Fitusiran Interactions

Brand names: Qfitlia

Antithrombin-directed RNA Interaction · Small Interfering RNA

Route: Subcutaneous

FDA Black Box Warning

WARNING: THROMBOTIC EVENTS AND ACUTE AND RECURRENT GALLBLADDER DISEASE WARNING: THROMBOTIC EVENTS and ACUTE AND RECURRENT GALLBLADDER DISEASE See full prescribing information for complete boxed warning. Thrombotic Events Serious thrombotic events have occurred in QFITLIA-treated patients with risk factors including persistent antithrombin (AT) activity less than 15%, QFITLIA 80 mg once monthly dosing, an indwelling venous catheter, and the post-operative setting when bleed management guidelines were not followed. Interrupt QFITLIA in patients with a thrombotic event and manage as clinically indicated. ( 5.1 ) Acute and Recurrent Gallbladder Disease Gallbladder disease has occurred in QFITLIA-treated patients, some requiring cholecystectomy or developing complications (e.g., pancreatitis). Monitor for signs and symptoms of gallbladder disease. Consider interruption or discontinuation of QFITLIA if gallbladder disease occurs. Consider alternative treatment for hemophilia if history of symptomatic gallbladder disease. ( 5.2 ) Thrombotic Events Serious thrombotic events have occurred in QFITLIA-treated patients with risk factors for thromboembolism including persistent antithrombin (AT) activity less than 15%, use of QFITLIA 80 mg once monthly, presence of indwelling venous catheters, and in the post-operative setting when bleed management guidelines were not followed. Monitor AT activity using an FDA-cleared test and target AT activity 15–35% to reduce the risk of thrombosis. Monitor patients for signs and symptoms of thrombotic events. Interrupt QFITLIA in patients with a thrombotic event and manage as clinically indicated. (5.1) Acute and Recurrent Gallbladder Disease Acute and recurrent gallbladder disease, including cholelithiasis and cholecystitis have occurred in QFITLIA-treated patients, some of whom required cholecystectomy or had complications (e.g., pancreatitis) related to gallbladder disease. Monitor patients for signs and symptoms of acute and recurrent ga

Contraindications

4 CONTRAINDICATIONS None. None ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no available data on QFITLIA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Reproduction studies in pregnant animals have not been conducted with fitusiran. It is not known whether QFITLIA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. QFITLIA should be used during pregnancy only if the potential benefit justifies the potential risks, including those to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

2 interactions on record