INDICATIONS AND IMPORTANT SAFETY INFORMATION
INDICATIONS:
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic
thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive
therapy.
CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to
caplacizumab-yhdp or to any of its excipients. Hypersensitivity reactions have included urticaria.
WARNINGS AND PRECAUTIONS:
Bleeding Risk:
• CABLIVI increases the risk of bleeding. In clinical studies, severe bleeding adverse reactions of
epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia were each
reported in 1% of subjects. Overall, bleeding events occurred in approximately 58% of patients
on CABLIVI versus 43% of patients on placebo. The risk of bleeding is increased, in patients with
underlying coagulopathies and concomitant use of CABLIVI with drugs affecting hemostasis.
• If clinically significant bleeding occurs, interrupt use of CABLIVI. Von Willebrand factor concentrate
may be administered to rapidly correct hemostasis. If CABLIVI is restarted, monitor closely for signs
of bleeding.
• Withhold CABLIVI for 7 days prior to elective surgery, dental procedures or other invasive
interventions. If emergency surgery is needed, the use of von Willebrand factor concentrate may be
considered to correct hemostasis. After the risk of surgical bleeding has resolved, and CABLIVI is
resumed, monitor closely for signs of bleeding.
ADVERSE REACTIONS:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and
gingival bleeding (16%).
CONCOMITANT USE OF ANTICOAGULANTS:
Concomitant use of CABLIVI with any anticoagulant may increase the risk of bleeding. Assess and
monitor closely for bleeding with concomitant use.
PREGNANCY:
There are no available data on CABLIVI use in pregnant women to inform a drug associated risk of major
birth defects and miscarriage.
• Fetal/neonatal adverse reactions: CABLIVI may increase the risk of bleeding in the fetus and
neonate. Monitor neonates for bleeding.
• Maternal adverse reactions: All patients receiving CABLIVI, including pregnant women, are at
risk for bleeding. Pregnant women receiving CABLIVI should be carefully monitored for evidence of
excessive bleeding.
Please see accompanying full Prescribing Information.
