Safety Profile of ICLUSIG (ponatinib) in the PACE trial
PACE established the safety profile for ICLUSIG in patients with Ph+ ALL1
Adverse Reactions (≥20%) in Patients with Ph+ ALL
aDerived from BP measurement.
bSepsis includes abdominal sepsis, bacteremia, device-related sepsis, escherichia bacteremia, fungemia, klebsiella bacteremia, klebsiella sepsis, neutropenic sepsis, sepsis, septic shock, staphylococcal bacteremia, staphylococcal sepsis, streptococcal bacteremia, and urosepsis. Graded using Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Serious Adverse Reactions2
Serious adverse reactions occurred in 69% of patients who received ICLUSIG. Serious adverse reactions in >2% of patients included AOEs (20%), pneumonia (10%), cardiac arrhythmias (8%), pancreatitis/lipase elevation (7%), abdominal pain (6%), cardiac failure (6%), hemorrhage (6%), sepsis (5%), VTEs (5%), fluid retention and edema (4.5%), pyrexia (4.5%), secondary malignancies (5%), anemia (3.3%), hypertension (3.1%), thrombocytopenia (3.1%), febrile neutropenia (2.9%), cellulitis (2.7%), and arthralgia (2.2%). Fatal adverse reactions occurred in 9% of patients who received ICLUSIG; the most frequent fatal adverse reactions were AOEs (2%), sepsis (1.6%), and hemorrhage (1.3%).
Arterial Occlusive Events2
26% of 449 patients experienced AOEs, of which 15%, 7%, and 11% experienced cardiovascular, cerebrovascular, and peripheral vascular AOEs, respectively. Some patients experienced recurrent or multisite vascular occlusion.
- Grade 3 or 4 AOEs occurred in 14% of patients; the most frequent Grade 3 or 4 AOEs were peripheral arterial occlusive disease (3.1%), myocardial infarction (2%), coronary artery disease (1.6%), and cerebral infarction (1.6%). Fatal AOEs occurred in 9 patients (2%); the most frequent fatal AOE was cardiac arrest (0.9%).
Permanent discontinuation of ICLUSIG due to an adverse reaction occurred in 21% of CP‑CML, 12% of AP-CML, 15% of BP-CML, and 9% of Ph+ ALL patients. The most frequent adverse reactions that led to treatment discontinuation were thrombocytopenia (4.5%) and AOEs (4%).
Please see the full Prescribing Information for a full list of adverse reactions.
Review the efficacy of ICLUSIG in Ph+ ALL
Discover the convenient dosing schedule for ICLUSIG
AOE=arterial occlusive effect; AP-CML=accelerated-phase chronic myeloid leukemia; BP=blood pressure; BP‑CML=blast phase chronic myeloid leukemia; CP‑CML=chronic phase chronic myeloid leukemia; Ph+ ALL=Philadelphia chromosome positive acute lymphoblastic leukemia; VTE=venous thromboembolic event; WBC=white blood cell.