Vamorolone: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 29, 2026🚩 Report this page

Vamorolone

Glucocorticoids

Sold as Agamree

EU EMAGB MHRACA Health Canada

Drug class: Glucocorticoids
Availability: See label
Routes: Oral
Markets covered: 3
Products on record: 3

Overview

Vamorolone is an active pharmaceutical ingredient in the Glucocorticoids group (H02AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	April 8, 2026
GB United Kingdom	MHRA	1	May 29, 2026
CA Canada	Health Canada	1	April 29, 2026

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised April 8, 2026[1]

AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older.

How to take

GBUnited Kingdom· MHRA

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [2].

Brands in United Kingdom (1)

AGAMREE

CACanada· Health Canada

1 product

1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Brands in Canada (1)

AGAMREEKYE PHARMACEUTICALS INC.

Sources & citations

[1]European Medicines Agency · EMEA/H/C/005679 · revised April 8, 2026
[2]MHRA (UK) · PLGB258350005 · revised May 29, 2026
[3]Health Canada (DPD) · 02561506 · revised April 29, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised April 8, 2026[1]

7%). These reactions are dose-dependent, usually reported in the first months of treatment and tend to decline or stabilise over time with continuous treatment. Vamorolone leads to the suppression of the hypothalamic-pituitary-adrenal axis, which correlates with dose and the duration of treatment.
4). Tabulated list of adverse reactions The adverse reactions are listed below according to MedDRA system organ class and frequency. The table contains adverse reactions in patients treated in the placebo-controlled study for patients treated with vamorolone 6 mg/kg/day (Pool 1).
The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to 8 < 1/1 000), very rare (< 1/10 000) (including isolated cases), not known (cannot be estimated from the available data).
6%). 7%). In the clinical study, cushingoid features were reported as mild to moderate “weight gain in the face”, or “rounded face”. 6% in Month 6 to 12 in vamorolone 6 mg/kg/day) and did not result in discontinuation of treatment. 7% in 6 mg/kg/day, no patient in 2 mg/kg/day or placebo).
The majority of behaviour problems occurred in the first 3 months of treatment and resolved without treatment discontinuation. 1% for vamorolone 2 mg/kg/day). Weight gain Vamorolone is associated with increase in appetite and weight.
9% in month 0 to 6 vs 0% in months 6 to 12). 9%). 4). 4). Paediatric population The adverse events in paediatric patients with DMD treated with vamorolone were similar in frequency and type in patients 4 years of age and older. The type and frequency of adverse events in patients older than 7 years were consistent with those seen in 4 to 7-year old patients.
There is no available information on the effects of vamorolone on pubertal development. 9 A higher frequency of behaviour problems was observed in patients <5 years compared to patients ≥5 years when treated with vamorolone 2-6 mg/kg/day.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised April 8, 2026[1]

4. Paediatric population The safety and efficacy of AGAMREE in children below 4 years of age has not been established. Method of administration AGAMREE is for oral use. 2). The oral suspension requires redispersing by shaking the bottle prior to dosing.
Only the oral syringe provided with the medicinal product should be used to measure the dose of AGAMREE in ml. After the appropriate dose is withdrawn into the oral syringe, it should be dispensed directly into the mouth. The oral syringe should be disassembled after use, rinsed under running cold tap water and air dried.
It should be stored in the box until next use. An oral syringe may be used for up to 45 days, then it should be discarded and the second oral syringe provided in the pack should be used. 6). 1. Severe liver impairment (Child-Pugh class C).
4). 4 Special warnings and precautions for use Alterations in endocrine function Vamorolone causes alterations in endocrine function, especially with chronic use. In addition, patients with altered thyroid function, or pheochromocytoma may be at increased risk for endocrine effects.
Risk of adrenal insufficiency Vamorolone produces dose-dependent and reversible suppression of the hypothalamic-pituitary- adrenal axis (HPA-axis), potentially resulting in secondary adrenal insufficiency, which may persist for months after discontinuation of prolonged therapy.
The degree of chronic adrenal insufficiency produced is variable among patients and depends on the dose, and duration of therapy. Acute adrenal insufficiency (also known as adrenal crisis) can occur during a period of increased stress or if vamorolone dose is reduced or withdrawn abruptly.
This condition can be fatal. Symptoms of adrenal crisis may include excess fatigue, unexpected weakness, vomiting, dizziness or confusion. 2). During periods of increased stress, such as acute infection, traumatic injuries or surgical procedure, patients should be monitored for signs of acute adrenal insufficiency and the regular treatment with AGAMREE should be temporarily supplemented with systemic hydrocortisone to prevent the risk of adrenal crisis.
There is no data available on the effects of increasing AGAMREE dose for situations of increased stress. The patient should be advised to carry the Patient Alert Card providing important safety information to support early recognition and treatment of adrenal crisis.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

GBUnited Kingdom· MHRA

CACanada· Health Canada

Drugs in the same class

Sources & citations