Tasigna
Generic Name
Nilotinib
Manufacturer
Novartis Pharmaceuticals Corporation
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 (nilotinib) is a kinase inhibitor indicated for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, and chronic, accelerated, or blast phase Ph+ CML in adult patients resistant or intolerant to prior therapy including imatinib.
Uses & Indications
Dosage
Adults
Newly diagnosed CML: 300 mg orally twice daily. Resistant/Intolerant CML: 400 mg orally twice daily.
Elderly
No specific dosage adjustment based on age, but monitor carefully due to increased risk of QT prolongation and other cardiovascular events.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. No data for severe renal impairment.
How to Take
Take orally on an empty stomach (at least 2 hours after food and 1 hour before food). Capsules should be swallowed whole with water.
Mechanism of Action
Nilotinib is a potent and selective inhibitor of the Bcr-Abl tyrosine kinase, which is responsible for the proliferation of CML cells. It binds to the Abl kinase domain, stabilizing it in an inactive conformation, thus inhibiting the proliferation of Bcr-Abl-positive cells.
Pharmacokinetics
Onset
Not directly specified, but clinical response seen within weeks to months.
Excretion
Mainly via feces (93%), with a small amount (6%) excreted via urine.
Half life
Approximately 17 hours.
Absorption
Peak plasma concentrations are reached approximately 3 hours after oral administration. Absolute bioavailability is approximately 30%. Food increases bioavailability.
Metabolism
Primarily metabolized by CYP3A4. Main metabolic pathways are oxidation and hydroxylation. Excretion is primarily via feces.
Side Effects
Contraindications
- Hypersensitivity to nilotinib or any excipients
- Hypokalemia, hypomagnesemia or long QT syndrome (uncorrected)
Drug Interactions
Antacids
May decrease nilotinib absorption. Separate administration by at least 2 hours.
H2 blockers/PPIs
May decrease nilotinib absorption. Avoid co-administration or consider alternative.
QT prolonging drugs (e.g., antiarrhythmics, antipsychotics)
Increased risk of QT prolongation. Use with caution, monitor ECG.
CYP3A4 inducers (e.g., rifampin, phenytoin, St. John's Wort)
Decreased nilotinib exposure, reduced efficacy. Avoid co-administration.
CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice)
Increased nilotinib exposure, increased risk of QT prolongation. Avoid co-administration.
Storage
Store at room temperature, below 30°C (86°F). Keep in original packaging to protect from moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Management involves supportive care and monitoring for QT prolongation, myelosuppression, and other adverse events.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Advise women of reproductive potential to use effective contraception. Not recommended during breastfeeding due to potential harm to the infant.
Side Effects
Contraindications
- Hypersensitivity to nilotinib or any excipients
- Hypokalemia, hypomagnesemia or long QT syndrome (uncorrected)
Drug Interactions
Antacids
May decrease nilotinib absorption. Separate administration by at least 2 hours.
H2 blockers/PPIs
May decrease nilotinib absorption. Avoid co-administration or consider alternative.
QT prolonging drugs (e.g., antiarrhythmics, antipsychotics)
Increased risk of QT prolongation. Use with caution, monitor ECG.
CYP3A4 inducers (e.g., rifampin, phenytoin, St. John's Wort)
Decreased nilotinib exposure, reduced efficacy. Avoid co-administration.
CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice)
Increased nilotinib exposure, increased risk of QT prolongation. Avoid co-administration.
Storage
Store at room temperature, below 30°C (86°F). Keep in original packaging to protect from moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. Management involves supportive care and monitoring for QT prolongation, myelosuppression, and other adverse events.
Pregnancy & Lactation
Pregnancy Category D. May cause fetal harm. Advise women of reproductive potential to use effective contraception. Not recommended during breastfeeding due to potential harm to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 36 months, varies by manufacturer and specific product.
Availability
Hospitals, Specialized pharmacies
Approval Status
FDA Approved
Patent Status
Patent held by Novartis (varies by region)
Clinical Trials
Key trials include ENESTnd (Evaluating Nilotinib Efficacy and Safety in clinical Trials of Newly Diagnosed Ph+ CML Patients) for newly diagnosed CML, and trials for imatinib-resistant/intolerant patients.
Lab Monitoring
- ECG (baseline and periodically, especially after dose changes)
- Electrolytes (potassium, magnesium) prior to initiation and periodically
- Liver function tests (ALT, AST, bilirubin) baseline and periodically
- Lipase and amylase baseline and periodically
- Complete blood count (CBC) every 2 weeks for 2 months, then monthly
- Glucose and lipid profiles baseline and periodically
Doctor Notes
- Emphasize strict adherence to dosing schedule and empty stomach administration.
- Monitor ECG, electrolytes, LFTs, CBC, lipase, amylase, glucose, and lipid profiles regularly.
- Counsel patients on symptoms of QT prolongation, vascular events, and pancreatitis.
- Manage concomitant medications carefully, especially CYP3A4 inhibitors/inducers and QT prolonging agents.
Patient Guidelines
- Take Tasigna exactly as prescribed by your doctor.
- Do not eat any food for at least 2 hours before and 1 hour after taking Tasigna.
- Swallow capsules whole; do not chew, open, or crush them.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Report any signs of unusual bleeding, bruising, fever, or infection immediately.
- Do not stop taking Tasigna without consulting your doctor.
Missed Dose Advice
If a dose is missed, do not take an additional dose. Take the next scheduled dose at its regular time. Do not double the dose.
Driving Precautions
Tasigna may cause side effects such as dizziness, fatigue, or blurred vision that could affect your ability to drive or operate machinery. Exercise caution until you know how it affects you.
Lifestyle Advice
- Maintain a healthy diet and stay hydrated.
- Avoid grapefruit and grapefruit juice.
- Discuss any changes in your diet or lifestyle with your healthcare provider.
- Regular exercise as advised by your doctor.
- Avoid excessive alcohol consumption.
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