caplacizumab (Rx)

Brand and Other Names:Cablivi, caplacizumab-yhdp
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and caplacizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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%)

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            Warnings

            Contraindications

            Documented hypersensitivity, including urticaria

            Cautions

            Bleeding

            • Increases bleeding risk; severe bleeding (epistaxis, gingival bleeding, upper GI hemorrhage, metrorrhagia) observed in clinical trials
            • Risk of bleeding is increased in patients with underlying coagulopathies (eg, hemophilia, other coagulation factor deficiencies)
            • Bleeding risk increased with coadministration with drugs affecting hemostasis and coagulation
            • 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
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            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.

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            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

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            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
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.