CABLIVI safety profile in HERCULES1,2,4
|
Number of subjects (%) with: | CABLIVI + PEX + Immunosuppression
(n=71) | Placebo + PEX + Immunosuppression
(n=73) |
|
At least 1 TEAE | 69 (97.2) | 71 (97.3) |
|
At least 1 study-drug-related TEAE | 41 (57.7) | 32 (43.8) |
|
At least 1 TEAE leading to study-drug discontinuation | 5 (7.0) | 9 (12.3) |
|
At least 1 SAE | 28 (39.4) | 39 (53.4) |
|
At least 1 study-drug-related SAE | 10 (14.1) | 4 (5.5) |
|
At least 1 TEAE leading to death | 1 (1.4) | 3 (4.1) |
- There were no treatment-related deaths in patients treated with CABLIVI in the clinical studies2
In some cases, bleeding events were serious and required medical attention; however, most were self-limiting, and all resolved1
One patient died in the CABLIVI group during the treatment-free follow-up period. The cause of death was cerebral ischemia and was adjudicated as TTP related, but assessed by the investigator to be unrelated to treatment.2
In case of active, clinically significant bleeding, treatment with CABLIVI should be interrupted. If needed, the use of von Willebrand factor concentrate could be considered to correct hemostasis. CABLIVI should only be restarted upon the advice of a healthcare professional experienced in the management of thrombotic microangiopathies.1
SAE=serious adverse event; TEAE=treatment-emergent adverse event.
CABLIVI safety profile in HERCULES1 (cont’d)
Tabulated list of adverse reactions1
| System organ class | Very common
(≥1/10) | Common
(≥1/100) to <1/10) |
| Nervous system disorders | Headache | Cerebral infarction |
| Eye disorders | - | Eye hemorrhage |
| Vascular disorders | - | Hematoma |
| Respiratory, thoracic, and mediastinal disorders | Epistaxis | Dyspnea, hemoptysis |
| Gastrointestinal disorders | Gingival bleeding | Hematemesis, hematochezia, melena, upper gastrointestinal hemorrhage, hemorrhoidal hemorrhage, rectal hemorrhage, abdominal wall hematoma |
| System organ class | Very common
(≥1/10) | Common
(≥1/100 to <1/10) |
| Skin and subcutaneous | Urticaria | - |
| Musculoskeletal and connective tissue disorders | - | Myalgia |
| Renal and urinary disorders | - | Hematuria |
| Reproductive system and breast disorders | - | Menorrhagia, vaginal hemorrhage |
| General disorders and administration site conditions | Pyrexia, fatigue | Injection site hemorrhage, injection site pruritus, injection site erythema, injection site reaction |
| Injury, poisoning, and procedural complications | - | Subarachnoid hemorrhage |
CABLIVI has a favorable safety profile, with mucocutaneous bleeding (epistaxis and gingival bleeding) as the most frequently reported bleeding-related adverse event and no treatment-related deaths1