Ponatinib 15 mg Tablet (Ponaxen)

What is Ponatinib?

Ponatinib 15 mg tablet (Ponaxen), a third-generation tyrosine kinase inhibitor, was first approved by the FDA on December 14, 2012, for the treatment of adult patients with Chronic Myeloid Leukemia (CML). Later, on March 19, 2024, accelerated approval was granted by the FDA for the treatment of adult patients with Philadelphia Chromosome Positive Acute Lymphoblastic Lymphoma (Ph+CML).

It was discovered and developed by ARIAD Pharmaceuticals and marketed with the brand name ICLUSIG. It is also available as a generic version (PONAXEN), which is manufactured and marketed by Everest Pharmaceuticals. 

Ponatinib Indications and Usage

This drug has been approved for the treatment of adult patients with

• Chronic phase, accelerated phase, and blast phase chronic myeloid leukemia (CML), when prior tyrosine kinase inhibitors did not work well enough.
• Later, it was also approved for the treatment of Philadelphia chromosome-positive acute lymphoblastic lymphoma (Ph+AML), when prior tyrosine kinase inhibitors did not work well enough.

How Does Ponatinib 15 mg (Ponaxen) Work in CML and Ph+ALL?

This medication targets and blocks specific cancer proteins that help cancer cells grow. In clinical studies, it has shown efficacy at stopping both the regular form of the BCR-ABL protein and a resistant type known as T315I, which is resistant to other tyrosine kinase inhibitors. It can also target other proteins, such as VEGFR, PDGFR, and FGFR. In animal studies, the treatment led to smaller tumor sizes, showing its strong potential to control cancers driven by these abnormal proteins.

Ponatinib Dose Information

The recommended dose for (CML and PH+AML) is 45 mg (three 15 mg tablets) daily once with or without food. Take the exact dose prescribed by your healthcare professional. Dosage modification or interruption for hematologic and non-hematologic toxicity depends on the patient’s tolerability and the doctor’s suggestion.

Ponatinib 15 mg (Ponaxen) Side Effects and Warnings

Thrombosis and Thromboembolism

Ponaxen 15 mg tablet may increase the risk of serious blood clots in the heart, brain, and blood vessels, where heart attacks, strokes, or blockages in the legs and arms have been reported during the treatment. Patients with high blood pressure, diabetes, high cholesterol, or a history of heart disease or smoking are at risk of these reactions. Blood clots in the veins, including deep vein thrombosis or pulmonary embolism, have also been reported. Your doctor may pause or stop treatment if such events occur.

Hepatotoxicity

It can cause serious liver problems, including liver failure and death. Some patients developed fatal liver failure within weeks of starting treatment. Elevated liver enzymes (ALT and AST), which signal liver injury, are common, occurring in more than half of patients, and sometimes remain unresolved. Due to these risk factors, the liver functions should be tested before starting treatment, and regular monitoring is necessary during and after the treatment. Inform your doctor immediately if you see yellowing of your eyes, yellowing skin, dark colored urine, and stool, or any other signs of jaundice.

Congestive heart failure

It can cause heart failure or reduce the heart’s pumping capability. In clinical studies, patients who took this medicaton 7% of them experienced heart-related problems, and 4 of them died from heart failure. Close monitoring is necessary for shortness of breath, swelling, or fatigue. Tell your doctor immediately if you see any of these signs.

Hypertension

Hypertension is not that common with this drug, but it can be serious during treatment. Call your doctor right away if it is severe. 

Pancreatitis

It can cause pancreatic inflammation sometimes leads to stopping the treatment. Most cases improved within two weeks after pausing or lowering the dose. High lipase levels, a sign of pancreatic irritation, were seen in about 40% of patients and should be monitored by the doctor frequently, especially in alcoholic patients. 

There are also other adverse reactions found in patients treated with Ponaxen tablet, such as

• Hemorrhage
• Fluid Retention 
• Cardiac Arrhythmias 
• Myelosuppression
• Tumor Lysis Syndrome
• Compromised Wound Healing and Gastrointestinal Perforation
• Embryo-Fetal Toxicity

What should I tell my doctor before taking the medication?

Tell about all your medical conditions, medicines you are taking, including prescription, non-prescription, dietary supplements, or herbal supplements. Tell them if you are 

• Pregnant or planning to get pregnant. Pregnancy is not safe during the treatment; your doctor will suggest that you use proper contraception.
• Breastfeeding or going to breastfeed. Active ingredients in Ponatinib tablets may pass through breast milk and can cause harm to children.
• Tell your doctor about your previous surgery. 
• Tell your doctor if you have heart problems, liver problems, Gastrointestinal problems, hematological problems, kidney problems, or any other problems with your internal organs.

Ponatinib Drug Interactions

Ponatinib may interact with drugs that affect liver enzymes, especially CYP3A inhibitors (like ketoconazole, clarithromycin) or inducers (like rifampin, phenytoin), which can alter its blood levels. Avoid using it with strong CYP3A modulators, anticoagulants, or herbal supplements such as St. John’s wort without medical advice.

Missed Dose

Take the missed dose as soon as possible. If it is closer to the next dose, skip the missed dose and go for the scheduled dose. Do not forget to inform your doctor if you miss several doses.

Storage and Handling

Store the medicine at room temperature, away from direct sunlight, children, and keep it in a dry place out of moisture. Keep the medication in the original container it comes with and out of children. Choose a safe method of disposal.

Frequently Asked Questions

How much does Ponaxen (Ponatinib) cost in Vietnam?

In Vietnam, the cost of 45 mg is 15207891 VND, and 15 mg costs 6336621 VND. To learn more about our prices and products, please contact Onus Pharma. 

Conclusion

Ponatinib 15 mg tablet (Ponaxen) is an advanced targeted therapy designed for patients with CML and Ph+ALL, especially those resistant to prior tyrosine kinase inhibitors. Its strong activity against T315I and other BCR-ABL mutations makes it a key option in difficult-to-treat cases. However, due to its potential side effects and drug interactions, treatment should always be guided and monitored by a qualified healthcare professional for safe and effective outcomes.

Disclaimer: Do not use this information as a medical substitute; always consult your doctor before taking any prescription medicine.