Caplacizumab

What is Caplacizumab?

• Caplacizumab (Cablivi) is a von Willebrand factor (vWF)-directed antibody.

What are the uses of this medicine?

• This medicine is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

How does this medicine work?

• Caplacizumab - a humanized, bivalent anti-von willebrand factor (vwf) nanobody, with potential anti-platelet and anti-thrombotic activities.
• Upon administration, caplacizumab specifically binds, with its two identical monovalent moieties, to the a1 domain of the adhesive glycoprotein vwf, thereby inhibiting and neutralizing vwf activity.
• This prevents the interaction of ultra-large vwf (ulvwf) with the platelet glycoprotein (gp)ib-ix-v receptor complex, and prevents ulvwf-mediated platelet adhesion, and aggregation, which reduces thrombus formation.
• Vwf is a glycoprotein and plays a key role in blood coagulation.
• Increased vwf, which is seen in a number of diseases, is associated with an increased risk in thrombosis; in thrombotic thrombocytopenic purpura (ttp), increased levels of ulvwf and thus increased and abnormal platelet aggregation are seen due to impaired breakdown of ulvwf.
• The nanobody formulation allows for rapid distribution, onset of action and clearance.
• The nanobody is based on the smallest functional fragments of the immunoglobulin heavy-chain variable domains that occur naturally in the camelidae family.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of the excipients.
• Hypersensitivity reactions have included urticaria.

What drug interactions can this medicine cause?

• Concomitant use of Cablivi with any anticoagulant may increase the risk of bleeding.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage Cablivi should be administered upon initiation of plasma exchange therapy.

The recommended dose of Cablivi is as follows:

• First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1.
• Subsequent days of treatment during daily plasma exchange: 11 mg subcutaneous injection once daily following plasma exchange.
• Treatment after plasma exchange period: 11 mg subcutaneous injection once daily continuing for 30 days following the last daily plasma exchange. If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days.
• Discontinue Cablivi if the patient experiences more than 2 recurrences of aTTP, while on Cablivi.

• The first dose should be administered by a healthcare provider as a bolus intravenous injection. Administer subsequent doses subcutaneously in the abdomen.

Administration

• Ensure the Cablivi vial and diluent syringe are at room temperature.
• Reconstitute Cablivi before administration using the provided syringe containing 1 mL Sterile Water for Injection, USP, to yield an 11 mg/mL single-dose solution.
• Using aseptic technique throughout the preparation of the solution, attach the vial adapter to the vial containing Cablivi.
• Remove the plastic cap from the syringe and attach it to the vial adapter by twisting it clockwise until it cannot twist any further.
• Slowly push the syringe plunger down until the syringe is empty. Do not remove the syringe from the vial adapter.
• Gently swirl the vial until the cake or powder is completely dissolved. Do not shake.
• Visually inspect that the reconstituted solution is clear and colorless.
• Withdraw all of the clear, colorless reconstituted solution from the vial into the syringe. Label the Cablivi syringe.
• Administer the full amount of reconstituted solution.
• For the initial intravenous injection, if using an intravenous line, the glass syringe should be connected to a standard Luer lock (and not a needleless connector) and flushed with either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.
• Use the Cablivi solution immediately. If not, use Cablivi within 4 hours after reconstitution when stored in the refrigerator at 2°C to 8°C (36°F to 46°F).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 11 mg as a lyophilized powder in a single-dose vial.

This medicine is available in fallowing brand namesː

• Cablivi

What side effects can this medication cause?

The most common side effects of this medicine include:

• epistaxis
• headache
• gingival bleeding

What special precautions should I follow?

• Cablivi increases the risk of bleeding.
• Severe bleeding can occur, risk is increased in patients with underlying coagulopathies.
• If clinically significant bleeding occurs, interrupt treatment.
• Withhold Cablivi 7 days prior to elective surgery, dental procedures, or other invasive interventions.

What to do in case of emergency/overdose?

• In case of overdose, based on the pharmacological action of Cablivi, there is the potential for an increased risk of bleeding.

Management for overdosage

• Close monitoring for signs and symptoms of bleeding is recommended.
• If needed, the use of von Willebrand factor concentrate could be considered to correct hemostasis.

Can this medicine be used in pregnancy?

• There are no available data on Cablivi use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and effectiveness of Cablivi in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• caplacizumab

Inactive ingredients:

• anhydrous citric acid
• polysorbate 80
• sucrose
• trisodium citrate dihydrate

Who manufactures and distributes this medicine?

• Packager: Genzyme Corporation

What should I know about storage and disposal of this medication?

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the 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 Cablivi to the refrigerator after it has been stored at room temperature.

‎

• Dailymed label info on Caplacizumab
• FDA Caplacizumab

Caplacizumab Resources
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Latest articles - Caplacizumab

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‎ Source: Data courtesy of the U.S. National Library of Medicine. Since the data might have changed, please query MeSH on Caplacizumab for any updates.

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