Fabhalta Special Precautions

Serious infections caused by encapsulated bacteria: The use of complement inhibitors, such as iptacopan, may predispose individuals to serious, life-threatening or fatal infections caused by encapsulated bacteria. To reduce the risk of infection, all patients must be vaccinated against encapsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae. It is recommended to vaccinate patients against Haemophilus influenzae type B if vaccine is available. Healthcare professionals should refer to local vaccination guideline recommendations.
Vaccines should be administered at least 2 weeks prior to administration of the first dose of iptacopan. If treatment must be initiated prior to vaccination, patients should be vaccinated as soon as possible and provided with antibacterial prophylaxis until 2 weeks after vaccine administration.
If necessary, patients may be revaccinated in accordance with local vaccination guideline recommendations.
Vaccination reduces, but does not eliminate, the risk of serious infection. Serious infection may rapidly become life-threatening or fatal if not recognised and treated early. Patients should be informed of and monitored for early signs and symptoms of serious infection. Patients should be immediately evaluated and treated if infection is suspected. The use of iptacopan during treatment of serious infection may be considered following an assessment of the risks and benefits (see Adverse Reactions).
PNH laboratory monitoring: Patients with PNH receiving iptacopan should be monitored regularly for signs and symptoms of haemolysis, including measuring lactate dehydrogenase (LDH) levels.
Monitoring of PNH manifestations after treatment discontinuation: If treatment must be discontinued, patients should be closely monitored for signs and symptoms of haemolysis for at least 2 weeks after the last dose. These signs and symptoms include, but are not limited to, elevated LDH levels along with sudden decrease in haemoglobin or PNH clone size, fatigue, haemoglobinuria, abdominal pain, dyspnoea, dysphagia, erectile dysfunction, or major adverse vascular events (MAVEs), including venous or arterial thrombosis. If treatment discontinuation is necessary, alternative therapy should be considered.
If haemolysis occurs after discontinuation of iptacopan, restarting treatment should be considered.
Co-administration with other medicinal products: Concomitant use of iptacopan with strong inducers of CYP2C8, UGT1A1, PgP, BCRP and OATP1B1/3 has not been studied clinically; therefore, concomitant use is not recommended due to the potential for reduced efficacy of iptacopan (see Interactions). If an alternative concomitant medicinal product cannot be identified, patients should be monitored for potential signs and symptoms of haemolysis.
Educational materials: All physicians who intend to prescribe FABHALTA must ensure they have received and are familiar with the physician educational materials. Physicians must explain and discuss the benefits and risks of FABHALTA therapy with the patient and provide them with the patient information pack. The patient should be instructed to seek prompt medical care if they experience any sign or symptom of serious infection or serious haemolysis following treatment discontinuation.
Effects on ability to drive and use machines: FABHALTA has no or negligible influence on the ability to drive and use machines.