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These brands contain the same active ingredient (Ponatinib Hydrochloride). Same strength and form. Confirm the switch with your doctor or pharmacist.
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Other strengths and forms by General Pharmaceuticals Ltd.
Indications & Uses
Chronic Myeloid Leukemia (CML): Ponatinib Hydrochloride is used in adults with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML). It is meant for people who are resistant to dasatinib or nilotinib, or who can't tolerate dasatinib or nilotinib and for whom treatment with imatinib afterwards is not clinically appropriate. It is also used in people who have the T315I mutation. Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): Ponatinib Hydrochloride is also used in adults with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Here it is meant for people who are resistant to dasatinib, or who can't tolerate dasatinib and for whom treatment with imatinib afterwards is not clinically appropriate. It is also used in people who have the T315I mutation.
Pharmacology
Ponatinib is a kinase inhibitor. In laboratory tests, it blocked the tyrosine kinase activity of ABL and of T315I mutant ABL, with IC 50 concentrations of 0.4 nM and 2.0 nM, respectively. It also blocked the in vitro activity of other kinases, with IC 50 concentrations between 0.1 nM and 20 nM. These include members of the VEGFR, PDGFR, FGFR, EPH receptors and SRC families of kinases, and KIT, RET, TIE2 and FLT3.
Ponatinib reduced the in vitro viability of cells expressing native or mutant BCR-ABL, including T315I. In mice, treatment with ponatinib made tumors expressing native or T315I mutant BCR-ABL smaller than those in the control animals.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Ponatinib treatment should be started by a physician experienced in diagnosing and treating patients with leukemia. Haematologic support, such as platelet transfusion and haematopoietic growth factors, can be used during treatment if clinically indicated. Before starting ponatinib, the patient's cardiovascular status should be assessed, including history and physical examination, and cardiovascular risk factors should be actively managed. Cardiovascular status should keep being monitored during treatment, and medical and supportive therapy for conditions that add to cardiovascular risk should be optimised.
Recommended dosage: The recommended starting dose is 45 mg of ponatinib once daily. Treatment should continue as long as the patient shows no evidence of disease progression or unacceptable toxicity. Stopping ponatinib should be considered if a complete haematologic response has not occurred by 3 months (90 days). The risk of arterial occlusive events is likely to be dose-related. For CP-CML patients who have achieved a major cytogenetic response, reducing the dose of ponatinib to 15 mg should be considered. The individual assessment should take these factors into account: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels. If the dose is reduced, close monitoring of response is recommended.
Elderly patients: Of the 449 patients in the clinical study of ponatinib, 155 (35%) were >65 years of age. Older patients are more likely than patients < 65 years to experience adverse reactions.
Hepatic impairment: Patients with hepatic impairment may receive the recommended starting dose. Caution is recommended when giving Ponatinib to patients with hepatic impairment.
Renal impairment: Renal excretion is not a major route of ponatinib elimination, and ponatinib has not been studied in patients with renal impairment. Patients with estimated creatinine clearance of > 50 mL/min should be able to receive ponatinib safely with no dosage adjustment. Caution is recommended when giving ponatinib to patients with estimated creatinine clearance of < 50 mL/min, or end-stage renal disease.
Paediatric population: The safety and efficacy of ponatinib in patients less than 18 years of age have not been established. No data are available.
Side Effects
The most common serious side effects of Ponatinib Hydrochloride, each seen in more than 2% of people during treatment, were pneumonia, pancreatitis, abdominal pain, atrial fibrillation, pyrexia, myocardial infarction, peripheral arterial occlusive disease, anaemia, angina pectoris, decreased platelet count, febrile neutropenia, hypertension, coronary artery disease, congestive cardiac failure, cerebrovascular accident, sepsis, cellulitis, acute kidney injury, urinary tract infection and increased lipase.
Cautions & Contraindications
Warnings & Precautions
Myelosuppression Ponatinib Hydrochloride can cause severe thrombocytopenia, neutropenia and anaemia (National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 or 4). Most patients with grade 3 or 4 low platelet count, anaemia or neutropenia developed it within the first 3 months of treatment. These events happen more often in patients with accelerated phase CML (AP-CML) or blast phase CML (BP-CML)/Ph+ ALL than in chronic phase CML (CP-CML). A complete blood count should be done every 2 weeks for the first 3 months, then monthly or as clinically indicated. Myelosuppression was generally reversible, and it was usually managed by withholding ponatinib for a time or reducing the dose. Arterial occlusion Patients treated with ponatinib have had arterial occlusions. These include fatal myocardial infarction, stroke, retinal arterial occlusions (in some cases with permanent visual impairment or vision loss), stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and renal artery stenosis (linked with worsening, labile or treatment-resistant hypertension). Some patients also needed urgent revascularization procedures. These events occurred in patients with and without cardiovascular risk factors, including patients aged 50 years or younger. They were more frequent with increasing age and in patients with a history of ischaemia, hypertension, diabetes or hyperlipidaemia. Venous thromboembolism Patients should be monitored for signs of thromboembolism. If it occurs, Ponatinib Hydrochloride should be interrupted immediately. The decision to restart ponatinib should be guided by a benefit-risk consideration. Hypertension Blood pressure should be checked and managed at each clinic visit during ponatinib treatment, and hypertension should be treated to normal. If the hypertension is not controlled with medicine, ponatinib should be interrupted temporarily. Congestive heart failure Fatal and serious heart failure or left ventricular dysfunction has occurred in patients treated with ponatinib, including events related to earlier vascular occlusive events. Patients should be monitored for signs or symptoms of heart failure and treated as clinically indicated, which includes interrupting ponatinib. Stopping ponatinib should be considered in patients who develop serious heart failure. Hepatotoxicity Ponatinib Hydrochloride may raise ALT, AST, bilirubin and alkaline phosphatase. Most patients who had hepatotoxicity had their first event in the first year of treatment. Hepatic failure, including with a fatal outcome, has been seen. Liver function tests should be done before treatment starts and checked periodically after that, as clinically indicated. Haemorrhage Severe haemorrhage, including deaths, occurred in patients treated with ponatinib. Severe bleeding was more common in patients with AP-CML, BP-CML and Ph+ ALL. Ponatinib Hydrochloride should be interrupted, and patients should be evaluated for serious or severe haemorrhage. Hepatitis B reactivation Hepatitis B has reactivated in chronic carriers of the virus after they received BCR-ABL tyrosine kinase inhibitors. Patients should be tested for HBV infection before ponatinib is started. Carriers of HBV who need ponatinib should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months after therapy ends.
