Gefitinib
(Redirected from Iressa)
What is Gefitinib?[edit | edit source]
- Gefitinib (Iressa) is a tyrosine kinase inhibitor used in the therapy of non-small cell lung cancer.
What are the uses of this medicine?[edit | edit source]
Gefitinib (Iressa) used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and:
- that have certain types of abnormal epidermal growth factor receptor (EGFR) genes, and
- who have not had previous treatment for cancer
Limitation of Use:
- It is not known if Iressa is safe and effective in people with NSCLC that have other types of EGFR genes.
How does this medicine work?[edit | edit source]
- Gefitinib (ge fi' ti nib) is a selective inhibitor of the tyrosine kinase receptor of epidermal growth factor (EGFR), which is often mutated and over expressed in cancer cells, particularly non-small cell lung cancer and some forms of breast cancer.
- The mutated EGF tyrosine kinase receptor is constitutively expressed which causes unregulated cell growth and proliferation.
- By inhibition of this growth factor receptor, gefitinib blocks the intracellular Ras signaling transduction cascade, which results in inhibition of the malignant cell growth.
- Highest rates of response to gefitinib are seen in patients with activating mutations of EGFR in the tumor tissue.
Who Should Not Use this medicine ?[edit | edit source]
Limitation of Use:
- It is not known if Iressa is safe and effective in people with NSCLC that have other types of EGFR genes.
What drug interactions can this medicine cause?[edit | edit source]
Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following:
- anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
- antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole (Nizoral)
- metoprolol (Lopressor, Toprol XL, in Dutoprol); phenytoin (Dilantin, Phenytek)
- tricyclic antidepressants such as imipramine (Tofranil) and amitriptyline
- If you take a proton pump inhibitor (PPI), H2 blocker, or an antacid medicine take antacid at least 6 hours before or 6 hours after taking gefitinib and take proton pump inhibitor at least 12 hours before or at least 12 hours after taking gefitinib.
Is this medicine FDA approved?[edit | edit source]
- Gefitinib received approval for use in the United States in 2009 for the treatment of advanced non-small cell lung cancer after failure of other therapies, but has been available in Japan since 2002.
How should this medicine be used?[edit | edit source]
Recommended dosage:
- Recommended dose is 250 mg orally, once daily with or without food.
Strong CYP3A4 Inducers:
- Increase Iressa to 500 mg daily in the absence of severe adverse drug reaction, and resume Iressa at 250 mg seven days after discontinuation of the strong CYP3A4 inducer.
Administration:
- Take Iressa 1 time each day.
- You can take Iressa with or without food.
- If you miss a dose of Iressa, take it as soon as you remember.
- If it is less than 12 hours until your next dose, skip the missed dose.
- Take your next dose at your regular time.
If you cannot swallow Iressa tablets whole:
- place your dose of Iressa in a container with 4 to 8 ounces of water and stir for about 15 minutes
- drink the mixture right away
- place another 4 to 8 ounces of water in the same container, and drink it right away
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Tablets: 250 mg
This medicine is available in fallowing brand namesː
- IRESSA
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- skin reactions
- diarrhea
IRESSA may cause serious side effects, including:
- lung or breathing problems
- liver problems
- perforation
- diarrhea
- eye problems
- skin reactions
- IRESSA may cause fertility problems in females.
What special precautions should I follow?[edit | edit source]
- Interstitial lung disease (ILD) occurred in patients taking Iressa. Withhold Iressa for worsening of respiratory symptoms. Discontinue Iressa if ILD is confirmed.
- Gefitinib therapy is associated with transient elevations in serum aminotransferase levels and rare instances of clinically apparent acute liver injury. Obtain periodic liver function testing. WithholdIressa for Grade 2 or higher for ALT and/or AST elevations. Discontinue for severe hepatic impairment.
- Gastrointestinal perforation occurred in three Iressa-treated patients. Discontinue Iressa for gastrointestinal perforation.
- Grade 3 or 4 diarrhea occurred in Iressa-treated patients. Withhold Iressa for Grade 3 or higher diarrhea.
- Ocular disorders occurred in the 2462Iressa-treated patients. Withhold Iressa for signs and symptoms of severe or worsening ocular disorders including keratitis. Discontinue for persistent ulcerative keratitis.
- Bullous conditions including toxic epidermal necrolysis, Stevens Johnson syndrome and erythema multiforme have been reported from treatment with Iressa. Withhold Iressa for Grade 3 or higher skin reactions or exfoliative conditions.
- Based on its mechanism of action and data from animal reproduction studies Iressa can cause fetal harm when administered to a pregnant woman. Advise of potential risk to a fetus and use of effective contraception.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
- Adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of Iressa.
Management of overdosage:
- In the event of suspected overdose, interrupt Iressa, institute supportive care, and observe until clinical stabilization.
- There are no specific measures/treatments that should be taken following Iressa overdosing.
Can this medicine be used in pregnancy?[edit | edit source]
- Based on its mechanism of action and animal data, IRESSA can cause fetal harm when administered to a pregnant woman.
- Advise pregnant women of the potential hazard to a fetus or potential risk for loss of the pregnancy.
Can this medicine be used in children?[edit | edit source]
- The safety and effectiveness of Iressa in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- Active ingredient: gefitinib
- Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate
- Tablet coating contains: hypromellose, polyethylene glycol 300, titanium dioxide, yellow iron oxide and red iron oxide.
Who manufactures and distributes this medicine?[edit | edit source]
Distributed by:
- AstraZeneca Pharmaceuticals LP
- Wilmington, DE
What should I know about storage and disposal of this medication?[edit | edit source]
- Store Iressa at room temperature between 68˚F to 77˚F (20˚C to 25˚C)
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