ICLUSIG 10/15/30/45 MG (PONATINIB)

What is Iclusig?

Iclusig is an oral kinase inhibitor that may be used to treat adults with:

• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in those who cannot receive any other kinase inhibitor medicines or have a specific type of abnormal gene (T315I-positive Ph+ ALL)
• Newly diagnosed Ph+ ALL in combination with chemotherapy (this approval is under the accelerated approval designation and is based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction)
• Chronic phase chronic myeloid leukemia (CML) who did not tolerate or no longer benefit from treatment with at least 2 prior kinase inhibitor medicines
• T315I-positive CML (chronic phase, accelerated phase, or blast phase)

💊 Medicine Name: Iclusig

• Generic Name: Ponatinib

• Brand Name: Iclusig

• International Manufacturer: Takeda Pharmaceuticals (originally developed by ARIAD Pharmaceuticals)

• Indian Importers: Indian Pharma Network, South Delhi Pharma, GNH India, 3S Corporation, etc.

🧪 Composition:

           Each tablet contains:

• Ponatinib Hydrochloride equivalent to:

• 15 mg or 45 mg of Ponatinib (base)

• Formulation: Film-coated tablet

🏷️ Drug Class:

• Tyrosine Kinase Inhibitor (TKI)

• Targets BCR-ABL fusion protein including the T315I mutation

Dosing information

           Usual Adult Dose for Chronic Myelogenous Leukemia:

Chronic phase chronic myeloid leukemia (CP-CML):
Initial Dose: 45 mg orally once a day
Upon achievement of 1% BCR-ABL1 or less (standardized according to International Scale): 15 mg orally once a day
For loss of response: Re-escalate to a previously tolerated dosage of 30 mg or 45 mg orally once a day

Accelerated phase chronic myeloid leukemia (AP-CML), blast phase chronic myeloid leukemia (BP-CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL):
-Initial dose: 45 mg orally once a day

Before taking this medicine

You should not use Iclusig if you are allergic to ponatinib.

To make sure Iclusig is safe for you, tell your doctor if you have ever had:

• heart failure, high blood pressure, heart rhythm problems;
• long QT syndrome (in you or a family member);
• a stroke or blood clot;
• diabetes;
• high cholesterol;
• liver disease;
• bleeding problems;
• lactose intolerance (tablets may contain lactose);
• pancreatitis; or
• if you’ve had surgery within the past 2 weeks.

⚠️ Important Considerations

• Prescription Requirement: A valid prescription from a registered medical practitioner is mandatory.

• Safety Monitoring: Regular monitoring is essential due to potential side effects, including cardiovascular events.

• Consultation: Always consult with your oncologist or hematologist before initiating therapy.