity).^{4 120 147 229}

EMG-guided injections often are recommended to ensure optimal placement of toxin for efficacy, particularly in patients who have not responded adequately to previous injections, and to minimize adverse effects on nonaffected tissue.^{120 140 143 147 296 297}

EMG guidance may allow more accurate identification of the neural motor end plate, facilitating more precise injection and improving effectiveness of lower doses.^{240 360}

Injection into midbelly of larger muscles where motor end plates are located may enhance benefit.^{240 296 360}

Cervical Dystonia

Total dose administered at each treatment session is given as several injections divided among affected muscles.^{2 65}

Identify affected muscles by careful clinical evaluation, including physical examination (e.g., for areas of hypertrophy, pain) and palpation.^{9 33 65} Palpation of contracting muscles while patient’s head is placed in position most favored by dystonic pulling of neck muscles is reportedly helpful.^{9 65}

EMG guidance also may be useful in delineating involved muscles for injection, particularly in obese patients or for muscles difficult to identify by palpation.^{35 37 39 56 65}

Cosmesis of Lateral Canthal Wrinkles (“Crow’s Feet”)†

If concurrent cosmetic alteration of the eyebrow† is planned,^{157 296 297} defer treatment of the lateral eyebrow until after treatment of lateral canthal wrinkles (“crow’s feet”); increased diffusion may accomplish sufficient cosmetic alteration of the eyebrow to eliminate the need for further treatment.^{157 296 297}

Administration Precautions for Facial Cosmesis

Some clinicians suggest that injection procedures be adapted to account for the relatively greater diffusion characteristics of botulinum toxin type B compared with type A.^{142 157 296 297 301 302}

Appears to have increased diffusion within the muscle (potentially reducing the number of injections and complications)^{142 157 301 302 353 354} and a somewhat faster onset of action (e.g., within 24–48 hours) than botulinum toxin type A;^{142 152 157 160 297 353} however, additional experience needed to establish the optimal dose, number of injection sites, and frequency of treatment for facial cosmesis.^{142 156 301 310 337}

Minimize risk of ptosis by avoiding injections near levator palpebrae superioris, especially in individuals with larger brow-depressor complexes.^{5 137 140 141 142 296 297}

In older individuals, do not inject lower portion of brow (this muscle is used to raise eyebrows in order to see).¹⁴³

Do not treat entire forehead and glabellar lines during a single session; high risk of ptosis.^{143 157 296 297}

Avoid eyelid ptosis by asking individual to remain upright (e.g., avoid naps in reclining position) for 4 hours following treatment, avoid rubbing or massaging treated area for 4 hours (to prevent excess diffusion and possible weakness of adjacent muscles), and frown and smile repeatedly for at least 1–4 hours^{143 296 297} following treatment.^{140 141 143 296 297}

Apply digital pressure at border of supraorbital ridge while injecting corrugator muscle to minimize potential for diffusion into levator muscle and resultant weakening.¹⁴³

When injection sites are marked (e.g., with a ball-point pen) to ensure optimal targeting,^{140 296 297} avoid injecting directly into marked areas to prevent tattooing of skin.²⁹⁸

Before injection, instruct the individual to accentuate specific facial lines to be treated by squinting (for lateral canthal wrinkles).¹⁴⁰

Controlling Injection Pain

Pretreatment with ice packs or topical or local anesthetics (e.g., lidocaine/prilocaine cream [EMLA] and an occlusive dressing, proparacaine hydrochloride ophthalmic drops) has been recommended prior to injection.^{120 140 275 296}

Some clinicians report that topical or local anesthetics are not useful to prevent injection pain since they do not penetrate underlying muscles and/or require additional injections.^{270 296 297}

Dilution with 0.9% sodium chloride injection containing a preservative (benzyl alcohol)† has been reported to reduce pain on injection;^{62 64 138 157 297 344} however, the manufacturer recommends use of 0.9% sodium chloride injection without preservative for reconstitution and/or dilution.^{1 2 5 298}

IV sedation or general anesthesia may be needed prior to injection in some patients (e.g., those in considerable pain).^{120 296 297}

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Data on several different serotypes (e.g., botulinum toxin types A, B, C, F) and/or formulations of botulinum toxin have been reported;^{1 2 4 5 255 257} assay methods used to determine potency of these various toxins are specific to each individual manufacturer and/or formulation.^{1 2 4 5}

Units of biologic activity for one serotype or formulation of botulinum toxin cannot be compared with or converted to units of other botulinum toxins.^{1 2 4 5}

Unless otherwise noted, all botulinum toxin doses in this monograph refer to units of Myobloc.

Adults

Cervical Dystonia

Patients With a History of Tolerating Botulinum Toxin Treatment

IM

Titrate initial and subsequent dosage considering previous response, adverse reactions, and severity of dystonia based on head and neck position, localization of pain, mass of target muscles and their proximity to critical toxin-sensitive anatomic structures (e.g., larynx, pharynx), and muscular hypertrophy.^{56 296 297}

Initially, total recommended dose per treatment session is 2500–5000 units divided among affected muscles.²

Total initial doses as high as 10,000 units per treatment session have been used in patients with cervical dystonia.^{2 296 297}

Toxin treatment-naive patients should receive a lower initial dose.^{2 296 297} (See Botulinum Toxin-naive Patients under Cautions.)

