Giotrif

Giotrif

afatinib

Manufacturer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Afatinib
Indications/Uses
Monotherapy treatment of locally advanced or metastatic non-squamous NSCLC w/ adenocarcinoma; locally advanced or metastatic squamous NSCLC progressing on or after platinum-based chemotherapy. EGFR exon 19 deletions, exon 21 (L858R and L861Q) substitutions, exon 18 (G719X) substitutions, or exon 20 (S768I) subtitution mutations, TKI-naive adult patients.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 3 hr after meals. Swallow whole w/ water.
Contraindications
Special Precautions
Interrupt & reduce dose or discontinue treatment in patients w/ severe diarrhoea, develops severe bullous, blistering or exfoliating conditions, ulcerative keratitis. Female gender, lower body wt & underlying renal impairment. Permanently discontinue if interstitial lung disease is diagnosed. Worsening of liver function or severe hepatic impairment. GI perforation. Acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain &/or red eye. Cardiac monitoring including left ventricular function assessment in patients w/ cardiac risk factor; P-glycoprotein interactions; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation.
Adverse Reactions
Diarrhea, stomatitis, paronychia, vomiting, dyspnea, fatigue, dehydration, pneumonia.
Drug Interactions
Strong P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarb or St. John’s wort) may decrease exposure to afatinib.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EB03 - afatinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Giotrif FC tab 20 mg
Packing/Price
4 × 1 × 7's
Form
Giotrif FC tab 30 mg
Packing/Price
4 × 1 × 7's
Form
Giotrif FC tab 40 mg
Packing/Price
4 × 1 × 7's
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