Vamorolone Dosage

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

Usual Adult Dose for Muscular Dystrophy

6 mg/kg orally once a day, preferably with a meal
Maximum daily dose in patients weighing more than 50 kg: 300 mg orally once a day

Comments:

• To minimize the risk of adrenal insufficiency, patients may switch from oral corticosteroid treatment (e.g., prednisone, deflazacort) to this drug without treatment interruption or a period of prior corticosteroid dosage reduction.
• Patients switching to this drug after long-term treatment with oral corticosteroids should start this drug at a dosage of 6 mg/kg/day.
• Doses may be titrated down to 2 mg/kg/day as needed, based on individual tolerability and response.
• If this drug has been administered for more than one week, then the dosage should be decreased gradually.

Use: For the treatment of Duchenne muscular dystrophy

Usual Pediatric Dose for Muscular Dystrophy

2 years or older: 6 mg/kg orally once a day, preferably with a meal
Maximum daily dose in patients weighing more than 50 kg: 300 mg orally once a day

Comments:

• To minimize the risk of adrenal insufficiency, patients may switch from oral corticosteroid treatment (e.g., prednisone, deflazacort) to this drug without treatment interruption or a period of prior corticosteroid dosage reduction.
• Patients switching to this drug after long-term treatment with oral corticosteroids should start this drug at a dosage of 6 mg/kg/day.
• Doses may be titrated down to 2 mg/kg/day as needed, based on individual tolerability and response.
• If this drug has been administered for more than one week, the dosage should be decreased gradually.

Use: For the treatment of Duchenne muscular dystrophy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A or B): 2 mg/kg orally once a day, preferably with a meal

• Maximum daily dose in patients weighing more than 50 kg: 100 mg orally once a day
• Doses may be titrated down based on individual tolerability.

Severe liver dysfunction: Data not available; there is no clinical experience in these patients.

Dose Adjustments

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

• Maximum daily dose in patients weighing more than 50 kg: 200 mg orally once a day
• Doses 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:

• Before starting this drug, administer all immunizations according to immunization guidelines; administer live-attenuated or live vaccines at least 4 to 6 weeks before starting this drug.
• Shake oral suspension well for 30 seconds before measuring out each dose; only use the oral dispenser provided with the product.
• Do not mix this drug with any type of liquids before administration.
• This drug should be given once a day, preferably with a meal, and dispensed directly into the mouth.
• Discard any unused oral suspension after 3 months of first opening the bottle.

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) in the original carton.
• After opening, store bottle upright in a refrigerator at 2C to 8C (36F to 46F).
• Do not freeze.

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 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 (if treatment continued 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; gradual dose reduction may be needed to reduce the risk of adrenal insufficiency.
• 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.
• If you are administered this drug for longer than 6 weeks, the intraocular pressure of your eyes should be monitored to prevent cataracts or glaucoma.
• 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.

Further information

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

Medical Disclaimer