Erlotinib 100 mg and 150 mg Tablets

Erlotinib is a drug used to treat non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is a receptor tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor (EGFR).

Medical uses of Erlotinib

Erlotinib has shown a survival benefit in the treatment of lung cancer in phase III trials. The SATURN (Sequential Tarceva in Unresectable Non-small cell lung cancer) study found that erlotinib added to chemotherapy improved overall survival by 19%, and improved progression-free survival (PFS) by 29%, when compared to chemotherapy alone.

The U.S. Food and Drug Administration (FDA) has approved erlotinib for the treatment of locally advanced or metastatic non-small cell lung cancer that has failed at least one prior chemotherapy regimen.

In November 2005, the FDA approved erlotinib in combination with gemcitabine for treatment of locally advanced, unresectable, or metastatic pancreatic cancer.

In lung cancer, erlotinib has been shown to be effective in patients with or without EGFR mutations, but appears to be more effective in patients with EGFR mutations. Overall survival, progression-free survival and one-year survival are similar to standard second-line therapy (docetaxel or pemetrexed). Overall response rate is about 50% better than standard second-line chemotherapy. Patients who are non-smokers, and light former smokers, with adenocarcinoma or subtypes like BAC are more likely to have EGFR mutations, but mutations can occur in all types of patients. A test for the EGFR mutation in cancer patients has been developed by Genzyme.

Erlotinib has recently been shown to be a potent inhibitor of JAK2V617F activity. JAK2V617F is a mutant of tyrosine kinase JAK2, is found in most patients with polycythemia vera (PV) and a substantial proportion of patients with idiopathic myelofibrosis or essential thrombocythemia. The study suggests that erlotinib may be used for treatment of JAK2V617F-positive PV and other myeloproliferative disorders.

The drug's US patent will expire in 2020. In May 2012, the US District Court of Delaware passed an order in favour of OSI Pharmaceutical LLC against Mylan Pharmaceuticals upholding the validity of the patent for Erlotinib. In India, generic pharmaceutical firm Cipla is battling with Roche against the Indian patent for this drug.

Side effects

Common:-

• Rash occurs in the majority of patients. This resembles acne and primarily involves the face and neck. It is self-limited and resolves in the majority of cases, even with continued use. Some clinical studies have indicated a correlation between the severity of the skin reactions and increased survival though this has not been quantitatively assessed. The Journal of Clinical Oncology reported in 2004 that "cutaneous [skin] rash seems to be a surrogate marker of clinical benefit, but this finding should be confirmed in ongoing and future studies. The newsletter Lung Cancer Frontiers reported in its October 2003 issue, "Patients with moderate to severe cutaneous reactions [rashes] have a far better survival, than those with only mild reactions and much better than those with no cutaneous manifestations of drug effects.
• Diarrhea
• Loss of appetite
• Fatigue
• Partial hair loss (by strands, not typically in clumps)

Rare

• interstitial pneumonitis, which is characterized by cough and increased dyspnea. This may be severe and must be considered among those patients whose breathing acutely worsens.
• ingrown hairs, such as eyelashes
• gastrointestinal tract toxicity

serious or fatal gastrointestinal tract perforations

• skin toxicity

bullous, blistering, and exfoliative skin conditions (some fatal)

Stevens–Johnson syndrome/toxic epidermal necrolysis

• ocular disorders

corneal lesions

• Pulmonary toxicity

interstitial pneumonitis

bronchiolitis obliterans with organizing pneumonia (BOOP)

pulmonary fibrosis

fatal asymmetric interstitial lung disease

Reported

• It has also been suggested that erlotinib can cause hearing loss.

Interactions

As per published report, erlotinib is not a substrate for either of hepatic OATPs (OATP1B1 or OATP1B3). Also, erlotinib is not an inhibitor of OATP-1B1 or OATP-1B3 transporter.

Erlotinib is mainly metabolized by the liver enzyme CYP3A4. Compounds which induce this enzyme (i.e. stimulate its production), such as St John's wort, can lower erlotinib concentrations, while inhibitors can increase concentrations.

Mechanism

Erlotinib is an epidermal growth factor receptor inhibitor (EGFR inhibitor). The drug follows Iressa (gefitinib), which was the first drug of this type. Erlotinib specifically targets the epidermal growth factor receptor (EGFR) tyrosine kinase, which is highly expressed and occasionally mutated in various forms of cancer. It binds in a reversible fashion to the adenosine triphosphate (ATP) binding site of the receptor. For the signal to be transmitted, two EGFR molecules need to come together to form a homodimer. These then use the molecule of ATP to trans-phosphorylate each other on tyrosine residues, which generates phosphotyrosine residues, recruiting the phosphotyrosine-binding proteins to EGFR to assemble protein complexes that transduce signal cascades to the nucleus or activate other cellular biochemical processes. When erlotinib binds to EGFR, formation of phosphotyrosine residues in EGFR is not possible and the signal cascades are not initiated.

Erlotinib 100 mg / 150 mg Tablets Brands In India

Erlonat 100mg - Natco Pharma Ltd.

Erlonat 150mg - Natco Pharma Ltd.

Erlocip 100mg - Cipla Limited.

Erlocip 150mg - Cipla Limited.

Erlotec 100mg - United Biotech Pvt. Ltd.

Erlotec 150mg - United Biotech Pvt. Ltd.

Erlotib 100mg - Intas Pharmaceuticals Ltd.

Erlotib 150mg - Intas Pharmaceuticals Ltd.

Lortinib 100mg - RPG Life Sciences Ltd.

Lortinib 150mg - RPG Life Sciences Ltd.

Tyrokinin 100mg - Dr. Reddy's Laboratories Ltd.

Tyrokinin 150mg - Dr. Reddy's Laboratories Ltd.

Erlokem 100mg - Alkem Laboratories Ltd.

Erlokem 150mg - Alkem Laboratories Ltd.

Birlotib 100mg - BDR Pharmaceuticals

Birlotib 150mg - BDR Pharmaceuticals

Erlotero 100mg - Hetero Drugs Ltd.

Erlotero 150mg - Hetero Drugs Ltd.

Erleva 100mg - Glenmark Pharmaceuticals

Erleva 150mg - Glenmark Pharmaceuticals

Zyceva 100mg - Zydus Oncosciences

Zyceva 150mg - Zydus Oncosciences

What are the side effects of Erlotinib?

• Cough
• Diarrhea
• Lower back or side pain
• Chills and fever
• Blurred vision
• Convulsions (seizures)
• Chest pain or discomfort
• Acid or sour stomach
• Hair loss
• Irritability
• Itching skin
• Joint pain
• Rash, mild
• Swollen joints
• Tiredness

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Source:- https://en.wikipedia.org/wiki/Erlotinib