CABLIVI Powder and Solvent for Solution for Injection

Caplacizumab

10 mg

ABLYNX NV

Pack size	1 Glass Vial (Powder) + 1 Syringe (Solvent) + 1 Sterile Vial Adapter + 1 Sterile Needle + 2 Alcohol Swabs
Dispensing mode	POM
Source	BELGIUM
Agent	GULF DRUG LLC
Retail Price	20997.00 AED

Indications

CABLIVI Powder and Solvent for Solution for Injection is used for: Thrombotic Thrombocytopenia Purpura

Adult Dose

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 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

Child Dose

Renal Dose

Renal impairment No dosage adjustment required for any degree of renal impairment

Administration

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

Contra Indications

Documented hypersensitivity, including urticaria

Precautions

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

Pregnancy-Lactation

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

Interactions

Adverse Effects

Side effects of Caplacizumab : >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%)

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

Note

CABLIVI 10 mg Powder and Solvent for Solution for Injection manufactured by ABLYNX NV. Its generic name is Caplacizumab. CABLIVI is availble in United Arab Emirates. Farmaco UAE drug index information on CABLIVI Powder and Solvent for Solution for Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.