Iclusig

PONATINIB HYDROCHLORIDE

Manufacturer: Takeda Pharmaceuticals America, Inc.

Score: 144.0

Quick Summary

Iclusig is a kinase inhibitor used for the treatment of adult patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) and Chronic Myeloid Leukemia (CML). The drug has shown efficacy in achieving major cytogenetic responses and has a recommended dosage of 45 mg orally once daily, with dose adjustments based on patient response and tolerability. However, Iclusig has important safety warnings, including the risk of arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity, and is not recommended for patients with newly diagnosed chronic phase CML. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of adult patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Treatment of adult patients with Chronic Myeloid Leukemia (CML)
Achievement of major cytogenetic responses in patients with CML

Important Safety Information

Warning

Arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity

Contraindications

None

Adverse Reactions

Rash and related conditions
Arthralgia
Abdominal pain
Headache
Constipation
Dry skin
Hypertension
Fatigue
Fluid retention and edema
Pyrexia
Nausea
Pancreatitis/lipase elevation
Hemorrhage
Anemia
Hepatic dysfunction
Arterial occlusive events

Dosing Recommendations

General Guidance

Dose reductions to 30 mg orally once daily or 15 mg orally once daily are allowed for the management of adverse reactions

Newly Diagnosed Ph+ ALL

Adult Dose

30 mg orally once daily in combination with chemotherapy, with a reduction to 15 mg once daily upon achievement of MRD-negative CR at the end of induction

Pediatric Dose

Monotherapy for Ph+ ALL

Adult Dose

45 mg orally once daily

Pediatric Dose

CP-CML

Adult Dose

45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR::ABL1 IS

Pediatric Dose

Special Population Considerations

Pregnancy

ICLUSIG can cause fetal harm when administered to a pregnant woman
Advise pregnant women of the potential risk to a fetus

Nursing Mothers

No information available

Pediatric Use

Safety and effectiveness of ICLUSIG have not been established in pediatric patients

Geriatric Use

Patients aged 65 years or older are more likely to experience adverse reactions
Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy