Complete† (CHR)
% 47% 21% 34%
(95% CI) (33,55) (12,33) (19,53)
Primary endpoint for patients with AP-CML, BP-CML, and Ph+ALL was MaHR, which combines complete hematologic responses and no evidence of leukemia.
†
CHR: WBC ≤ institutional ULN, ANC ≥1000/mm3, platelets ≥100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils <5% in peripheral blood, No extramedullary involvement (including no hepatomegaly or splenomegaly).
The median time to MaHR in patients with AP-CML, BP-CML, and Ph+ALL was 21 days (range: 12 to 176 days), 29 days (range 12 to 113 days), and 20 days (range: 11 to 168 days), respectively. The median duration of MaHR for patients with AP-CML, BP-CML, and Ph+ALL was 9.5 months (range: 1.1 to 17.7 months), 4.7 months (range: 1.8 to 14.1+ months), and 3.2 months (range: 1.8 to 8.8+ months), respectively.
How Supplied/Storage and Handling
Iclusig tablets are available in the following configurations:
Strength NDC Number Description Presentation
15 mg 76189-535-60 round, white, film-coated tablets with debossed "A5" on one side and plain on the other side 60 tablets in a wide-mouth white high density polyethylene (HDPE) bottle with child resistant closures that incorporate an induction heat seal liner
76189-535-80 180 tablets in a wide-mouth white high density polyethylene (HDPE) bottle with child resistant closures that incorporate an induction heat seal liner
45 mg 76189-534-30 round, white, film-coated tablets with debossed "AP4" on one side and plain on the other side 30 tablets in a wide-mouth white high density polyethylene (HDPE) bottle with child resistant closures that incorporate an induction heat seal liner
76189-534-90 90 tablets in a wide-mouth white high density polyethylene (HDPE) bottle with child resistant closures that incorporate an induction heat seal liner
Iclusig tablets should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15°to30° C (59° to 86° F) [see USP Controlled Room Temperature]. Keep away from children.
Patient Counseling Information
See FDA-Approved Patient Labeling (Medication Guide).
Advise patients of the following and provide a copy of the Medication Guide:
Thrombosis and Thromboembolism
Inform patients that serious arterial thromboses (including arterial stenosis sometimes requiring revascularization) and venous thromboembolism events have occurred. Advise patients to immediately contact their health care provider with any symptoms suggestive of a blood clot such as chest pain, shortness of breath, weakness on one side of the body, speech problems, leg pain, or leg swelling [see Warnings and Precautions (5.1)].
Hepatotoxicity
Inform patients of the possibility of developing liver function abnormalities and serious hepatic toxicity. Advise patients to immediately contact their health care provider if signs of liver failure occur, including yellowing of the eyes or skin, "tea"-colored urine, or drowsiness [see Warnings and Precautions (5.2)].
Congestive Heart Failure and Cardiac Arrhythmias
Inform patients of the possibility of congestive heart failure, and abnormally slow or fast hear
