Onpattro 2 mg/mL
patisiran · INJECTION, LIPID COMPLEX · Alnylam Pharmaceuticals, Inc.
Onpattro is a injection, lipid complex containing patisiran at 2 mg/mL, taken intravenous. Manufactured by Alnylam Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Onpattro
- Generic Name
- patisiran
- NDC Code (Product)
71336-1000- Manufacturer
- Alnylam Pharmaceuticals, Inc.
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, LIPID COMPLEX
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA210922
- Marketing Start
- 08/13/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. ONPATTRO contains a transthyretin-directed small interfering RNA and is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Dosage & Administration
2 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 ) 2.1 Dosing Information ONPATTRO should be administered by a healthcare professional. ONPATTRO is administered via intravenous (IV) infusion. Dosing is based on actual body weight. For patients weighing less than 100 kg, the recommended dosage is 0.3 mg/kg once every 3 weeks. For patients weighing 100 kg or more, the recommended dosage is 30 mg once every 3 weeks. Missed Dose If a dose is missed, administer ONPATTRO as soon as possible. If ONPATTRO is administered within 3 days of the missed dose, continue dosing according to the patient's original schedule. If ONPATTRO is administered more than 3 days after the missed dose, continue dosing every 3 weeks thereafter. 2.2 Required Premedication All patients should receive premedication prior to ONPATTRO administration to reduce the risk of infusion-…
Contraindications
4 CONTRAINDICATIONS None. None
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-Related Reactions [see Warnings and Precautions (5.1) ] 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 . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of ONPATTRO cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. A total of 224 patients with polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) received ONPATTRO in the placebo-controlled and open-label clinical studies, including 186 patients exposed for at least 1 year, 137 patients exposed for at least 2 years, and 52 patients exposed for at least 3 years. In the…
Frequently Asked Questions
What is Onpattro used for?
Onpattro contains patisiran. It is a injection, lipid complex taken intravenous. Consult your doctor for specific uses.
Is Onpattro a controlled substance?
Onpattro is not classified as a controlled substance by the DEA.
What is the generic name for Onpattro?
The generic name for Onpattro is patisiran. There are no other listed brand versions of patisiran.
What is the NDC code for Onpattro 2 mg/mL?
The NDC (National Drug Code) for Onpattro 2 mg/mL is 71336-1000, listed by Alnylam Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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