Vamorolone Dosage

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

Applies to the following strengths: 40 mg/mL

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.