FABHALTA (iptacopan hcl)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Lactation
Meningococcal meningitis
Meningococcemia

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Infection

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Hyperlipidemia

There are 7 severe adverse reactions.

More Frequent	Less Frequent
Bacterial infection Viral infection	COVId-19 Pyelonephritis Urinary tract infection

Rare/Very Rare
Bacteremia Pneumonia

There are 14 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Allergic rhinitis Diarrhea Headache disorder Nausea Pharyngitis Rhinitis Skin rash Upper respiratory infection	Arthralgia Dizziness Hypertension Thrombocytopenic disorder Urticaria

Rare/Very Rare
None.

There is insufficient evidence with iptacopan in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated PNH, IgAN, and complement 3 glomerulopathy (C3G) in pregnancy. These risks include adverse maternal outcomes of worsening cytopenias, thrombosis, infections, bleeding, miscarriages, increased maternal mortality, and adverse fetal outcomes including death and premature delivery.

The use of iptacopan in pregnant women or women planning to become pregnant may be considered following an assessment of risks and benefits. In animal reproduction studies, oral administration of iptacopan to pregnant rats and rabbits during organogenesis at exposures 4 to 6-times the human exposure (based on AUC) at the maximum recommended human dose (MRHD) of 200 mg twice daily did not induce embryo or fetal toxicity. In a pre- and postnatal development study in rats, oral administration of iptacopan during gestation, parturition, and lactation did not cause adverse effects in the offspring when given up to the highest dosage of 1,000 mg/kg per day, which corresponds to 4-times the MRHD based on AUC.

There are no data on the presence of iptacopan or its metabolite in human milk, the effects on the breast-fed child, or the effects on milk production. Since many drugs are distributed into human milk, and because of the potential for serious adverse reactions in the breast-fed child, breastfeeding should be discontinued during treatment and for 5 days after the final dose.

Clinical studies with iptacopan did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently than younger patients. There were 29 PNH patients >=65 years of age in the APPLY-PNH and APPOINT-PNH trials. Of the total number of iptacopan-treated patients during the 24-week treatment period in these studies, 21 (20.6%) were 65 years of age and older, while 7 (6.9%) were 75 years of age and older.

In the APPLAUSE-IgAN trial, there were 8 patients with IgAN who were >=65 years of age. Of the total number of iptacopan-treated patients during the trial, 3 (2.4%) were 65 years of age and older.