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Erlogem 100/150 Tablets

Generic Name- Erlotinib

Drug Class- Antineoplastic agent

Erlotinib is a tyrosine kinase receptor inhibitor used in the management of some types of non-small cell lung cancer and advanced pancreatic cancer. It acts by selectively and reversibly inhibiting the tyrosine kinase activity of epidermal growth factor receptors which are involved in cancer cell proliferation, apoptosis, angiogenesis, invasions and metastasis.

Category

Product Description

Erlogem 100/150 (Erlotinib) is a chemotherapeutic agent available in form of tablets for oral administration.

Indications and Usage

Erlotinib is indicated for:

  • Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen
  • Maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
  • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine

Dosage and Administration

  • Dosage Regimen for NSCLC
Erlotinib Monotherapy
Erlotinib 150 mg/day
  • Dosage Regimen for Pancreatic Cancer
GEM-ERL (Gemcitabine plus Erlotinib) Regimen
Erlotinib 100 mg/day
Gemcitabine 1000 mg/m2 weekly for the

first 3 weeks in a 4-week cycle

  • Erlotinib should be taken on an empty stomach at least one hour before or two hours after food.
  • Dose can be reduced to 50mg/ day, whenever required2

Dosage Forms and Strengths

  • Supplied as tablets for oral use
  • Available in 100 mg and 150 mg strengths

Clinical Efficacy

  • Improves symptoms control, survival outcomes and quality of life when used as a standard treatment for advanced NSCLC in second- or third-line settings3
  • Enhances the cytotoxic effects and outcomes of chemotherapy, when used in combination with other chemotherapy drugs in patients with advanced NSCLC3
  • Shows promising activity with survival benefits in treatment of patients with advanced pancreatic cancer4

Adverse Reactions

  • The most common adverse reactions observed with use of erlotinib in maintenance treatment are rash-like events and diarrhea
  • The most common adverse events observed after use of erlotinib as 2nd line NSCLC

are anorexia, fatigue, dyspnea, rash, cough, diarrhea, nausea, vomiting and infection

  • The most common adverse events observed after use of erlotinib in patients with pancreatic cancer are diarrhea, abdominal pain, nausea, vomiting, constipation, fatigue, rash, anorexia, weight decrease, infection, edema, pyrexia, bone pain, dyspnea, stomatitis and myalgia

Contraindications

  • None

Special Precautions

  • Interrupt erlotinib use in patients with the risk of an acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever. Discontinue erlotinib, if serious interstitial lung disease is diagnosed
  • Determine renal function and electrolytes in patients at risk of dehydration and interrupt erlotinib use in cases of severe dehydration
  • Monitor periodic liver function carefully and discontinue use of erlotinib in patients with severe hepatic impairment, hepatic failure and hepatorenal syndrome
  • Erlotinib use is associated with risk of developing myocardial infarction/ischemia, microangiopathic hemolytic anemia with thrombocytopenia and cerebrovascular accidents in patients with pancreatic cancer
  • Discontinue use of erlotinib in patients reporting gastrointestinal perforations, bullous & exfoliative skin disorders and corneal perforation & ulceration after treatment
  • Prothrombin time and International Normalized Ratio (INR) should be monitored in patients taking warfarin and coumarin-derivative anticoagulants as erlotinib use can cause elevations in INR and bleeding events in these patients
  • Erlonitib can cause fetal harm, so it should not be administered to pregnant women and women with child bearing potential should be advised to avoid pregnancy
Erlogem 100/150 Tablets - ADMAC Life Science