Cablivi ISTH Email

Cablivi caplacizumab-yhdp injection 11mg ISTH GUIDWLINES RECOMMEND CABLIVI* SEE START SUPPORT

ISTH Guidelines
recommend CABLIVI^1*

See aTTP^†—Diagnosis determined through clinical assessment

Start CABLIVI*—Consider early administration of CABLIVI in combination with PEX and immunosuppressive therapy

Support with ADAMTS13—ADAMTS13 results inform treatment decisions²

Dear [HCP],

The International Society on Thrombosis and Haemostasis (ISTH) published the first evidence-based, international guidelines on the diagnosis, treatment, and management of aTTP. The guidelines recommend CABLIVI*—the first and only therapy targeted to prevent microthrombi in adults with aTTP—be started in the early phase of acute aTTP events (initial or relapsing).^1-4

Explore the efficacy and safety of CABLIVI in combination with PEX and immunosuppressive therapy:

*	A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP. If ADAMTS13 testing is not available, do not add CABLIVI.

^†	The ISTH TTP Guidelines refer to aTTP as iTTP.

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 full Prescribing Information.

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aTTP=acquired thrombotic thrombocytopenic purpura; iTTP=immune thrombotic thrombocytopenic purpura; PEX=plasma exchange.

References: 1. Zheng XL, Vesely SK, Cataland SR, et al. ISTH guidelines for treatment of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020;(jth.15010). doi:10.1111/jth.15010 2. Zheng XL, Vesely SK, Cataland SR, et al. ISTH guidelines for the diagnosis of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020;(jth.15006). doi:10.1111/jth.15006 3. CABLIVI. Prescribing Information. Genzyme Corporation; 2019. 4. Scully M, Cataland SR, Peyvandi F, et al; for the HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346.

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