CABLIVI safety was established in more than 100 patients across 2 studies¹*

Most frequent adverse reactions in phase 2 and phase 3 clinical studies

CABLIVI + PEX + Immunosuppressive Therapy N=106 n (%)

Placebo + PEX + Immunosuppressive Therapy N=110 n (%)

GI disorders

Gingival bleeding

Rectal hemorrhage

Abdominal wall hematoma

17 (16)

4 (4)

3 (3)

0 (0)

1 (1)

General disorders and administration site conditions

Fatigue

Pyrexia

Injection site hemorrhage

Catheter site hemorrhage

Injection site pruritus

16 (15)

14 (13)

6 (6)

3 (3)

10 (9)

12 (11)

1 (1)

5 (5)

0 (0)

Musculoskeletal and connective tissue disorders

Back pain

Myalgia

7 (7)

6 (6)

4 (4)

2 (2)

Nervous system disorders

Headache

Paresthesia

22 (21)

13 (12)

15 (14)

11 (10)

Renal and urinary disorders

Urinary tract infection

Hematuria

6 (6)

4 (4)

3 (3)

Reproductive system and breast disorders

Vaginal hemorrhage

Menorrhagia

5 (5)

4 (4)

2 (2)

1 (1)

Respiratory, thoracic, and mediastinal disorders

Epistaxis

Dyspnea

31 (29)

10 (9)

6 (6)

5 (5)

Skin and subcutaneous tissue disorders

Urticaria^†

15 (14)

7 (6)

Severe bleeding was reported in 1% of patients for each of the following events:

Epistaxis
Gingival bleeding
Upper GI hemorrhage
Metrorrhagia

View Study Design

GI=gastrointestinal; PEX=plasma exchange.

*Adverse reactions reported in ≥2% of patients treated with CABLIVI and that occurred more frequently than placebo during the blinded periods of the phase 2 and phase 3 studies.¹

^†Urticaria was seen during PEX.¹

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.

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.

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.

CABLIVI safety was established in more than 100 patients across 2 studies¹*

Most frequent adverse reactions in phase 2 and phase 3 clinical studies

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

CONCOMITANT USE OF ANTICOAGULANTS:

PREGNANCY:

INDICATIONS:

CABLIVI safety was established in more than 100 patients across 2 studies1*

Most frequent adverse reactions in phase 2 and phase 3 clinical studies

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

CONCOMITANT USE OF ANTICOAGULANTS:

PREGNANCY:

INDICATIONS:

CABLIVI safety was established in more than 100 patients across 2 studies¹*