Patisiran Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 3, 2023.

Applies to patisiran: intravenous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine may lower the vitamin A levels in your body, which may cause eye or vision problems (eg, night blindness, blurred vision, difficulty with reading, or any other change in vision). Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Serious side effects of patisiran

Along with its needed effects, patisiran may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking patisiran:

Other side effects of patisiran

Some side effects of patisiran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to patisiran: intravenous solution.

General adverse events

The most common adverse reactions were upper respiratory tract infections, infusion-related reactions and peripheral edema.^[Ref]

Cardiovascular

• Common (1% to 10%): Atrioventricular (AV) heart block^[Ref]

There were 3.7% of patients with atrioventricular heart block, of which three cases were complete AV block.^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory infection (29%)
• Common (1% to 10%): Dyspnea, bronchitis^[Ref]

Upper respiratory infections included nasopharyngitis, upper respiratory tract infection, respiratory tract infection, pharyngitis, rhinitis, sinusitis, viral upper respiratory tract infection, and upper respiratory tract congestion.^[Ref]

Ocular

• Common (1% to 10%): Dry eye, blurred vision, vitreous floaters^[Ref]

Musculoskeletal

• Common (1% to 10%): Muscle spasms, arthralgia^[Ref]

Other

• Common (1% to 10%): Vertigo^[Ref]

Dermatologic

• Common (1% to 10%): Erythema^[Ref]

Gastrointestinal

• Common (1% to 10%): Dyspepsia^[Ref]

Immunologic

• Very common (10% or more): Infusion-related reactions (up to 19%)
• Common (1% to 10%): Antibody formation^[Ref]

Among patients who experienced infusion-related reactions (IRR), up to 79% occurred within the first two infusions and the frequency decreased over time. IRR led to infusion interruption in 5% of patients and resulted in permanent discontinuation in less than 1%.

There was no evidence that anti-drug antibodies influenced the clinical efficacy, safety, pharmacokinetic or pharmacodynamic profiles of this drug; however, the data are limited.^[Ref]

Local

• Very common (10% or more): Peripheral edema (29.7%)
• Uncommon (0.1% to 1%): Extravasation^[Ref]

In all cases of peripheral edema, the severity was mild to moderate, and did not result in treatment discontinuation.^[Ref]

See also:

Frequently asked questions

• What type of drug is Onpattro?
• Onpattro vs Tegsedi - how do they compare?
• How does Onpattro (patisiran) work?

Further information

Patisiran side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer