Afatinib

[Drug Name]

Generic Name: Afatinib Maleate Tablets

Trade name: GIOTRIF®, English: GIOTRIF®.

English name: Afatinib Dimaleate Tablets

Hanyu Pinyin: Malaisuan Afatini Pian

[Indications

This product is indicated for the treatment of patients with

Locally advanced or metastatic non-small cell lung cancer (NSCLC) with a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene that has not been previously treated with an EGFR tyrosine kinase inhibitor (TKI).

Locally advanced or metastatic squamous histologic type of non-small cell lung cancer (NSCLC) with disease progression during or after platinum-containing chemotherapy

[Usage and dosage]

This product should be used under the supervision of an experienced physician. Mutational status of EGFR should be determined using a well-validated assay prior to initiating therapy.

recommended dose

The recommended dose of this product is 40mg once daily. There is insufficient evidence to support that patients may derive greater benefit from the 50mg dose.

This product should not be taken with food. Take this product at least 3 hours after eating or at least 1 hour before eating. (See [Drug Interactions] and [Pharmacokinetics]). Tablets should be swallowed whole with water.

[Adverse Reaction]

onychomycosis, cystitis, decreased appetite, dehydration, hypokalemia, taste disturbance, conjunctivitis, dry eye, keratitis, epistaxis, rhinorrhea, interstitial lung disease, diarrhea, stomatitis, nausea, vomiting, dyspepsia, xerostomia, pancreatitis, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), skin rashes, acneiform dermatitis, itchy skin, dry skin, loss of sensation of the palms and metatarsals erythema syndrome, muscle cramps, renal impairment, renal failure, fever, weight loss.

[Storage]

Store at a temperature not exceeding 25°C and out of the reach of children.