Monograph Details
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Neoplasms
> Kinase inhibitors
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IRESSA |
| Manufacturer |
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AstraZeneca Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Tyrosine kinase inhibitor. |
| Generic Name |
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Gefitinib 250mg; tabs. |
| Indications |
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Monotherapy in the treatment of locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel therapies in patients who are benefiting or have benefited from gefitinib therapy. See literature. |
| Children |
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Not recommended. |
| Adults |
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250mg once daily. May disperse tabs in plain water, then drink or give via NG tube. Consider interrupting if diarrhea or skin reactions (for up to 14 days) or eye symptoms occur. Concomitant potent CYP3A4 inducers (see Interactions): may increase to 500mg/day. |
| Precautions |
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Suspend if symptoms of interstitial lung disease occur (eg, dyspnea, cough, fever); discontinue if confirmed and treat. Prior chemotherapy, radiation, or pulmonary fibrosis may increase risk of interstitial lung disease. Monitor liver function; discontinue if severe changes occur. Consider suspending if eye symptoms (eg, eyelash changes) develop; remove aberrant eyelashes. Severe renal impairment. Pregnancy (Cat.D), nursing mothers: not recommended. |
| Interactions |
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CYP3A4 inducers (eg, rifampicin, phenytoin) may decrease levels; consider increasing gefitinib dose if used with potent inducers. CYP3A4 inhibitors (eg, ketoconazole) may increase levels. May potentiate warfarin. May be antagonized by drugs that increase gastric pH (eg, H2 blockers, proton pump inhibitors). May exacerbate neutropenia with vinorelbine. |
| Adverse Reactions |
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GI upset, rash, acne, dry skin, pruritus, asthenia, peripheral edema, dyspnea, conjunctivitis, stomatitis, eye symptoms (eg, amblyopia, pain, corneal erosion/ulcer, aberrant eyelash growth); rare: pancreatitis, severe skin rashes, interstitial lung disease (may be fatal). |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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