ONPATTRO- patisiran injection, lipid complex

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

patisiran sodium (UNII: WO0YM16LKG) (patisiran - UNII:50FKX8CB2Y)

Διαθέσιμο από:

Alnylam Pharmaceuticals, Inc.

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 [e-mail]. 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

Περίληψη προϊόντος:

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).

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

ONPATTRO- PATISIRAN INJECTION, LIPID COMPLEX
ALNYLAM PHARMACEUTICALS, INC.
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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