Fabhalta Side Effects

Generic name: iptacopan

Medically reviewed by Drugs.com. Last updated on Jan 10, 2025.

Note: This document provides detailed information about Fabhalta Side Effects associated with iptacopan. Some dosage forms listed on this page may not apply specifically to the brand name Fabhalta.

Applies to iptacopan: oral capsules.

Important warnings This medicine can cause some serious health issues

REMS:

FDA approved a REMS for iptacopan to ensure that the benefits outweigh the risks.

The REMS may apply to one or more preparations of iptacopan and consists of the following: medication guide, elements to assure safe use, and implementation system.

See the FDA REMS page ([Web]).¹

Side effects include:

Most common adverse effects (≥10%) in PNH: headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, rash.

Most common adverse effects (≥5%) in IgAN: upper respiratory tract infection, lipid disorder, abdominal pain.

For healthcare professionals

Applies to iptacopan: oral capsule.

General adverse events

The most common adverse reactions included headache, nasopharyngitis, diarrhea, abdominal pain, bacterial infection, viral infection, nausea, rash, upper respiratory tract infection, and lipid disorder.^[Ref]

Cardiovascular

• Common (1% to 10%): Systemic hypertension
• Frequency not reported: Increased blood pressure

In 2 studies, increases in blood pressure (particularly diastolic blood pressure) were observed, with mean increases of 4.4 and 3.4 mmHg, respectively, at month 6; mean diastolic blood pressure did not exceed 80 mmHg.

Dermatologic

• Common (1% to 10%): Rash, urticaria

Rash included allergic dermatitis, acne, erythema multiforme, 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

Abdominal pain included abdominal pain, upper abdominal pain, and abdominal tenderness.

Genitourinary

• Common (1% to 10%): Urinary tract infection

Hematologic

• Very common (10% or more): Thrombocytopenia (up to 43%)
• Common (1% to 10%): Decreased platelet count

Decreased platelet count included thrombocytopenia and decreased platelet count.

Of 37 patients who had normal platelet counts at baseline, 43% experienced thrombocytopenia (any grade) during the study.

Metabolic

• Very common (10% or more): Hypercholesterolemia (up to 43%)
• Common (1% to 10%): Lipid disorder

Lipid disorder included dyslipidemia, increased blood cholesterol, increased low-density lipoprotein, hypercholesterolemia, increased blood triglycerides, and hyperlipidemia.

In 2 studies, 54 and 34 patients had normal total cholesterol levels at baseline; 43% and 24%, respectively, developed grade 1 hypercholesterolemia.

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): Increased serum triglyceride (up to 27%), viral infection (up to 18%), increased low-density lipoprotein (LDL) cholesterol (up to 17%), bacterial infection (up to 11%)
• Frequency not reported: Increased total cholesterol

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

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.

In 2 studies, 37 and 52 patients had normal triglyceride levels at baseline; 27% and 23%, respectively, developed grade 1 elevated triglycerides.

During 1 study, 60 patients had LDL cholesterol up to 130 mg/dL at baseline; LDL cholesterol increased to greater than 130 to 160 mg/dL, greater than 160 to 190 mg/dL, and greater than 190 mg/dL in 17%, 8%, and 7% of patients, respectively. In another study, 36 patients had LDL cholesterol up to 130 mg/dL at baseline; LDL cholesterol increased to greater than 130 to 160 mg/dL and greater than 160 to 190 mg/dL in 11% and 3% of patients, respectively.

In 2 studies, mean increases from baseline of about 37 mg/dL (0.952 mmol/L) and 17 mg/dL (0.433 mmol/L), respectively, were seen at month 6 for total cholesterol, and 32 mg/dL (0.83 mmol/L) and 18 mg/dL (0.467 mmol/L), respectively, for LDL cholesterol; mean values remained within the normal ranges.

Renal

• Frequency not reported: Pyelonephritis

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 19.4%), nasopharyngitis (up to 16%)
• Common (1% to 10%): Bronchitis
• Frequency not reported: COVID-19, bacterial pneumonia

Upper respiratory tract infections included nasopharyngitis, pharyngitis, sinusitis, and upper respiratory tract infection.

Nasopharyngitis included allergic rhinitis, upper respiratory tract infection, pharyngitis, and rhinitis.

Bronchitis included bronchitis, Haemophilus bronchitis, and bacterial bronchitis.

Further information

Fabhalta 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