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Manufacturer / Innovator:
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Iclusig (ponatinib) is an oral tyrosine kinase inhibitor (TKI) designed to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), particularly in patients whose disease is resistant to other TKIs or who carry the T315I mutation, which makes leukemia cells resistant to most other BCR-ABL inhibitors.
Iclusig is FDA-approved for adult patients with T315I-positive CML (chronic, accelerated, or blast phase) or T315I-positive Ph+ ALL, and for adults with chronic phase, accelerated phase, or blast phase CML, or Ph+ ALL, for whom no other tyrosine kinase inhibitor therapy is indicated.
Ponatinib inhibits the BCR-ABL fusion protein that drives uncontrolled white blood cell proliferation in CML and Ph+ ALL, including the T315I-mutant form that evades other approved TKIs.
The standard starting dose is 45 mg orally once daily, with dose modifications based on response and tolerability. Lower starting doses (such as 15 mg or 30 mg) may be used depending on disease phase and cardiovascular risk assessment, at the treating hematologist's discretion.
Boxed Warning — Iclusig: Iclusig carries an FDA boxed warning for arterial occlusive events, venous thromboembolic events, heart failure, and hepatotoxicity. Serious and fatal arterial occlusive events, including myocardial infarction, stroke, stenosis of large arterial vessels, and severe peripheral vascular disease, have occurred in Iclusig-treated patients. Because of this risk, Iclusig is available only through a restricted distribution program called the Iclusig REMS.
Monitor for evidence of thrombosis and vascular occlusion. Interrupt or discontinue Iclusig for new or worsening events.
Fatal and serious heart failure or left ventricular dysfunction has occurred. Monitor cardiac function throughout treatment.
Monitor liver function tests before and during treatment; dose modification or discontinuation may be required.
Monitor and manage blood pressure; treatment interruption may be needed for severe hypertension.
Check lipase periodically; interrupt or reduce dose for pancreatitis.
Monitor complete blood counts regularly, particularly during the first months of treatment.
Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.
Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.
Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.
Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.
Iclusig (ponatinib) received initial FDA accelerated approval in December 2012 and is manufactured by Takeda Pharmaceutical Company Limited. Due to its boxed warning for vascular occlusive events, Iclusig is dispensed only through a restricted distribution program (REMS) in the US.
Import of Iclusig through a Named Patient Program requires a valid prescription from the treating hematologist/oncologist, confirmation of BCR-ABL mutation status (including T315I testing where relevant), and supporting clinical documentation as required by Indian regulatory authorities.
NPP sources Iclusig directly from Takeda's authorized supply chain to ensure product authenticity and regulatory compliance.
Iclusig is sourced through verified, GDP-compliant channels from Takeda's authorized supply chain to ensure authenticity and quality.
Iclusig tablets should be stored at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F).
Once sourced, Iclusig is packed and transported under appropriate temperature-controlled conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.
Patients across India can access Iclusig through NPP's regulated import pathway, with hematology-oncology specialists in major cities supporting the treatment process.
Leading hematology-oncology centers in Mumbai support BCR-ABL mutation testing and treatment coordination for Iclusig access.
Delhi's major cancer hospitals assist patients with molecular testing and prescription support for Iclusig.
Bangalore's oncology network offers access to mutation testing and treatment planning for eligible CML/ALL patients.
Chennai-based specialists coordinate Iclusig access alongside comprehensive leukemia care.
Hyderabad's cancer care institutions support patients pursuing Iclusig therapy following confirmed T315I or resistant-disease status.
Kolkata's oncology centers help coordinate documentation and treatment access for Iclusig.
Pune-based hematologists assist with mutation testing and Iclusig treatment planning.
Ahmedabad's specialty hospitals support the import and treatment process for Iclusig.
Kochi's oncology units assist patients with the documentation needed for Iclusig access.
Chandigarh's cancer care centers support Iclusig treatment coordination for patients from North India.
Jaipur's oncology specialists help patients navigate the Iclusig access process.
Lucknow-based cancer centers assist patients pursuing Iclusig therapy.
Bhubaneswar's oncology institutions support access to Iclusig for eligible patients.
Guwahati's specialists help coordinate Iclusig access for patients across the Northeast.
Patients in other cities across India can also access Iclusig through NPP's nationwide coordination network.
Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 09 September 2026
Sources: FDA • CDSCO
Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 09 September 2026
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