Fitusiran

Class
Antihemophilic agents
Subclass
Antithrombin-directed small interfering RNA
Substance name
Fitusiran
Brand names
Qfitlia®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Bleeding episodes in patients with hemophilia A
•
50 mg SC q2 months
Administered subcutaneously in the thigh or abdomen region, except for the 5 cm around the umbilicus. Monitor AT activity and adjust the dose and/or dosing interval to maintain AT activity between 15-35%. Reduce the dose if AT activity is < 15%. Consider increasing the dose if AT activity is > 35% after 6 months or if the patient has not achieved satisfactory bleeding control.
Bleeding episodes in patients with hemophilia B
•
50 mg SC q2 months
Administered subcutaneously in the thigh or abdomen region, except for the 5 cm around the umbilicus. Monitor AT activity and adjust the dose and/or dosing interval to maintain AT activity between 15-35%. Reduce the dose if AT activity is < 15%. Consider increasing the dose if AT activity is > 35% after 6 months or if the patient has not achieved satisfactory bleeding control.
Indications for use
Labeled indications
Adults
•
Prevention of bleeding episodes in patients with hemophilia A
•
Prevention of bleeding episodes in patients with hemophilia B
Children
•
Prevention of bleeding episodes (in patients ≥ 12 years) with hemophilia A
•
Prevention of bleeding episodes (in patients ≥ 12 years) with hemophilia B
Safety risks
Boxed warnings
Gallbladder disease
•
Maintain a high level of suspicion, as fitusiran has been associated with an increased risk of acute and recurrent gallbladder disease, including cholelithiasis and cholecystitis. Consider alternative treatment for hemophilia in patients with a history of symptomatic gallbladder disease.
Thrombotic events
•
Maintain a high level of suspicion, as fitusiran has been associated with an increased risk of thrombotic events, especially in patients with persistent AT activity <15%, comorbidities predisposing to thrombosis, nonadherence to hemorrhage management guidelines in the postoperative setting, presence of an indwelling venous catheter, or use of the 80 mg once monthly (non-AT-based) dose. Monitor AT activity and target 15-35% to reduce the risk of thrombosis. Interrupt fitusiran in patients with a thrombotic event and manage as clinically indicated.
Warnings and precautions
Hepatotoxicity
•
Maintain a high level of suspicion, as fitusiran has been associated with elevations in serum aminotransferase levels. Obtain baseline liver tests including AST, ALT, and TBIL before initiation, monthly for at least the first 6 months of treatment, and monthly for at least 6 months after a dose increase, and periodically thereafter as clinically indicated.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
Avoid use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if benefits outweigh potential risks.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Bacterial infections, gallbladder disease, ↑ serum transaminases, nasopharyngitis, viral infections
Common 1-10%
•
Cholecystectomy, drug-induced liver injury, ↑ plasma prothrombin fragment 1+2, arthralgia, dyspepsia, abdominal pain, headache, cough, injection site reactions, thrombotic events
Interactions
Drug(s)
Check Interactions
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