The dosing regimen of CABLIVI in HERCULES resulted in proven efficacy and safety^1,2

CABLIVI treatment starts at the hospital and continues at home. Prior to discharge, patients or caregivers should be taught how to reconstitute and administer CABLIVI.

Learn about administering CABLIVI >

IN THE HOSPITAL

DAY 1

INITIATION OF CABLIVI
11-mg bolus IV injection before PEX* + 11-mg SC injection after PEX

VARIABLE

ADMINISTRATION DURING PEX PERIOD
11-mg SC injection daily after PEX

*Administer bolus dose at least 15 minutes prior to PEX.

If a dose of CABLIVI is missed during the PEX period, it should be given as soon as possible¹

AT HOME

30 DAYS

ADMINISTRATION AFTER PEX PERIOD
11-mg SC injection daily

UP TO 28 DAYS

TREATMENT EXTENSION (IF NEEDED^†)
11-mg SC injection daily

If a dose of CABLIVI is missed after the PEX period, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, the missed dose should be skipped and the next daily dose administered according to the usual dosing schedule¹

^†Administration can be continued for up to 28 additional days if signs of underlying disease persist, such as suppressed ADAMTS13 levels.

Discontinue CABLIVI if the patient experiences >2 recurrences of acquired/immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP) while on CABLIVI.
Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions.

In HERCULES, the median duration of treatment with CABLIVI was 35 days and mean days receiving PEX was approximately 6 days^2‡

HERCULES was a pivotal, phase 3, double-blind, randomized controlled trial of 145 patients with aTTP/iTTP assessing the efficacy and safety of CABLIVI in combination with PEX and immunosuppressive therapy.

Discover results from HERCULES >

For more support for your patients, enroll them in CABLIVI Patient Solutions

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SEE HOW

^‡In HERCULES, the mean number of days receiving PEX for patients receiving CABLIVI was 5.8 days.²
IV=intravenous; PEX=plasma exchange; SC=subcutaneous.

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.

IMPORTANT SAFETY INFORMATION

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:

Hemorrhage:

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.
In the postmarketing setting cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI.
The risk of bleeding is increased in patients with underlying coagulopathies (e.g. hemophilia, other coagulation factor deficiencies). It is also increased with concomitant use of CABLIVI with drugs affecting hemostasis and coagulation.
Avoid concomitant use of CABLIVI with antiplatelet agents or anticoagulants. 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 OR ANTIPLATELET AGENTS:

Concomitant use of CABLIVI with any anticoagulant or antiplatelet agent may increase the risk of bleeding. Avoid concomitant use when possible. 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.
Instructions For Use
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INDICATIONS

IMPORTANT SAFETY INFORMATION

References: 1. CABLIVI. Prescribing information. Genzyme Corporation. 2. Scully M, Cataland SR, Peyvandi F, et al; HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346. doi:10.1056/NEJMoa1806311

The CABLIVI® (caplacizumab-yhdp) dosing regimen

The dosing regimen of CABLIVI in HERCULES resulted in proven efficacy and safety1,2

DAY 1

INITIATION OF CABLIVI 11-mg bolus IV injection before PEX* + 11-mg SC injection after PEX

VARIABLE

ADMINISTRATION DURING PEX PERIOD 11-mg SC injection daily after PEX

If a dose of CABLIVI is missed during the PEX period, it should be given as soon as possible1

30 DAYS

ADMINISTRATION AFTER PEX PERIOD 11-mg SC injection daily

UP TO 28 DAYS

TREATMENT EXTENSION (IF NEEDED†) 11-mg SC injection daily

If a dose of CABLIVI is missed after the PEX period, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, the missed dose should be skipped and the next daily dose administered according to the usual dosing schedule1

Discontinue CABLIVI if the patient experiences >2 recurrences of acquired/immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP) while on CABLIVI. Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions.

In HERCULES, the median duration of treatment with CABLIVI was 35 days and mean days receiving PEX was approximately 6 days2‡

For more support for your patients, enroll them in CABLIVI Patient Solutions

Ease the transition from hospital to home

INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

CONCOMITANT USE OF ANTICOAGULANTS OR ANTIPLATELET AGENTS:

PREGNANCY:

INDICATIONS

IMPORTANT SAFETY INFORMATION

The CABLIVI^® (caplacizumab-yhdp) dosing regimen

The dosing regimen of CABLIVI in HERCULES resulted in proven efficacy and safety^1,2

INITIATION OF CABLIVI
11-mg bolus IV injection before PEX* + 11-mg SC injection after PEX

ADMINISTRATION DURING PEX PERIOD
11-mg SC injection daily after PEX

If a dose of CABLIVI is missed during the PEX period, it should be given as soon as possible¹

ADMINISTRATION AFTER PEX PERIOD
11-mg SC injection daily

TREATMENT EXTENSION (IF NEEDED^†)
11-mg SC injection daily

If a dose of CABLIVI is missed after the PEX period, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, the missed dose should be skipped and the next daily dose administered according to the usual dosing schedule¹

Discontinue CABLIVI if the patient experiences >2 recurrences of acquired/immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP) while on CABLIVI.
Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions.

In HERCULES, the median duration of treatment with CABLIVI was 35 days and mean days receiving PEX was approximately 6 days^2‡