Duration of response to 5000–10,000 units is generally 12–16 weeks.^{2 14 16 17}

Cosmesis of Lateral Canthal Wrinkles (“Crow’s Feet”)†

IM

1500 units divided among 3 injection sites per side (total dosage 3000 units) has been used;³¹⁰ wrinkle severity was reduced by day 30 and generally had returned to baseline by day 90 and 120.³¹⁰

750 units divided among 3 injection sites per side also has been used (total dosage 1500 units if both sides treated); resolution of wrinkles occurred at 7 days.¹⁵²

Prescribing Limits

Adults

Cervical Dystonia

IM

Do not exceed recommended dosage or frequency of administration; safety and efficacy of higher dosages have not been evaluated.^{2 296}

Special Populations

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.²⁹⁶

Cautions for Myobloc

Contraindications

• 
  

  Hypersensitivity to botulinum toxin type B or any ingredient in the formulation.²

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adherence to Recommended Dosage

Do not exceed recommended dosage or frequency of administration; safety and efficacy of higher dosages have not been evaluated.^{2 296} Severe adverse effects, including a botulism-like syndrome, have been reported with use of higher than recommended dosages of botulinum toxins and/or unlicensed preparations of botulinum toxins.^{371 374 376 377 378 379}

Comorbid Disorders

Increased risk of serious adverse systemic effects, including severe dysphagia, muscle weakness, and/or respiratory compromise, with recommended doses in patients with underlying conditions such as peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, motor neuropathy) or neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome); exercise caution when used in such patients.^{2 4 18 27 29 37 57 58 140 141 219 259 371 375 376} May be related to use of higher dosages in such patients.^{374 376}

Rarely, extreme sensitivity to systemic effects of usual clinical doses reported in patients with known or unrecognized neuromuscular disorders; some patients experienced several months of severe dysphagia and required a gastrostomy or nasogastric tube.^{2 9 57 69}

Some clinicians state that use for cosmetic treatment of neck wrinkles is contraindicated in patients with amyotrophic lateral sclerosis.¹⁴¹

Serious systemic effects related to distant spread of botulinum toxin reported, more often and with greater severity in children with cerebral palsy receiving such therapy; hospitalizations and deaths have occurred.^{371 372 373 374}

Dysphagia

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Dysphagia is the most common serious adverse effect reported in patients with cervical dystonia;^{2 11 14 15 16 17 35 53 57 65 69 95 96 122 261} also can occur in patients receiving botulinum toxin type B for other indications (e.g., torticollis, muscle spasticity associated with cerebral palsy).^{371 375 376} Results from the diffusion of the toxin to tissues (e.g., posterior pharyngeal muscles) outside the injected muscles.^{29 30 33 57 58 60 65 83 371} Rarely, dysphagia may require placement of gastric feeding tube.²

Rarely, fatal aspiration pneumonia or other serious debilities may develop subsequent to dysphagia.^{2 9 53 64 68}

Risk increased in patients with cervical dystonia and smaller neck muscle mass (e.g., female) receiving bilateral injections and/or relatively high doses into the sternocleidomastoid muscle.^{2 9 35 57 86}

Use lowest effective dose in such high-risk muscles.^{65 296}

Risk of Creutzfeldt-Jakob Disease

Formulation contains human albumin derived from blood.² Theoretical but remote risk of transmission of Creutzfeldt-Jakob disease (CJD) via albumin component; however, no cases of CJD identified to date.²

Major Toxicities

Systemic Toxicity (Botulism)

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Serious systemic toxicity, including respiratory compromise and death, reported during an ongoing FDA safety review of botulinum toxins type A and type B.^{371 372 373 374} More frequent and severe in children with limb spasticity associated with cerebral palsy.^{371 372 373 374} Causal relationship not established to date; FDA will review additional safety data from clinical studies, medical literature, and postmarketing adverse event reports to further evaluate risk of systemic toxicity.^{371 372 374}

Botulism also possible after iatrogenic overdose or misinjection of botulinum toxin.^{1 2 5 51 58 59 60 65 70 87 377 378} Following IM injection of usual therapeutic doses, botulinum toxin type B generally not present in the peripheral blood and generally does not induce systemic effects (e.g., generalized or distant muscle weakness) in patients without predisposing neuromuscular dysfunction.^{2 14} However, systemic autonomic or anticholinergic effects (e.g., dry mouth, dyspepsia,²⁹⁶ swallowing difficulties, accommodation difficulty, corneal and conjunctival irritation, dryness of nasal mucosa, reduced sweating, and urinary voiding difficulties) reported.^{160 261 296 340 352}

To date, botulism not reported after IM injections of botulinum toxin type B;² however, generalized muscle weakness and a generalized botulism-like syndrome, including respiratory arrest, reported rarely after IM injections of therapeutic doses of another botulinum toxin serotype (type A).^{14 26 32 33 38 52 58 142 293}

Precise risk of systemic autonomic or anticholinergic effects and/or generalized muscle weakness after treatment has not been fully elucidated.^{14 26 58 60 160 261 296 352}

Maximum safe dose that does not produce toxicity is not known.³⁷ Serious systemic toxicity has been reported during postmarketing experience with doses of 388–625 units/kg in children and doses of 10,000–20,000 units in adults.³⁷¹

Manifestations of overdose (botulism) include diplopia, ptosis, blurred vision, photophobia, dry mouth, difficulty speaking and swallowing, autonomic dysfunction such as bowel stasis, and generalized muscle weakness that can progress to a symmetric, descending flaccid paralysis;^{70 87 89 250} manifestations not apparent immediately after the drug is injected.²

