With twice-daily oral dosing, FABHALTA gives your adult patients an option without infusions1
FABHALTA is the first and only FDA-approved oral treatment for adults with C3G, to reduce proteinuria1
.
FABHALTA is available as a 200-mg capsule that should be taken orally twice daily without regard to food. Patients should swallow capsules whole. Instruct patients to not open, break, or chew capsules1
No refrigeration requirement1,*
*Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).1
If a dose or doses are missed, advise your patient to take 1 dose of FABHALTA as soon as possible (even if it is soon before the next scheduled dose) and then to resume the regular dosing schedule1
Concomitant use of CYP2C8 inducers (eg, rifampin) may decrease FABHALTA exposure, which may result in loss of or reduced efficacy of FABHALTA. Monitor the clinical response and discontinue use of the CYP2C8 inducer if loss of efficacy of FABHALTA is evident1
Concomitant use of strong CYP2C8 inhibitors (eg, gemfibrozil) may increase FABHALTA exposure, which may result in an increased risk for adverse reactions with FABHALTA. Coadministration with a strong CYP2C8 inhibitor is not recommended1
Those who are breastfeeding1:
Because of the potential for serious adverse reactions in a breastfed child, breastfeeding should be discontinued during treatment with FABHALTA and for 5 days after the final dose
Those with hepatic impairment1:
FABHALTA is not recommended in patients with severe hepatic impairment (Child-Pugh class C). No dose adjustment is required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment
RECOMMENDED VACCINATION AND PROPHYLAXIS FOR ENCAPSULATED BACTERIA INFECTIONS1
Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y, and B), according to current ACIP recommendations at least 2 weeks prior to starting FABHALTA
If urgent FABHALTA therapy is indicated in a patient who is not up-to-date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible
Health care professionals who prescribe FABHALTA must enroll in the FABHALTA REMS. See Getting Started for more information