Ponatinix
Generic Name
ponatinix-45-mg-tablet
Manufacturer
Takeda Pharmaceutical Company Limited
Country
Japan
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ponatinix 45 mg tablet | ৳ 1,937.60 | ৳ 58,128.00 |
Description
Overview of the medicine
Ponatinix 45 mg Tablet contains Ponatinib, an oral tyrosine kinase inhibitor used to treat specific types of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that are resistant or intolerant to other treatments.
Uses & Indications
Dosage
Adults
Recommended initial dose is 45 mg orally once daily. Dosage may be reduced to 15 mg or 30 mg once daily based on safety and efficacy.
Elderly
No specific dosage adjustment recommended for elderly patients based on age alone.
Renal_impairment
No specific dosage adjustment recommended for mild or moderate renal impairment. For severe renal impairment or end-stage renal disease, consider starting with a reduced dose or closer monitoring.
How to Take
Administer orally once daily, with or without food. Swallow the tablet whole; do not crush, cut, or chew.
Mechanism of Action
Ponatinib is a potent oral multi-targeted tyrosine kinase inhibitor. It targets BCR-ABL, including the T315I mutation, which is resistant to other available BCR-ABL inhibitors. It also inhibits other kinases like FLT3, RET, KIT, and FGFR.
Pharmacokinetics
Onset
Clinical response typically observed within weeks, but onset of full effect varies.
Excretion
Mainly excreted in feces (approximately 87%) with a small amount in urine (approximately 5%).
Half life
Approximately 24 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations are reached within 4-6 hours.
Metabolism
Primarily metabolized by CYP3A4, and to a lesser extent by CYP2C8, CYP2D6, CYP3A5, and flavin-containing monooxygenase 3 (FMO3). Main metabolic pathways include oxidation and hydrolysis.
Side Effects
Contraindications
- Hypersensitivity to ponatinib or any component of the formulation.
- Severe arterial occlusive events (history of MI, stroke, severe peripheral artery disease) - *Note: This is a strong warning rather than an absolute contraindication for some, but often treated as such due to high risk.*
Drug Interactions
QT interval prolonging drugs
Use with caution due to potential additive effect on QT prolongation.
Strong CYP3A Inducers (e.g., Rifampicin, Carbamazepine)
May decrease ponatinib exposure; avoid co-administration or consider alternative agents.
Strong CYP3A Inhibitors (e.g., Ketoconazole, Clarithromycin)
May increase ponatinib exposure; consider reducing ponatinib dose.
Storage
Store at room temperature (20°C to 25°C), away from moisture and heat. Keep out of reach of children.
Overdose
Limited data on overdose. Adverse reactions may be exacerbated. Management should include general supportive measures and discontinuation of ponatinib. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception during treatment and for 3 weeks after the last dose. It is unknown if ponatinib is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to ponatinib or any component of the formulation.
- Severe arterial occlusive events (history of MI, stroke, severe peripheral artery disease) - *Note: This is a strong warning rather than an absolute contraindication for some, but often treated as such due to high risk.*
Drug Interactions
QT interval prolonging drugs
Use with caution due to potential additive effect on QT prolongation.
Strong CYP3A Inducers (e.g., Rifampicin, Carbamazepine)
May decrease ponatinib exposure; avoid co-administration or consider alternative agents.
Strong CYP3A Inhibitors (e.g., Ketoconazole, Clarithromycin)
May increase ponatinib exposure; consider reducing ponatinib dose.
Storage
Store at room temperature (20°C to 25°C), away from moisture and heat. Keep out of reach of children.
Overdose
Limited data on overdose. Adverse reactions may be exacerbated. Management should include general supportive measures and discontinuation of ponatinib. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception during treatment and for 3 weeks after the last dose. It is unknown if ponatinib is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 2 weeks after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date, check product specific labeling.
Availability
Pharmacies, Hospitals, Specialty Oncology Centers
Approval Status
FDA Approved
Patent Status
Under Patent
Clinical Trials
Ponatinib was approved based on results from the PACE trial, an open-label, single-arm, multicenter trial evaluating efficacy and safety in patients with resistant CML and Ph+ ALL. Further studies continue to evaluate long-term safety and new indications.
Lab Monitoring
- Complete blood counts (CBC) with differential every 2 weeks for the first 3 months, then monthly or as clinically indicated.
- Liver function tests (ALT, AST, bilirubin, alkaline phosphatase) every 2 weeks for the first 3 months, then monthly or as clinically indicated.
- Lipase and amylase levels weekly for the first 2 months, then monthly or as clinically indicated.
- Electrolytes (potassium, magnesium, calcium, phosphate) periodically.
- Blood glucose periodically.
- Cardiovascular risk factors (blood pressure, lipids) should be monitored and managed.
Doctor Notes
- Closely monitor for arterial and venous thrombotic events, especially in patients with pre-existing cardiovascular risk factors.
- Regularly assess blood pressure and manage hypertension aggressively.
- Consider dose reduction in patients experiencing significant adverse events to maintain treatment continuity, rather than complete discontinuation if possible.
- Emphasize patient education regarding symptom recognition and reporting due to the high risk of serious adverse events.
Patient Guidelines
- Take exactly as prescribed by your doctor.
- Do not stop taking Ponatinix without consulting your doctor.
- Report any new or worsening symptoms, especially chest pain, shortness of breath, sudden numbness or weakness, vision changes, severe headache, or severe abdominal pain.
- Avoid grapefruit products while taking this medicine.
- Use effective contraception during treatment and for some time after.
Missed Dose Advice
If a dose is missed, take the next dose at the regularly scheduled time. Do not take two doses at the same time to make up for a missed dose.
Driving Precautions
Ponatinib may cause fatigue, headache, or dizziness, which could affect your ability to drive or operate machinery. Exercise caution until you know how the medicine affects you.
Lifestyle Advice
- Maintain a healthy diet and engage in regular, moderate exercise if possible, as advised by your doctor.
- Manage blood pressure and cholesterol effectively as per your doctor's recommendations.
- Avoid smoking and excessive alcohol consumption.
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