Ponaxen 45MG (Ponatinib)
Product Name : Ponaxen
Generic Name : Ponatinib
Formulation : Tablet
Available Pack Size : 30’s
Available Strengths : 45mg
Registrations : Bangladesh
Product Information
Ponaxen (Ponatinib) 45mg is a third-generation BCR-ABL tyrosine kinase inhibitor used to treat Chronic Myeloid Leukaemia (CML) and Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia (Ph+ ALL), and is the only approved TKI with activity against the treatment-resistant T315I mutation. It works by inhibiting the BCR-ABL fusion protein, the abnormal enzyme responsible for driving uncontrolled white blood cell production in these leukaemias, including in patients whose disease has become resistant to other TKIs. Manufactured by Everest Pharmaceuticals Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.
Basic Product Information of Ponaxen (Ponatinib) 45mg
| Brand Name | Ponaxen (Ponatinib) |
| Generic Name | Ponatinib (as Ponatinib Hydrochloride) INN |
| Drug Class | Third-Generation BCR-ABL Tyrosine Kinase Inhibitor |
| Available Strength | 45mg |
| Formulation | Film-Coated Tablet |
| Pack Size | 30 Tablets per Pack |
| Primary Indication | Chronic Myeloid Leukaemia and Philadelphia Chromosome-Positive ALL, Including T315I-Mutated Disease |
| Regulatory Approvals | USFDA Approved (CML and Ph+ ALL, Including T315I-Positive Disease). EMA Approved. Carries an FDA Boxed Warning for vascular occlusion, heart failure, and hepatotoxicity. |
| Originator Brand | Iclusig by Takeda |
| Manufacturer | Everest Pharmaceuticals Ltd., Dhaka, Bangladesh |
| Global Supplier | Mediaid Pharmacy, Worldwide Shipping Available |
| Registration | Registered in Bangladesh |
| Storage Conditions | Store below 30 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 potent, third-generation inhibitor of the BCR-ABL fusion protein, the abnormal, constitutively active tyrosine kinase produced by the Philadelphia chromosome. This fusion protein drives the uncontrolled proliferation of white blood cells seen in Chronic Myeloid Leukaemia and Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia.
Ponatinib was specifically engineered to retain potent activity against BCR-ABL even when the protein carries the T315I “gatekeeper” mutation, a resistance mutation that renders earlier-generation BCR-ABL inhibitors ineffective. This makes Ponaxen a critical option for patients who have exhausted other TKI therapies due to resistance or intolerance.
Ponaxen is taken as a once-daily oral tablet, with the starting dose and subsequent adjustments individualised based on treatment response and tolerability, given its significant vascular safety profile described below.
Indications for Ponaxen (Ponatinib)
Ponaxen (Ponatinib) is indicated for the following conditions:
|
T315I-Positive CML or Ph+ ALL For adult patients with chronic-phase, accelerated-phase, or blast-phase CML, or Ph+ ALL, that is T315I-mutation positive, as detected by an approved test. |
CML or Ph+ ALL Resistant/Intolerant to Prior TKI Therapy For adult patients with chronic-phase, accelerated-phase, or blast-phase CML, or Ph+ ALL, for whom no other TKI therapy is indicated. |
Benefits of Ponaxen (Ponatinib) 45mg
|
Only TKI Active Against T315I Ponaxen is the only approved BCR-ABL TKI with meaningful activity against the T315I resistance mutation, a critical option when other TKIs have failed. |
Clean, Single-Tablet Standard Dosing The 45mg strength delivers the standard starting CML dose as a single tablet, rather than requiring multiple lower-strength tablets combined together. |
Option for Multi-TKI-Resistant Disease For patients whose CML or Ph+ ALL is resistant or intolerant to earlier-generation TKIs, Ponaxen offers continued treatment potential where other options have been exhausted. |
|
Affordable Alternative to Iclusig Ponaxen contains the same active ingredient as Iclusig by Takeda, at a significantly lower cost, making this critical later-line therapy more financially accessible. |
Companion Strength Available Mediaid Pharmacy also stocks Ponaxen 15mg, allowing physicians to reach the reduced maintenance dose and the Ph+ ALL starting dose precisely. |
WHO-GMP Certified Manufacturing Produced by Everest Pharmaceuticals Ltd. under WHO-GMP-compliant manufacturing standards, helping ensure consistent quality, purity, and potency in every batch of Ponaxen tablets. |
How to Take Ponaxen (Ponatinib)
Route: Oral, with or without food. Tablets should be swallowed whole and not crushed or chewed.
Standard starting dose for CML: 45mg (one tablet) once daily. Once a defined level of treatment response is achieved, the dose is typically reduced to 15mg once daily to help lower the risk of arterial occlusive events, using the companion 15mg strength; exact timing and target dose are determined by the prescribing haemato-oncologist.
Standard starting dose for Ph+ ALL: 30mg once daily (using two 15mg tablets), rather than the 45mg strength; please refer to the companion Ponaxen 15mg product for this indication, or confirm the correct tablet combination with your prescribing physician.
Missed dose: If a dose is missed by more than 12 hours, skip that dose and take the next dose at its normal scheduled time; do not double up doses.
