Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 11mg/single-dose vial
Thrombotic Thrombocytopenia Purpura
Indicated for acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy
Administer upon initiation of plasma exchange therapy
- First day: 11 mg IV bolus at least 15 minutes before plasma exchange, followed by 11 mg SC after completion of plasma exchange on day 1
- Subsequent days during daily plasma exchange: 11 mg SC qDay following plasma exchange
- After plasma exchange period: 11 mg SC qDay for 30 days following last daily plasma exchange
- After initial treatment course: If sign(s) of persistent underlying disease (eg, suppressed ADAMTS13 activity levels remain present), treatment may be extended for a maximum of 28 days
- Discontinue if ≥2 recurrences of aTTP occur while on caplacizumab
Dosage Modifications
Renal impairment
- No dosage adjustment required for any degree of renal impairment
Hepatic impairment
- No formal studies have been done and no information is available regarding use in patients with severe acute or chronic hepatic impairment
- Owing to potential increased bleeding risk in patients with severe hepatic impairment, use in these patients requires close monitoring for hemorrhage
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (37)
- abciximab
caplacizumab, abciximab. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- alteplase
caplacizumab, alteplase. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- anagrelide
caplacizumab, anagrelide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- antithrombin alfa
caplacizumab, antithrombin alfa. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- antithrombin III
caplacizumab, antithrombin III. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- apixaban
caplacizumab, apixaban. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- argatroban
caplacizumab, argatroban. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- aspirin
caplacizumab, aspirin. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- axicabtagene ciloleucel
caplacizumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- betrixaban
caplacizumab, betrixaban. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- bivalirudin
caplacizumab, bivalirudin. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
caplacizumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cangrelor
caplacizumab, cangrelor. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- cilostazol
caplacizumab, cilostazol. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
caplacizumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- clopidogrel
caplacizumab, clopidogrel. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- dabigatran
caplacizumab, dabigatran. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- dalteparin
caplacizumab, dalteparin. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- dipyridamole
caplacizumab, dipyridamole. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- edoxaban
caplacizumab, edoxaban. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- enoxaparin
caplacizumab, enoxaparin. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- eptifibatide
caplacizumab, eptifibatide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- fondaparinux
caplacizumab, fondaparinux. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- heparin
caplacizumab, heparin. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
caplacizumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- isavuconazonium sulfate
caplacizumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
caplacizumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pentosan polysulfate sodium
caplacizumab, pentosan polysulfate sodium. Either increases effects of the other by anti-hypertensive channel blocking. Avoid or Use Alternate Drug.
- prasugrel
caplacizumab, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- reteplase
caplacizumab, reteplase. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- rivaroxaban
caplacizumab, rivaroxaban. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- tenecteplase
caplacizumab, tenecteplase. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
- ticagrelor
caplacizumab, ticagrelor. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- tirofiban
caplacizumab, tirofiban. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug.
- tisagenlecleucel
caplacizumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- vorapaxar
caplacizumab, vorapaxar. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
caplacizumab, vorapaxar. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. - zanubrutinib
caplacizumab, zanubrutinib. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.
