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) |
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) 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) |
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:
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
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.
Bleeding Risk:
The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
Concomitant use of CABLIVI with any anticoagulant may increase the risk of bleeding. Assess and monitor closely for bleeding with concomitant use.
There are no available data on CABLIVI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage.
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.