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Qfitlia
fitusiran
Black Box Warnings .
Thrombotic Events
serious events have occurred; risk factors incl. thrombosis-predisposing comorbidities, persistent antithrombin (AT) activity <15%, 80 mg SC qmo dose, indwelling venous catheter, and post-op setting when bleed management guidelines not followed; target AT activity 15-35% to reduce risk; monitor s/sx thrombosis; if thrombotic event occurs, interrupt tx, manage as clinically indicated, and consider risk/benefit prior to tx restart
Acute and Recurrent Gallbladder Dz
incl. cholelithiasis and cholecystitis has occurred; monitor s/sx gallbladder dz; if occurs, consider tx interruption or D/C; consider alternative tx if symptomatic gallbladder dz hx
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 50 mg per 0.5 mL; INJ (vial): 20 mg per 0.2 mL
routine bleeding prophylaxis, hemophilia A or B
- [individualize dose SC q1-2mo]
- Start: 50 mg SC q2mo; Info: target AT activity between 15-35%; see pkg insert for dose adjustments based on AT activity; D/C prophylactic clotting factor concentrates or bypassing agents no later than 7 days after tx start; may use clotting factor concentrates or bypassing agents for breakthrough bleeding
renal dosing
- [see below]
- eGFR >60: no adjustment; eGFR <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A, B, or C: avoid use
Peds Dosing .
- Dosage forms: INJ (pre-filled syringe): 50 mg per 0.5 mL; INJ (vial): 20 mg per 0.2 mL
routine bleeding prophylaxis, hemophilia A or B
- [12 yo and older]
- Dose: individualize dose SC q1-2mo; Start: 50 mg SC q2mo; Info: target AT activity between 15-35%; see pkg insert for dose adjustments based on AT activity; D/C prophylactic clotting factor concentrates or bypassing agents no later than 7 days after tx start; may use clotting factor concentrates or bypassing agents for breakthrough bleeding
renal dosing
- [see below]
- eGFR >60: no adjustment; eGFR <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A, B, or C: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- baseline AT activity <60%
- hepatic impairment
- caution: thrombosis risk
- caution: venous catheter, indwelling
- caution: gallbladder dz, symptomatic
Drug Interactions .
Overview
fitusiran
antithrombin-directed siRNA
- thrombogenic effects
Avoid/Use Alternative
- desogestrel (contraceptive)
- dienogest (contraceptive)
- drospirenone (contraceptive)
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- levonorgestrel (contraceptive)
- medroxyprogesterone (contraceptive)
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- segesterone (contraceptive)
- tranexamic acid
- vaccinia immune globulin
Monitor/Modify Tx
- abemaciclib
- abrocitinib
- aflibercept
- aminocaproic acid
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- asciminib
- asparaginase
- atidarsagene autotemcel
- avatrombopag
- axitinib
- baricitinib
- bazedoxifene
- bevacizumab
- binimetinib
- botulism immune globulin
- brolucizumab
- C1 esterase inhibitor
- cabozantinib
- calaspargase
- carfilzomib
- celecoxib
- chorionic gonadotropin
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- concizumab
- cytomegalovirus immune globulin
- danazol
- darbepoetin alfa
- deflazacort
- deuruxolitinib
- dexamethasone
- diclofenac
- diclofenac topical
- diflunisal
- drospirenone (hormone replacement)
- eltrombopag
- epirubicin
- epoetin alfa
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (hormone replacement)
- etodolac
- everolimus
- factor XIII concentrate
- faricimab
- fedratinib
- fenofibrate
- fenofibric acid
- fenoprofen
- flurbiprofen
- follitropin
- fruquintinib
- hepatitis B immune globulin
- ibuprofen
- immune globulin
- indomethacin
- iohexol
- iopamidol
- ketoprofen
- ketorolac
- lazertinib
- lenalidomide
- lenvatinib
- levonorgestrel (hormone replacement)
- luspatercept
- lusutrombopag
- meclofenamate
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- menotropins
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
- momelotinib
- nabumetone
- naproxen
- necitumumab
- nintedanib
- norethindrone acetate (hormone replacement)
- norgestimate (hormone replacement)
- olaparib
- ospemifene
- oxaprozin
- pacritinib
- pazopanib
- pegaspargase
- piroxicam
- pomalidomide
- ponatinib
- porfimer
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- prothrombin complex concentrate (human)
- raloxifene
- ramucirumab
- ranibizumab
- Rho(D) immune globulin
- ritlecitinib
- romiplostim
- ruxolitinib
- ruxolitinib topical
- salsalate
- sipuleucel-T
- sodium tetradecyl sulfate
- sotatercept
- sulindac
- tamoxifen
- testosterone
- thalidomide
- tivozanib
- tofacitinib
- tolmetin
- toremifene
- trametinib
- tretinoin
- upadacitinib
- vadadustat
- valoctocogene roxaparvovec
- vamorolone
- varicella zoster immune globulin
- von Willebrand factor
- vorinostat
- ziv-aflibercept
Adverse Reactions .
Serious Reactions
- thrombosis
- gallbladder dz
- cholelithiasis
- cholecystitis
- pancreatitis
- hepatotoxicity
Common Reactions
- infection
- hepatotoxicity
- arthralgia
- prothrombin fragment 1.2 incr.
- injection site rxn
- headache
- cough
Safety/Monitoring .
Monitoring Parameters
AT activity at baseline, wk 4, wk 12, wk 20, wk 24 after tx start or dose change, then annually; LFTs at baseline, qmo for at least 6mo after tx start or dose incr, then periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available
Individuals of Reproductive Potential
consider non-hormonal contraception in pts using oral contraceptives or hormonal contraception associated w/ thrombosis risk
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: other; CYP450: none
Excretion: urine 14.6% (unchanged); Half-life: 5.6h (20 mg dose), 8h (50 mg dose)
Subclass: Antithrombin Small Interfering Ribonucleic Acids (siRNAs)
Mechanism of Action
causes degradation of antithrombin (AT) mRNA, reducing plasma AT levels, thereby increasing thrombin generation and enhancing coagulation (small interfering ribonucleic acid (siRNA))
Formulary .
No Formulary Selected
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