Important safety information

Clinical use

Pediatrics (<18 years of age): The safety and efficacy of FABHALTA^® in pediatric patients below 18 years of age have not been established; therefore, Health Canada has not authorized an indication for pediatric use.

Geriatrics (≥65 years of age): FABHALTA^® may be administered to patients aged 65 years and over. Evidence from clinical studies suggests that use in the geriatric population is not associated with differences in safety or effectiveness.

Contraindications

• Hypersensitivity to iptacopan or to any of the other excipients.
• Patients who are not currently vaccinated against Neisseria meningitidis and Streptococcus pneumoniae unless the risk of delaying FABHALTA^® treatment outweighs the risk of developing an infection from these encapsulated bacteria.
• Initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B.

Most serious warnings and precautions

Serious infections caused by encapsulated bacteria:

Due to its mechanism of action, the use of FABHALTA may predispose individuals to serious infections caused by encapsulated bacteria, such as Streptococcus pneumoniae and Neisseria meningitidis.

• Comply with the most current National Advisory Committee on Immunization (NACI) recommendations or regional practice guidelines for vaccinations against encapsulated bacteria, deficiencies.
• Patients must be vaccinated against encapsulated bacteria, specifically Neisseria meningitidis and Streptococcus pneumoniae, at least 2 weeks prior to initiating FABHALTA^®, unless the risks of delaying FABHALTA^® therapy outweigh the risks of developing a serious infection.
• Patients who initiate treatment with FABHALTA^® less than 2 weeks after vaccination must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
• Vaccination reduces, but does not eliminate, the risk of serious infections. Monitor patients for early signs of serious infections and treat immediately if infection is suspected. 
• FABHALTA^® is only available through a controlled distribution program under which prescribers must enroll patients and confirm vaccination against encapsulated bacteria. Prescribers must also counsel patients about the risk of serious infection and provide them with the Patient Guide and Patient Card. Information about the FABHALTA^® controlled distribution program is available at www.fabhalta.ca.

Other relevant warnings and precautions

• Monitoring and laboratory tests: Patients with PNH receiving FABHALTA^® should be monitored as per standard PNH management and regularly for signs and symptoms of hemolysis, including measuring lactate dehydrogenase levels. Patients should also be monitored for increased diastolic blood pressure and cholesterol. If treatment with FABHALTA^® must be discontinued, patients must be closely monitored for signs and symptoms of hemolysis for at least 2 weeks after the last dose. If discontinuation of FABHALTA^® is necessary, consider alternative therapy. If hemolysis occurs after discontinuation of FABHALTA^®, restarting FABHALTA^® treatment or initiating an alternative therapy should be considered.
• Fertility: There are no data on the effect of FABHALTA^® on human fertility. In animal fertility studies, iptacopan did not impact fertility in male rats up to the highest dose tested, which corresponds to 4-fold the maximum recommended human dose (MRHD) based on AUC. Reversible effects on the male reproductive system were observed in repeated dose toxicity studies in dogs at doses 3-fold the MRHD based on AUC, with no apparent effects on sperm numbers, morphology or motility. In female rats, increased pre- and post-implantation losses and, consequently, decreased numbers of live embryos, were observed at 4-fold the MRHD based on AUC.
• Pregnant women: There are insufficient data on FABHALTA^® use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with untreated PNH in pregnancy. The use of FABHALTA^® in pregnant women or women planning to become pregnant may be considered following an assessment of the risks and benefits.
• Disease-associated maternal and/or embryo/fetal risk: PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenia, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, as well as adverse fetal outcomes, including fetal death and premature delivery.
• Breastfeeding: It is not known if iptacopan is transferred into human milk after oral administration of FABHALTA^®. There are no data on the effects of FABHALTA^® on the breastfed child or on milk production. As potential serious adverse effects in breastfed infants cannot be ruled out, breastfeeding should be discontinued during treatment and for 5 days after the final dose.

For more information

Consult the Product Monograph at www.novartis.ca/fabhaltamonograph for important information relating to adverse drug reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-363-8883 or emailing [email protected].