Vamorolone Dosage

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Usual Adult Dose for Muscular Dystrophy

Recommended dose: 6 mg/kg orally once a day, preferably with a meal
Maximum daily dose (weight greater than 50 kg): 300 mg orally once a day

Comments:

• Dose may be titrated down to 2 mg/kg/day as needed based on individual tolerability and response.
• To minimize the risk of adrenal insufficiency, patients on oral corticosteroids (e.g., prednisone, deflazacort) can transition to therapy without dose reduction or interruption of the prior corticosteroid.
• Patients switching to this drug after long-term treatment with oral corticosteroids should start therapy at the recommended dose.
• If discontinuing therapy, decrease the dose gradually if the patient has been treated for more than 1 week.

Use: For the treatment of Duchenne muscular dystrophy

Usual Pediatric Dose for Muscular Dystrophy

2 YEARS OR OLDER:
Recommended dose: 6 mg/kg orally once a day, preferably with a meal
Maximum daily dose (weight greater than 50 kg): 300 mg orally once a day

Comments:

• Dose may be titrated down to 2 mg/kg/day as needed based on individual tolerability and response.
• To minimize the risk of adrenal insufficiency, patients on oral corticosteroids (e.g., prednisone, deflazacort) can transition to therapy without dose reduction or interruption of the prior corticosteroid.
• Patients switching to this drug after long-term treatment with oral corticosteroids should start therapy at the recommended dose.
• If discontinuing therapy, decrease the dose gradually if the patient has been treated for more than 1 week.

Use: For the treatment of Duchenne muscular dystrophy

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Mild or Moderate Liver Dysfunction (Child-Pugh A or B): 2 mg/kg orally once a day, preferably with a meal

• Maximum daily dose (weight greater than 50 kg): 100 mg orally once a day; dose may be titrated down based on individual tolerability.

Severe Liver Dysfunction (Child-Pugh C): Data not available

Dose Adjustments

Use with Strong CYP450 3A4 Inhibitors: Reduce to 4 mg/kg orally once a day, preferably with a meal

• Maximum daily dose (weight greater than 50 kg): 200 mg orally once a day; dose may be titrated down based on individual tolerability.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to either the active component or to any of the ingredients; instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Prior to therapy, administer all guideline-recommended immunizations; live-attenuated or live vaccines should be given at least 4 to 6 weeks before starting this drug.
• Administer treatment once a day, preferably with a meal, and dispense directly into the mouth.
• Before administration, shake oral suspension well for 30 seconds and only use the oral syringe provided for dosing.
• Do not mix this drug with any type of liquids prior to administration.

Storage requirements:

• Store bottle upright at room temperature between 20C to 25C (68F to 77F).
• Temperature excursions permitted between 15C to 30C (59F to 86F) while in the original carton.
• After opening, store bottle upright in a refrigerator at 2C to 8C (36F to 46F); do not freeze.
• Discard any unused suspension 3 months after first opening the bottle.

General:

• Duchenne muscular dystrophy is mostly a disease of children and young adults; there is no experience with this drug in older adults.

Monitoring:

• Cardiovascular: Blood pressure and for volume overload (during therapy)
• Endocrine: For signs/symptoms of Cushing's syndrome and adrenal insufficiency (after withdrawal of this drug)
• Hepatic: Hepatitis B (prior to therapy)
• Infections/Infestations: Amebiasis (prior to therapy), and for the development of or exposure to infections, including fungal, Strongyloides, varicella, and/or measles (during therapy)
• Metabolic: Blood glucose (regularly during therapy); for hyperglycemia (after withdrawal of this drug); serum potassium/sodium levels (during long-term therapy)
• Musculoskeletal: For decreases in bone mineral density (during long-term therapy)
• Ocular: Intraocular pressure (for treatment longer than 6 weeks)

Patient advice:

• Read the US FDA-approved patient labeling (Instructions for Use).
• Do not stop this drug abruptly or without first consulting health care providers.
• Inform your health care provider regarding recent or ongoing infections; some infections can be severe and/or fatal.
• Avoid exposure to chickenpox or measles; if exposed, notify health care provider immediately.
• Seek medical attention if psychiatric symptoms (especially depressed mood or suicidal ideation) develop.
• Understand that intraocular pressure should be monitored during long term therapy.
• Avoid the use of live-attenuated or live vaccines during treatment.
• Inform your health care provider of all the medications you are taking, including over-the-counter medications.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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