- Approval Id
- f47a41bb5b58e7bb
- Drug Name
- ALVOCEVA FILM-COATED TABLETS 100MG
- Product Name
- ALVOCEVA FILM-COATED TABLETS 100MG
- Approval Number
- SIN16045P
- Approval Date
- 2020-11-19
- Registrant
- LOTUS INTERNATIONAL PTE. LTD.
- Licence Holder
- LOTUS INTERNATIONAL PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
Erlotinib treatment should be supervised by a physician experienced in the use of anti-cancer therapies.
Posology
**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 summary of product characteristics of gemcitabine for the pancreatic cancer indication).
**Special Dosage Instructions**
Drug Interactions: Concomitant use of CYP 3A4 substrates and modulators may require dose adjustment.
_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 4.4 and 5.2 – _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 sections 4.5 and section 5.2 – _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 5.2 – _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 population_
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 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Method of administration
For oral use.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
Non-Small Cell Lung Cancer (NSCLC):
Erlotinib is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.
Erlotinib is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.
Erlotinib is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer 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 (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Pancreatic cancer:
Erlotinib in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
- Contraindications
- **4.3 Contraindications**
Hypersensitivity to erlotinib or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Atc Code
- L01EB02
- Atc Item Name
- erlotinib
- Pharma Manufacturer Name
- LOTUS INTERNATIONAL PTE. LTD.
- Company Detail Path
- /organization/lotus-international-pte-ltd
