Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
patisiran sodium (UNII: WO0YM16LKG) (patisiran - UNII:50FKX8CB2Y)
Alnylam Pharmaceuticals, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ONPATTRO during pregnancy. Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the program by calling 1-877-256-9526 or by contacting alnylampregnancyprogram@iqvia.com. Risk Summary There are no available data on ONPATTRO use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. ONPATTRO treatment leads to a decrease in serum vitamin A levels, and vitamin A supplementation is advised for patients taking ONPATTRO. Vitamin A is essential for normal embryofetal development; however, excessive levels of vitamin A are associated with adverse developmental effects. The effects on the fetus of a reduction in maternal serum TTR caused by ONPATTRO and of vitamin A supplementation are unknown [see
ONPATTRO is a sterile, preservative-free, white to off-white, opalescent, homogeneous solution for intravenous infusion supplied as a 10 mg/5 mL (2 mg/mL) solution in a single-dose glass vial. The vial stopper is not made with natural rubber latex. ONPATTRO is available in cartons containing one single-dose vial each. The NDC is: 71336-1000-1. Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Discard vial if it has been frozen. If refrigeration is not available, ONPATTRO can be stored at room temperature up to 25°C (up to 77°F) for up to 14 days. For storage conditions of ONPATTRO after dilution in the infusion bag, see Dosage and Administration (2.3).
New Drug Application
ONPATTRO- PATISIRAN INJECTION, LIPID COMPLEX ALNYLAM PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ONPATTRO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONPATTRO. ONPATTRO (PATISIRAN) LIPID COMPLEX INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2018 INDICATIONS AND USAGE ONPATTRO contains a transthyretin-directed small interfering RNA and is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. (1) DOSAGE AND ADMINISTRATION For patients weighing less than 100 kg, the recommended dosage is 0.3 mg/kg every 3 weeks by intravenous infusion. For patients weighing 100 kg or more, the recommended dosage is 30 mg (2.1) Premedicate with a corticosteroid, acetaminophen, and antihistamines (2.2) Filter and dilute prior to administration (2.3) Infuse over approximately 80 minutes (2.4) DOSAGE FORMS AND STRENGTHS Lipid Complex Injection: 10 mg/5 mL (2 mg/mL) in a single-dose vial (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Infusion-related reactions: Monitor for signs and symptoms during infusion. Slow or interrupt the infusion if clinically indicated. Discontinue the infusion if a serious or life-threatening infusion-related reaction occurs (5.1) Reduced serum vitamin A levels and recommended supplementation: Supplement with the recommended daily allowance of vitamin A. Refer to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur (5.2) ADVERSE REACTIONS The most frequently reported adverse reactions (that occurred in at least 10% of ONPATTRO-treated patients and at least 3% more frequently than on placebo) were upper respiratory tract infections and infusion-related reactions (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALNYLAM PHARMACEUTICALS AT 1-877-256- 9526 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2023 FULL PRESCRIBING INFORMATION: CONTENTS* 1 I Izlasiet visu dokumentu