If accidental injection or ingestion occurs, closely monitor patient for up to several weeks for manifestations of systemic weakness or muscle paralysis.² If botulism suspected, hospitalization may be required to monitor closely for systemic weakness, paralysis, and incipient respiratory failure.² Recovery occurs through neurogenesis of axonal sprouts and motor end plates; can require weeks or months.^{32 37 79 70}

In event of an overdose or misinjection (i.e., wrong muscle), contact manufacturer immediately for additional information and state health department to obtain botulinum antitoxin through CDC;² if state health department is not available, contact CDC by telephone at 404-639-2206 or 404-639-2888 (after hours).⁷⁰ Antitoxin will not reverse botulinum toxin-induced muscle weakness already evident at the time of antitoxin administration but may stabilize the deficits.^{2 265}

Antitoxin to a given type of botulinum toxin does not neutralize other types (e.g., anti-A botulinum antitoxin does not neutralize botulinum toxin types B through G).^{2 31 32 37 70 73 75 79}

For information about overdosage, contact Solstice Neurosciences at 888-461-2255.^{2 297 367}

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Botulinum Toxin-naive Patients

Initiate treatment of botulinum toxin-naive patients with lower doses from the recommended dosage range.²

Clinical experience in patients who have not previously tolerated treatment with botulinum toxin type A is limited; to date, only a few such patients have been evaluated.^{2 296 297}

Experience of Clinician

The manufacturer states that the drug should be administered to patients with cervical dystonia only by clinicians familiar with and experienced in the assessment and management of this condition.²

Thorough knowledge of diagnosis, management, and regional anatomy of the treated disorder, careful dose selection, and accomplished injection techniques are critical to obtaining therapeutic benefit and minimizing adverse effects.^{2 54 56} Some experts recommend limiting use to clinicians with specialized training.^{37 65 66 296 297}

Working knowledge of EMG techniques useful for accurate injection of target muscles in patients with cervical dystonia,³⁵ particularly when palpation is inadequate or adequate relief not obtained with conventional administration.^{9 35 83}

Systemic Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Local spread of toxin may result in weakness to adjacent muscles.^{9 10 11 12 13 18 30 31 32 33 34 35 37 65 142 371} Systemic spread of botulinum toxin also is possible and can cause a botulism-like syndrome (e.g., dysphagia, muscle weakness, ptosis, respiratory failure).^{371 372 373 374} Condition treated determines muscles injected and therefore proximate muscles possibly affected by infiltration and resultant undesired weakness.^{29 37}

Systemic autonomic or anticholinergic effects (e.g., dry mouth, dyspepsia,²⁹⁶ swallowing difficulties, accommodation difficulty, corneal and conjunctival irritation, dryness of nasal mucosa, reduced sweating, and urinary voiding difficulties) reported; incidence not fully elucidated.^{160 261 296 340 352 369}

Incidence of autonomic effects (e.g., anticholinergic effects such as dry mouth, ptosis, accommodation difficulty) may be higher with botulinum toxin type B than with type A, possibly because of diffusion characteristics and systemic distribution of type B and/or different relative affinities of toxin serotypes for neuromuscular and autonomic nerve endings.^{142 160 261 296 320 340 345 352}

Anticholinergic effects (e.g., dry mouth) appear to be dose related; reported more frequently with doses >10,000 units.^{243 261 340}

Incidence of dry mouth appears dose-related in cervical dystonia after injections in the splenius capitis, trapezius, and sternocleidomastoid muscles.²

Monitor patients for possible systemic effects including dysphagia, dysphonia, respiratory compromise, and generalized weakness following administration of botulinum toxin type B.³⁷¹

Injection-related Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Ecchymosis reported.²

Administer with caution to patients with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or those receiving anticoagulant therapy.^{53 296 297}

Antibody Formation and Tolerance

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Antibodies to the drug may develop in patients receiving repeated treatment; may have neutralizing activity.^{2 14} Such patients may still respond to the drug.^{14 31 79}

Clinical importance has not been determined.² It is not known if patients with neutralizing antibodies to botulinum toxin type A are at increased risk of developing tolerance to the type B toxin.^{345 351}

Neutralizing antibodies generally not detected until after 6 months of treatment.²

Patients who develop tolerance to botulinum toxin type A may respond to botulinum toxin type B or other botulinum toxin serotypes (e.g., botulinum toxin type F);^{3 32 35 41 42 60 64 65 79 137 348 350} however, long-term response to other serotypes in such patients has not been fully elucidated.^{14 32 33 41 359}

Dosing Precautions

Ensure accuracy of dosing information; units of biologic activity for different serotypes or formulations of botulinum toxin cannot be compared with or converted to units of other botulinum toxins.^{2 4}

Dosing errors reported;^{32 76 77 157 173 296 297} use care in evaluating medical literature on different toxin serotypes (e.g., botulinum toxin types A, B, C, F) since assay methods used to determine potency of different serotypes are specific to each individual manufacturer and/or formulation.^{1 2 4 5 255 257}

Specific Populations

Pregnancy

Category C.²

Lactation

Not known whether distributed into human milk.² Use with caution.²

Pediatric Use

Safety and efficacy not established in children <18 years of age with cervical dystonia.^{2 297}

Serious systemic toxicity resembling botulism (e.g., dysphagia, respiratory failure) reported during postmarketing experience in children <16 years of age.³⁷¹ Such effects were observed with botulinum toxin

Mylanta Gas Maximum Strength

Generic Name: simethicone (sye METH i cone)

Brand Names: Alka-Seltzer Anti-Gas, Equalize Gas Relief Drops, Gas Aide, Gas Free Extra Strength, Gas-X, Gas-X Extra Strength, Gas-X Infant Drops, Gas-X Maximum Strength, Gas-X Thin Strips Cinnamon, Gas-X Thin Strips Peppermint, Gas-X Tongue Twisters Thin Strips Children's, Gas-X Ultra Softgels, Genasyme, Infantaire Gas Relief, Little Tummys, Maalox Anti-Gas, Maalox Anti-Gas Extra Strength, Mi-Acid Gas Relief, Mylanta Gas, Mylanta Gas Maximum Strength, Mylicon, Mytab Gas, Phazyme, Phazyme Maximum Strength, Phazyme Ultra, Phazyme-125, Phazyme-95

What is Mylanta Gas Maximum Strength (simethicone)?

