Adult Dosing
Locally advanced or metastatic non-small cell lung cancer
- 250 mg PO daily
- Alternative: 500 mg PO daily, if concomitant CYP3A4 inducer is administer
- Note: Refer the package insert for the toxicity related dose adjustments
- Restricted Distribution in US call 1-800-601-8933 or go to www.iressa-us.com for more info
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Interstitial lung disease (ILD) presented as acute onset of dyspnea, cough or low-grade fever, often becoming severe within a short time and requiring hospitalization, has been reported with gafitinib therapy. Interrupt the therapy if there is an acute onset or worsening of pulmonary symptoms and discontinue the treatment once ILD is confirmed and provide appropriate therapy
- Gafitinib causes fetal harm when administered to a pregnant woman, women of childbearing potential should be advised to avoid becoming pregnant and if become pregnant while on therapy, she should be apprised of the potential hazard to the fetus or potential risk for loss of the pregnancy
- Asymptomatic increases in liver transaminases can occur with gafitinib therapy. Consider periodic monitoring of LFT and discontinue the therapy if severe changes occurs
- New onset of eye symptoms such as pain can occur with gafitinib therapy, medically evaluate the patient, if required interrupt the therapy and consider removal of an aberrant eyelash if present
- Patients should be advised to seek prompt medical advise if there is severe or persistent diarrhea, nausea, anorexia, or vomiting, or if there is an onset or worsening of pulmonary symptoms or if there is an eye irritation
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Pulmonary diseases
- Ocular diseases
Pregnancy Category:D
Breastfeeding: Safety unknown; as per manufacturer's data high levels of gefitinib and its metabolites are excreted in rat milk. It is unknown whether excreted in human milk, as many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breast-feeding while receiving gefitnib therapy.
Drug Name: Iressa 250 MG Oral Tablet
Ingredient(s): Gefitinib
Imprint: IRESSA;250
Color(s): Brown
Shape: Round
Size (mm): 11.00
Score: 1
Inactive Ingredient(s): lactose monohydrate / cellulose, microcrystalline / croscarmellose sodium / povidone / sodium lauryl sulfate / magnesium stearate / hypromellose / polyethylene glycol 300 / titanium dioxide / ferric oxide red / ferric oxide yellow
Drug Label Author:
AstraZeneca Pharmaceuticals LP
DEA Schedule:
Non-Scheduled
