Ponaxen 15MG & 45MG (Ponatinib)
Product Name : Ponaxen
Generic Name : Ponatinib
Formulation : Tablet
Available Pack Size : 30’s
Available Strengths : 15mg & 45mg
Registrations : Bangladesh
Product Information
Ponaxen (Ponatinib) 15mg and 45mg is a third-generation, multi-targeted BCR-ABL tyrosine kinase inhibitor (TKI) used to treat Chronic Myeloid Leukaemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) in adult patients, including those with the treatment-resistant T315I mutation. It works by blocking the constitutively active BCR-ABL fusion kinase that drives uncontrolled proliferation of leukaemic cells, and is the only approved TKI with activity against all known BCR-ABL resistance mutations. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Ponaxen (Ponatinib) 15mg and 45mg
| Brand Name | Ponaxen (Ponatinib) |
| Generic Name | Ponatinib (as Ponatinib Hydrochloride) INN |
| Drug Class | Third-Generation, Pan-BCR-ABL Tyrosine Kinase Inhibitor (TKI) |
| Available Strengths | 15mg and 45mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 30 Tablets per Pack (Each Strength) |
| Primary Indication | Chronic Myeloid Leukaemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia (Ph+ ALL), Including T315I-Mutated Disease |
| Regulatory Approvals | USFDA Approved (CML and Ph+ ALL). EMA Approved (CML and Ph+ ALL). |
| Originator Brand | Iclusig by Takeda (developed by ARIAD Pharmaceuticals) |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration | Registered in Bangladesh |
| Storage Conditions | Store between 20 and 25 degrees Celsius. Keep in a dry place away from light and moisture. Keep out of the reach of children. |
How Ponaxen (Ponatinib) Works
Ponaxen contains Ponatinib, a third-generation tyrosine kinase inhibitor developed using a computational, structure-based drug design approach to inhibit the BCR-ABL fusion kinase. In CML and Ph+ ALL, the Philadelphia chromosome creates an abnormal BCR-ABL protein that is constitutively active, driving uncontrolled proliferation and survival of leukaemic white blood cells.
Ponatinib was engineered with multiple contact points within the ABL kinase domain, allowing it to maintain high-affinity binding even in the presence of resistance mutations. This makes Ponaxen the only approved TKI with activity against the T315I gatekeeper mutation, a resistance mutation that renders imatinib, dasatinib, nilotinib, and bosutinib ineffective. By blocking BCR-ABL signalling across native and mutant forms of the protein, Ponaxen suppresses the growth of leukaemic cells and promotes their death.
Ponaxen is administered as a once-daily oral tablet, with treatment typically starting at a higher dose and reduced once an adequate molecular or cytogenetic response has been achieved, in order to balance sustained efficacy with long-term tolerability.
Indications for Ponaxen (Ponatinib)
Ponaxen (Ponatinib) is indicated for the following conditions:
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Chronic Phase CML For adult patients with chronic phase CML who are resistant or intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate. |
Accelerated or Blast Phase CML For adult patients with accelerated phase or blast phase CML for whom no other tyrosine kinase inhibitor therapy is clinically indicated. |
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Ph+ Acute Lymphoblastic Leukaemia For adult patients with Philadelphia chromosome-positive ALL who are resistant or intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate. |
T315I-Positive Disease For adult patients with T315I-positive CML (any phase) or T315I-positive Ph+ ALL, a resistance mutation not covered by any other approved TKI. |
Benefits of Ponaxen (Ponatinib) 15mg and 45mg
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Only TKI Active Against T315I Ponaxen is the only approved tyrosine kinase inhibitor with activity against the T315I gatekeeper mutation, offering a treatment option for patients who have exhausted other TKI therapies. |
Two Strengths for Clean Dosing With both 15mg and 45mg tablets available, the standard starting dose and the reduced maintenance dose can each be taken as a single tablet, simplifying day-to-day dosing. |
Dose-Optimised Treatment Strategy Treatment can begin at a higher dose and reduce to the 15mg maintenance dose once a meaningful response is achieved, helping balance long-term efficacy with tolerability. |
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Affordable Alternative to Iclusig Ponaxen contains the same active ingredient as Iclusig, at a significantly lower cost, making long-term third-generation TKI therapy more financially accessible to patients worldwide. |
Combination Regimen Compatible In Ph+ ALL, Ponaxen can be used in combination with chemotherapy protocols, giving haemato-oncologists flexibility in structuring induction and consolidation regimens. |
cGMP Certified Manufacturing Produced by Everest Pharmaceuticals Ltd. under cGMP-compliant manufacturing standards, helping ensure consistent quality, purity, and potency in every batch of Ponaxen tablets. |
How to Take Ponaxen (Ponatinib)
Route: Oral, taken by mouth. Tablets should be swallowed whole and not chewed, crushed, dissolved, or divided.
