Fitusiran Side Effects

Applies to fitusiran: subcutaneous solution.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Seek medical help right away if you show signs of a blood clot such as sudden numbness or weakness (especially on one side of the body), severe headache, confusion, vision changes, slurred speech, chest pain, shortness of breath, fast heart rate, dizziness, coughing up blood, or pain, swelling, or warmth in arms or legs.

Call your doctor at once if you have:

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• gallbladder problems--stomach pain after eating, nausea, vomiting, heartburn, bloating, and severe upper stomach pain that may spread to your back.

Common side effects may include:

• bacterial or viral infections; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to fitusiran: subcutaneous solution.

General adverse events

The most common adverse reactions in patients treated with the antithrombin-based dose regimen were viral infection, nasopharyngitis, and bacterial infection.

Refer to the manufacturer product information for detailed descriptions of adverse reactions and/or for definitions of included terms.^[Ref]

Cardiovascular

• Common (1% to 10%): Serious thrombotic events
• Frequency not reported: Cerebral venous sinus thrombosis, post-operative deep vein thrombosis

Dermatologic

• Frequency not reported: Pruritus

Gastrointestinal

• Common (1% to 10%): Acute or recurrent gallbladder disease, including cholelithiasis and cholecystitis
• Frequency not reported: Dyspepsia, abdominal pain

Hematologic

• Common (1% to 10%): Prothrombin fragment 1.2 increased

Hepatic

• Common (1% to 10%): Hepatic/liver injury, including increased ALT/AST

Immunologic

• Common (1% to 10%): Antidrug antibodies

Local

• Common (1% to 10%): Injection site reaction

Adverse effects at the injection site included bruising, erythema, pain, hematoma, atrophy, hemorrhage, discomfort, swelling, discoloration, pruritus, induration, nodule, mass, vesicles, deformation, rash, and joint pain.

Musculoskeletal

• Common (1% to 10%): Arthralgia

Nervous system

• Common (1% to 10%): Headache
• Frequency not reported: Cerebral infarction

Other

• Very common (10% or more): Viral infection (29%), bacterial infection (11%)

Respiratory

• Very common (10% or more): Nasopharyngitis (26%)
• Common (1% to 10%): Cough

See also:

Further information

Fitusiran 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