Active Ingredient: Zilucoplan
Zilucoplan is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≤ 56 kg, subcutaneous, 16.6 milligrams zilucoplan, once daily.
Regimen B: In case that patient weight is ≥ 6 kg and patient weight is ≤ 77 kg, subcutaneous, 23 milligrams zilucoplan, once daily.
Regimen C: In case that patient weight is ≥ 77 kg, subcutaneous, 32.4 milligrams zilucoplan, once daily.
Before starting therapy, patients must be vaccinated against Neisseria meningitidis. If treatment needs to start less than 2 weeks after vaccination, the patient must receive appropriate prophylactic antibiotic treatment until 2 weeks after the first vaccination dose.
The recommended dose should be given as a subcutaneous injection once daily and administered about the same time every day.
Total daily dose by body weight range:
Body weight | Dose* |
---|---|
<56 kg | 16.6 mg |
≥56 to <77 kg | 23 mg |
≥77 kg | 32.4 mg |
* The recommended dose corresponds to approximately 0.3 mg/kg.
Zilucoplan has not been studied in gMG patients with a Myasthenia Gravis Foundation of America (MGFA) Class V.
If a dose is missed, it should be administered the same day; then, normal dosing should be continued the following day. No more than one dose should be administered per day.
Administered by subcutaneous injection.
Suitable injection sites include front of the thighs, abdomen and the back of the upper arms.
Injection sites should be rotated and injections should not be given in areas where the skin is tender, erythematous, bruised, indurated or where the skin has scars or stretch marks.
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