Applies to patisiran: intravenous solution.

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:

More common

• Back pain
• body aches or pain
• chest tightness
• chills
• cough
• difficulty in breathing
• ear congestion
• feeling of warmth
• fever
• headache
• loss of voice
• nasal congestion
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness
• vomiting

Less common

• Blurred vision
• chest pain
• cough producing mucus
• dizziness
• dry eye
• fainting
• pounding, slow heartbeat
• seeing floating dark spots or material before the eyes

Rare

• Blistering, crusting, irritation, itching, or reddening of the skin burning, pain, redness, or swelling at the injection site
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• cracked, dry, scaly skin

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:

Less common

• Belching
• feeling of constant movement of self or surroundings
• heartburn
• indigestion
• muscle spasms
• sensation of spinning
• stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to patisiran: intravenous solution.

General

The most commonly reported adverse reactions have included infusion-related reactions such as flushing, back pain, nausea, abdominal pain, dyspnea, and headache.^[Ref]

Cardiovascular

Atrioventricular heart block was reported (2.7%) of patients; in 3 cases it was a complete AV block.

Common (1% to 10%): Atrioventricular heart block

Respiratory

Upper respiratory infections included nasopharyngitis, upper respiratory tract infection, respiratory tract infection, pharyngitis, rhinitis, sinusitis, viral upper respiratory tract infection, upper respiratory tract congestion. Upper respiratory tract infections were reported in 21% of placebo treated patients.

Very common (10% or more): Upper respiratory infection (29%)

Common (1% to 10%): Dyspnea, bronchitis

Ocular

Common (1% to 10%): Dry eye, blurred vision, vitreous floaters

Musculoskeletal

Common (1% to 10%): Muscle spasms, arthralgia

Other

Common (1% to 10%): Vertigo

Dermatologic

Common (1% to 10%): Erythema

Gastrointestinal

Common (1% to 10%): Dyspepsia

Immunologic

There was no evidence that the presence of anti-drug antibodies influenced clinical efficacy, safety, or the pharmacokinetic or pharmacodynamic profiles of this drug, however, the data is limited.

Common (1% to 10%): Antibody formation

Local

Infusion-related reactions (IRR) included but were not limited to: arthralgia or pain (including back, neck, or musculoskeletal pain), flushing (including erythema of face or skin warm), nausea, abdominal pain, dyspnea or cough chest discomfort or chest pain, headache, rash, chills, dizziness, fatigue, increased heart rate or palpitations, hypotension, hypertension, and facial edema. During clinical trials, all patients received premedication. Most patients who experienced an IRR, experienced it within the first 2 infusions. IRR led to infusion interruption in 5% of patients and resulted in permanent discontinuation in less than 1%. The most commonly reported IRR were flushing, back pain, nausea, abdominal pain, dyspnea, and headache. One severe reaction of hypotension and syncope was reported during an infusion. Extravasation was observed in less than 0.5% of infusions; signs and symptoms included phlebitis or thrombophlebitis, infusion or injection site swelling, dermatitis (subcutaneous inflammation), cellulitis, erythema or injection site redness, burning sensation, or injection site pain.

Very common (10% or more): Infusion related reactions (19%)

Uncommon (0.1% to 1%): Extravasation