Active Ingredient: Patisiran
Patisiran is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 300 micrograms patisiran per kilogram of body weight, once every 3 weeks.
Regimen B: In case that patient weight is ≥ 100 kg, intravenous, 300 micrograms patisiran per kilogram of body weight, once every 3 weeks. The maximum allowed total dose is 30,000 micrograms patisiran per kilogram of body weight every 3 weeks.
The recommended dose of patisiran is 300 micrograms per kg body weight administered via intravenous (IV) infusion once every 3 weeks.
Dosing is based on actual body weight. For patients weighing ≥100 kg, the maximum recommended dose is 30 mg.
Vitamin A supplementation at approximately 2500 IU vitamin A per day is advised for patients treated with patisiran.
All patients should receive premedication prior to patisiran administration to reduce the risk of infusion-related reactions (IRRs). Each of the following medicinal products should be given on the day of patisiran infusion at least 60 minutes prior to the start of infusion:
For premedications not available or not tolerated intravenously, equivalents may be administered orally.
If clinically indicated, the corticosteroid may be tapered in decrements no greater than 2.5 mg to a minimum dose of 5 mg of dexamethasone (IV), or equivalent. The patient should receive at least 3 consecutive IV infusions of patisiran without experiencing IRRs before each reduction in corticosteroid premedication.
Additional or higher doses of one or more of the premedications may be administered to reduce the risk of IRRs, if needed.
If a dose is missed, patisiran should be administered as soon as possible.
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