Agamree的用法用量

Agamree is the first and only DMD medicinal product fully approved in the EU, primarily for the treatment of DMD patients aged 4 years and older, regardless of underlying mutation and ambulatory status. It is currently available in China. This article will introduce in detail the standard usage and dosage, contraindications and medication guidance for special groups of Agamree to help patients and medical workers better understand and apply this innovative drug.

Agamree usage and dosage

Agamree’s medication regimen needs to be accurately adjusted according to the patient’s individual conditions and must be administered under the guidance of a doctor.

Standard dosage regimen

The recommended starting dose is 6 mg/kg once daily. Taking it with food can improve the drug absorption rate. The maximum daily dose for patients weighing more than 50 kg should not exceed 300 mg. Some sensitive patients can start with 2mg/kg per day and gradually adjust according to tolerance.

Dose adjustment for special groups

Patients with mild to moderate hepatic impairment (Child-Pugh A to B) need to reduce the dose to 2 mg/kg per day, and the maximum dose for those weighing over 50 kg is 100 mg/day. When used concomitantly with strong CYP3A4 inhibitors, the dose should be adjusted to 4 mg/kg per day, with a maximum daily dose of 200 mg.

Dosing Operation Specifications

Shake the solution well for 30 seconds before use, and use a special oral syringe to accurately measure the dose. It needs to be kept refrigerated after opening and should be discarded if not used within 3 months. After long-term use, the dose must be gradually reduced and discontinued to avoid adrenal insufficiency.

Following these medication specifications can ensure that Agamree exerts its best efficacy while reducing the risk of adverse reactions.

Contraindications of Agamree

Patients should understand the contraindications of Agamree before taking the medicine.

Absolute contraindications

Patients who are allergic to Vamorolone or its excipients are strictly prohibited from using it. It is contraindicated in patients with active systemic fungal infection because the drug may aggravate the infection. Oral suspension dosage forms are contraindicated in children under 2 years of age.

Relative contraindications

Use with caution in patients with severe hepatic insufficiency due to lack of clinical data support. Patients with uncontrolled hypertension, diabetes, or osteoporosis require careful assessment of the risk-benefit ratio. Patients with recent myocardial infarction need to be particularly vigilant.

Restrictions under special circumstances

Those who have not completed the necessary vaccinations should postpone their medication, especially live vaccinations which need to be completed 4-6 weeks in advance. Patients at high risk of gastrointestinal perforation should be used with caution after thorough evaluation.

Knowing these contraindications can help avoid potential risks of medication.

Agamree medication for special groups

Different groups of people need to pay special attention to individualized medication plans when using Agamree.

Pediatric Medication

The safety and effectiveness of pediatric patients 2 years old and above have been verified, and the recommended dose is the same as that for adults, calculated based on body weight. Oral suspension is prohibited for use in children under 2 years of age due to the presence of benzyl alcohol excipients.

Pregnant and lactating women

Pregnant women should only consider using it when the benefits clearly outweigh the risks. It may increase the risk of low birth weight in newborns. Breastfeeding women need to weigh the pros and cons, as glucocorticoids may affect the baby through breast milk.

Patients with abnormal liver and kidney function

Patients with mild to moderate liver damage should use reduced dosage. No dose adjustment is required in patients with renal impairment, but close monitoring is required. Elderly patients require individualized assessment due to lack of data.

Medication guidance for these special groups can help achieve personalized and precise treatment.