Getinib
Generic Name
Gefitinib
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| getinib 250 mg tablet | ৳ 150.00 | ৳ 1,050.00 |
Description
Overview of the medicine
Gefitinib is an antineoplastic agent used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating mutations of the epidermal growth factor receptor (EGFR) tyrosine kinase.
Uses & Indications
Dosage
Adults
The recommended dose is 250 mg orally once daily. Tablets can be taken with or without food, but should be taken at approximately the same time each day.
Elderly
No specific dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment is required for patients with mild to moderate renal impairment. Data are limited for severe renal impairment.
How to Take
Take orally, once daily, with or without food. Swallow the whole tablet with water. Do not crush or chew. If unable to swallow, tablet can be dispersed in half a glass of non-carbonated water.
Mechanism of Action
Gefitinib is a selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. It blocks the intracellular phosphorylation of EGFR, thereby inhibiting the signal transduction pathways involved in the proliferation, survival, angiogenesis, and metastasis of cancer cells.
Pharmacokinetics
Onset
Clinical response seen over several weeks to months, not immediate.
Excretion
Mainly excreted via feces (86%), with minor urinary excretion (4%).
Half life
Terminal half-life is approximately 48 hours.
Absorption
Slowly absorbed after oral administration, with peak plasma concentrations occurring 3-7 hours post-dose. Absolute bioavailability is approximately 59%.
Metabolism
Primarily metabolized in the liver by cytochrome P450 CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to gefitinib or to any of the excipients.
- Pregnancy and breastfeeding.
Drug Interactions
CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine)
May decrease gefitinib plasma concentrations, reducing efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Erythromycin)
May increase gefitinib plasma concentrations, increasing risk of adverse reactions.
Gastric pH Elevating Agents (e.g., PPIs, H2-receptor antagonists, antacids)
May decrease gefitinib absorption and efficacy. Avoid co-administration where possible or take gefitinib at least 6 hours after antacids/H2 blockers.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
Limited experience with overdose. In clinical trials, a few patients received doses higher than recommended. Reported adverse events were similar to the usual safety profile. There is no specific antidote. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Gefitinib is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment and for at least 1 month after the last dose. It is not known whether gefitinib is excreted in human milk, but breastfeeding should be discontinued.
Side Effects
Contraindications
- Hypersensitivity to gefitinib or to any of the excipients.
- Pregnancy and breastfeeding.
Drug Interactions
CYP3A4 Inducers (e.g., Rifampicin, Phenytoin, Carbamazepine)
May decrease gefitinib plasma concentrations, reducing efficacy.
CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole, Erythromycin)
May increase gefitinib plasma concentrations, increasing risk of adverse reactions.
Gastric pH Elevating Agents (e.g., PPIs, H2-receptor antagonists, antacids)
May decrease gefitinib absorption and efficacy. Avoid co-administration where possible or take gefitinib at least 6 hours after antacids/H2 blockers.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
Limited experience with overdose. In clinical trials, a few patients received doses higher than recommended. Reported adverse events were similar to the usual safety profile. There is no specific antidote. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Gefitinib is contraindicated during pregnancy and lactation. Women of childbearing potential should use effective contraception during treatment and for at least 1 month after the last dose. It is not known whether gefitinib is excreted in human milk, but breastfeeding should be discontinued.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Gefitinib has been extensively studied in various clinical trials (e.g., ISEL, IPASS, FLAURA) for NSCLC, demonstrating its efficacy and safety profile in different patient populations and lines of therapy.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) regularly.
- Renal function tests if clinically indicated.
- Electrolyte monitoring if severe diarrhea occurs.
Doctor Notes
- Confirm EGFR mutation status before starting gefitinib.
- Monitor for signs and symptoms of ILD (e.g., dyspnea, cough, fever) and liver dysfunction.
- Educate patients on managing common adverse events like rash and diarrhea.
Patient Guidelines
- Take Gefitinib exactly as prescribed by your doctor.
- Report any new or worsening symptoms, especially shortness of breath, cough, fever, or skin reactions.
- Use effective contraception during treatment and for at least 1 month after the last dose.
Missed Dose Advice
If a dose is missed, and less than 12 hours have passed since the usual time, take it as soon as you remember. If more than 12 hours have passed, skip the missed dose and take the next dose at the regular time. Do not take a double dose.
Driving Precautions
Gefitinib may cause asthenia and eye disorders (e.g., blurred vision) which could affect the ability to drive or operate machinery. Patients should be cautious.
Lifestyle Advice
- Avoid prolonged sun exposure and use sunscreen.
- Stay hydrated, especially if experiencing diarrhea.
- Maintain good skin hygiene to manage rash.
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