To ensure the correct use of Agamree, reading the drug package insert is crucial. This article will explain how to use the medication correctly in accordance with the information in the package insert, covering key details such as dosage, administration method, and contraindications. It aims to help patients avoid common mistakes and ensure the reliability and effectiveness of the medication.

Agamree (vamorolone): indications, dosage and precautions

(I) Indications

AGAMREE is indicated for the treatment of Duchenne Muscular Dystrophy (DMD) in patients aged 2 years and older.

(II) Recommended Dosage

The recommended usual dose is 6 mg/kg taken orally once daily, preferably with meals. For patients weighing more than 50 kg, the maximum daily dose is 300 mg.

Some patients may respond to a dose of 2 mg/kg per day. The dose can be reduced to 2 mg/kg per day based on individual tolerance.

(III) Target Population

This medication is intended for patients with clinically confirmed Duchenne Muscular Dystrophy (DMD), and is suitable for those aged 2 years and older.

(IV) Contraindications

AGAMREE is contraindicated in patients with:

Hypersensitivity to vamorolone or any of the inactive ingredients (excipients) in this formulation (including patients who have experienced allergic reactions or anaphylactic shock).

(V) Side Effects

Adverse reactions mainly include (some data are derived from clinical trial experience):

Cushingoid-like changes

Psychiatric and behavioral disorders

Gastrointestinal reactions

Weight gain

Vitamin D deficiency

Other adverse reactions: Some patients may experience cough, headache, increased appetite, and runny nose. Long-term use may also lead to endocrine disorders, decreased bone mineral density, ocular complications, and an increased risk of infections due to immunosuppression.

(VI) Precautions

Abnormal endocrine function

Immunosuppression and infection risk

Monitoring of cardiovascular and renal function

Gastrointestinal risks

Behavioral and mood changes

Effects on bone metabolism

Ocular effects

Immunizations

(VII) Drug Interactions

Strong CYP3A4 inhibitors

Moderate or weak CYP3A4 inhibitors

[Warm Reminder]

The package inserts of some products are updated frequently. Please refer to the actual product package insert for the most accurate information.