Giotrif - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||Carcinoma (Cancer), Non-Small Cell Lung Cancer|
|Ingredients:||afatinib (as afatinib dimaleate), colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose 2910, indigocarmine aluminium lake (E132, only used for 40 mg and 30 mg tablets), macrogol 400, polysorbate 80, talc, titanium dioxide|
(Afatinib) Film-coated Tablets
About this Medication
What the medication is used for
GIOTRIF is used to treat people with a certain type of lung cancer that has spread to other parts of the body. GIOTRIF is used in patients with lung cancer that have an epidermal growth factor receptor (EGFR) gene mutation.
What it does
GIOTRIF works by permanently (irreversibly) blocking the activity of a group of proteins called ErbB family, which includes EGFR (ErbB1), HER2 (ErbB2) and ErbB4. These proteins are involved in the growth and spread of cancer cells. By blocking the activity of the ErbB family of proteins GIOTRIF can inhibit growth and spread of cancer cells.
When it should not be used
- If you are hypersensitive (allergic) to afatinib or any of the other ingredients of GIOTRIF. See What the non-medicinal ingredients are.
What the medicinal ingredient is
Afatinib (as afatinib dimaleate)
What the non-medicinal ingredients are
Tablet Core: colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Film coating: hypromellose 2910, indigocarmine aluminium lake (E132, only used for 40 mg and 30 mg tablets), macrogol 400, polysorbate 80, talc, titanium dioxide
What dosage forms it comes in
GIOTRIF film-coated tablets are provided in a PVC/PVDC blister and desiccant in an aluminium pouch.
GIOTRIF film-coated tablets are available in three different strengths:
- 20 mg tablets are white to slightly yellowish, round, biconvex, bevel-edged tablets;
- 30 mg tablets are dark blue, round, biconvex, bevel-edged tablets;
- 40 mg tablets are light blue, round, biconvex, bevel-edged tablets.
One side of these film-coated tablets is debossed with the code "T20", "T30" or "T40" and the other side with the Boehringer Ingelheim company symbol "BI".
GIOTRIF film-coated tablets are available in packs containing 1, 2 or 4 pouches. Each pouch contains one aluminium blister card perforated into 7 unit dose of film-coated tablets. Each blister card is packed together with a desiccant sachet in an aluminium pouch.
Warnings and precautions
Serious Warnings and Precautions
GIOTRIF should be prescribed and managed only by a doctor who is experienced with anticancer drugs.
You must have a confirmed mutation of the EGFR gene in your tumour prior to starting GIOTRIF.
Serious side effects some of which may lead to death:
- Diarrhea which can result in electrolyte imbalance and kidney problems.
- Skin problems. GIOTRIF can cause redness, rash and acne. In rare cases, GIOTRIF can cause redness, pain, swelling or blistering of lips, eyes or mouth, skin peeling and flu-like symptoms.
- Interstitial Lung Disease. GIOTRIF can cause trouble breathing or shortness of breath, cough or fever.
- GIOTRIF may cause liver problems.
BEFORE you use GIOTRIF talk to your doctor or pharmacist if you:
- have liver disease or kidney disease;
- have a dairy or lactose intolerance;
- have a history of lung inflammation (interstitial lung disease);
- have a history of severe dry eye or eye inflammation; (keratitis) or use contact lenses;
- have heart problems;
- have any other medical conditions;
- are pregnant, or plan to become pregnant. GIOTRIF may; harm your unborn baby;
- are breastfeeding. GIOTRIF may pass into your breast milk and harm your baby;
- are female and have a low body weight of less than 50 kg.
You should not become pregnant while taking GIOTRIF. Women who are able to become pregnant should use birth control during treatment and for at least 2 weeks after stopping GIOTRIF. Talk to your doctor about the birth control methods that may be right for you.
If you become pregnant, tell your doctor right away.
Avoid exposure to the sun while you are taking GIOTRIF. Rash or acne may occur or worsen in areas exposed to the sun. You may burn more easily and get severe sunburns. To help protect against skin problems wear clothes that protect your skin, including your head, face, hands, arms, and legs and use a sunscreen.
Caution is required when driving a car as some side effects may affect your ability to do so.
Interactions with this Medication
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. GIOTRIF and certain other medicines may interact with each other. This may cause serious side effects.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
Discuss with your doctor or pharmacist if you take any of the following:
- Antifungals (such as ketoconazole, itraconazole);
- Antibiotics (such as erythromycin);
- Drugs to treat tuberculosis (TB) (such as rifampicin);
- Drugs to treat HIV-AIDS/viral infections (such as nelfinavir, saquinavir);
- Calcium channel blockers (such as verapamil);
- Antiarrhythmics (such as quinidine, amiodarone);
- Anticonvulsants (such as carbameazeapine, phenytoin and phenobarbital);
- Chemotherapy drugs for cancer;
- Immunosuppressants (such as tacrolimus);
- Statins used to lower cholesterol;
- St. John's Wort.
Proper Use of this Medication
EGFR TKI-naive patients
The usual dose is one 40 mg tablet taken orally once a day in patients with lung cancer not previously treated with an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI).
- Take the tablet once daily at about the same time each day.
- Take GIOTRIF on an empty stomach at least 1 hour before or 3 hours after eating.
- Do not break or crush the tablet.
- Swallow the tablet whole with a glass of water.
Always take GIOTRIF exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are unsure.
