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Patients take 1 capsule twice daily1
Patients take 1 capsule twice daily1
200-mg capsule
FABHALTA can be taken without regard to food
No refrigeration requirement*
Patients should swallow capsules whole. Do not open, break, or chew capsules
*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
Show your patients a world without infusions1
No need to schedule infusion appointments or travel to infusion centers
No potential for injection-site reactions
No loading dose or dose adjustment required
What to do if your patient misses a dose1
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 schedule.
Switching from C5is (eculizumab and ravulizumab)1
To reduce the potential risk of hemolysis with abrupt discontinuation of other PNH therapies:
For patients switching from eculizumab, initiate FABHALTA no later than 1 week after the last dose of eculizumab
For patients switching from ravulizumab, initiate FABHALTA no later than 6 weeks after the last dose of ravulizumab
There is no available information regarding time frame for initiation of FABHALTA after other PNH therapies.
Drug interactions with FABHALTA1
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 evident
Concomitant use of strong CYP2C8 inhibitors (eg, gemfibrozil) may increase FABHALTA exposure, which may result in an increased risk of adverse reactions with FABHALTA. Coadministration with a strong CYP2C8 inhibitor is not recommended
Use of FABHALTA in specific populations1
Those who are breastfeeding:
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 renal impairment:
FABHALTA is not recommended in patients with severe renal impairment (eGFR <30 mL/ min/1.73 m2) with or without hemodialysis. No dose adjustment is required in patients with mild (eGFR 60 to <90 mL/min/1.73 m2) or moderate (eGFR 30 to <60 mL/min/1.73 m2) renal impairment
Those with hepatic impairment:
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
After discontinuing treatment with FABHALTA, closely monitor patients for at least 2 weeks after the last dose for signs and symptoms of hemolysis. These signs include elevated lactate dehydrogenase (LDH) levels along with sudden decrease in hemoglobin or PNH clone size, fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events (such as thrombosis, stroke, and myocardial infarction), dysphagia, or erectile dysfunction. If discontinuation of FABHALTA is necessary, consider alternative therapy.
If hemolysis occurs after discontinuation of FABHALTA, consider restarting treatment with FABHALTA, if appropriate, or initiating another treatment for PNH.1
To prescribe FABHALTA, you will need to enroll in the FABHALTA REMS1
FABHALTA can fit into your patients' lifestyles1
WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
FABHALTA, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. Life-threatening and fatal infections with encapsulated bacteria have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
Because of the risk of serious infections caused by encapsulated bacteria, FABHALTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FABHALTA REMS.
INDICATION
FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).
Definitions
C5i, complement 5 inhibitor; PNH, paroxysmal nocturnal hemoglobinuria; REMS, risk evaluation and mitigation strategy.
Reference
1. Fabhalta. Prescribing information. Novartis Pharmaceuticals Corp.