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Alhemo (concizumab-mtci)
concizumab
Adult Dosing .
Dosage forms: INJ (pen): 60 mg per 1.5 mL, 150 mg per 1.5 mL, 300 mg per 3 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = concizumab-mtci
routine bleeding prophylaxis, hemophilia A or B w/ inhibitors
- [0.15-0.25 mg/kg/dose SC qd starting wk 5]
- Start: 1 mg/kg/dose SC x1, then 0.2 mg/kg/dose SC qd x4wk; Info: D/C other hemostatic products before tx start; round dose to nearest 0.4 mg for 60 mg per 1.5 mL pen and to nearest 1 mg for 150 mg per 1.5 mL or 300 mg per 3 mL pens; individualize maintenance dose based on concizumab plasma conc. 4wk after tx start, see pkg insert; may use bypassing agents for breakthrough bleeding
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: INJ (pen): 60 mg per 1.5 mL, 150 mg per 1.5 mL, 300 mg per 3 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = concizumab-mtci
routine bleeding prophylaxis, hemophilia A or B w/ inhibitors
- [12 yo and older]
- Dose: 0.15-0.25 mg/kg/dose SC qd starting wk 5; Start: 1 mg/kg/dose SC x1, then 0.2 mg/kg/dose SC qd x4wk; Info: D/C other hemostatic products before tx start; round dose to nearest 0.4 mg for 60 mg per 1.5 mL pen and to nearest 1 mg for 150 mg per 1.5 mL or 300 mg per 3 mL pens; individualize maintenance dose based on concizumab plasma conc. 4wk after tx start, see pkg insert; may use bypassing agents for breakthrough bleeding
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- activated recombinant factor VII use w/in prior 12h
- activated prothrombin complex concentrate use w/in prior 48h
- factor VIII use w/in prior 24h
- factor IX use w/in prior 24h
- bleeding, active (tx initiation use)
- major surgery w/in prior 10-14 days
- avoid: tx for at least 4 days before major surgery
- caution: pts of childbearing potential
- caution: high-dose bypassing agent use, concurrent
- caution: frequent bypassing agent use, concurrent
- caution: atherosclerotic dz
- caution: crush injury
- caution: cancer
- caution: DIC
- caution: thrombotic microangiopathy
- caution: septicemia
Drug Interactions .
Overview
concizumab
tissue factor pathway inhibitor antagonist
- thrombogenic effects
- combo w/ other hemostatic agents may incr. risk of thromboembolism; consider product half-lives
Avoid/Use Alternative
- 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)
- 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
- cytomegalovirus immune globulin
- danazol
- darbepoetin alfa
- deflazacort
- desogestrel (contraceptive)
- deuruxolitinib
- dexamethasone
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- eltrombopag
- epirubicin
- epoetin alfa
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- everolimus
- factor XIII concentrate
- faricimab
- fedratinib
- fenofibrate
- fenofibric acid
- fenoprofen
- fitusiran
- flurbiprofen
- follitropin
- fruquintinib
- hepatitis B immune globulin
- ibuprofen
- immune globulin
- indomethacin
- iohexol
- iomeprol
- iopamidol
- ketoprofen
- ketorolac
- lazertinib
- lenalidomide
- lenvatinib
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- luspatercept
- lusutrombopag
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- menotropins
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
- momelotinib
- nabumetone
- naproxen
- necitumumab
- nintedanib
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- 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
- segesterone (contraceptive)
- 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
- thromboembolism
- hypersensitivity rxn
- anaphylaxis
Common Reactions
- injection site rxn
- urticaria
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available; possible risk of fetal harm based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x7wk after D/C in pts of childbearing potential
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: catabolism; CYP450: unknown
Excretion: other; Half-life: 1 day
Subclass: Hemostasis: Anti-Tissue Factor Pathway Inhibitors (TFPIs)
Mechanism of Action
binds Tissue Factor Pathway Inhibitor (TFPI) Kunitz domain 2, neutralizing TFPI activity and enhancing coagulation (monoclonal antibody)
Formulary .
No Formulary Selected
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