Details for: APO-ERLOTINIB
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02461862 | APO-ERLOTINIB | ERLOTINIB (ERLOTINIB HYDROCHLORIDE) | 25 MG | TABLET | ORAL |
| 02461870 | APO-ERLOTINIB | ERLOTINIB (ERLOTINIB HYDROCHLORIDE) | 100 MG | TABLET | ORAL |
| 02461889 | APO-ERLOTINIB | ERLOTINIB (ERLOTINIB HYDROCHLORIDE) | 150 MG | TABLET | ORAL |
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
| 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:
- Report online at www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada.html
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
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.