Fabhalta Side Effects

Generic name: iptacopan

Note: This document contains side effect information about iptacopan. Some dosage forms listed on this page may not apply to the brand name Fabhalta.

Applies to iptacopan: oral capsule.

Warning

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

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

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

fever, chills, sore throat;
mouth sores, red or swollen gums;
pale skin, easy bruising, unusual bleeding;
chest discomfort, wheezing, dry cough or hack, rapid weight loss; or
symptoms of meningitis--headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, drowsiness.

Your condition may get worse if you stop taking this medicine. If you stop using iptacopan (the active ingredient contained in Fabhalta) tell your doctor if you have any new or worsening symptoms, such as tiredness, confusion, stomach pain, trouble breathing or swallowing, blood in your urine, difficulty having an erection, chest pain, pain in one leg, or numbness or weakness on one side of the body.

Common side effects may include:

headache;
infections caused by bacteria or virus;
cold symptoms such as stuffy nose, sneezing, sore throat;
rash; or
diarrhea, nausea, stomach pain.

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 iptacopan: oral capsule.

General

The most common adverse effects observed in more than 10% patients were headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, and rash.

Cardiovascular

Common (1% to 10%): Systemic hypertension^[Ref]

Dermatologic

Common (1% to 10%): Rash, urticaria

Rash included allergic dermatitis, acne, multiforme erythema, maculopapular rash, and erythematous rash.

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 15%), diarrhea (up to 15%)

Common (1% to 10%): Nausea

Hematologic

Very common (10% or more): Thrombocytopenia (up to 43%)

Metabolic

Very common (10% or more): Hypercholesterolemia (up to 43%), increased low-density lipoprotein (LDL)-cholesterol (up to 17%), serum triglyceride (up to 27%)

Common (1% to 10%): Lipid disorder

Lipid disorder included dyslipidemia, increased blood cholesterol, increased LDL, hypercholesterolemia, increased blood triglycerides, and hyperlipidemia.

Musculoskeletal

Common (1% to 10%): Arthralgia

Nervous system

Very common (10% or more): Headache (up to 28%)

Common (1% to 10%): Dizziness

Other

Very common (10% or more): Bacterial infection (up to 11%), viral infection (up to 18%)

Bacterial infection included pyelonephritis, urinary tract infection, bacterial bronchitis, Haemophilus bronchitis, cholecystitis, folliculitis, cellulitis, bacterial arthritis, sepsis, Klebsiella infection, staphylococcal infection, Pseudomonas infection, hordeolum, and bacterial pneumonia.

Viral infection included COVID-19, herpes zoster, oral herpes, nasal herpes, influenza A virus test positive, and influenza.