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Birlotib 100mg - Erlotinib Tablets

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Birlotib 100mg - Erlotinib Tablets

Birlotib 100mg is an oral anticancer medication containing Erlotinib, a targeted therapy used primarily for non-small cell lung cancer (NSCLC) and pancreatic cancer. It works by inhibiting the activity of the epidermal growth factor receptor (EGFR), thereby stopping cancer cell growth.

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Description Product Details
General Information:
Generic Name: Erlotinib
Brand Name: Birlotib
Packing: Strip/Bottle of 30 tablets
Strength: 100mg per tablet
Manufacturer: BDR Pharmaceuticals
Form: Oral tablets
Category: Tyrosine Kinase Inhibitor / Antineoplastic Agent
Product Intro:
Birlotib 100mg is a targeted therapy used in the management of cancers that express EGFR mutations. By blocking the EGFR tyrosine kinase, Birlotib helps slow or stop the growth of cancer cells. It is commonly prescribed for patients with advanced or metastatic non-small cell lung cancer and for combination treatment in pancreatic cancer.
Uses:
  1. Non-Small Cell Lung Cancer (NSCLC) – with EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution)
  2. Pancreatic Cancer – used in combination with gemcitabine
  3. Recurrent or Metastatic NSCLC – second-line therapy
  4. Locally advanced/metastatic disease – in patients unfit for chemotherapy
  5. Maintenance therapy – post-first-line treatment in NSCLC
  6. Off-label use – for other EGFR-expressing tumors in clinical settings
Storage Instructions:
  • Store at 15°C to 30°C (59°F to 86°F)
  • Protect from moisture, light, and heat
  • Keep in the original container
  • Keep out of reach of children
How it Works (Mechanism of Action):
Erlotinib inhibits the epidermal growth factor receptor (EGFR) tyrosine kinase, an enzyme that helps cells grow and divide. By blocking EGFR activation, Erlotinib interferes with the signal pathways that promote cancer cell proliferation and survival, particularly in tumors driven by EGFR mutations.
Side Effects:
Common Side Effects:
  • Rash or acne-like skin eruptions
  • Diarrhea
  • Loss of appetite
  • Fatigue
  • Nausea and vomiting
  • Cough
Serious Side Effects:
  • Interstitial lung disease (ILD) – rare but potentially fatal
  • Severe liver toxicity – monitor liver function
  • GI perforation – rare but serious
  • Corneal ulceration or other ocular issues
  • Severe skin reactions (Stevens-Johnson syndrome)
Dosage (Typical Recommended Dose):
  • NSCLC: 150mg once daily
  • Pancreatic cancer (with gemcitabine): 100mg once daily
  • Dose may be adjusted based on tolerability and side effects
Method of Administration:
  • Oral use only
  • Take at least 1 hour before or 2 hours after meals
  • Swallow whole with water
  • Take at the same time every day
Precautions:
  • Test for EGFR mutation status before initiating therapy
  • Monitor for signs of lung toxicity, diarrhea, and liver function abnormalities
  • Use sunscreen and protective clothing due to photosensitivity risk
  • Avoid smoking, as it reduces drug levels and efficacy
  • Use with caution in hepatic and renal impairment
Drug Interactions:
  • Proton pump inhibitors (PPIs) – reduce erlotinib absorption
  • CYP3A4 inhibitors (e.g., ketoconazole) – increase drug levels
  • CYP3A4 inducers (e.g., rifampin, phenytoin) – reduce efficacy
  • Anticoagulants (e.g., warfarin) – monitor INR closely
  • Smoking – induces CYP1A1, lowers erlotinib levels
Allergies:
  • Contraindicated in patients allergic to Erlotinib or any excipients
  • Discontinue and seek immediate medical help if signs of allergic reaction occur:
    • Hives, swelling, severe rash
    • Breathing difficulty
    • Dizziness or fainting
Overdose Information:
  • Symptoms: Severe diarrhea, rash, and liver dysfunction
  • Action: Symptomatic and supportive treatment
  • No specific antidote available
Missed Dose Instructions:
  • If a dose is missed, take it as soon as remembered unless it's close to the next dose
  • Do not double dose
  • Resume the regular dosing schedule
Additional Notes:
  • Regular monitoring of EGFR mutation status, liver enzymes, and lung function is essential
  • Smoking cessation is strongly advised during treatment
  • Advise patients about the potential for skin toxicity and eye symptoms
  • Ensure adequate hydration and nutrition throughout therapy
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