Standard dose for resistant/intolerant CP-CML: 45mg (one 45mg tablet) once daily, with dose reduction to 15mg (one 15mg tablet) once daily considered upon achievement of an adequate molecular response, exactly as directed by the prescribing haemato-oncologist.
Standard dose for AP-CML, BP-CML, and T315I-positive disease: 45mg (one 45mg tablet) once daily, continued until loss of response or unacceptable toxicity.
Standard dose for Ph+ ALL (in combination with chemotherapy): 30mg (two 15mg tablets) once daily, reduced to 15mg (one 15mg tablet) once daily upon achievement of MRD-negative complete remission at the end of induction.
With food: Can be taken with or without food, at approximately the same time each day.
Missed dose: If a dose is missed, take it as soon as remembered on the same day; if it is close to the next scheduled dose, skip the missed dose and resume the normal schedule. Do not double up doses.
Hepatic impairment: Patients with hepatic impairment may generally receive the recommended starting dose; caution and closer monitoring are advised, and dose reduction may be required at the discretion of the prescribing physician.
Renal impairment: Ponatinib has not been extensively studied in renal impairment. Patients with creatinine clearance above 50 mL/min require no dose adjustment; caution is recommended below this threshold or in end-stage renal disease.
CYP3A4 interactions: Avoid coadministration with strong CYP3A4 inhibitors where possible, or reduce the dose if unavoidable. Avoid coadministration with strong CYP3A4 inducers, as these reduce Ponatinib plasma exposure.
Paediatric use: The safety and efficacy of Ponaxen in patients under 18 years of age have not been established. No data are currently available.
Monitoring and Dosage Adjustments
Regular monitoring is essential throughout Ponaxen treatment. Your haemato-oncologist will monitor for signs of arterial occlusion (chest pain, numbness, vision changes, or limb pain), venous thromboembolism, and cardiac function, including periodic assessment of blood pressure and, where indicated, echocardiography. Monitoring also includes liver function tests at baseline and periodically during treatment, complete blood counts for myelosuppression, serum lipase and amylase to monitor for pancreatitis, and BCR-ABL1 transcript levels to guide dose reduction decisions. Report any chest pain, breathlessness, sudden weakness, severe abdominal pain, unusual bruising or bleeding, or swelling of the legs to your doctor immediately.
Drug Interactions and Important Information
Avoid concomitant use of Ponaxen with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, clarithromycin, and ritonavir) where possible; if coadministration cannot be avoided, dose reduction as directed by the prescribing physician is required. Avoid concomitant use with strong CYP3A4 inducers (such as rifampicin, carbamazepine, phenytoin, and St. John’s Wort), as these substantially reduce Ponatinib plasma exposure and may reduce efficacy.
Use with caution alongside other medicines affecting coagulation or platelet function, and inform your physician of any history of pancreatitis, cardiovascular disease, or hypertension before starting treatment. Women of childbearing potential should verify pregnancy status before initiating treatment and use effective contraception during therapy. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Ponaxen.
Side Effects and Precautions
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Common Side Effects Hypertension Rash and dry skin Abdominal pain and constipation Headache and dizziness Fatigue and decreased appetite Arthralgia and musculoskeletal pain Nausea and pyrexia Low platelet and blood cell counts |
Serious Warnings and Precautions Arterial occlusive events, including fatal myocardial infarction, stroke, and severe peripheral vascular disease. Venous thromboembolic events, including deep vein thrombosis and pulmonary embolism. Heart failure and cardiac dysfunction, including fatal cases. Hepatotoxicity, including cases of liver failure. Pancreatitis and severe haemorrhage. Severe myelosuppression requiring dose interruption or transfusion support. Embryo-foetal toxicity. Not recommended during pregnancy or breastfeeding. |
Who Should Use Ponaxen (Ponatinib)?
Ponaxen is suitable for adult patients diagnosed with chronic, accelerated, or blast phase Chronic Myeloid Leukaemia or Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia who are resistant or intolerant to prior TKI therapy, for whom imatinib is not clinically appropriate, or who carry the T315I resistance mutation. It is prescribed by haemato-oncologists experienced in managing leukaemia and TKI-related cardiovascular risk. A thorough medical assessment including cardiovascular risk evaluation, baseline liver function, blood counts, and BCR-ABL1 mutation testing is required before initiating treatment.