Dose modification for toxicity: Dose interruption, reduction, or discontinuation may be required to manage arterial occlusion, venous thromboembolism, heart failure, hepatotoxicity, pancreatitis, or hypertension, according to defined steps directed by the prescribing physician.
Hepatic impairment: A reduced starting dose is recommended in patients with hepatic impairment; consult your physician for specific guidance.
Paediatric use: The safety and efficacy of Ponaxen in paediatric patients have not been established. No data are currently available.
Monitoring and Dosage Adjustments
Regular monitoring is essential throughout Ponaxen treatment. Your haemato-oncologist will assess cardiovascular risk factors before starting treatment and periodically thereafter, monitor blood pressure, liver function tests monthly or as clinically indicated, and signs of heart failure. Monitoring also includes periodic complete blood counts, lipase or amylase if pancreatitis is suspected, and assessment for signs of thrombosis. Report any chest pain, weakness or numbness on one side of the body, difficulty speaking, leg swelling or pain, sudden breathlessness, severe abdominal pain, or yellowing of the skin or eyes to your doctor immediately.
Drug Interactions and Important Information
Avoid concomitant use of Ponaxen with strong CYP3A4 inhibitors where possible; if unavoidable, a dose reduction is required, as directed by the prescribing physician. Avoid concomitant use with strong CYP3A4 inducers, as these may reduce Ponatinib effectiveness. Avoid grapefruit and grapefruit juice during treatment.
Inform your physician of any personal or family history of cardiovascular disease, blood clots, or liver disease before starting treatment. Women of childbearing potential should use effective contraception during treatment. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Ponaxen.
Side Effects and Precautions
|
Common Side Effects Hypertension Rash and dry skin Fatigue and abdominal pain Headache and constipation Arthralgia (joint pain) and nausea Elevated liver enzymes and low blood counts |
Serious Warnings and Precautions Arterial occlusive events, including fatal myocardial infarction and stroke. Venous thromboembolic events, and heart failure, including fatal cases. Hepatotoxicity, including fatal liver failure. Pancreatitis and severe hypertension. Embryo-foetal toxicity. Not recommended during pregnancy or breastfeeding. |
Who Should Use Ponaxen (Ponatinib)?
Ponaxen is suitable for adult patients with T315I-mutation positive CML or Ph+ ALL, and for adult patients with CML or Ph+ ALL for whom no other TKI therapy is appropriate, whether due to resistance or intolerance to prior treatment. It is prescribed by haemato-oncologists experienced in managing BCR-ABL-driven leukaemias and the significant cardiovascular and hepatic risks associated with this therapy. A thorough medical assessment including BCR-ABL mutation testing, cardiovascular risk evaluation, and liver function 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 WHO-GMP-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 a bioequivalent alternative to Iclusig by Takeda 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 treatment option for CML and Ph+ ALL patients who have exhausted other TKI therapies, including those with the treatment-resistant T315I mutation. As the generic equivalent of Iclusig by Takeda, it delivers the same active ingredient, Ponatinib, with the same proven BCR-ABL inhibition mechanism at a dramatically more affordable price. Manufactured by Everest Pharmaceuticals Ltd. under WHO-GMP-compliant standards and distributed globally by Mediaid Pharmacy, Ponaxen gives patients worldwide access to this essential later-line 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 used to treat adult patients with Chronic Myeloid Leukaemia or Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia, particularly disease carrying the T315I resistance mutation, or disease resistant or intolerant to other TKI therapies. It works by blocking the abnormal BCR-ABL protein that drives these leukaemias.
How should I take Ponaxen (Ponatinib)?
Ponaxen is taken orally, once daily, with or without food. The standard CML starting dose is 45mg (one tablet), often reduced to 15mg once a response is achieved. Ph+ ALL uses a 30mg starting dose made up of 15mg tablets. Always follow your haemato-oncologist’s exact instructions, as dosing is individualised and closely tied to safety monitoring.
What strength is this Ponaxen product available in?
This Ponaxen pack is a 45mg tablet, supplied in a pack of 30 tablets. A companion 15mg strength is also available, needed for dose reduction after response, and for the Ph+ ALL starting dose.
Is Ponaxen the same as Iclusig (Ponatinib by Takeda)?
Yes. Ponaxen is the generic equivalent of Iclusig. Both contain the same active ingredient, Ponatinib, and work through the same BCR-ABL inhibition mechanism. 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 high blood pressure, rash, fatigue, joint pain, and nausea. Ponaxen carries a boxed warning for serious blood clots, heart failure, and liver damage, which is why close cardiovascular and liver monitoring is required throughout treatment. Always consult your haemato-oncology team for a complete assessment of your individual risks and benefits before starting treatment.
Can Ponaxen be used with other medications?
Ponaxen should not be combined with strong CYP3A4 inducers, and requires a dose reduction if a strong CYP3A4 inhibitor cannot be avoided. Avoid grapefruit products during treatment. Always inform your physician of all medications, supplements, and herbal products you are taking before starting Ponaxen.
Is Ponaxen (Ponatinib) safe during pregnancy or breastfeeding?
No. Ponaxen is not recommended during pregnancy or breastfeeding, as it can cause foetal harm. Women of childbearing potential should use effective contraception during treatment. 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) 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) 45mg with Worldwide Shipping
Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com
