Indications and Dosage of Erlotinib Tablets

Prescribing information (PI): "For full information read PI" and consult a Physician before initiating any treatment.

Erlotinib is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations.
This medication is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not progressed on first-line chemotherapy. Efficacy is influenced by tumour characteristics.

It also can be indicated for use in treating patients with locally advanced or metastatic non-small cell lung cancer after the failure of earlier chemotherapy.

Pancreatic cancer: Erlotinib tablets in combination with the gemcitabine is recommended for the treatment of patients who are with locally advanced pancreatic cancer, unresectable or metastatic pancreatic cancer.

Very common side effects: The few very common side effects may occur such as rash. If you are exposed to the sun, you can wear protective cloth or can use sunscreen. Some other probable very common side effects are as follows:
Infection

• Loss of appetite, decreased weight
• Depression
• Headache
• Altered skin sensation
• Numbness in the extremities
• Difficulty in breathing, cough
• Nausea
• Mouth irritation
• Stomach pain, indigestion and flatulence
• Abnormal blood tests for the liver function
• Itching, dry skin and loss of hair
• Tiredness, fever, rigors

Discuss with your doctor as soon as you can if you suffer from any of the above side effects. In a few cases, your healthcare professionals may need to reduce your dose of this drug or interrupt the treatment. 

Dosage and Administration:

Non-small cell lung cancer: It is recommended that EGFR mutation testing should be performed prior to initiation of erlotinib 100 mg therapy in chemo-naive patients with advanced or metastatic non small cell lung cancer. A well validated and also robust test for activating the EGFR mutations should be recommended. The recommended dose of Erlotinib is 150 mg, which must be consumed at least an hour prior or a couple of hours after the ingestion of the meal.

Pancreatic cancer: Daily recommended dose of erlotinib is 100 mg, which should be consumed at least an hour before or a couple of hours after the ingestion of a meal, in combination with the gemcitabine (please refer the gemcitabine PI (prescribing information) in order to get the correct dosage of gemcitabine for a patient with pancreatic cancer).

Special Dosage Instructions:

Drug interactions: Concomitant use of CYP 3A4 substrates and modulators may require dose adjustment. When the adjustment of dose is necessary, it is recommended in order to reduce the dose in 50 mg increments. 

Hepatic impairment: Erlotinib is mainly eliminated by hepatic metabolism as well as biliary excretion. Although the exposure of erlotinib was identical in patients with the moderately impaired hepatic function compared with patients with the adequate hepatic function, caution must be imposed when administering this lung cancer medication to patients who are with the hepatic impairment. Dose interruption or reduction should be picked up if severe side effects occur. Safety as well efficacy have not been observed in patients with severe hepatic impairment.

Renal impairment: The safety, as well as the efficacy of this drug, has not been specified in patients with renal impairment.

Paediatric use: The safety and efficacy of this drug in the approved indications have not been established in patients who are under the age of 18 years.

Smokers: Smoking of cigarettes has been shown to reduce erlotinib exposure by 50 - 60%. The maximum tolerated dose of this tablets in non small cell lung cancer patients who are smoking is 300 mg. Erlotinib 300 mg dose has not been specified in order to improve the efficacy when used as the second-line lung cancer treatment after the failure of the chemotherapy compared to the recommended dose of 150 mg in patients who continue smoking cigarettes.

Contraindication: This Medication should be avoided in patients with the severe hypersensitivity to erlotinib or to any component of it.

Overdose: In some cases, severe adverse events have been reported such as rash, diarrhoea and possibly liver transaminase elevation with the recommended dose of 150 mg. In circumstances of suspected overdose, Erlotinib 150 mg should be withheld and also symptomatic treatment started. Treatment should consist of general supportive measures. Contact with the Poisons Information Centre in order to get instructions on the management of the overdosage.

Read:- Guide on Lung cancer