• Bleeding disorders

Bleeding disorders:

Indications for CABLIVI:

For the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Adult:

Administer upon initiation of plasma exchange therapy. 1st bolus IV inj requires administration by healthcare provider. Give subsequent SC inj (after proper training) into the abdomen; rotate inj sites. Avoid inj around the navel. Day 1: Initially 11mg bolus IV inj at least 15mins prior to plasma exchange, then 11mg SC inj after plasma exchange completion. Subsequent Days (during daily plasma exchange): 11mg SC inj once daily following plasma exchange; (after plasma exchange period): 11mg SC inj once daily continuing for 30 days following the last daily plasma exchange; may further extend treatment for max 28 days if signs of persistent underlying disease are present (eg, suppressed ADAMTS13 activity levels). Discontinue if >2 recurrences of aTTP during treatment.

Children:

Not established.

Warnings/Precautions:

Increased risk of bleeding; interrupt treatment if severe; monitor closely. Withhold treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions. Severe hepatic impairment; monitor closely. Coagulopathy (eg, hemophilia, other coagulation factor deficiencies). Pregnancy, neonates: monitor closely. Nursing mothers.

Pharmacologic Class:

von Willebrand factor (vWF)-directed antibody fragment.

Interactions:

Concomitant anticoagulants may increase risk of bleeding; monitor closely.

Adverse Reactions:

Epistaxis, headache, gingival bleeding, fatigue, urticaria, pyrexia, paresthesia, dyspnea.

Generic Availability:

NO

How Supplied:

Single-dose vial—1 (w. diluent, supplies)