Gefitinib Sandoz

Gefitinib Sandoz

gefitinib

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma

Marketer:

Novartis
Concise Prescribing Info
Contents
Gefitinib
Indications/Uses
1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of EGFR-TK. Locally advanced or metastatic NSCLC in patients who have previously received chemotherapy.
Dosage/Direction for Use
250 mg once daily. Patients w/ poorly tolerated diarrhoea or skin adverse reactions Reinstate 250 mg dose after 14 days of treatment interruption.
Administration
May be taken with or without food: Take at approx the same time each day w/ water. For patients w/ difficulty swallowing, tab may be dispersed in ½ glass of non-carbonated drinking water. No other liqd should be used. Drop the tab in water & w/o crushing it, swirl glass occasionally until tab is dispersed (approx 20 min). Drink the liqd immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via nasogastric or gastrostomy tube.
Contraindications
Special Precautions
Discontinue use if interstitial lung disease; ulcerative keratitis is confirmed. Cerebral haemorrhage; severe or persistent diarrhoea, nausea, vomiting or anorexia; keratitis; GI perforation or ulceration, bowel metastases at perforation site; smoking. Assess EGFR mutation of tumour tissue prior to treatment. Periodically monitor liver function. Regularly monitor prothrombin time or INR changes in patients taking warfarin. Concomitant use w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort; drugs causing significant sustained gastric pH elevations eg, proton-pump inhibitors, H2-antagonists; vinorelbine; steroids or NSAIDs. May affect ability to drive & use machines. Mild to moderate hepatic function changes. Women of childbearing potential. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. Elderly.
Adverse Reactions
Mild or moderate anorexia; mainly mild or moderate diarrhoea, vomiting, nausea, mild stomatitis; mild-moderate ALT elevations; mainly mild-moderate skin reactions, pustular rash, sometimes itchy w/ dry skin including skin fissures on an erythematous base; mild asthenia. Conjunctivitis, blepharitis & mainly mild dry eye; haemorrhage eg, epistaxis & haematuria; often severe interstitial lung disease; dehydration, secondary to diarrhoea, nausea, vomiting, anorexia, dry mouth, mild-moderate AST & total bilirubin elevations; nail disorder, alopecia, allergic reactions including angioedema & urticaria; asymptomatic laboratory elevations in blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Decreased clearance w/ drugs that inhibit CYP3A4. Increased plasma conc w/ CYP3A4 potent inhibitors eg, ketoconazole, posaconazole, voriconazole, PIs, clarithromycin, telithromycin. Increased mean AUC w/ itraconazole. Reduced efficacy w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort. Reduced mean AUC w/ rifampicin, ranitidine. Increased metoprolol exposure. Inhibited BCRP transporter protein. Elevated INR &/or bleeding events w/ warfarin.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EB01 - gefitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Gefitinib Sandoz FC tab 250 mg
Packing/Price
3 × 10's
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