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Details for: APO-ERLOTINIB

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02461862APO-ERLOTINIBERLOTINIB (ERLOTINIB HYDROCHLORIDE)25 MGTABLETORAL
02461870APO-ERLOTINIBERLOTINIB (ERLOTINIB HYDROCHLORIDE)100 MGTABLETORAL
02461889APO-ERLOTINIBERLOTINIB (ERLOTINIB HYDROCHLORIDE)150 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

APO-ERLOTINIB is prescribed to you because you have nonsmall cell lung cancer at an advanced stage and;

  • chemotherapy has not helped to stop your disease or
  • your cancer cells have certain changes in the gene for a protein called epidermal growth factor receptor (EGFR) and your disease has not worsened after 4 cycles of first line chemotherapy, or
  • your cancer cells have certain changes in the EGFR gene.

What it does

APO-ERLOTINIB belongs to a group of medicines called epidermal growth factor receptor tyrosine kinase inhibitors which are used to treat cancer. APO-ERLOTINIB prevents the activity of a protein called epidermal growth factor receptor. This protein is known to be involved in the growth and spread of cancer cells.

When it should not be used

Do not take APO-ERLOTINIB if you are hypersensitive (allergic) to erlotinib or any of the other ingredients of APOERLOTINIB. See What the nonmedicinal ingredients are.

What the medicinal ingredient is

Erlotinib (as erlotinib hydrochloride)

What the non-medicinal ingredients are

Tablet core:
Anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

Tablet coating:
Hydroxypropyl cellulose, hypromellose, titanium dioxide, and triethyl citrate.

What dosage form it comes in
  • Tablets
  • Each tablet contains 25, 100 or 150 mg erlotinib as erlotinib hydrochloride.

APO-ERLOTINIB is a white to off-white, round, biconvex coated tablet and is available in bottle of 100 and 500 tablets and blister of 30 tablets.

Warnings and precautions

Serious Warnings and Precautions

Interactions with this medication

Proper use of this medication

Usual Dose

Overdose

Missed Dose

Side effects and what to do about them

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Frequent
Example: 1    
   
   
   
Less Frequent
     
     
     
     
Rare
     
     
     
     
Very rare
     
     
     
     

How to store

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

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