Manufacturer: Everest Pharmaceuticals Ltd.
Everest Pharmaceuticals Ltd. is a vertically integrated pharmaceutical company based in Dhaka, Bangladesh, focused on complex, technology-driven specialty medicines across oncology, nephrology, and virology. Operating under Bangladesh’s TRIPS/Doha Declaration exemption for least-developed countries, Everest manufactures advanced generics such as Ponaxen under cGMP-compliant standards, with the stated mission of making high-cost, life-saving medicines accessible and affordable to patients around the world. Ponaxen is one of Everest’s specialty oncology products, offering an affordable and bioequivalent alternative to Iclusig at a fraction of the cost.
Global Supplier: Mediaid Pharmacy with Worldwide Shipping
Mediaid Pharmacy is a trusted global supplier of specialty and oncology medications. We ensure Ponaxen (Ponatinib) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.
Why Choose Ponaxen (Ponatinib) from Mediaid Pharmacy?
Ponaxen represents a critical option for patients who have exhausted other tyrosine kinase inhibitor therapies. As the generic equivalent of Iclusig, it delivers the same active ingredient, Ponatinib, with the same pan-BCR-ABL inhibition mechanism, including activity against the T315I mutation, at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under cGMP-compliant standards and distributed globally by Mediaid Pharmacy, Ponaxen gives patients worldwide access to advanced leukaemia therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Ponatinib option with worldwide delivery, Ponaxen from Mediaid Pharmacy is the trusted choice.
Frequently Asked Questions About Ponaxen (Ponatinib)
What is Ponaxen (Ponatinib) used for?
Ponaxen (Ponatinib) is a third-generation BCR-ABL tyrosine kinase inhibitor used to treat adult patients with chronic, accelerated, or blast phase Chronic Myeloid Leukaemia, and Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia, including disease driven by the treatment-resistant T315I mutation. It is used when other TKIs are no longer effective, not tolerated, or not clinically appropriate.
How should I take Ponaxen (Ponatinib)?
Ponaxen is taken orally once daily, with or without food. Depending on the condition being treated, the starting dose is typically 45mg (one 45mg tablet) for CML/T315I disease or 30mg (two 15mg tablets) for Ph+ ALL, with dose reduction to 15mg (one 15mg tablet) once daily considered once an adequate response is achieved. Always follow your haemato-oncologist’s exact instructions, as dosing is individualised and closely monitored.
What strengths is Ponaxen (Ponatinib) available in?
Ponaxen is available in 15mg and 45mg film-coated tablets, each supplied in a pack of 30 tablets. Having both strengths available means the standard starting dose and the reduced maintenance dose can each be taken as a single tablet, exactly as prescribed by your haemato-oncologist.
Is Ponaxen the same as Iclusig (Ponatinib)?
Yes. Ponaxen is the generic equivalent of Iclusig. Both contain the same active ingredient, Ponatinib, and work through the same pan-BCR-ABL inhibition mechanism, including activity against the T315I resistance mutation. Ponaxen is manufactured by Everest Pharmaceuticals Ltd. in Bangladesh and offers the same clinical mechanism as Iclusig at a significantly lower cost.
What are the side effects of Ponaxen (Ponatinib)?
Common side effects include hypertension, rash, abdominal pain, fatigue, headache, and low blood counts. Ponaxen carries a boxed warning for serious risks including arterial occlusive events, venous thromboembolism, heart failure, and hepatotoxicity. Always consult your haemato-oncologist for a complete assessment of your individual risks and benefits, including cardiovascular risk, before starting treatment.
Can Ponaxen be combined with other cancer medications?
In Ph+ ALL, Ponaxen is often used in combination with chemotherapy protocols under close haemato-oncology supervision. It should not be combined with strong CYP3A4 inhibitors or inducers without a physician-directed dose adjustment, and caution is needed with medicines affecting coagulation or platelet function.
Is Ponaxen (Ponatinib) safe during pregnancy or breastfeeding?
No. Ponaxen is not recommended during pregnancy or breastfeeding, as it can cause foetal harm. Pregnancy status should be verified before starting treatment, and effective contraception should be used during therapy. Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.
Can I order Ponaxen (Ponatinib) online with worldwide shipping?
Yes. Mediaid Pharmacy supplies Ponaxen (Ponatinib) 15mg and 45mg globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.
Order Ponaxen (Ponatinib) 15mg and 45mg with Worldwide Shipping
Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com
