SEE aTTP/iTTP	START CABLIVI,* an established standard of care in aTTP/iTTP¹	STOP MICROTHROMBI FORMATION³
Diagnosis through clinical assessment	Consider early administration of CABLIVI in combination with PEX and immunosuppressive therapy	While awaiting ADAMTS13 results

2025 ISTH Guidelines updated: more evidence supports CABLIVI.³

CABLIVI treatment should start as early as possible (ideally within 3 days), as it blocks microthrombi formation in the absence of ADAMTS13³

ISTH Guidelines acknowledge the growing body of evidence for CABLIVI^3*:

CABLIVI^† may accelerate recovery, shorten hospital stays, and reduce the number of PEX sessions and exacerbations

Adding CABLIVI to PEX and immunosuppressive therapy may be more cost-effective for managing aTTP/iTTP than PEX alone

ISTH Guidelines are intended to describe common clinical considerations and/or procedural steps for the use of referenced products but may not be appropriate for every patient or case. Physicians will assess the patient’s individualized needs for medical care. Assessments appropriate to individual patients may vary depending upon the clinical judgment of the treating physician, and the patient’s need. Sanofi does not promote or encourage the use of its products outside their FDA-approved labeling.

^†In combination with PEX and immunosuppressive therapy.

Identifying aTTP/iTTP is crucial for initiation of an appropriate therapeutic strategy²

Clinical assessment²

Risk assessment tools^‡

Patient presentation prompting suspicion of aTTP:

Thrombocytopenia (<100 × 10⁹/L)
Evidence of microangiopathic hemolytic anemia
- Hb and hematocrit below reference range
- Low haptoglobin
- Elevated LDH
- Presence of schistocytes in peripheral blood smear
Relatively preserved renal function

Available risk assessment tools include:

PLASMIC score
French score

The higher the risk assessment score, the more likely patients have severe ADAMTS13 deficiency and aTTP/iTTP

^‡ISTH did not appraise the evidence for these 2 tools.

Recommended diagnostic and management strategy for initial, acute events with access to ADAMTS13 results within 7 days

Who should not start CABLIVI?

CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients
Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions

*A conditional recommendation defined as desirable effects of the recommendation outweighing the undesirable effects. Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP/iTTP. If ADAMTS13 testing is not available, do not add CABLIVI.
^§List includes laboratory tests and results only; exclusive of physical symptoms, such as petechiae.
^||Hb and hematocrit below reference range, low haptoglobin, elevated LDH, presence of schistocytes in peripheral blood smear.
^¶ISTH guidelines assume high likelihood of aTTP/iTTP based on clinical assessment or a formal clinical risk assessment tool (French or PLASMIC score) and timely access to ADAMTS13 (within 72 hours).

Adapted from ISTH Guidelines for Diagnosis of TTP.

According to the ISTH TTP Guidelines, treatment of relapses for a patient previously diagnosed with aTTP/iTTP could be started safely based on clinical grounds without the need for a confirmatory ADAMTS13 test²

DOWNLOAD THE ISTH TTP GUIDELINES INFOGRAPHIC

Timely access to ADAMTS13 results is key to providing optimal care for patients with aTTP/iTTP

Select US labs testing ADAMTS13 activity, inhibitors, and antibodies:

These listings do not constitute an endorsement by Sanofi and are not included in the ISTH Guidelines. The above is a selection of national laboratories offering ADAMTS13 tests for activity, inhibitor, and antibody testing. This is not an exhaustive list of labs that offer one or more of these tests or an endorsement of any lab. Other testing options may be available, including at local or regional laboratories. Content is current as of July 2020, and tests may not be available in all states. Please call laboratory to confirm test availability, sample shipping information, and all other logistics.

Choose CABLIVI upon clinical suspicion and block microthrombi formation

DISCOVER HOW

The CABLIVI dosing regimen starts in the hospital and continues at home

LEARN MORE

Who should not start CABLIVI?

CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients
Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions

ADAMTS13=a disintegrin and metalloproteinase with a thrombospondin type 1 motif, 13; aTTP/iTTP=acquired/immune-mediated thrombotic thrombocytopenic purpura; Hb=hemoglobin; ISTH=International Society on Thrombosis and Haemostasis; LDH=lactate dehydrogenase; MAHA=microangiopathic hemolytic anemia; PEX=plasma exchange.

INDICATION

CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:
CABLIVI is contraindicated in patients with 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, thrombolytic drugs, heparin 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:
In adults, the most common adverse reactions (>15% of patients) are epistaxis, headache, and gingival bleeding. In pediatric patients, the most frequently reported adverse reactions are epistaxis and tachycardia.

DRUG INTERACTIONS:
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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INDICATION

IMPORTANT SAFETY INFORMATION

References: 1. Zheng XL, Vesely SK, Cataland SR, et al. ISTH guidelines for treatment of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020;18(10):2496-2502. 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;18(10):2486-2495. doi:10.1111/jth.15006 3. Zheng XL, Al‑Housni Z, Cataland SR, et al; International Society on Thrombosis and Haemostasis. 2025 focused update of the 2020 ISTH guidelines for management of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2025;S1538-7836(25)00360-5. doi:10.1016/j.jtha.2025.06.002

ISTH Guidelines recommend CABLIVI® (caplacizumab-yhdp) in combination with PEX and immunosuppressive therapy for acute aTTP/iTTP events in adults—initial and relapsing1,2*

SEE aTTP/iTTP

START CABLIVI,*an established standard of care in aTTP/iTTP1

STOP MICROTHROMBI FORMATION3

2025 ISTH Guidelines updated: more evidence supports CABLIVI.3

CABLIVI treatment should start as early as possible (ideally within 3 days), as it blocks microthrombi formation in the absence of ADAMTS133

ISTH Guidelines acknowledge the growing body of evidence for CABLIVI3*:

Identifying aTTP/iTTP is crucial for initiation of an appropriate therapeutic strategy2

Diagnose aTTP/iTTP through clinical assessment or risk assessment tools prior to ADAMTS13 testing

START CABLIVI*—Consider early administration of CABLIVI in combination with PEX and immunosuppressive therapy1,2

According to the ISTH TTP Guidelines, treatment of relapses for a patient previously diagnosed with aTTP/iTTP could be started safely based on clinical grounds without the need for a confirmatory ADAMTS13 test2

Timely access to ADAMTS13 results is key to providing optimal care for patients with aTTP/iTTP

ARUP Labs

LabCorp

Machaon Diagnostics

Mayo Clinical Laboratories

Quest Diagnostics

Versiti

Choose CABLIVI upon clinical suspicion and block microthrombi formation

The CABLIVI dosing regimen starts in the hospital and continues at home

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

ISTH Guidelines recommend CABLIVI^® (caplacizumab-yhdp) in combination with PEX and immunosuppressive therapy for acute aTTP/iTTP events in adults—initial and relapsing^1,2*

START CABLIVI,*
an established standard of care in aTTP/iTTP¹

STOP MICROTHROMBI FORMATION³

2025 ISTH Guidelines updated: more evidence supports CABLIVI.³

CABLIVI treatment should start as early as possible (ideally within 3 days), as it blocks microthrombi formation in the absence of ADAMTS13³

ISTH Guidelines acknowledge the growing body of evidence for CABLIVI^3*:

Identifying aTTP/iTTP is crucial for initiation of an appropriate therapeutic strategy²

According to the ISTH TTP Guidelines, treatment of relapses for a patient previously diagnosed with aTTP/iTTP could be started safely based on clinical grounds without the need for a confirmatory ADAMTS13 test²