Patient Medication Information: uses, side effects, how to take - Apo-Gefitinib
What is APO-GEFITINIB used for?
APO-GEFITINIB is used in adults to treat a type of cancer called ‘non-small cell lung cancer’ (NSCLC). APO-GEFITINIB is used as your first treatment when your cancer:
- cannot be treated with other therapies or has spread from the lung to other parts of the body.
- has mutations (changes) in a gene called epidermal growth factor receptor tyrosine kinase (EGFR-TK).
A test is used to see if you have mutations in your EGFR-TK genes to determine whether APO-GEFITINIB is right for you.
How does APO-GEFITINIB work?
APO-GEFITINIB works by binding to EGFR-TK mutations found on the surface of non-small cell lung cancer cells. This blocks the signalling from the EGFR-TK genes that are involved in the growth and spread of cancer cells. This may help to slow or stop your lung cancer from growing, or help to shrink the tumour.
What are the ingredients in APO-GEFITINIB?
Serious Warnings and Precautions
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Medicinal ingredients: gefitinib
Non-medicinal ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, ferric oxide red, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
APO-GEFITINIB comes in the following dosage forms:
APO-GEFITINIB is an oral tablet and each tablet contains 250 mg gefitinib. APO-GEFITINIB comes in blister packs of 30 tablets and bottles of 30 and 100 tablets.
Do not use APO-GEFITINIB if:
You are allergic to gefitinib or any of the other ingredients of APO-GEFITINIB or the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-GEFITINIB. Talk about any health conditions or problems you may have, including if you:
- Have, or have had, lung diseases other than lung cancer. Some of them may worsen during treatment with APO-GEFITINIB.
- Have a history of stomach, intestine, or bowel problems.
- Smoke.
- Are at an increased age.
- Are taking steroids or non-steroidal anti-inflammatory drugs (NSAIDS).
- Have cancer that has spread to the bowel.
- Have heart problems.
- Are pregnant, or plan to become pregnant.
- Are breastfeeding.
- Have liver problems.
- Have kidney problems.
- Have eye problems, had eye surgery or wear contact lenses.
Other warnings you should know about:
- Bleeding problems: Bleeding has been reported with the use of gefitinib. Bleeding problems include nosebleeds, blood in the urine, coughing up of blood and bleeding from the lungs.
- Gastrointestinal (stomach, intestine or bowel) problems: Serious or constant diarrhea, nausea, vomiting and weight loss eating disorders can occur. This might lead to dehydration. Tell your healthcare professional right away if you have these symptoms. If untreated, dehydration may lead to kidney problems.
- Liver problems: Liver problems, such as liver failure, hepatitis (liver inflammation) and cirrhosis (liver scarring) have occurred in patients taking APO-GEFITINIB, which may cause death. You will get blood tests while taking APO-GEFITINIB. These blood tests will tell your healthcare professional how your liver is working.
Lung problems: Lung problems, such as Interstitial lung disease (a disease that inflames or scars lung tissue) have occurred in patients taking APO-
- GEFITINIB, which may cause death.
- Skin problems: Toxic epidermal necrolysis and Stevens Johnson syndrome (severe skin rashes) and erythema multiforme (allergic skin reaction) have occurred in patients taking APO-GEFITINIB, which may cause death.
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Pregnancy and breastfeeding:
- Avoid becoming pregnant while taking APO-GEFITINIB. It may harm your unborn child or make you lose the pregnancy.
- Tell your healthcare professional right away if you become pregnant or think you are pregnant during treatment with APO-GEFITINIB. They will discuss the risks with you.
- You should not breastfeed while taking APO-GEFITINIB. It is not known if APO-GEFITINIB passes into breast milk. Talk to your healthcare professional about the best way to feed your baby during this time.
Driving and using machines:
APO-GEFITINIB may make you feel weak. This may affect your ability to drive or use machines. Before driving or using machines, wait until you are feeling well again.
Pediatric Patients: APO-GEFITINIB is not for use in patients 16 years of age or younger.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-GEFITINIB:
- St. John’s Wort, used to treat depression.
- Rifampicin, a drug used to treat bacterial infections.
- Macrolide antibiotics used to treat infections, such as erythromycin or clarithromycin.
- Drugs to treat fungal infections, such as itraconazole and ketoconazole.
