Ponatinix
Generic Name
Ponatinib
Manufacturer
Natco Pharma Limited
Country
India
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ponatinix 15 mg tablet | ৳ 656.60 | ৳ 39,396.00 |
Description
Overview of the medicine
Ponatinib is a potent oral multi-targeted tyrosine kinase inhibitor (TKI) used to treat certain types of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) that are resistant to other TKIs or have the T315I mutation.
Uses & Indications
Dosage
Adults
The recommended starting dose is 45 mg orally once daily. Dosage may be reduced to 15 mg or 30 mg based on response and tolerability, particularly to manage adverse events.
Elderly
No specific dosage adjustment required, but monitor for adverse reactions.
Renal_impairment
No dose adjustment required for mild to moderate renal impairment. Data for severe renal impairment is limited; caution is advised.
Hepatic_impairment
Reduce starting dose to 30 mg orally once daily for patients with moderate to severe hepatic impairment.
How to Take
Take orally once daily with or without food. Swallow the tablet whole. Do not crush, dissolve, or chew.
Mechanism of Action
Ponatinib inhibits multiple tyrosine kinases, including BCR-ABL and VEGFR, FGFR, and PDGFR. It is specifically designed to overcome the T315I mutation in BCR-ABL, which confers resistance to other TKIs.
Pharmacokinetics
Onset
Not explicitly defined, but anti-leukemic effects can be seen within weeks.
Excretion
Primarily excreted via feces (approximately 87%), with a small amount (approximately 5%) excreted in urine.
Half life
Approximately 24-30 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, and CYP3A5.
Side Effects
Contraindications
- Hypersensitivity to ponatinib or any of its excipients.
- Uncontrolled hypertension (relative contraindication, requires strict management).
Drug Interactions
P-glycoprotein (P-gp) Inhibitors/Inducers
Ponatinib is a substrate of P-gp.
Strong CYP3A Inducers (e.g., rifampin, phenytoin)
May decrease ponatinib concentrations. Avoid co-administration.
Strong CYP3A Inhibitors (e.g., ketoconazole, clarithromycin)
May increase ponatinib concentrations. Avoid co-administration or reduce ponatinib dose.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management of overdose should consist of general supportive measures.
Pregnancy & Lactation
Pregnancy Category D: May cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception. Lactation: Not known if excreted in human milk. Due to potential 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 of its excipients.
- Uncontrolled hypertension (relative contraindication, requires strict management).
Drug Interactions
P-glycoprotein (P-gp) Inhibitors/Inducers
Ponatinib is a substrate of P-gp.
Strong CYP3A Inducers (e.g., rifampin, phenytoin)
May decrease ponatinib concentrations. Avoid co-administration.
Strong CYP3A Inhibitors (e.g., ketoconazole, clarithromycin)
May increase ponatinib concentrations. Avoid co-administration or reduce ponatinib dose.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management of overdose should consist of general supportive measures.
Pregnancy & Lactation
Pregnancy Category D: May cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception. Lactation: Not known if excreted in human milk. Due to potential 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
24 months
Availability
Hospitals, Oncology Centers, Specialized Pharmacies
Approval Status
FDA Approved
Patent Status
Patent Protected
Clinical Trials
Extensive clinical trials, including PACE trial (Phase 2), established efficacy and safety in resistant CML/ALL. Ongoing post-marketing surveillance and phase 3 studies.
Lab Monitoring
- Complete blood counts (CBC) with differential, liver function tests (LFTs), serum lipase, serum amylase, electrolytes, and blood pressure regularly.
- Cardiac monitoring (ECG, echocardiogram) as clinically indicated.
Doctor Notes
- Closely monitor patients for cardiovascular events, hypertension, pancreatitis, and liver function throughout treatment.
- Consider dose reduction for chronic phase CML patients who achieve major molecular response.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking ponatinib without consulting your doctor.
- Report any new or worsening side effects immediately.
Missed Dose Advice
If a dose is missed, take the next scheduled dose at its regular time. Do not take two doses to make up for a missed dose.
Driving Precautions
May cause fatigue, dizziness, or visual disturbances. Patients should be cautioned about driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Maintain a healthy diet and exercise regime.
- Avoid smoking and excessive alcohol consumption.
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