There is no specific antidote for overdosage with GIOTRIF.
|In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you miss a dose, take it as soon as you remember. If it is close to your next dose (within 8 hours), skip the dose and just take your next dose at your regular time. Do not take 2 doses of GIOTRIF at the same time.
If you throw up after taking GIOTRIF and are concerned that some of the drug is lost, do NOT take a replacement tablet and just take your next dose at your regular time.
Do not take GIOTRIF for a condition for which it was not prescribed. Do not give GIOTRIF to other people, even if they have the same condition.
Side Effects and what to do about them
Like all medicines, GIOTRIF can have side effects.
The very common side effects (more than 1 out of 10 patients) include:
- Inflammation of the lining of the mouth (stomatitis);
- Infection of the nail bed (paronychia);
- Loss of appetite;
- Skin eruptions resembling acne;
- Itchy/scratchy skin;
- Dry skin.
The common side effects (less than 1 out of 10 patients) include:
- Inflammation of the urinary bladder resulting in a burning sensation during urination and frequent urgent need to urinate (cystitis);
- Excessive loss of body water (dehydration);
- Low blood potassium levels;
- Taste disturbance or loss of taste;
- Inflammation or infection of the membrane lining the eyelids (conjunctivitis);
- Dry eye;
- Runny nose;
- Indigestion, stomach pain;
- Inflammation of the lips;
- Redness, swelling, and pain on the palms of the hands and/or the soles of the feet (Palmar-plantar erythrodysaesthesia syndrome);
- Muscle spasm;
- Kidneys not working properly or failing;
- Fever or high temperature;
- Loss in weight;
- Increase in liver enzymes;
- Inflammation of the cornea;
- Inflammation or scarring of the lungs (interstitial lung disease).
Seek medical advice promptly if the following signs or symptoms occur:
Talk to your doctor before you take GIOTRIF on how best to control and minimize any symptoms of diarrhea.
Your doctor should prescribe diarrhea medicine before you start GIOTRIF therapy. You should not substitute the prescribed diarrhea medicine without talking to your doctor. You should have the medicine readily available at all times.
If you have diarrhea, contact your doctor as soon as possible to discuss the symptom and start your diarrhea medicine immediately and any further action/treatment, if needed.
Diarrhea should be treated as soon as it starts. Take the diarrhea medicine exactly as your doctor has told you. Drink plenty of fluids and take medicines to help your diarrhea exactly as your doctor tells you to. If you don't drink enough fluids, you could become dehydrated and it could affect your kidneys. Seek medical attention right away if your diarrhea becomes worse and/or your diarrhea medicine is not working.
Until the symptoms of diarrhea resolve, you should modify your diet to include bananas, rice, apple sauce and toast (BRAT diet), and increase your fluid intake with clear liquids. The daily fluid intake should be greater than 2 liters a day (about 8 glasses of 250 mL) to avoid dehydration. Some fluids should contain sugar or salt to avoid low blood sugar or salt. The use of caffeinated drinks should be avoided. Appropriate follow-up with your doctor should be scheduled. You should avoid foods that contain lactose, are greasy, spicy and/or fried, and are difficult to digest.
It is important to seek treatment for a rash as soon as you notice it. Take medicines to help your rash exactly as your doctor tells you to. Seek medical attention right away if your rash becomes severe (for example, you have peeling or blistering of the skin).
Interstitial Lung Disease:
Tell your doctor right away if you have any new or worsening lung symptoms, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, and fever.
Tell your doctor right away if you get any of these symptoms of a liver problem during treatment:
- your skin or the whites of your eyes turn yellow.
- you feel tired.
- your urine turns dark or brown (tea colored).
- you have nausea or vomiting.
- you have decreased appetite.
- you have a pain on the right side of your stomach.
- you bleed or bruise more easily than normal.
Tell your doctor right away if you get any of these symptoms during treatment:
- eye pain, swelling, or redness;
- blurred vision or other vision changes.
This is a painful, red, swollen area around the nail, often at the cuticle or at the site of a hangnail or other injury. It can be caused by bacteria, yeast or fungus. Nail changes may occur. For example, the nail may look detached, abnormally shaped, or have an unusual color. Your doctor will prescribe the proper medicine to treat your nails.
This is an inflammation anywhere in the mouth and includes the inside of the cheeks, gums, tongue, lips, and roof of the mouth (palate). Your doctor will be able to advise you on how best to treat it.
Serious side effects, how often they happen and what to do about them
|Symptom / effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
(> 1/10 patients)
|Inflammation of the lining of the mouth||✓|
|Infection of the nail bed||✓|
(<1/ 10 patients)
|Abnormal laboratory test results||✓|
|Little or no urine output||✓|
|Inflammation of the cornea (eye pain and worsening/loss of vision)||✓|
|Inflammation of the lungs (sudden difficulty in breathing with cough or fever)||✓|
This is not a complete list of side effects. For any unexpected effects while taking GIOTRIF, contact your doctor or pharmacist.
How to store it
Store at 15 - 30°C.
Open only one pouch at a time until all the tablets in the blister card are consumed before opening the next pouch.
Store the blister card in the original package in order to protect from moisture and light.
Store in a safe place out of the reach of children.
Do not use GIOTRIF after the expiry date on the blister pack.
Remember to return any unused GIOTRIF to your pharmacist.
Reporting Suspected 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.healthcanada.gc.ca/medeffect
- 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
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site
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.
This document plus the DULCOLAX Prescribing Information prepared for health professionals can be found at: http://www.boehringer-ingelheim.ca or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd. at: 1-800-263-5103, ext. 84633 (Medical Information).