Consumer Information for: PMS-ERLOTINIB
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
pms-ERLOTINIB is prescribed to you because you have non-small 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
pms-ERLOTINIB belongs to a group of medicines called epidermal growth factor receptor tyrosine kinase inhibitors which are used to treat cancer. pms-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 pms-ERLOTINIB if you are hypersensitive (allergic) to erlotinib or any of the other ingredients of pms-ERLOTINIB (see What the non-medicinal ingredients are).
What the medicinal ingredient is
Erlotinib (as erlotinib hydrochloride)
What the non-medicinal ingredients are
Hydroxypropyl Cellulose, Hydroxypropyl methyl Cellulose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Sodium Lauryl Sulphate, Sodium Starch Glycolate and Titanium Dioxide.
What dosage form it comes in
- Each 100 mg coated tablet contains 100 mg erlotinib as erlotinib hydrochloride.
- Each 150 mg coated tablet contains 150 mg erlotinib as erlotinib hydrochloride.
pms-ERLOTINIB is a white to yellowish, round, coated tablet and is available in blister pack sizes of 30 tablets and bottle of 100 tablets.
Warnings and precautions
Serious Warnings and Precautions
pms-ERLOTINIB should be prescribed and managed only by a doctor who is experienced with anticancer drugs.
You must have a confirmed activating mutation of the EGFR-TK prior to starting of first-line pms-ERLOTINIB monotherapy.
Erlotinib has not been studied in patients with severely reduced liver function
Erlotinib has not been studied in patients with severely reduced kidney function
Serious side effects that have been reported with erlotinib include:
- liver failure, including fatal cases.
- gastrointestinal perforation (a hole through the wall of the stomach or small intestine, or large bowel), including fatal cases.
BEFORE you use pms-ERLOTINIB, talk to your doctor or pharmacist if:
- you have liver problems
- you have kidney problems
- you have gastrointestinal ulcers (bleeding of the stomach or intestines) or diverticular disease
- you have cataracts, have had cataract surgery, or wear contact lenses
- you have lung disease
- you smoke tobacco
- you plan to become pregnant
- you plan to breastfeed. Breastfeeding should be avoided while being treated with pms-ERLOTINIB and for at least 2 weeks after the final dose.
- you have been told by your doctor that you cannot tolerate some sugars
Avoid pregnancy while being treated with pms-ERLOTINIB. If you are a woman who could become pregnant, use adequate contraception during treatment and for at least 2 weeks after taking the last tablet. If you become pregnant while you are being treated with pms-ERLOTINIB, immediately inform your doctor who will decide if the treatment should be continued.
Smoking tobacco may reduce pms-ERLOTINIB blood level.
Interactions with this medication
Tell your doctor if you are taking other drugs, including non- prescription and natural health products, because they may speed up or slow down the breakdown of pms-ERLOTINIB. For example:
- Antifungals (such as ketoconazole, fluconazole)
- Calcium channel blockers (such as diltiazem, verapamil)
- Macrolide antibiotics (such as erythromycin, clarithromycin)
- Fluoroquinolone antibiotics (such as ciprofloxacin, norfloxacin)
- Other antibiotics (such as rifampin)
- Some antivirals (such as ritonavir, indinavir)
- Grapefruit juice
- St. John’s Wort
- Anticonvulsants (such as carbamazepine and phenytoin)
- Blood thinners (such as warfarin)
- Medications which reduce acid in the stomach (such as omeprazole, ranitidine)
- Statin drugs to treat high cholesterol
Proper use of this medication
Usual Dose
The usual dose is one 150 mg tablet each day. Take your pms-ERLOTINIB tablet:
- at least 1 hour before you eat or
- at least 2 hours after you have eaten
If you are taking medications which reduce acid in the stomach (such as ranitidine 150 mg twice a day), take your pms-ERLOTINIB tablet:
- 2 hours before your morning dose of the medication and
- 10 hours after your evening dose of the medication
Swallow your tablet with a glass of plain water.
Always take pms-ERLOTINIB exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are unsure.
This medicine has been prescribed for you personally and should not be passed on to others. It may harm them even if their symptoms are the same as yours.
Overdose
Missed Dose
If you miss one or more doses of pms-ERLOTINIB, contact your doctor or pharmacist as soon as possible.
Do not take a double dose to make up for forgotten individual doses.
Side effects and what to do about them
Like all medicines, pms-ERLOTINIB can have side effects.
The most common side effects (more than 5 out of 10 patients):
- rash
- diarrhea
If diarrhea occurs, drink plenty of water throughout the day to reduce the risk of dehydration. If you are having difficulty drinking liquids due to severe nausea/vomiting, please call your doctor immediately to be assessed for possible dehydration, low potassium levels and kidney failure.
Very common side effects (more than 1 out of 10 patients): tiredness, loss of appetite, difficulty in breathing, cough, infection, nausea, vomiting, mouth irritation, stomach pain, itching, dry skin, eye irritation.
Common side effects (less than 1 out of 10 patients):
- Bleeding from the stomach or the intestines
- Abnormal blood tests for the liver function.
- Headaches and dizziness
- Hair and nail changes. They included inflammatory reactions around the fingernail (common), excess body and facial hair of a male distribution pattern (uncommon), eyelash and eyebrow changes (uncommon), and brittle and lose nails (uncommon)
- Acne or other red or pink little bumps at hair follicles
Contact your doctor as soon as possible if you suffer from any of the above side effects.
Uncommon serious side effects (less than 1 out of 100 patients):
- Interstitial lung disease, a rare form of lung inflammation and can have a fatal outcome in some cases. If you develop symptoms such as sudden difficulty of breathing associated with cough or fever, contact your doctor immediately
- Gastrointestinal bleeding or perforation (a hole through the entire wall of stomach, intestine, or bowel)
- Corneal perforation, the risk is higher in patients who have had cataract surgery or wear contact lenses
- Severe skin reactions (Stevens-Johnson Syndrome)
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
| 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 |
|---|---|---|---|
| Most common (> 5/10 patients) | |||
| Rash | ✔ | ||
| Diarrhea | ✔ | ||
| Loss of appetite | ✔ | ||
| Difficulty in breathing | ✔ | ||
| Cough | ✔ | ||
| Infection | ✔ | ||
| Vomiting | ✔ | ||
| Nausea | ✔ | ||
| Stomach pain | ✔ | ||
| Common (< 1/10 patients) | |||
| Bleeding from stomach or intestine | ✔ | ||
| Abnormal tests for liver function | ✔ | ||
| Uncommon (< 1/100 patients) | |||
| Interstitial lung disease (sudden difficulty in breathing associated with cough or fever) | ✔ | ||
| Gastrointestinal perforation (abdominal pain-severe, fever, nausea and vomiting) | ✔ | ||
| Corneal perforation (eye pain, worsening of vision or loss of vision) | ✔ | ||
| Severe skin reactions (skin rash, discolouration, blistering, or pain) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking pms-ERLOTINIB, contact your doctor or pharmacist.
How to store
Store between 15°C and 30°C.
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the label.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Pharmascience Inc. at 1-888-550-6060.
This leaflet was prepared by
Pharmascience Inc.
Montréal, Canada
H4P 2T4
www.pharmascience.com
Last revised: November 27, 2018
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| AMIODARONE | 02385465 | SIVEM PHARMACEUTICALS ULC | AMIODARONE HYDROCHLORIDE 200 MG |