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Erlonat (100mg / 150mg) - Erlotinib Tablets

Erlonat (100mg / 150mg) - Erlotinib Tablets

Erlonat is an oral anti-cancer agent containing Erlotinib, a targeted EGFR tyrosine kinase inhibitor used to treat specific types of cancer like non–small cell lung cancer (NSCLC) and pancreatic cancer. It is especially effective in tumors with EGFR mutations.

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Description Product Details
General Information:
Generic Name: Erlotinib
Brand Name: Erlonat
Packing: Pack of 30 tablets
Strengths Available: 100 mg and 150 mg
Manufacturer: Natco Pharma Ltd.
Form: Oral tablet
Category: Antineoplastic agent, EGFR Tyrosine Kinase Inhibitor
Product Intro:
Erlonat is a precision therapy that interferes with the growth of cancer cells dependent on the epidermal growth factor receptor (EGFR). It is a first-generation tyrosine kinase inhibitor (TKI) used both as a first-line and maintenance therapy in EGFR-positive cancers, especially lung and pancreatic types.
Uses (Indications):
  1. Non–Small Cell Lung Cancer (NSCLC):
    • For advanced or metastatic NSCLC with EGFR mutations.
    • First-line, second-line, or maintenance therapy after chemotherapy.
  2. Pancreatic Cancer:
    • Used in combination with gemcitabine for locally advanced or metastatic cases.
  3. EGFR Mutation–Positive Cancers:
    • Effective against tumors with exon 19 deletions or exon 21 (L858R) point mutations.
  4. Central Nervous System (CNS) Metastases:
    • Sometimes used off-label for brain metastases in EGFR-positive patients due to its partial CNS penetration.
  5. Resistance Cases:
    • In cases with mild resistance to chemotherapy, as a targeted second-line treatment.
  6. Other Solid Tumors (under study):
    • Being investigated in cancers like head and neck, colorectal, and ovarian tumors.
Storage Instructions:
  1. Store at temperatures below 30°C in a dry location.
  2. Protect from light and moisture.
  3. Keep in original packaging until use.
  4. Keep out of reach of children.
5. How It Works (Mechanism of Action):
Erlotinib selectively inhibits the tyrosine kinase domain of the EGFR (ErbB1 receptor) by binding to the ATP-binding site. This action blocks downstream signaling cascades involved in cell growth, proliferation, and survival, particularly the RAS/RAF/MEK/ERK and PI3K/AKT pathways. This inhibition is most effective in cancer cells that rely on mutated EGFR for survival and division.
Side Effects:
Common Side Effects:
  1. Rash and acneiform eruptions (most frequent and linked to efficacy)
  2. Diarrhea (mild to moderate, often manageable)
  3. Fatigue and weakness
  4. Nausea and vomiting
  5. Loss of appetite and weight loss
Severe or Less Common Side Effects:
  1. Interstitial Lung Disease (ILD): Rare but serious; monitor respiratory symptoms.
  2. Hepatotoxicity: Elevated liver enzymes; regular liver function testing is advised.
  3. Corneal ulceration or keratitis: Eye discomfort or changes in vision.
  4. GI bleeding or perforation: Rare, but more likely in patients with a history of ulcers.
  5. Renal dysfunction or electrolyte imbalances in some patients.
Dosage (Typical Recommended Dose):
  1. NSCLC: 150 mg orally once daily on an empty stomach
  2. Pancreatic Cancer: 100 mg once daily (with gemcitabine)
  3. Dose Adjustments: Required for liver impairment or significant adverse effects
  4. Therapy is continued until disease progression or unacceptable toxicity
Method of Administration:
  1. Take on an empty stomach (at least 1 hour before or 2 hours after food)
  2. Swallow the tablet whole with water—do not crush or split
  3. Take the dose at the same time daily to maintain consistent drug levels
  4. Avoid grapefruit juice, which may increase drug levels
Precautions:
  1. Test for EGFR mutations before starting therapy
  2. Smoking decreases efficacy—patients should stop smoking before and during treatment
  3. Monitor for respiratory symptoms, which may indicate interstitial lung disease
  4. Use contraception during and at least 1 month post-therapy (pregnancy category D)
  5. Hepatic and renal function monitoring is essential
  6. Sun protection is advised due to increased risk of skin rash and photosensitivity
Drug Interactions:
  1. Proton Pump Inhibitors (PPIs): May reduce absorption; use H2 blockers cautiously
  2. CYP3A4 inhibitors (e.g., ketoconazole): Increase drug concentration and toxicity risk
  3. CYP3A4 inducers (e.g., phenytoin, rifampin): Reduce Erlonat efficacy
  4. Warfarin: Increases risk of bleeding—monitor INR
  5. NSAIDs: May increase gastrointestinal risks
Allergies (Warnings for Allergic Reactions):
  1. Rare hypersensitivity reactions—may include rash, facial swelling, or itching
  2. Severe allergic responses like anaphylaxis are uncommon but require immediate discontinuation
  3. Avoid re-challenge in confirmed allergic reactions
Overdose Information:
  1. Symptoms may include severe diarrhea, rash, vomiting, or QT prolongation
  2. No specific antidote exists—treatment is supportive
  3. Hospitalization may be needed for fluid management and monitoring
Missed Dose Instructions:
  1. Take the missed dose as soon as remembered if not close to the next scheduled dose
  2. Do not double the dose to compensate for the missed one
  3. Resume normal schedule and consult the physician if multiple doses are missed
Additional Notes:
  1. Patients with rash may experience better clinical outcomes
  2. Long-term resistance may develop due to secondary EGFR mutations like T790M
  3. Regular imaging and molecular monitoring are advised to assess disease response
  4. Close dermatological monitoring is required, especially in the first month
  5. Counsel patients thoroughly on smoking cessation, adherence, and skin care

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