Onpattro Approval History
Reviewed on Aug 15, 2018 by J.Stewart B.Pharm
FDA Approved: Yes (First approved August 10, 2018)
Brand name: Onpattro
Generic name: patisiran
Dosage form: Injection
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Hereditary Transthyretin-Mediated Amyloidosis (hATTR)
Onpattro (patisiran) is a small interfering ribonucleic acid (siRNA) therapeutic for the treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR).
Dosage and Administration
- Onpattro is administered via intravenous infusion over approximately 80 minutes. For patients weighing less than 100 kg, the recommended dosage is 0.3 mg/kg every 3 weeks and for patients weighing 100 kg or more, the recommended dosage is 30 mg every 3 weeks.
- All patients should receive premedication (corticosteroid, acetaminophen, and antihistamines) to reduce the risk of infusion-related reactions.
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.
- 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 (e.g., night blindness).
- Pregnancy: Instruct patients that if they are pregnant or plan to become pregnant while taking Onpattro they should inform their healthcare provider. Advise female patients of childbearing potential of the potential risk to the fetus.
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.
Development History and FDA Approval Process for Onpattro
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