Carceva
Generic Name
erlotinib
Manufacturer
Beacon Pharmaceuticals Ltd.
Country
Bangladesh
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Description
Overview of the medicine
Erlotinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer and pancreatic cancer.
Uses & Indications
Dosage
Adults
For NSCLC: 150 mg once daily, taken at least one hour before or two hours after food. For Pancreatic Cancer: 100 mg once daily, taken at least one hour before or two hours after food, in combination with gemcitabine.
Elderly
No specific dose adjustments are required for elderly patients, but monitoring for adverse effects is recommended.
Renal_impairment
No specific dose adjustments are needed for patients with renal impairment, but caution is advised in severe cases.
How to Take
Take orally once daily, at least one hour before or two hours after a meal. Swallow the tablet whole with water.
Mechanism of Action
Erlotinib reversibly inhibits the intracellular phosphorylation of the epidermal growth factor receptor (EGFR) and downstream signaling pathways, which are often overactive in various cancers.
Pharmacokinetics
Onset
Therapeutic effects are typically observed after several weeks of continuous treatment, as tumor response is gradual.
Excretion
Erlotinib and its metabolites are primarily excreted in the feces (83%), with a smaller portion excreted in the urine (8%).
Half life
The mean plasma half-life is approximately 36.2 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations achieved in approximately 4 hours. Absolute bioavailability is about 59%.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4 and to a lesser extent by CYP1A2, with minor contributions from CYP2D6.
Side Effects
Contraindications
- Hypersensitivity to erlotinib or any components of the formulation.
Drug Interactions
Warfarin
May increase INR and risk of bleeding; monitor closely.
Strong CYP3A4 inducers
May decrease erlotinib exposure, requiring dose adjustment (e.g., rifampicin, phenytoin).
Strong CYP3A4 inhibitors
May increase erlotinib exposure, requiring dose reduction (e.g., ketoconazole, clarithromycin).
Proton pump inhibitors (PPIs) and H2 antagonists
Significantly reduce erlotinib absorption; co-administration should be avoided (e.g., omeprazole, ranitidine).
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.
Overdose
Single doses of erlotinib up to 1000 mg in healthy volunteers and up to 1500 mg in cancer patients have been associated with adverse events such as rash and diarrhea. In case of suspected overdose, discontinue erlotinib and institute symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category D. Erlotinib can cause fetal harm. Advise pregnant women of the potential risk to a fetus. It is not known whether erlotinib is excreted in human milk; however, because of the potential for serious adverse reactions in breastfed infants, women should be advised against breastfeeding during treatment and for 2 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to erlotinib or any components of the formulation.
Drug Interactions
Warfarin
May increase INR and risk of bleeding; monitor closely.
Strong CYP3A4 inducers
May decrease erlotinib exposure, requiring dose adjustment (e.g., rifampicin, phenytoin).
Strong CYP3A4 inhibitors
May increase erlotinib exposure, requiring dose reduction (e.g., ketoconazole, clarithromycin).
Proton pump inhibitors (PPIs) and H2 antagonists
Significantly reduce erlotinib absorption; co-administration should be avoided (e.g., omeprazole, ranitidine).
Storage
Store at room temperature (below 30°C), protected from light and moisture. Keep out of reach of children.
Overdose
Single doses of erlotinib up to 1000 mg in healthy volunteers and up to 1500 mg in cancer patients have been associated with adverse events such as rash and diarrhea. In case of suspected overdose, discontinue erlotinib and institute symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category D. Erlotinib can cause fetal harm. Advise pregnant women of the potential risk to a fetus. It is not known whether erlotinib is excreted in human milk; however, because of the potential for serious adverse reactions in breastfed infants, women should be advised against breastfeeding during treatment and for 2 weeks after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months from manufacturing date when stored correctly.
Availability
Hospitals, specialized pharmacies
Approval Status
FDA Approved
Patent Status
Generics available
Clinical Trials
Erlotinib has undergone extensive clinical trials, including BR.21 and SATURN for NSCLC, and PA.3 for pancreatic cancer, demonstrating significant improvements in progression-free and overall survival in selected patient populations.
Lab Monitoring
- Monitor liver function tests (ALT, AST, bilirubin) regularly.
- Monitor renal function and electrolytes.
- Dermatologic exams for skin reactions.
- Pulmonary function monitoring if ILD is suspected.
Doctor Notes
- Confirm EGFR mutation status before initiating treatment for NSCLC.
- Counsel patients extensively on potential dermatologic and gastrointestinal toxicities and their management.
- Consider dose reductions for intolerable side effects.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor.
- Do not change your dose or stop taking it without consulting your doctor.
- Take it on an empty stomach, at least 1 hour before or 2 hours after a meal.
- Report any new or worsening side effects promptly.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Erlotinib may cause fatigue or changes in vision. Patients should exercise caution when driving or operating machinery until they know how the drug affects them.
Lifestyle Advice
- Protect your skin from the sun (use sunscreen and protective clothing) as rash can be exacerbated by sun exposure.
- Maintain good skin hygiene and moisturize regularly to manage skin dryness.
- Avoid smoking as it can reduce erlotinib effectiveness.
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