Glivir
Generic Name
Imatinib
Manufacturer
Hypothetical Manufacturer
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| glivir 80 mg tablet | ৳ 5.00 | N/A |
Description
Overview of the medicine
Glivir (Imatinib) is a tyrosine kinase inhibitor used to treat various types of cancer, primarily chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It works by blocking certain proteins that signal cancer cells to grow.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on the indication. For CML (chronic phase), typically 400 mg once daily. For CML (accelerated phase or blast crisis) and GIST, typically 600 mg once daily. Doses may be adjusted based on efficacy and tolerability. For an 80mg tablet, specific regimens would involve taking multiple tablets.
Elderly
No specific dose adjustment is generally required for elderly patients, but monitoring for adverse effects is recommended.
Renal_impairment
Caution is advised. A lower starting dose (e.g., 20-50% reduction) should be considered, and patients should be closely monitored for adverse reactions.
How to Take
Glivir tablets should be taken orally with a meal and a large glass of water to minimize gastrointestinal irritation. The tablets should be swallowed whole; do not crush, cut, or chew them.
Mechanism of Action
Imatinib selectively inhibits the Bcr-Abl tyrosine kinase, which is characteristic of chronic myeloid leukemia, as well as PDGF-R and c-Kit tyrosine kinases, found in GIST and other conditions. By inhibiting these kinases, it blocks cell proliferation and induces apoptosis in cancer cells.
Pharmacokinetics
Onset
Clinical effects may be observed within weeks, but a full hematologic response can take several months. Molecular and cytogenetic responses take longer.
Excretion
Approximately 68% of the dose is excreted in feces and 13% in urine, primarily as metabolites and a smaller proportion as unchanged drug.
Half life
The elimination half-life of imatinib is approximately 18 hours. Its major active metabolite, CGP74588, has a half-life of approximately 40 hours.
Absorption
Rapidly and almost completely absorbed after oral administration. Peak plasma concentrations are typically reached within 2 to 4 hours. Oral bioavailability is approximately 98%.
Metabolism
Primarily metabolized in the liver by the cytochrome P450 CYP3A4 enzyme. The main active metabolite is the N-demethylated piperazine derivative.
Side Effects
Contraindications
- Hypersensitivity to imatinib or to any of the excipients of Glivir.
Drug Interactions
Warfarin and other coumarin derivatives
Imatinib may increase the anticoagulant effect of these drugs, necessitating careful monitoring of INR and dose adjustment.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin)
May significantly increase plasma concentrations of imatinib, potentially leading to increased toxicity. Dose reduction of imatinib may be necessary.
CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
May significantly decrease plasma concentrations of imatinib, potentially leading to reduced efficacy. Avoid co-administration or consider increasing imatinib dose.
Substrates of CYP3A4 (e.g., ciclosporin, simvastatin, calcium channel blockers)
Imatinib may increase the plasma concentrations of these drugs, potentially increasing their toxicity. Dose reduction of co-administered drugs may be required.
Storage
Store Glivir tablets below 30°C (86°F) in a dry place, protected from direct light and moisture. Keep out of reach of children. Do not use after the expiry date.
Overdose
In case of overdose, increased severity of side effects such as myelosuppression, gastrointestinal disturbances, and fluid retention may occur. Management should be symptomatic and supportive, with close monitoring of vital signs and hematological parameters.
Pregnancy & Lactation
Pregnancy Category D. Glivir should be avoided during pregnancy unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment. It is not recommended during breastfeeding due to the potential for serious adverse reactions in the infant.
Side Effects
Contraindications
- Hypersensitivity to imatinib or to any of the excipients of Glivir.
Drug Interactions
Warfarin and other coumarin derivatives
Imatinib may increase the anticoagulant effect of these drugs, necessitating careful monitoring of INR and dose adjustment.
CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin)
May significantly increase plasma concentrations of imatinib, potentially leading to increased toxicity. Dose reduction of imatinib may be necessary.
CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
May significantly decrease plasma concentrations of imatinib, potentially leading to reduced efficacy. Avoid co-administration or consider increasing imatinib dose.
Substrates of CYP3A4 (e.g., ciclosporin, simvastatin, calcium channel blockers)
Imatinib may increase the plasma concentrations of these drugs, potentially increasing their toxicity. Dose reduction of co-administered drugs may be required.
Storage
Store Glivir tablets below 30°C (86°F) in a dry place, protected from direct light and moisture. Keep out of reach of children. Do not use after the expiry date.
Overdose
In case of overdose, increased severity of side effects such as myelosuppression, gastrointestinal disturbances, and fluid retention may occur. Management should be symptomatic and supportive, with close monitoring of vital signs and hematological parameters.
Pregnancy & Lactation
Pregnancy Category D. Glivir should be avoided during pregnancy unless the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment. It is not recommended during breastfeeding due to the potential for serious adverse reactions in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 to 3 years from the manufacturing date when stored under recommended conditions.
Availability
Pharmacies, hospitals, specialized oncology centers
Approval Status
Approved by regulatory bodies (e.g., FDA, EMA, DGDA)
Patent Status
Patent expired for generic versions, innovator patent expired
WHO Essential Medicine
YesClinical Trials
Imatinib has undergone extensive clinical trials demonstrating its efficacy and safety in various indications, including newly diagnosed CML, advanced CML, GIST, and other rare malignancies. Post-marketing surveillance and ongoing studies continue to gather long-term data and explore new therapeutic applications.
Lab Monitoring
- Complete Blood Count (CBC) with differential (weekly for the first month, then monthly or as clinically indicated)
- Liver Function Tests (LFTs) including AST, ALT, alkaline phosphatase, and bilirubin (weekly for the first month, then monthly or as clinically indicated)
- Renal Function Tests (serum creatinine, BUN)
- Electrolytes (especially potassium, phosphorus, calcium)
- Fluid retention assessment (weight monitoring, physical examination)
Doctor Notes
- Emphasize the importance of patient adherence to the prescribed dosing regimen to ensure optimal efficacy and minimize resistance.
- Monitor complete blood counts (CBCs) and liver function tests (LFTs) frequently, especially during the initial months of therapy and with any dose adjustments.
- Educate patients about the signs and symptoms of fluid retention and advise them to report any significant weight gain or swelling promptly.
- Counsel patients on potential drug and food interactions, particularly avoiding grapefruit and St. John's Wort.
- Assess cardiac function in patients with pre-existing cardiac conditions or risk factors before and during treatment.
Patient Guidelines
- Take Glivir exactly as prescribed by your doctor, usually with a meal and a large glass of water.
- Do not crush, cut, or chew the tablets. Swallow them whole.
- Report any unusual bleeding, bruising, swelling (especially around ankles, feet, or face), severe fatigue, or persistent nausea/vomiting to your doctor immediately.
- Attend all scheduled follow-up appointments and laboratory tests, as regular monitoring is crucial for safety and efficacy.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins, to avoid potential drug interactions.
Missed Dose Advice
If a dose of Glivir is missed, the patient should take it as soon as they remember, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Do not double the dose to compensate for a missed one.
Driving Precautions
Glivir may cause side effects such as dizziness, blurred vision, or fatigue. Patients should exercise caution when driving or operating machinery until they know how Glivir affects them.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids throughout the day.
- Avoid consuming grapefruit or grapefruit juice, as they can interact with Glivir and increase its levels in the body.
- Both male and female patients of reproductive potential should use effective contraception during treatment and for at least one month after the last dose.
- Avoid direct sun exposure and use sun protection, as Glivir can increase sensitivity to sunlight.
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