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Caplacizumab(Cablivi)

Acetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine InjectionAcetylcysteine Injection, FLUIMUCIL, Acetylcysteine Injection

Reference price:

Manufacturer:

Formulation:

INJECTION

Validity period:

The shelf-life of the unopened, un-reconstituted vial is not explicitly stated in the provided excerpts.

Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.

CABLIVI (caplacizumab-yhdp) is a recombinant, monoclonal antibody fragment that specifically targets von Willebrand factor (vWF). This targeted mechanism helps prevent the formation of microthrombi in the microcirculation by inhibiting the interaction between vWF and platelets, which is central to the pathogenesis of acquired thrombotic thrombocytopenic purpura (aTTP). As part of the treatment regimen for aTTP, CABLIVI is used in combination with plasma exchange and immunosuppressive therapy. This combination provides a multifaceted approach to reduce the burden of thrombotic events, control platelet consumption, and mitigate organ damage, ultimately improving patient outcomes.

Administered through intravenous and subcutaneous routes, CABLIVI provides flexibility in treatment delivery. The recommended dosage schedule involves an initial bolus intravenous injection, followed by subcutaneous injections during the plasma exchange phase. Treatment continues for up to 30 days post-plasma exchange, with adjustments based on disease activity. Notably, CABLIVI has demonstrated efficacy in reducing aTTP relapse and improving recovery, although treatment may be extended in certain cases with persistent symptoms.

Generic name

Caplacizumab(Cablivi)

English name

Caplacizumab

Alternative Names

Cablivi

Drug prices

Indications

CABLIVI is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Therapeutic Target

A1-domain of von Willebrand factor (vWF). By binding to vWF

Active Ingredients

Each single-dose vial contains 11 mg of caplacizumab-yhdp.

Dosage form

INJECTION

specifications

Supplied as a single-dose vial containing 11 mg of caplacizumab-yhdp lyophilized powder.

Description

Caplacizumab-yhdp is a von Willebrand factor (vWF)-directed antibody fragment. It consists of two identical humanized building blocks linked by a three-alanine linker. Caplacizumab-yhdp is produced in Escherichia coli by recombinant DNA technology and has an approximate molecular weight of 28 kDa. CABLIVI (caplacizumab-yhdp) for injection is supplied as a sterile, white, preservative-free, lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, USP, it yields an 11 mg/mL single-dose solution.

Dosage and Administration

General: CABLIVI should be administered upon initiation of plasma exchange therapy.

First Day of Treatment:

An 11 mg bolus intravenous injection administered at least 15 minutes prior to plasma exchange.

Followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1.

Subsequent Treatment During Daily Plasma Exchange:

An 11 mg subcutaneous injection once daily following plasma exchange.

Treatment After the Plasma Exchange Period:

An 11 mg subcutaneous injection once daily for 30 days beyond the last plasma exchange.

If signs of persistent underlying disease (e.g., suppressed ADAMTS13 activity levels) remain after the initial treatment course, treatment may be extended for a maximum of an additional 28 days.

Discontinuation: Discontinue CABLIVI if the patient experiences more than 2 recurrences of aTTP while on CABLIVI.

Administration Route: The first dose is administered by a healthcare provider as a bolus intravenous injection. Subsequent doses are administered subcutaneously in the abdomen (avoiding the navel and not using the same abdominal quadrant for consecutive injections). Patients or caregivers may administer subcutaneous injections after proper training.

Reconstitution: Reconstitute the 11 mg vial with 1 mL Sterile Water for Injection, USP, to yield an 11 mg/mL solution. The reconstituted solution should be clear and colorless. Use immediately or within 4 hours if stored refrigerated (2°C to 8°C or 36°F to 46°F).

Missed Dose:

During plasma exchange period: Administer as soon as possible.

After plasma exchange period: Administer if within 12 hours of the scheduled time. If beyond 12 hours, skip the missed dose and administer the next dose at the usual scheduled time.

Surgery and Other Interventions: Withhold CABLIVI 7 days prior to elective surgery, dental procedures, or other invasive interventions.

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