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Erlocip (100mg / 150mg) - Erlotinib Tablets

Erlocip (100mg / 150mg) - Erlotinib Tablets

Erlocip is an oral anticancer medication containing Erlotinib, a targeted therapy that inhibits epidermal growth factor receptor (EGFR) tyrosine kinase. It is mainly used to treat non–small cell lung cancer (NSCLC) and pancreatic cancer, particularly in patients with EGFR mutations.

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Description Product Details
General Information:
Generic Name: Erlotinib
Brand Name: Erlocip
Packing: Bottle of 30 tablets
Strength: 100 mg and 150 mg per tablet
Manufacturer: Cipla Ltd.
Form: Oral tablet
Category: Targeted therapy, EGFR tyrosine kinase inhibitor, Antineoplastic agent
Product Intro:
Erlocip is a first-generation EGFR tyrosine kinase inhibitor (TKI) developed to target specific cancer cells with EGFR gene mutations. It helps prevent cancer cell growth and spread by blocking the signaling pathways that promote tumor proliferation. Erlocip is widely used in both first-line and maintenance settings for EGFR-positive tumors.
Uses (Indications):
  1. Non–Small Cell Lung Cancer (NSCLC):
    • First-line treatment for patients with EGFR-activating mutations.
    • Also used for maintenance or second-line therapy after chemotherapy failure.
  2. Pancreatic Cancer:
    • Used in combination with gemcitabine for locally advanced or metastatic disease.
  3. EGFR-Mutated Tumors:
    • Effective in cancers that express mutated forms of EGFR (e.g., exon 19 deletions, exon 21 L858R).
  4. Brain Metastases in Lung Cancer:
    • Due to its ability to cross the blood-brain barrier in some cases, used off-label in CNS disease.
  5. Recurrent or Advanced Cancers:
    • Used as a salvage or palliative therapy in select patients with EGFR sensitivity.
  6. Other Solid Tumors (Under Investigation):
    • Colorectal, head and neck, and ovarian cancers in clinical research contexts.
Storage Instructions:
  1. Store below 30 °C in a cool, dry place.
  2. Keep away from direct light and moisture.
  3. Keep out of reach of children.
  4. Do not use tablets beyond the expiration date printed on the pack.
How It Works (Mechanism of Action):
Erlotinib selectively inhibits the tyrosine kinase domain of the EGFR (ErbB1). By blocking phosphorylation of the receptor, it prevents downstream activation of pathways like RAS-RAF-MEK-ERK and PI3K-AKT, which are involved in cellular proliferation, survival, and angiogenesis. This blockade halts tumor cell division and can induce apoptosis in EGFR-dependent tumor cells.
Side Effects:
Common Side Effects:
  1. Rash or Acneiform Eruption: Occurs in up to 70% of patients—typically on the face, upper chest, and back.
  2. Diarrhea: Mild to moderate in severity—dose reduction may be required.
  3. Fatigue: Common but often mild and manageable.
  4. Nausea and Vomiting: Seen in some patients—treated with supportive medications.
  5. Loss of Appetite and Weight Loss
Serious or Severe Side Effects:
  1. Interstitial Lung Disease (ILD): Rare but potentially fatal—presents with shortness of breath and cough.
  2. Hepatotoxicity: Elevated liver enzymes; monitor LFTs regularly.
  3. Gastrointestinal Perforation: Very rare, more common in patients with GI ulcers or metastases.
  4. Keratitis and Ocular Toxicity: Eye redness, dryness, and vision changes may occur.
  5. Renal Failure: Especially in dehydrated patients or those with comorbid kidney disease.
Dosage (Typical Recommended Dose):
  1. NSCLC: 150 mg orally once daily on an empty stomach.
  2. Pancreatic Cancer: 100 mg orally once daily with gemcitabine.
  3. Dose Adjustments: May be needed for hepatic impairment or adverse reactions (e.g., rash or diarrhea).
  4. Duration: Continued until disease progression or unacceptable toxicity.
  5. No dose modification based solely on age.
Method of Administration:
  1. Take Erlocip on an empty stomach, at least 1 hour before or 2 hours after meals.
  2. Swallow tablets whole with water—do not crush or chew.
  3. Take the dose at the same time each day for consistent drug levels.
  4. Avoid grapefruit or grapefruit juice, which may alter drug metabolism.
Precautions:
  1. EGFR Mutation Testing: Confirm mutation status before initiating therapy.
  2. Smoking Reduces Effectiveness: Nicotine induces CYP1A1/1A2 enzymes that increase drug clearance.
  3. Pulmonary Monitoring: Watch for symptoms of ILD—stop therapy if suspected.
  4. Liver Function: Monitor LFTs periodically, especially in patients with hepatic impairment.
  5. Sun Exposure: Increases risk of rash—advise sunscreen and protective clothing.
  6. Pregnancy Category D: Use contraception during and for at least 1 month after therapy.
Drug Interactions:
  1. Proton Pump Inhibitors (e.g., omeprazole): Reduce absorption of Erlocip—avoid if possible.
  2. CYP3A4 Inhibitors (e.g., ketoconazole): Increase drug levels and risk of toxicity.
  3. CYP3A4 Inducers (e.g., rifampin, phenytoin): Decrease drug levels—may reduce efficacy.
  4. Warfarin: Increased bleeding risk—monitor INR closely.
  5. NSAIDs and Aspirin: Can increase GI irritation—caution advised.
Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity Reactions: Rare but may include rash, itching, or facial swelling.
  2. Anaphylaxis is uncommon—discontinue immediately if signs appear.
  3. Skin Testing Not Required: Monitor for signs of dermatologic toxicity.
Overdose Information:
  1. Symptoms: Severe rash, diarrhea, liver enzyme elevation, or QT prolongation.
  2. Management: No specific antidote—supportive care, IV fluids, electrolyte correction.
  3. Contact Poison Control: In case of accidental or intentional overdose.
Missed Dose Instructions:
  1. If you miss a dose, take it as soon as you remember, unless it's almost time for the next dose.
  2. Do not double the dose to make up for a missed one.
  3. Inform your oncologist if multiple doses are missed.
Additional Notes:
  1. Skin rash is associated with better outcomes—may indicate effective EGFR blockade.
  2. Blood and liver tests should be done regularly during treatment.
  3. EGFR mutation-positive patients respond better than wild-type.
  4. Drug resistance may develop over time (e.g., T790M mutation)—may require second-line TKIs.
  5. Patient counseling is crucial regarding rash, diet, sun protection, and adherence.

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