Pregnancy & Breastfeeding
Pregnancy: There aren't enough data on the use of ponatinib in pregnant women. Animal studies have shown reproductive toxicity, but the possible risk for humans isn't known. Ponatinib should be used during pregnancy only when clearly necessary. If a patient does take it while pregnant, she must be told about the possible risk to the foetus.
Breast-feeding: Nobody knows whether ponatinib passes into human milk. The pharmacodynamic and toxicological data available can't rule out that it does. Breast-feeding should be stopped during treatment with ponatinib.
Fertility: There are no human data on how ponatinib affects fertility. In rats, treatment with ponatinib affected female fertility, while male fertility was not affected. Whether these findings matter for human fertility is unknown.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Overdoses with ponatinib were reported in clinical trials. In one case, a patient was given the entire contents of a bottle of study medication through a nasogastric tube by accident. The investigator estimated that the patient received 540 mg of ponatinib. Two hours later, the uncorrected QT interval was 520 ms. Later ECGs showed normal sinus rhythm, with uncorrected QT intervals of 480 ms and 400 ms. The patient died 9 days after the overdose from pneumonia and sepsis.
Another patient took 165 mg by accident on Cycle 1 Day 2. On Day 3 this patient had fatigue and non-cardiac chest pain. A third patient took multiple doses of 90 mg per day for 12 days and developed pneumonia, systemic inflammatory response, atrial fibrillation and a moderate pericardial effusion.
If an overdose of ponatinib happens, stop ponatinib, observe the patient and give appropriate supportive treatment.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Ponatinib Hydrochloride in a cool, dry place, and don't store it above 30°C. If you think it may have been exposed to temperatures greater than 40°C, don't take it. Keep the medicine out of the reach and sight of children.
Drug Interactions
Common questions about Ponatigen 45 mg
What is Ponatigen 45 mg Tablet?
Ponatigen 45 mg Tablet is a medicine that contains Ponatinib Hydrochloride. It is made by General Pharmaceuticals Ltd. It belongs to the Tyrosine Kinase Inhibitor group of medicines.
What is Ponatigen used for?
Chronic Myeloid Leukemia (CML): Ponatinib Hydrochloride is used in adults with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML). It is meant for people who are resistant to dasatinib or nilotinib, or who can't tolerate dasatinib or nilotinib and for whom treatment with imatinib afterwards is not clinically appropriate.
What are the side effects of Ponatigen?
The most common serious side effects of Ponatinib Hydrochloride, each seen in more than 2% of people during treatment, were pneumonia, pancreatitis, abdominal pain, atrial fibrillation, pyrexia, myocardial infarction, peripheral arterial occlusive disease, anaemia, angina pectoris, decreased platelet count, febrile neutropenia, hypertension, coronary artery disease, congestive cardiac failure, cerebrovascular accident, sepsis, cellulitis, acute kidney injury, urinary tract infection and increased lipase.
Can I take Ponatigen during pregnancy or while breastfeeding?
Pregnancy: There aren't enough data on the use of ponatinib in pregnant women. Animal studies have shown reproductive toxicity, but the possible risk for humans isn't known. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Ponatigen?
Overdoses with ponatinib were reported in clinical trials. In one case, a patient was given the entire contents of a bottle of study medication through a nasogastric tube by accident. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Ponatigen?
Keep Ponatinib Hydrochloride in a cool, dry place, and don't store it above 30°C. If you think it may have been exposed to temperatures greater than 40°C, don't take it.
Can I take other medicines with Ponatigen?
Some medicines can interact with Ponatinib Hydrochloride, for example: Carbamazepine, Phenytoin, Rifampicin, Phenobarbitone, Clarithromycin, Itraconazole. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Ponaxen by Everest Pharmaceuticals Ltd. has the same ingredient and strength for ৳1,660.00 per unit, compared with ৳1,850.00 for Ponatigen. Ask your doctor or pharmacist before switching.
Do I need a prescription for Ponatigen?
Ponatigen is a prescription (Rx) medicine. Take it as your doctor advises.