Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
PATISIRAN AS SODIUM
MEDISON PHARMA LTD
N07XX12
CONCENTRATE FOR SOLUTION FOR INFUSION
PATISIRAN AS SODIUM 2 MG / 1 ML
I.V
Required
ALNYLAM NETHERLANDS B.V, THE NETHERLANDS
PATISIRAN
Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy
2020-09-21
1 PHYSICIAN’S PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Onpattro 2 mg/mL concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains patisiran sodium equivalent to 2 mg patisiran. Each vial contains patisiran sodium equivalent to 10 mg patisiran formulated as lipid nanoparticles. Excipients with known effect Each mL of concentrate contains 3.99 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). White to off-white, opalescent, homogeneous solution (pH: 6.6-7.5). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated under the supervision of a physician knowledgeable in the management of amyloidosis. Posology The recommended dose of Onpattro 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 2 500 IU vitamin A per day is advised for patients treated with Onpattro (see section 4.4). _ _ _Required premedication _ All patients should receive premedication prior to Onpattro administration to reduce the risk of infusion-related reactions (IRRs) (see section 4.4). Each of the following medicinal products should be given on the day of Onpattro infusion at least 60 minutes prior to the start of infusion: • Intravenous corticosteroid (dexamethasone 10 mg, or equivalent) • Oral paracetamol (500 mg) 2 • Intravenous H1 blocker (diphenhydramine 50 mg, or equivalent) • Intravenous H2 blocker (ranitidine 50 mg, or equivalent) For premedications not available or not tolerated intravenously, equivalents may be administered orally. If clinically i Přečtěte si celý dokument