LOTYRO 25 ERLOTINIB FILM COATED TABLETS 25MG [SIN17082P]

Product Info

LOTYRO 25 ERLOTINIB FILM COATED TABLETS 25MG

[SIN17082P]

2.1. Therapeutic indications
Non-small cell lung cancer:
Erlotinib is indicated for

• the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations.

• switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.

• the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-negative tumours.

Pancreatic cancer:
Erlotinib in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

2.2 Dosage and Method of Administration

General
Non-small cell lung cancer:
EGFR mutation testing should be performed prior to initiation of Erlotinib as first-line or maintenance therapy in patients with locally advanced or metastatic NSCLC.
The recommended daily dose of Erlotinib is 150 mg taken at least one hour before or two hours after the ingestion of food.

Pancreatic cancer:
The recommended daily dose of Erlotinib is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the label of gemcitabine for the pancreatic cancer indication).

Special Dosage Instructions
Drug Interactions: Concomitant use of CYP 3A4 substrates and modulators may require dose adjustment (see section 2.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment: Erlotinib is eliminated by hepatic metabolism and biliary excretion. Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7–9) compared with patients with adequate hepatic function, caution should be used when administering Erlotinib to patients with hepatic impairment. Dose reduction or interruption of Erlotinib should be considered if severe adverse reactions occur. Safety and efficacy have not been studied in patients with severe hepatic impairment (see sections 2.4 Warnings & Precautions [Hepatitis, hepatic failure] and 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Smokers: Cigarette smoking has been shown to reduce erlotinib exposure by 50–60%. The maximum tolerated dose of Erlotinib in NSCLC patients who currently smoke cigarettes was 300 mg. The 300 mg dose did not show improved efficacy in second line treatment after failure of chemotherapy compared to the recommended 150 mg dose in patients who continue to smoke cigarettes (see section 2.5, Interactions with other Medicinal Products and other Forms of Interaction and section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment: The safety and efficacy of Erlotinib has not been studied in patients with renal impairment (see section 3.2.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Based on pharmacokinetic data, no dose adjustments appear necessary in patients with mild or moderate renal impairment. Use of Erlotinib in patients with severe renal impairment is not recommended.

Paediatric use: The safety and efficacy of Erlotinib, in the approved indications has not been established in patients under the age of 18 years.

When dose adjustment is necessary, it is recommended to reduce in 50 mg steps (see section 2.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

2.3 Contraindications
Erlotinib is contraindicated in patients with severe hypersensitivity to erlotinib or to any component of Erlotinib.