Simethicone allows gas bubbles in the stomach and intestines to come together more easily, which allows for easier passage of gas.

Simethicone is used to relieve painful pressure caused by excess gas in the stomach and intestines. Simethicone is for use in babies, children, and adults.

Simethicone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Mylanta Gas Maximum Strength (simethicone)?

Never use more than the recommended dose of simethicone.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs, or if you have any type of serious illness (especially one that affects your stomach or intestines).

Simethicone works best if you take it after meals and at bedtime.

Simethicone may be only part of a complete program of treatment that may also include a special diet or increased exercise. It is very important to follow the diet and exercise plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

There may be other drugs that can interact with simethicone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Mylanta Gas Maximum Strength (simethicone)?

You should not use this medication if you are allergic to simethicone.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs, or if you have any type of serious illness (especially one that affects your stomach or intestines).

Simethicone is not expected to harm an unborn baby. It is not known whether simethicone passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

The liquid form may contain phenylalanine. Talk to your doctor before using this form of simethicone if you have phenylketonuria (PKU).

How should I take Mylanta Gas Maximum Strength (simethicone)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not take more of this medication than is directed.

Simethicone works best if you take it after meals and at bedtime.

The simethicone chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one. Clean the medicine dropper after each use. Allow it to air dry.

Simethicone liquid drops can be mixed with water, baby formula, or other liquids to make swallowing easier for an infant or child.

Children should never be given more than the recommended dose of simethicone. Call your doctor if the child's gas symptoms do not improve after treatment with simethicone.

Simethicone may be only part of a complete program of treatment that may also include a special diet or increased exercise. It is very important to follow the diet and exercise plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must avoid to help control your condition.

Store at room temperature away from moisture, heat, and light. Do not allow the liquid form of this medicine to freeze.

What happens if I miss a dose?

Since simethicone is used on an as needed basis, you are not likely to miss a dose. Do not use more of this medication than is directed.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Mylanta Gas Maximum Strength (simethicone)?

Ask a doctor or pharmacist before using any other stomach medicine or antacid. Simethicone is contained in many combination medicines. Taking certain products together can cause you to get too much simethicone.

Mylanta Gas Maximum Strength (simethicone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mylanta Gas Maximum Strength (simethicone)?

There may be other drugs that can interact with simethicone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Mylanta Gas Maximum Strength resources

• Mylanta Gas Maximum Strength Side Effects (in more detail)
• Mylanta Gas Maximum Strength Use in Pregnancy & Breastfeeding
• Drug Images
• 0 Reviews for Mylanta Gas Maximum Strength - Add your own review/rating

• Simethicone Professional Patient Advice (Wolters Kluwer)


• Simethicone Monograph (AHFS DI)


• Alka-Seltzer Anti-Gas Advanced Consumer (Micromedex) - Includes Dosage Information


• Bicarsim MedFacts Consumer Leaflet (Wolters Kluwer)


• Gas-X Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Gas-X Extra Strength MedFacts Consumer Leaflet (Wolters Kluwer)


• Gas-X Infant Drops Liquid Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Genasyme Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Mylanta Gas Maximum Strength with other medications

• Endoscopy or Radiology Premedication
• Functional Gastric Disorder
• Gas
• Postoperative Gas Pains

Where can I get more information?

• Your pharmacist can provide more information about simethicone.

See also: Mylanta Gas Maximum Strength side effects (in more detail)

meningococcal conjugate vaccine

Generic Name: meningococcal conjugate vaccine (me NIN je KOK al KON je gate vax EEN)

Brand Names: Menactra, Menveo

What is meningococcal conjugate vaccine?

Meningococcal disease is a serious infection caused by a bacteria. Meningococcal bacteria can infect the blood, spinal cord, and brain. These conditions can be fatal.

Meningococcal disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.

Meningococcal conjugate vaccine is used to prevent infection caused by meningococcal bacteria. The vaccine contains four of the most common types of meningococcal bacteria.

Meningococcal conjugate vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes your body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Meningococcal conjugate vaccine is for use in children and adults between the ages of 9 months and 55 years old.

Like any vaccine, meningococcal conjugate vaccine may not provide protection from disease in every person.

Becoming infected with meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

What is the most important information I should know about meningococcal conjugate vaccine?

You should not receive this vaccine if you have ever had an allergic reaction to a meningococcal or a diphtheria vaccine, if you are allergic to latex, or if you have a history of Guillain-Barre syndrome.

Before receiving meningococcal conjugate vaccine, tell your doctor if you have a bleeding or blood clotting disorder, a weak immune system, or if you are receiving steroids, chemotherapy, or radiation treatment. If you have any of these conditions, your vaccine may need to be postponed or not given at all.

You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection. Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you recover before receiving this vaccine.

