Vamorolone is a prescription medicine indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. It is available as kits for oral use. MedsAcross supplies Vamorolone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Source: US FDA prescribing information
Vamorolone is a corticosteroid that acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which vamorolone exerts its effect in patients with DMD is unknown.
Source: US FDA prescribing information
The recommended dosage is 6 mg/kg taken orally once daily preferably with a meal, up to a maximum daily dosage of 300 mg for patients weighing more than 50 kg. In patients with mild to moderate hepatic impairment, the recommended dosage is 2 mg/kg taken orally once daily preferably with a meal, up to a maximum daily dosage of 100 mg for patients weighing more than 50 kg. Decrease dosage gradually when administered for more than one week.
Source: US FDA prescribing information
AGAMREE is contraindicated in patients with known hypersensitivity to vamorolone or to any of the inactive ingredients of AGAMREE. Instances of hypersensitivity, including anaphylaxis, have occurred in patients receiving corticosteroid therapy. Hypersensitivity to vamorolone or any of the inactive ingredients in AGAMREE
Source: US FDA prescribing information
Alterations in Endocrine Function: Hypothalamic-pituitary-adrenal axis suppression, cushingoid features, and hyperglycemia can occur. Monitor patients for these conditions with chronic use of AGAMREE. Immunosuppression and Increased Risk of Infection: Increased risk of new infections, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal, signs and symptoms of infections may be masked. Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure and monitor sodium and potassium levels in patients chronically treated with AGAMREE. Gastrointestinal Perforation: Increased risk in patients with certain GI disorders, signs and symptoms may be masked. Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis.
Source: US FDA prescribing information
The following serious adverse reactions are discussed in more detail in other sections: Alterations in Endocrine Function Immunosuppression and Increased Risk of Infection Alterations in Cardiovascular/Renal Function Gastrointestinal Perforation Behavioral and Mood Disturbances Effects on Bones Ophthalmic Effects Immunizations Effects on Growth and Development Myopathy Kaposi's Sarcoma Thromboembolic Events Anaphylaxis The most common adverse reactions (>10% for AGAMREE and greater than placebo) are cushingoid features, psychiatric disorders, vomiting, weight increased, and vitamin D deficiency.
Source: US FDA prescribing information
Strong CYP3A4 inhibitors: The maximum recommended daily dose is 4 mg/kg up to a maximum daily dosage of 200 mg for patients weighing more than 50 kg.
Source: US FDA prescribing information
Store the bottle upright at room temperature between 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F) in the original carton. See USP controlled room temperature. Do not freeze. After opening, store the bottle upright in a refrigerator 2°C to 8°C (36°F to 46°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Vamorolone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Agamree kitOral | Catalyst Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Vamorolone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Vamorolone, including Agamree.
Yes. The US FDA first approved Vamorolone on 26 October 2023, according to Drugs@FDA.
Yes. Vamorolone has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Vamorolone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Vamorolone is classified under ATC code H02AB18 (Vamorolone).
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