Qualitinib

Qualitinib

gefitinib

Manufacturer:

Admac Lifesciences

Distributor:

Qualimed

Marketer:

Bliss Pharma
Concise Prescribing Info
Contents
Gefitinib
Indications/Uses
Monotherapy for continued treatment of locally advanced/metastatic non-small cell lung cancer after failure of both platinum-based & docetaxel chemotherapies.
Dosage/Direction for Use
250 mg daily. Patient w/ poorly tolerated diarrhea or skin adverse drug reactions Brief therapy interruption up to 14 days followed by reinstatement of 250 mg daily. Patient receiving potent CYP3A4 inducer eg, rifampicin or phenytoin Consider increasing the dose to 500 mg daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Pulmonary toxicity. Hepatotoxicity; consider periodic liver function testing. Hepatic & severe renal impairment. Pregnancy & lactation. Not indicated for use in childn.
Adverse Reactions
Diarrhea, rash, acne, dry skin, nausea & vomiting.
Drug Interactions
Increased exposure of metoprolol. Reduced mean AUC w/ rifampicin; high doses of ranitidine w/ Na bicarbonate. Increased mean AUC w/ itraconazole. INR elevations &/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
Qualitinib FC tab 250 mg
Packing/Price
30's
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