Gefitinib

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What is Gefitinib?[edit | edit source]

Gefitinib structure
Gefitinib ball-and-stick
Gefitinib 3d



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:

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:

  • 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:

IRESSA may cause serious side effects, including:

  • 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:


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)

Alphabetic list of antineoplastic agents - 0-9 - A1 - A2 - A3 - A4 - A5 -A6 - B - C - D - E - F - G - H - I - JK - L - M - NO - PQ - R - S - T - UVW - XYZ


 

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