Becoming infected with meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Like any vaccine, meningococcal conjugate vaccine may not provide protection from disease in every person.

What should I discuss with my healthcare provider before receiving meningococcal conjugate vaccine?

You should not receive this vaccine if you have ever had an allergic reaction to a meningococcal or a diphtheria vaccine, if you are allergic to latex, or if you have a history of Guillain-Barre syndrome.

To make sure you can safely receive this vaccine, tell your doctor if you have any of these other conditions:

• 
  

  a bleeding or blood clotting disorder, such as hemophilia;

  
  


• 
  

  any condition that weakens the immune system (such as HIV, AIDS, or cancer); or

  
  


• 
  

  if you are receiving steroids, chemotherapy, or radiation treatments.

  
  

If you have any of these conditions, you may not be able to receive meningococcal conjugate vaccine, or you may need to wait until your condition changes or you have completed your treatments.

FDA pregnancy category C. It is not known whether meningococcal conjugate vaccine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant soon after receiving this vaccine. If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of meningococcal conjugate vaccine on the baby. It is not known whether this vaccine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. The Menactra brand of this vaccine should not be given to anyone younger than 9 months or older than 55 years of age. The Menveo brand should not be given to anyone younger than 2 years or older than 55 years of age.

How is meningococcal conjugate vaccine given?

This vaccine is injected into a muscle. You will receive this injection in a doctor's office or clinic setting.

Meningococcal conjugate vaccine is recommended in the following situations:

• 
  

  for all children 9 months to 18 years old;

  
  


• 
  

  for people who are in the military;

  
  


• 
  

  for laboratory workers who are routinely exposed to meningococcal bacteria;

  
  


• 
  

  for people who live in dormitories or other group housing; and

  
  


• 
  

  for people who travel or live among certain populations where meningococcal outbreak is common.

  
  

This vaccine is usually given as a one-time injection to adults and children who are at least 2 years old. Unless your doctor's tells you otherwise, you will not need a booster vaccine.

In children younger than 2 years old, meningococcal conjugate vaccine is given in two doses. The first shot is usually given when the child is 9 months old. The booster shot is then given 3 months later.

Be sure your child receives all recommended doses of this vaccine. Your child may not be fully protected against disease if he or she does not receive the full series.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you recover before receiving this vaccine.

Your doctor may recommend treating fever and pain with an aspirin free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

What happens if I miss a dose?

Contact your doctor if you miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

What happens if I overdose?

An overdose of this vaccine is not likely to occur.

What should I avoid before or after getting meningococcal conjugate vaccine?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Meningococcal conjugate vaccine side effects

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects. Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);

  
  


• 
  

  high fever; or

  
  


• 
  

  unusual bleeding.

  
  

Less serious side effects may include:

• 
  

  low fever;

  
  


• 
  

  redness, pain, swelling, or a lump where the vaccine was injected;

  
  


• 
  

  headache, tired feeling;

  
  


• 
  

  joint or muscle pain;

  
  


• 
  

  diarrhea;

  
  


• 
  

  nausea, vomiting, loss of appetite; or

  
  


• 
  

  fussiness, irritability, crying for an hour or longer.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Meningococcal conjugate vaccine Dosing Information

Usual Adult Dose for Meningococcal Meningitis Prophylaxis:

The safety and efficacy of meningococcal conjugate vaccine in adults older than 55 years has not been established.

55 years or younger:
0.5 mL intramuscularly once.

Usual Pediatric Dose for Meningococcal Meningitis Prophylaxis:

9 through 23 months of age:
0.5 mL intramuscularly. Two doses, three months apart.

2 years or older:
0.5 mL intramuscularly once.

ACIP Recommendations [CDC, 2011]:
Children 11 to 18 years of age: Routine Vaccination: One dose at 11 or 12 years of age with a booster dose at age 16. If primary dose was given at age 13 to 15 years, one booster dose should be given at 16 to 18 years of age. If primary dose was given 16 years of age or older, no booster dose is needed.

What other drugs will affect meningococcal conjugate vaccine?

Before receiving this vaccine, tell your doctor about all other vaccines you have recently received.

Also tell the doctor if you are using a blood thinner (warfarin, Coumadin, Jantoven), or if you have recently received drugs or treatments that can weaken the immune system, including:

• 
  

  an oral, nasal, inhaled, or injectable steroid medicine;

  
  


• 
  

  medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), etanercept (Enbrel), leflunomide (Arava), and others; or

  
  


• 
  

  medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

  
  

This list is not complete and other drugs may interact with meningococcal conjugate vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More meningococcal conjugate vaccine resources

• Meningococcal conjugate vaccine Side Effects (in more detail)
• Meningococcal conjugate vaccine Use in Pregnancy & Breastfeeding
• Meningococcal conjugate vaccine Drug Interactions
• Meningococcal conjugate vaccine Support Group
• 0 Reviews for Meningococcal conjugate vaccine - Add your own review/rating

• Menactra Advanced Consumer (Micromedex) - Includes Dosage Information


• Menactra Consumer Overview


• Menactra MedFacts Consumer Leaflet (Wolters Kluwer)


• Menveo Prescribing Information (FDA)


• Menveo Consumer Overview


• Menveo MedFacts Consumer Leaflet (Wolters Kluwer)

Compare meningococcal conjugate vaccine with other medications

• Meningococcal Meningitis Prophylaxis

Where can I get more information?

• Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

See also: meningococcal conjugate vaccine side effects (in more detail)

Measles, Mumps, and Rubella Vaccine

Pronunciation: MEE-zills, mumps, and rue-BELL-a
Generic Name: Measles, Mumps, and Rubella Vaccine
Brand Name: M-M-R II

Measles, Mumps, and Rubella Vaccine is used for:

Preventing measles, mumps, and rubella.

Measles, Mumps, and Rubella Vaccine is a vaccine. It stimulates the body to produce antibodies against infection of measles, mumps, or rubella.

Do NOT use Measles, Mumps, and Rubella Vaccine if:

• you are allergic to any ingredient in Measles, Mumps, and Rubella Vaccine, including gelatin, or you have a severe allergy to neomycin


• you are pregnant


• you have advanced HIV, AIDS, a weakened immune system, a blood disease, low blood levels of gamma globulin, untreated active tuberculosis (TB), an illness accompanied by fever, or an illness affecting bone marrow or lymph systems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Measles, Mumps, and Rubella Vaccine:

Some medical conditions may interact with Measles, Mumps, and Rubella Vaccine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a family history of immune system problems, fever, a tumor, or low white blood cell counts


• if you have recently received a blood or plasma transfusion, or human immune serum globulin

Some MEDICINES MAY INTERACT with Measles, Mumps, and Rubella Vaccine. However, no specific interactions with Measles, Mumps, and Rubella Vaccine are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Measles, Mumps, and Rubella Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Measles, Mumps, and Rubella Vaccine:

Use Measles, Mumps, and Rubella Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Measles, Mumps, and Rubella Vaccine is administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor any questions that you may have about Measles, Mumps, and Rubella Vaccine.


• If you miss a dose of Measles, Mumps, and Rubella Vaccine, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Measles, Mumps, and Rubella Vaccine.

Important safety information:

• If you have a TB skin test within 8 months of receiving this vaccine, tell the doctor that you have received this vaccine.


• In adult women, joint pain may occur 2 to 4 weeks after an injection. This usually lasts only a short time.


• Measles, Mumps, and Rubella Vaccine is not recommended for use in INFANTS younger than 15 months of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Measles, Mumps, and Rubella Vaccine if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. After receiving Measles, Mumps, and Rubella Vaccine, do not become pregnant for at least 3 months without checking with your doctor. It is unknown if Measles, Mumps, and Rubella Vaccine is excreted in breast milk. If you are or will be breast-feeding while you are using Measles, Mumps, and Rubella Vaccine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Measles, Mumps, and Rubella Vaccine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning or stinging at the injection site; cough; diarrhea; dizziness; feeling ill; fever; headache; nausea; painful or swollen joints 2 to 4 weeks after receiving the vaccination; sore throat; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); pain, redness, or swelling at the injection site; swelling of the glands in the jaw; swelling of the testicles.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Measles, Mumps, and Rubella Vaccine:

Measles, Mumps, and Rubella Vaccine is usually handled and stored by a health care provider. If you are using Measles, Mumps, and Rubella Vaccine at home, store Measles, Mumps, and Rubella Vaccine as directed by your pharmacist or health care provider. Keep Measles, Mumps, and Rubella Vaccine out of the reach of children and away from pets.

General information:

• If you have any questions about Measles, Mumps, and Rubella Vaccine, please talk with your doctor, pharmacist, or other health care provider.


• Measles, Mumps, and Rubella Vaccine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Measles, Mumps, and Rubella Vaccine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Measles, Mumps, and Rubella Vaccine resources

• Measles, Mumps, and Rubella Vaccine Use in Pregnancy & Breastfeeding
• Measles, Mumps, and Rubella Vaccine Drug Interactions
• Measles, Mumps, and Rubella Vaccine Support Group
• 0 Reviews for Measles, Mumps, and Rubella - Add your own review/rating

Compare Measles, Mumps, and Rubella Vaccine with other medications

• Measles Prophylaxis
• Mumps Prophylaxis
• Rubella Prophylaxis

Miglustat

Class: Other Miscellaneous Therapeutic Agents
VA Class: HS900
Chemical Name: 1-Butyl-2-(hydroxymethyl)piperidine-3,4,5-triol
Molecular Formula: C₁₀H₂₁NO₄
CAS Number: 72599-27-0
Brands: Zavesca

Introduction

Glucosylceramide synthase (ceramide glucosyltransferase) inhibitor; decreases glucocerebroside accumulation in macrophages and some manifestations (hepatomegaly, splenomegaly) of type 1 Gaucher’s disease.^{1 15 19 20 21}

Uses for Miglustat

Gaucher’s Disease

Management of mild to moderate nonneuronopathic (type 1) Gaucher’s disease in adults for whom enzyme replacement therapy is unsuitable (e.g., because of allergy, hypersensitivity, poor venous access).¹

Safety and efficacy not established in patients with severe type 1 Gaucher’s disease (i.e., hemoglobin <9 g/dL, platelet count <50,000/mm³, or active bone disease).¹

Designated an orphan drug by the FDA for the management of Gaucher’s disease.¹⁸

Enzyme replacement therapy with alglucerase or imiglucerase is current treatment of choice for type 1 Gaucher’s disease.^{1 2 3 4 6 7 11 12 13 14 16}

Miglustat Dosage and Administration

General

• 
  

  If a dose is missed, that dose should be skipped and the next dose taken at the usual time.¹

  
  


• 
  

  Reduced dosage may be necessary in some patients because of adverse effects (e.g., diarrhea, tremor).^{1 16}

  
  

Administration

Oral Administration

Administer 3 times daily at regular intervals, without regard to meals.¹

Dosage

Adults

Gaucher’s Disease

Oral

100 mg 3 times daily.^{1 16}

Reduce dosage to 100 mg once or twice daily if necessary because of adverse effects.^{1 16}

Special Populations

Renal Impairment

Dosage in Renal Impairment

Clcr (mL/min)	Initial dosage
50–70	100 mg twice daily1
30–50	100 mg once daily1
<30	Use not recommended1

Geriatric Patients

Select dosage with caution because of possible age-related decreases in renal, hepatic, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Miglustat

Contraindications

• 
  

  Known hypersensitivity to miglustat or any ingredient in the formulation.¹

  
  


• 
  

  Women who are or may become pregnant.¹

  
  

Warnings/Precautions

Warnings

Peripheral Neuropathy

Peripheral neuropathy reported; monitor all patients with neurologic evaluation at baseline and every 6 months while on therapy.¹

If symptoms (e.g., numbness, tingling) occur, reassess risk versus benefit of therapy; consider discontinuance.¹

General Precautions

Therapy should be directed by clinicians knowledgeable in the management of Gaucher’s disease.¹

Tremor

Tremor or exaggerated physiologic hand tremor reported in about 30% of patients.^{1 24}

Usually began within the first month, often resolved between month 1 and 3 of treatment.¹

Dosage reduction may ameliorate tremor, usually within days; drug discontinuance occasionally necessary.¹

Diarrhea and Weight Loss

Diarrhea in approximately 85% of patients studied; associated with increased use of antidiarrheal drugs, usually loperamide.^{1 24}

Apparently osmotic in nature, resulting from inhibition of disaccharidase; incidence decreases over time with continued use.¹

Patients should avoid foods with high carbohydrate content.¹

Weight loss in up to 65% of patients studied, generally during first 12 months of therapy.¹

Weight loss may result from diarrhea and associated GI complaints, decreased food intake, or a combination of these and other factors.¹

Effect on Fertility in Males

Adversely affects spermatogenesis and sperm parameters; decreases fertility (rats).¹

All males should use effective birth control while on therapy.¹

Before attempting conception, discontinue therapy and maintain effective contraceptive methods for 3 months.¹

Specific Populations

Pregnancy

Category X.¹ (See Contraindications under Cautions.)

Lactation

Not known whether miglustat is distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently from younger adults; select dosage with caution.¹

Renal Impairment

Dosage adjustments necessary based on degree of renal impairment; do not use in severe renal impairment. (See Renal Impairment under Dosage and Administration.) ¹

Common Adverse Effects

Diarrhea, flatulence, abdominal pain, abdominal distension with or without gas, nausea, vomiting, bloating, anorexia, dyspepsia, epigastric pain (not related to food), constipation, dry mouth, weight loss, headache, tremor, dizziness, unsteady gait, leg cramps, cramps, back pain, paresthesia, heaviness in limbs, generalized weakness, migraine, visual disturbance, memory loss, thrombocytopenia, menstrual disorder.^{1 24}

Interactions for Miglustat

Drugs Metabolized by Hepatic Microsomal Enzymes

No evidence of metabolism in humans; pharmacokinetic interactions unlikely.¹

Specific Drugs

Drug	Interaction	Comments
Imiglucerase	Possible decreased plasma imiglucerase concentrations 1 Possible decreased peak plasma miglustat concentrations (22%) and AUC (14%) 1	Concomitant use increased imiglucerase clearance by 70%; results inconclusive (small number of patients studied, variable imiglucerase dosages)1 Effect on miglustat pharmacokinetics not considered clinically important1 Combination use not indicated1
Loperamide	Pharmacokinetic interaction unlikely1	Concomitant administration apparently did not substantially alter pharmacokinetics of miglustat1

Miglustat Pharmacokinetics

Absorption

Food

Food decreases the rate but not the extent of absorption.¹

Distribution

Extent

Distributed into extravascular tissues.¹

Not known whether miglustat crosses the placenta or is distributed into milk.¹

Plasma Protein Binding

Does not bind to plasma proteins.¹

Elimination

Metabolism

No evidence of metabolism in humans.¹

Elimination Route

Excreted unchanged in urine.^{1 15}

Half-life

6–7 hours.^{1 15}

Special Populations

In patients with mild, moderate, or severe renal impairment, miglustat clearance is reduced by approximately 40, 60, or ≥70%, respectively.^{1 15}

Stability

Storage

Oral

Capsules

20–25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  N-alkylated imino sugar; competitive and reversible inhibitor of ceramide glucosyltransferase (glucosylceramide synthase), which catalyzes the formation of glucosylceramide (glucocerebroside).^{1 15}

  
  


• 
  

  Inhibits the formation of glucocerebroside, substrate for glucocerebrosidase enzyme deficient in type 1 Gaucher’s disease.^{1 15}

  
  


• 
  

  Substrate reduction therapy with miglustat allows residual activity of deficient endogenous glucocerebrosidase to be more effective, decreasing glucocerebroside accumulation in macrophages;^{1 15 19 20} decreases hepatomegaly and splenomegaly but has limited effect on increasing hemoglobin and platelet counts in patients with type 1 Gaucher’s disease.^{1 15 21}

  
  


• 
  

  Actions are unlike those of enzyme replacement therapy, which increases glucocerebroside degradation in macrophages to reduce manifestations of Gaucher’s disease.^{1 2 3 4 6 7 11 12 13 14 15 16}

  
  


