Tasigna
Generic Name
Nilotinib
Manufacturer
Novartis Pharma AG
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tasigna 200 mg capsule | ৳ 3,040.00 | ৳ 42,560.00 |
Description
Overview of the medicine
Tasigna is an oral medication containing Nilotinib, a tyrosine kinase inhibitor used for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). It works by targeting and inhibiting the BCR-ABL protein, which is found in CML cells, thereby preventing cancer cell growth and survival.
Uses & Indications
Dosage
Adults
For newly diagnosed Ph+ chronic phase CML: 300 mg orally twice daily. For Ph+ chronic phase and accelerated phase CML resistant or intolerant to prior therapy: 400 mg orally twice daily.
Elderly
No specific dose adjustment is required, but caution is advised due to potential for increased cardiovascular events.
Renal_impairment
No dose adjustment is required in patients with renal impairment.
Hepatic_impairment
For severe hepatic impairment, a reduced dose of 200 mg once daily for newly diagnosed CML or 300 mg once daily for resistant/intolerant CML may be considered.
How to Take
Take Tasigna orally twice daily, approximately 12 hours apart. Do not take with food. Take at least 2 hours after any food and wait at least 1 hour before eating any food. Swallow capsules whole with water; do not chew, crush, or open them. If a dose is missed, do not take an extra dose, just take the next scheduled dose.
Mechanism of Action
Nilotinib is a potent and selective inhibitor of the BCR-ABL tyrosine kinase. It binds to the ATP-binding site of the BCR-ABL protein, locking it in an inactive conformation and preventing phosphorylation of its substrates. This leads to inhibition of proliferation and induction of apoptosis in CML cell lines expressing BCR-ABL.
Pharmacokinetics
Onset
Sustained inhibition of BCR-ABL activity is achieved with regular dosing.
Excretion
Mainly excreted via feces, with approximately 93% of the dose recovered, predominantly as unchanged drug.
Half life
The elimination half-life is approximately 17 hours.
Absorption
Nilotinib is absorbed orally. Peak plasma concentrations are achieved approximately 3 hours after oral administration. Food increases the absorption and bioavailability, therefore it must be taken on an empty stomach.
Metabolism
Primarily metabolized by CYP3A4. Major metabolites are oxidized and hydroxylated derivatives.
Side Effects
Contraindications
- Hypersensitivity to nilotinib or to any of the excipients.
- Correct hypokalemia or hypomagnesemia prior to initiation of Tasigna and monitor periodically.
- Patients with long QT syndrome.
Drug Interactions
Proton Pump Inhibitors (PPIs) and H2 blockers
May decrease nilotinib absorption. Separate administration by at least 10 hours for H2 blockers or consider alternatives to PPIs.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, St. John's Wort)
Concurrent use decreases nilotinib concentration, potentially reducing efficacy. Avoid concurrent use.
QT prolonging drugs (e.g., antiarrhythmics, antipsychotics, fluoroquinolones)
Concurrent use may increase the risk of QT prolongation. Avoid or use with extreme caution.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, grapefruit juice)
Concurrent use increases nilotinib concentration and may increase risk of adverse events, including QT prolongation. Avoid or use with caution and dose adjustment.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
There is limited experience with Tasigna overdose. In cases of overdose, patients should be observed for signs or symptoms of adverse reactions and appropriate supportive treatment should be initiated.
Pregnancy & Lactation
Pregnancy Category D: Nilotinib can cause fetal harm when administered to a pregnant woman. It is not recommended during pregnancy. Lactation: It is unknown whether nilotinib is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment and for 2 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to nilotinib or to any of the excipients.
- Correct hypokalemia or hypomagnesemia prior to initiation of Tasigna and monitor periodically.
- Patients with long QT syndrome.
Drug Interactions
Proton Pump Inhibitors (PPIs) and H2 blockers
May decrease nilotinib absorption. Separate administration by at least 10 hours for H2 blockers or consider alternatives to PPIs.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, St. John's Wort)
Concurrent use decreases nilotinib concentration, potentially reducing efficacy. Avoid concurrent use.
QT prolonging drugs (e.g., antiarrhythmics, antipsychotics, fluoroquinolones)
Concurrent use may increase the risk of QT prolongation. Avoid or use with extreme caution.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, grapefruit juice)
Concurrent use increases nilotinib concentration and may increase risk of adverse events, including QT prolongation. Avoid or use with caution and dose adjustment.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
There is limited experience with Tasigna overdose. In cases of overdose, patients should be observed for signs or symptoms of adverse reactions and appropriate supportive treatment should be initiated.
Pregnancy & Lactation
Pregnancy Category D: Nilotinib can cause fetal harm when administered to a pregnant woman. It is not recommended during pregnancy. Lactation: It is unknown whether nilotinib is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not 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, check specific packaging for expiry date.
Availability
Available in specialized pharmacies globally
Approval Status
FDA Approved
Patent Status
Patented by Novartis, generics may be available post-expiry
Clinical Trials
Tasigna has been extensively studied in several pivotal clinical trials (e.g., ENESTnd, ENESTcmr, ENESTop) demonstrating its efficacy and safety in patients with CML, including those newly diagnosed and those resistant/intolerant to imatinib.
Lab Monitoring
- Complete blood counts (CBC) with differential every 2 weeks for the first 2 months, then monthly or as clinically indicated.
- Liver function tests (ALT, AST, bilirubin) regularly.
- Serum lipase and amylase levels monthly.
- Electrolytes (potassium, magnesium) corrected before initiation and monitored periodically.
- ECG to monitor QTc interval before treatment, 7 days after starting, and periodically thereafter.
Doctor Notes
- Emphasize strict adherence to dosing schedule and empty stomach administration due to food effect and PK variability.
- Pre-treatment and periodic ECG monitoring for QTc prolongation, along with electrolyte correction (K+, Mg++), is mandatory.
- Monitor for cardiovascular risk factors and events, including lipids and blood glucose. Consider managing these aggressively.
- Counsel patients on the importance of reporting new or worsening symptoms of vascular events or pancreatitis.
- Careful consideration for patients with a history of long QT syndrome or other cardiac risk factors.
Patient Guidelines
- Take Tasigna exactly as prescribed by your doctor, do not stop without consulting.
- Take on an empty stomach, at least 2 hours after food and 1 hour before food.
- Swallow capsules whole; do not chew, crush, or open them.
- Avoid grapefruit and grapefruit juice while on this medication.
- Report any new or worsening symptoms, especially heart problems or abdominal pain, immediately to your doctor.
Missed Dose Advice
If a dose is missed, do not take an extra dose. Simply take your next scheduled dose at the regular time. Do not take two doses to make up for a missed dose.
Driving Precautions
Tasigna may cause side effects such as dizziness, fatigue, or visual disturbances. If you experience these symptoms, you should avoid driving or operating machinery.
Lifestyle Advice
- Maintain a healthy diet and regular exercise to help manage cardiovascular risk factors.
- Avoid excessive alcohol consumption.
- Manage stress effectively.
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