Monitor Closely (4)
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of caplacizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of caplacizumab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of caplacizumab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- ublituximab
ublituximab and caplacizumab both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (0)
Adverse Effects
>10%
Epistaxis (29%)
Headache (21%)
Gingival bleeding (16%)
Fatigue (15%)
Urticaria (14%)
Pyrexia (13%)
Paresthesia (12%)
1-10%
Dyspnea (9%)
Back pain (7%)
Myalgia (6%)
Urinary tract infection (6%)
Vaginal hemorrhage (5%)
Rectal hemorrhage (4%)
Hematuria (4%)
Menorrhagia (4%)
Abdominal wall hematoma (3%)
Postmarketing Reports
Injection site erythema
Warnings
Contraindications
Documented hypersensitivity, including urticaria
Cautions
Bleeding
- Increases bleeding risk; severe bleeding (epistaxis, gingival bleeding, upper GI hemorrhage, metrorrhagia) observed in clinical trials
- Cases of life-threatening and fatal bleeding were reported
- Risk of bleeding is increased in patients with underlying coagulopathies (eg, hemophilia, other coagulation factor deficiencies)
- Avoid coadministration with antiplatelet agents or anticoagulants; interrupt use if clinically significant bleeding occurs; if restarted after bleed resolves, monitor closely for signs of bleeding
- If needed, von Willebrand factor concentrate may be administered to rapidly correct hemostasis or if emergent surgery needed
- Withhold for 7 days before surgery or other invasive interventions
Pregnancy
Pregnancy
Data are not available regarding use in pregnant women for risk of birth defects and miscarriage; however, there are potential risks of hemorrhage in the mother and fetus associated with caplacizumab use
Animal studies
- No evidence of adverse developmental outcomes with IM administration during organogenesis in guinea pigs at exposures ~30x the human AUC at the recommended SC 11-mg dose
Lactation
No data are available regrading presence in human milk, effects on breastfed infants, or on milk production
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Targets the A1-domain of von Willebrand factor (vWF), and inhibits the interaction between vWF and platelets; thereby, reducing both vWF-mediated platelet adhesion and platelet consumption
Absorption
Bioavailability (SC): ~90%
Peak plasma time: 6-7 hr
Peak plasma concentration: 348-528 ng/mL
AUC: 6808-7951 hr·rng/mL
Distribution
Vd: 6.33 L
Metabolism
Target-bound caplacizumab is metabolized within the liver
Because caplacizumab is a monoclonal antibody fragment, it is expected to be catabolized by various proteolytic enzymes
Elimination
Half-life: Concentration and target-level dependent
Excretion: Nonclinical data suggest unbound drug is cleared renally
Administration
IV Compatibilities
0.9% NaCl
D5W
IV or SC Preparation
Each carton contains 11-mg single-dose vial, 1-mL sterile water for injection prefilled glass syringe (diluent), sterile vial adapter, 30-gauge sterile needle, and 2 packaged alcohol swabs
Ensure vial and diluent syringe are at room temperature
Reconstitute vial using provided syringe containing 1 mL sterile water for injection to yield an 11-mg/mL single-dose solution
Using aseptic technique throughout the preparation of the solution, attach vial adapter to caplacizumab vial
Remove the plastic cap from syringe and attach it to the vial adapter by twisting it clockwise until it cannot twist any further
Slowly push syringe plunger down until the syringe is empty; do not remove syringe from the vial adapter
Gently swirl the vial until the cake or powder is completely dissolved; do not shake
Visually inspect reconstituted solution; it should appear clear and colorless
Withdraw all of the clear, colorless reconstituted solution from the vial into the syringe and label the syringe
IV or SC Administration
First dose (IV): Administered by healthcare provider as an IV bolus
For the initial IV injection, if using an IV line, the glass syringe should be connected to a standard Luer lock (and not a needleless connector) and flushed with either 0.9% NaCl or D5W
Subsequent SC doses
- Administer SC doses in abdomen; avoid injections around the navel
- Do not administer consecutive injections in the same abdominal quadrant
- Patients or caregivers may inject SC after proper training on the preparation and administration, including aseptic technique
Missed dose
- During plasma exchange period: Administer missed dose as soon as possible
- After the plasma exchange period: Administer missed dose within 12 hr of the scheduled time of administration; if beyond 12 hr, skip the missed dose and administer the next daily dose administered according to schedule
Withhold for surgery and other interventions
- Withhold treatment 7 days before elective surgery, dental procedures, or other invasive interventions
Storage
Unopened vial
- Refrigerate at 2-8°C (36-46°F) in original carton to protect from light
- Do not freeze
- Unopened vials may be stored in the original carton at room temperature up to 30°C (86°F) for a single period of up to 2 months
- Do not return to refrigerator after vial has been stored at room temperature
Reconstituted solution
- If not used immediately, refrigerate at 2-8°C (36-46°F) and use within 4 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Cablivi injection - | 11 mg kit |  |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
