Description

Erlotinib Tablets 100 mg

Erlotinib Tablets 100 mg is a prescription oral cancer medication used to treat specific types of non-small cell lung cancer (NSCLC) and advanced pancreatic cancer. It belongs to a class of drugs known as tyrosine kinase inhibitors (TKIs) and works by blocking a protein called the epidermal growth factor receptor (EGFR), which plays a role in the growth and spread of cancer cells.

This medication is often used in patients with EGFR mutation-positive NSCLC and is typically part of a targeted therapy plan either as a first-line treatment for advanced cancer or after failure of prior therapy.

Brand Reference: Tarceva
Generic Name: Erlotinib
Form: Oral tablet
Strength available: 100 mg (also available in 25 mg and 150 mg)

Therapeutic Indications

Erlotinib 100 mg is indicated for:

• Locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations
• Pancreatic cancer (locally advanced/unresectable or metastatic) in combination with gemcitabine
• Maintenance therapy in NSCLC patients after first-line chemotherapy

Use of this tablet must follow confirmed testing for EGFR mutation status as per clinical guidelines.

Mechanism of Action

Erlotinib works by selectively inhibiting the tyrosine kinase activity of the EGFR protein. EGFR is overexpressed in a number of cancers and is involved in the regulation of:

• Cell proliferation
• Apoptosis inhibition
• Angiogenesis
• Tumor cell invasion

By blocking EGFR, Erlotinib halts the cell signaling pathways that promote cancer progression, thereby slowing tumor growth and potentially reducing its size over time.

Dosage and Administration

• Strength: 100 mg per tablet
• Route: Oral
• Typical Dose:
  • NSCLC: 150 mg once daily (100 mg may be used for dose reductions)
  • Pancreatic cancer (with gemcitabine): 100 mg once daily
• Administration: Take on an empty stomach (at least 1 hour before or 2 hours after eating)
• Swallow tablet whole; do not crush, break, or chew

Dose adjustments may be necessary based on side effects, liver function, or tolerance.

Composition

• Active Ingredient: Erlotinib Hydrochloride equivalent to Erlotinib 100 mg
• Excipients: Microcrystalline cellulose, sodium starch glycolate, magnesium stearate (may vary by manufacturer)
• Packaging: Supplied in blister strips or bottles of varying pack sizes (typically 30 tablets per bottle)

Common Side Effects

• Rash
• Diarrhea
• Fatigue
• Loss of appetite
• Nausea and vomiting
• Conjunctivitis or eye irritation
• Dry skin

Serious Side Effects

• Interstitial lung disease (rare but potentially fatal)
• Liver enzyme elevation
• Gastrointestinal perforation
• Kidney failure
• Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)

All patients should be monitored regularly, especially for liver and lung function.

Warnings and Precautions

• Smoking decreases the efficacy of Erlotinib; patients should avoid tobacco during treatment
• Pregnancy: Contraindicated; may cause harm to fetus
• Breastfeeding: Not recommended
• Use with caution in individuals with hepatic or renal impairment
• Monitor for rash, diarrhea, and lung toxicity regularly
• Avoid concurrent use with acid-reducing agents (e.g., PPIs, antacids) which may reduce drug absorption

Drug Interactions

• Drugs affecting CYP3A4 enzyme may alter Erlotinib concentrations (e.g., ketoconazole, rifampin, phenytoin)
• May increase bleeding risk when taken with warfarin
• Grapefruit juice should be avoided
• Avoid tobacco and herbal supplements like St. John’s Wort

Storage Instructions

• Store at room temperature (15–30°C)
• Keep in original packaging
• Protect from exposure to moisture and heat
• Keep out of reach of children

Frequently Asked Questions (FAQs)

1. What is Erlotinib 100 mg used for?
It is used to treat EGFR mutation-positive non-small cell lung cancer (NSCLC) and certain forms of pancreatic cancer, often in combination with chemotherapy.

2. Can Erlotinib be used as a first-line treatment?
Yes, especially in NSCLC with confirmed EGFR mutations. Genetic testing is required before initiating therapy.

3. What is the usual dose of Erlotinib?
Depends on the condition. For NSCLC, 150 mg daily is standard. 100 mg is typically used in pancreatic cancer or in dose adjustments.

4. How should I take Erlotinib tablets?
Take once daily on an empty stomach, at least one hour before or two hours after food.

5. Can I cut or crush the tablet?
No. Tablets should be swallowed whole with water.

6. What are the most common side effects?
Rash, diarrhea, and fatigue are among the most frequently reported effects.

7. Can I take Erlotinib with antacids or acid reducers?
No. These can reduce the drug’s absorption. Speak with your doctor before taking anything for acid reflux.

8. Is Erlotinib chemotherapy?
It is a targeted therapy, which works differently than traditional chemotherapy by selectively acting on cancer-related pathways.

9. Can pregnant women take this drug?
No. Erlotinib should not be used during pregnancy due to the risk of harm to the unborn baby.

10. Do I need a prescription to buy Erlotinib?
Yes. Erlotinib is a prescription-only medication and should be taken under specialist supervision.