Vamorolone (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SUSPENSION.
Routes of administration: ORAL.
Brand Names
- AGAMREE
Indications and Usage
AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
Contraindications
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 [see Warnings and Precautions ( 5.13)].
Adverse Reactions
The following serious adverse reactions are discussed in more detail in other sections: Alterations in Endocrine Function [see Warnings and Precautions ( 5.1)] Immunosuppression and Increased Risk of Infection [see Warnings and Precautions ( 5.2)] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions ( 5.3)] Gastrointestinal Perforation [see Warnings and Precautions ( 5.4)] Behavioral and Mood Disturbances [see Warnings and Precautions ( 5.5)] Effects on Bones [see Warnings and Precautions ( 5.6)] Ophthalmic Effects [see Warnings and Precautions ( 5.7)] Immunizations [see Warnings and Precautions ( 5.8)] Effects on Growth and Development [see Warnings and Precautions ( 5.9)] Myopathy [see Warnings and Precautions ( 5.10)] Kaposi’s Sarcoma [see Warnings and Precautions ( 5.11)] Thromboembolic Events [see Warnings and Precautions ( 5.12)] Anaphylaxis [see Warnings and Precautions ( 5.13)]
Mechanism of Action
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.
Overdosage
Treatment of acute overdosage of vamorolone is by immediate supportive and symptomatic therapy. Gastric lavage or emesis can be considered.