- Drugs used to treat HIV/AIDS (protease inhibitors).
- Drugs used to treat seizures, such as phenytoin, carbamazepine, barbiturates.
- Drugs used to treat stomach acid, such as ranitidine, cimetidine, proton-pump inhibitors.
- Warfarin, a drug used to treat blood clots.
- Chemotherapy drugs such as vinorelbine.
- Grapefruit juice.
How to take APO-GEFITINIB:
- Take APO-GEFITINIB exactly as your healthcare professional tells you. Do not change your dose or stop taking APO-GEFITINIB unless your healthcare professional tells you.
Take your dose with or without food.
Usual dose:
Take one 250 mg tablet once daily, at about the same time each day.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-GEFITINIB, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
- If there is at least 12 hours before the next dose, take the missed dose as soon as you remember. Take the next dose at your regular time.
- If there is less than 12 hours to the next dose, skip the missed dose. Wait until the regular time for your next dose.
- Do not take a double dose to make up for a missed dose.
What are possible side effects from using APO-GEFITINIB?
These are not all the possible side effects you may feel when taking APO-GEFITINIB. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Diarrhea
- Nausea, vomiting
- Loss of appetite
- Red and sore mouth (stomatitis)
- Dry mouth
- Cough
- Dehydration
- Skin reactions like rash, acne, itching dry and/or cracked skin
- Dry, itchy red eyes
- Weakness, tiredness
- Hair loss
- Fever
- Nosebleeds
- Nail problems
- Burning sensations during urination and frequency, urgent need to urinate
APO-GEFITINIB can cause abnormal urine and blood test results. Your healthcare professional might do some tests before, during and after your treatment. They will tell you if your test results are abnormal and if you need treatment.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| VERY COMMON | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Gastrointestinal problems: Severe diarrhea, vomiting, nausea (feeling sick), eating disorders like anorexia, dehydration, thirst, loss of appetite, decreased urine. | √ | ||
| COMMON | |||
| Allergic reactions: hives or rash, swelling of the face, lips, tongue or throat. | √ | ||
Bleeding problems: coughing up blood, nosebleeds, bloody urine. | √ | ||
Conjunctivitis (eye infection), blepharitis (inflamed eyelids) and dry eyes: blurred vision, increased sensitivity of the eyes to light, red and itchy eye, red and sore eyelids, eye irritation. | √ | ||
Lung problems, such as interstitial lung disease (diseases that inflame or scar lung tissue): shortness of breath when rest (gets worse with exertion) with or without dry cough, fever. | √ | ||
| UNCOMMON | |||
Corneal erosion (damaged outer layer of the eye) and Keratitis (inflamed eye): blurred or change in vision, new eye problems, such as pain, redness, watery eyes, increased sensitivity of eyes to light, eye ulcers with or without abnormal eyelash growth. | √ | ||
Gastrointestinal perforation (a hole through the wall of the stomach or bowels): severe abdominal pain and tenderness, nausea, vomiting, chills or fever. | √ | ||
| Liver problems, such as inflammation of the liver or liver failure: general feeling of being unwell, nausea, vomiting, with or without yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, unusual dark urine, unusual | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
tiredness, bleeding easily, swollen abdomen. | |||
Pancreatitis (inflammation of the pancreas): upper abdominal pain, fever, rapid pulse, nausea, vomiting. | √ | ||
| RARE | |||
| Cutaneous vasculitis (inflammation of the blood vessels in the skin): bruising or patches of non-blanching rash on the skin. | √ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the centre with or without mild itching or burning, peeling of the skin; possibly swollen lips. | √ | ||
Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands. | √ | ||
| Hemorrhagic cystitis (inflammation of bladder): Burning sensation when passing urine and frequency, urgent need to urinate with blood in the urine. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Storage:
- Keep out of the reach and sight of children.
- Store at room temperature 15°C to 25°C. Protect from moisture.
- Keep APO-GEFITINIB in the original package in order to protect it from moisture.
- Do not use APO-GEFITINIB after the expiry date on the blister pack.
- Remember to return any unused APO-GEFITINIB to your pharmacist.
If you want more information about APO-GEFITINIB:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708. This leaflet can also be found at: http://www.apotex.ca/products.
Last Revised: January 20, 2022
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |