Apo-gefitinib tablet   

This product is manufactured by Apotex Inc. using the ingredient gefitinib.

This product is taken orally.


Why is it prescribed?

Gefitinib is used for the treatment of locally advanced or metastatic non-small cell lung cancer.

If you forget to take a dose, take the last missed dose as soon as you remember, as long as it is at least 12 hours before the next dose is due.
If it is less than 12 hours until the next dose, do not take the dose you have missed.

Store at room temperature 15°C to 25°C. Store in the original packaging to protect from moisture.


Other products that have the same ingredient as Apo-gefitinib tablet are •Iressa® tablets •NAT-Gefitinib tablet •Sandoz gefitinib tablet •

See other products used in the treatment of •non-small cell lung cancer •

The recommended daily dose is 250 mg with or without food.

Gefitinib is an Epidermal Growth Factor Receptor Tyrosine Kinase inhibitor. Epidermal Growth Factor Receptor, or EGFR, is expressed on the surface of normal cells and cancer cells. Increased EGFR signalling can promote tumour growth and cancer spread. Mutations in the tyrosine kinase portion of the EGFR gene are only found in tumour cells. This makes gefitinib able to target tumour cells over normal cells. In patients whose tumour cells contain a mutation of the EGFR-tyrosine kinase gene, gefitinib may be able to lead to tumour shrinkage.

 Along with its therapeutic benefit, gefitinib can cause the following side effects:

  • nausea, vomiting, and diarrhea
  • mouth sores
  • skin rash
  • nose bleeds
  • hair loss
  • dry eyes
  • interstitial lung disease

 Tell your doctor immediately if you develop trouble breathing, cough or fever.

Gefitinib should be administered under the supervision of a qualified health professional who is experienced in the treatment and management of patients with cancer.
Before starting gefitinib, your doctor will run a test to deterimine if your tumour cells have the activating EGFR-TK mutation. Only patients with this mutation should be treated with gefitinib.

There have been cases of patients treated with gefitinib developing Insterstitial Lung Disease. Approximately 1/3 of the cases have been fatal. If patients taking gefitinib develop worsening of respiratory symptoms such as shortness of breath, cough and fever, gefitinib therapy should be interrupted. If a diagnosis of Interstitial Lung Disease is made, then the patient must discontinue gefitinib.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • lung disease (e.g., pulmonary fibrosis)
  • severe kidney disease,
  • eye problems,
  • stomach/intestinal ulcers, other stomach/intestinal problems (such as diverticulitis, blockage, bowel disease),
  • smoking,
  • cancer that has spread to the bowels.

Gefitinib may interact with other medications: 

  • blood thinners" (warfarin),
  • rugs which reduce stomach acid (e.g., ranitidine, cimetidine, famotidine, omeprazole, lansoprazole, rabeprazole),
  • certain liver enzyme inhibitors such as ketoconazole, itraconazole, erythromycin, clarithromycin)
  • oral anti-inflammatory medications (such as ibuprofen, naproxen),
  • corticosteroids (such as prednisone)
  • rifampin, St. John's wort or phenytoin

Do not use if pregnant or breastfeeding.   Take precautions against conceiving while taking this medication. (Men and women)

Page Last Updated: 05/10/2016