HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useONPATTRO™ safely and effectively. See full prescribinginformation for ONPATTRO.
ONPATTRO (patisiran) lipid complex injection, for intravenoususe
Initial U.S. Approval: 2018
-----------------------INDICATIONS AND USAGE---------------------
ONPATTRO contains a transthyretin-directed small interfering RNAand is indicated for the treatment of the polyneuropathy of hereditarytransthyretin-mediatedamyloidosis in adults. (1)
------------------DOSAGE AND ADMINISTRATION-----------------
•For patients weighing less than 100 kg, the recommended dosageis 0.3 mg/kg every 3 weeks by intravenous infusion. For patientsweighing 100 kg or more, the recommended dosage is 30 mg(2.1)
•Premedicate with a corticosteroid, acetaminophen, andantihistamines (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-dosevial (3)
-------------------------CONTRAINDICATIONS------------------------
None (4)
-------------------WARNINGS AND PRECAUTIONS-----------------
•Infusion-related reactions: Monitor for signs and symptomsduring infusion. Slow or interrupt the infusion if clinicallyindicated. Discontinue the infusion if aserious or life-threateninginfusion-related reaction occurs (5.1)
•Reduced serum vitamin A levels and recommendedsupplementation: Supplement with the recommended dailyallowance of vitamin A. Refer to an ophthalmologist if ocularsymptoms suggestive of vitamin A deficiency occur (5.2)
--------------------------ADVERSE REACTIONS------------------------
The most frequently reported adverse reactions (that occurred in atleast 10% of ONPATTRO-treated patients and at least 3% morefrequently than on placebo) were upper respiratory tract infectionsand infusion-related reactions (6.1)
To report SUSPECTED ADVERSE REACTIONS, contactAlnylam Pharmaceuticals at 1-877-256-9526 or FDA at 1-800FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION
Revised: 8/2018
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
2.2 Required Premedication
2.3 Preparation Instructions
2.4 Infusion Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Infusion-Related Reactions
5.2 Reduced Serum Vitamin A Levels and Supplementation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections o
