TM Owner Alnylam Pharmaceuticals
Onpattro 2mg/mL Injection
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Indications & Clinical Uses
- Onpattro 2 mg/mL is a brand of patisiran, a small interfering RNA (siRNA) medicine that lowers production of the transthyretin protein in the liver.
- It is approved to treat the polyneuropathy (nerve damage causing numbness, pain and weakness) caused by hereditary transthyretin-mediated (hATTR) amyloidosis in adults, a rare inherited condition in which abnormal transthyretin protein builds up in nerves and other tissues.
- Onpattro is NOT currently approved for the cardiomyopathy (heart) form of ATTR amyloidosis: in 2023 the US FDA issued a Complete Response Letter declining that additional indication, and Alnylam has not pursued it further in the US.
- Onpattro is specialist- and hospital-administered only, given as an intravenous infusion by trained staff with required premedication; it is never a self-injected or oral medicine.
Side Effects
- The most common reactions are upper respiratory tract infections and infusion-related reactions, which affect around 1 in 5 patients and include flushing, back or joint pain, nausea, abdominal pain, shortness of breath, low blood pressure and chest pain during or shortly after the infusion; these are why the infusion is given slowly under close observation, with the rate slowed, paused or stopped if reactions occur.
- Onpattro also lowers blood levels of vitamin A, on average by about 60%, so night vision changes, dry eyes or other eye symptoms should be reported promptly, and an eye specialist referral may be advised.
- There is no boxed warning on the current Onpattro label.
- Seek urgent medical help for severe breathlessness, chest pain, facial swelling or fainting during an infusion.
Precautions & Warnings
- Before each infusion you will be given a course of premedication - a corticosteroid, paracetamol and antihistamines (H1 and H2 blockers) - to reduce the risk of infusion-related reactions; do not skip these.
- Because Onpattro reduces vitamin A levels, daily supplementation at the recommended dietary allowance is required for as long as you are treated, together with regular monitoring for visual problems.
- There are no human pregnancy data; animal studies showed harm to the developing fetus only at high doses, so treatment during pregnancy should be discussed carefully with your specialist.
- It is not known whether Onpattro passes into breast milk.
- Onpattro is for intravenous infusion only, given over about 80 minutes through an in-line filter, and must never be given by any other route.
Avoid Interactions
- There are no major drug-metabolism interactions identified with Onpattro because it is not broken down by the liver's usual CYP450 enzyme pathways, but you should still tell your healthcare provider about every medicine, herbal remedy and supplement you take.
- The main interaction concern is pharmacological, not chemical: taking Onpattro alongside other treatments or conditions that already affect vitamin A levels, or delaying vitamin A supplementation, can increase the risk of deficiency-related eye problems, so supplementation must not be stopped without medical advice.
- Premedication drugs (corticosteroid, paracetamol, and H1/H2 antihistamines) are required before every infusion and should not be omitted, since they reduce the chance of an infusion reaction.
- Onpattro must not be mixed with other infusion solutions or medicines in the same line.
References
Frequently Asked Questions
Onpattro (patisiran) treats the polyneuropathy - nerve damage causing numbness, pain and weakness - caused by hereditary transthyretin-mediated (hATTR) amyloidosis in adults. It is not currently approved for the heart (cardiomyopathy) form of this disease; the FDA declined that use in 2023.
Onpattro is given as an intravenous infusion by a healthcare team, usually every three weeks, over about 80 minutes. The dose depends on your body weight. You always receive premedication beforehand, and it is never self-injected.
Upper respiratory infections and infusion-related reactions, such as flushing, back pain, nausea or breathlessness during the infusion, are the most common effects of Onpattro. It also lowers vitamin A levels, so night vision changes should be reported. There is no boxed warning.
Do not skip the required premedication (steroid, paracetamol and antihistamines) given before each Onpattro infusion, as it lowers the risk of a reaction. Do not stop your daily vitamin A supplement without medical advice, since Onpattro reduces vitamin A levels.
You receive premedication about an hour beforehand, then Onpattro is infused into a vein over roughly 80 minutes while staff monitor you for flushing, chest pain, breathlessness or low blood pressure. The infusion can be slowed or stopped if a reaction occurs.
Onpattro lowers blood vitamin A by around 60% on average, which can affect night vision and eye health. Daily vitamin A supplementation at the standard recommended amount is required throughout treatment, along with reporting any vision changes to your care team promptly.
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