• 
  

  In type 1 Gaucher’s disease, lipid-engorged macrophages infiltrate the viscera (especially liver and spleen), lymph nodes, and bone marrow, resulting in lipidosis and clinical manifestations of hepatosplenomegaly, anemia, thrombocytopenia, and bone lesions in severe disease.^{2 3 6 7 8 9 10 13 15}

  
  

Advice to Patients

• 
  

  Importance of informing patients of risks and benefits of miglustat therapy, and about alternative therapy (e.g., enzyme replacement therapy).¹

  
  


• 
  

  Importance of advising patients that diarrhea and other adverse GI effects and weight loss are common, and to adhere to dietary instructions.¹

  
  


• 
  

  Importance of informing clinician of any numbness, pain, or burning in the hands or feet and of the occurrence or worsening of tremor.¹

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and, if pregnancy occurs, to advise woman of risk to the fetus.¹

  
  


• 
  

  Importance of men using effective birth control methods during miglustat use and for 3 months following discontinuance of the drug.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Miglustat

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	100 mg	Zavesca	Actelion

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Actelion Pharmaceuticals. Zavesca (miglustat) capsules prescribing information. South San Francisco, CA; 2003 Jul 31.

2. Beutler E. Gaucher’s disease. N Engl J Med. 1991; 325:1354-60. [IDIS 287428] [PubMed 1922238]

3. Anon. Alglucerase for Gaucher’s disease. Med Lett Drugs Ther. 1991; 33:82. [PubMed 1865852]

4. Elstein D, Abrahamov A, Hadas-Halpern I et al. Low-dose low-frequency imiglucerase as a starting regimen of enzyme replacement therapy for patients with type I Gaucher disease. QJM. 1998; 91:483-8. [PubMed 9797931]

5. Elstein D, Abrahamov A, Hadas-Halpern I et al. Gaucher’s Disease. Lancet. 2001; 358:324-7. [IDIS 467174] [PubMed 11498237]

6. Genzyme Corporation. Cerezyme (imiglucerase) prescribing information. Cambridge, MA; 2003 Mar.

7. Barton NW, Furbish FS, Murray GJ et al. Therapeutic response to intravenous infusions of glucocerebrosidase in a patient with Gaucher disease. Proc Natl Acad Sci USA. 1990; 87:1913-6. [PubMed 2308952]

8. Brady RO, Kanfer JN, Shapiro D. Metabolism of glucocerebrosides: II. Evidence of an enzymatic deficiency in Gaucher’s disease. Biochem Biophys Res Commun. 1965; 18:221-5. [PubMed 14282020]

9. Britton DE, Leinikki PO, Barranger JA et al. Gaucher’s disease: lack of antibody response to intravenous glucocerebrosidase. Life Sci. 1978; 23:2517-20. [PubMed 732537]

10. Basu A, Prence E, Garrett K et al. Comparison of N-acyl phosphatidylethanolamines with different N-acyl groups as activators of glucocerebrosidase in various forms of Gaucher’s disease. Arch Biochem Biophys. 1985; 243:28-34. [PubMed 3933429]

11. Genzyme Corporation. Ceredase (alglucerase) prescribing information. Cambridge, MA; 1992 Feb.

12. Reviewers’ comments (personal observations) on alglucerase.

13. Weinreb NJ, Charrow J, Andersson HC et al. Effectiveness of enzyme replacement therapy in 1028 patients with type 1 Gaucher disease after 2 to 5 years of treatment: a report from the Gaucher Register. Am J Med. 2002; 113:112-9. [IDIS 484109] [PubMed 12133749]

14. Niederau C, Haussinger D. Gaucher’s disease: a review for the internist and hepatologist. Hepatogastroenterology. 2000; 47:984-7. [PubMed 11020862]

15. McCormack PL, Goa KL. Miglustat. Drugs. 2003;63:2427-34.

16. Grabowski GA, Barton NW, Pastores G et al. Enzyme therapy in type 1 Gaucher disease: comparative efficacy of mannose-terminated glucocerebrosidase form natural and recombinant sources. Ann Intern Med. 1995; 122:33-9. [IDIS 339881] [PubMed 7985893]

17. Genzyme Corporation, Cambridge, MA. Personal observation on alglucerase.

18. Food and Drug Administration. Cumulative list of orphan drugs designated and/or approved. Rockville, MD; 2004, Aug 31. From FDA web site (http: / / www.fda.gov / ForIndustry / DevelopingProductsforRareDiseasesConditions / HowtoapplyforOrphanProductDesignation / default.htm).

19. Lachmann RH, Platt FM. Substrate reduction therapy for glycosphingolipid storage disorders. Expert Opin Invest Drugs. 2001; 10:455-66.

20. Pastores GM, Barnett NL. Substrate reduction therapy: miglustat as a remedy for symptomatic patients with Gaucher disease type 1. Expert Opin Invest Drugs. 2003; 23:273-81.

21. Cox T, Lachmann R, Hollak C et al. Novel oral treatment of Gaucher’s disease with N-butyldeoxynojirimycin. (OGT 918) to decrease substrate biosynthesis. Lancet. 2000; 355:1481-5. [IDIS 446631] [PubMed 10801168]

22. Heitner R, Elstein D, Aerts J et al. Low-dose N-butyldeoxynojirimycin. (OGT 918) for type 1 Gaucher disease. Blood Cells Mol Dis. 2002; 28:127-33. [PubMed 12064906]

23. Oxford GlycoSciences Plc. Oxford GlycoSciences Plc swith/combination study 004 results on Vevesca (OGT 918) presented at EWGGD [media release]. 2002 May 2.

24. Actelion. South San Francisco, CA: Personal communication.

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