GIOTRIF is and what it is used for
GIOTRIF is a medicine that contains the active substance amphetinib. It blocks the action of a group of proteins called the ErbB family (including EGFR [ErbB1 receptor, HER2 [ErbB2], ErbB3 and ErbB4). These proteins are involved in the growth and spread of cancer cells and may be affected by mutations in the genes that produce them. By blocking the action of these proteins, this drug can suppress the growth and spread of cancer cells.
This drug is used alone to treat adult patients with a specific type of lung cancer (non-small cell lung cancer) that is characterized by a mutation in the EGFR gene. GIOTRIF may be prescribed as your first treatment or if your previous chemotherapy was not enough.
2. What you need to know before you take GIOTRIF
Do not take GIOTRIF:
If you are allergic to apatinib or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
If you are a woman, if your weight is less than 50 kg or if you have kidney problems. If any of these conditions apply to you, your doctor may monitor you more closely because the side effects may be more pronounced. Treatment with this medicine is not recommended if you suffer from severe kidney disease;
If you have had pulmonary inflammation (interstitial lung disease);
If you have liver problems. Your doctor may have some liver tests done. Treatment with this medicine is not recommended if you suffer from severe liver disease;
If you have eye problems, for example, Severe eye dryness, inflammation of the front eye (cornea), or wounds affecting the outside of the eye or if you wear contact lenses;
If you have heart problems. Your doctor may decide to monitor you more closely.
Tell your doctor immediately while taking this medicine:
If you get diarrhea. It is important that the treatment of diarrhea begins with the onset of the first symptoms;
If you get rash on your skin. It is important that the treatment is started early;
If it suddenly occurs or worsens shortness of breath, possibly with cough or fever. These may be symptoms of inflammation of the lung (interstitial lung disease) that could endanger your life;
If sudden redness and eye pain, increased tearing, blurred vision and / or sensitivity to light occur or worsen. Emergency treatment may be needed.
See also section 4 “Possible side effects”.
Children and adolescents
There are no studies of GIOTRIF in children and adolescents. Do not give this medicine to children and adolescents under the age of 18 years.
Other medicines and GIOTRIF
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
In particular, if taken before GIOTRIF, the following medicines may increase GIOTRIF levels in the blood and therefore the risk of side effects. Therefore, they should be taken as much as possible from time to time by GIOTRIF. This means preferably 6 (twice daily) or 12 hours (for once-daily medications) before or after GIOTRIF:
Ritonavir, ketoconazole (except shampoo), itraconazole, erythromycin, nelfinavir, saquinavir, used to treat various types of infections;
Verapamil, quinidine, amiodarone that are used in heart problems;
Cyclosporine A, tacrolimus – medicines that affect the immune system.
The following medications may reduce the effectiveness of GIOTRIF:
Carbamazepine, phenytoin, phenobarbital, which are used to treat seizures;
St. John’s Wort (Hypericum perforatum), herbal medicine for the treatment of depression;
Rifampicin, an antibiotic for the treatment of tuberculosis.
Ask your doctor if you are not sure when to take these medicines.
GIOTRIF may increase blood levels of other medicines, including but not limited to:
Sulfasalazine, which is used to treat inflammation / infection;
Rosuvastatin, which is used to lower cholesterol.
Tell your doctor before taking these medicines along with GIOTRIF.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
You should not get pregnant while you are taking this medicine. If it is possible for you to become pregnant, use appropriate contraception during treatment and for at least 1 month after you have taken the last dose of this medicine as there may be a risk of harm to the fetus.
If you become pregnant while taking this medicine, tell your lord immediately
If you are planning a pregnancy after taking the last dose of this medicine, you should consult your doctor as your body may not have completely removed the medicine.
You should not breast-feed while you are taking this medicine as a possible risk to the infant can not be excluded.
Driving and using machines
If you get treatment-related symptoms that affect your vision (eg redness and / or eye irritation, dry eyes, tears, light sensitivity) or your ability to concentrate and react, it is advisable not to drive Do not use machines until these side effects have passed (see Section 4, “Possible Side Effects”).
GIOTRIF contains lactose
This medicine contains a sugar called lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take GIOTRIF
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 40 mg every day.
Your doctor may adjust (increase or decrease) the dose depending on how you take this medicine.
When to take GIOTRIF
It is important to take this medicine without food.
Take this medicine at least 1 hour before a meal.
If you have already eaten, wait at least 3 hours before taking this medicine.
Take this medicine once a day, at about the same time each day. This will make it easier to remember to take this medicine.
Do not break, chew or crush the tablet.
Swallow the tablet whole with a glass of non-carbonated water.
GIOTRIF should be taken orally. If you have difficulty swallowing the tablet, dissolve it in a glass of non-carbonated water. You should not use other liquids. Drop the tablet in water without crushing it and occasionally stir for up to 15 minutes until the tablet crumbles into very small particles. Drink the liquid immediately. Then fill the glass with water again and drink it to make sure you have taken all the medicine.
If you can not swallow a gastric tube, your doctor may suggest that your medicine be given through the probe.
If you take more GIOTRIF than you should
Contact your doctor or pharmacist immediately. Increased side effects may occur, so your doctor may discontinue your treatment and undertake maintenance treatment.
If you forget to take GIOTRIF
If your next dose is taken after more than 8 hours, take the missed dose as soon as you remember.
If your next dose is less than 8 hours, do not take the missed dose and take the next dose at the usual time. Then continue to take the tablets regularly at the usual time.
Do not take a double dose (two tablets at a time instead of one) to make up for the forgotten dose.
If you stop taking GIOTRIF
Do not stop taking this medicine without consulting your doctor. It is important to take this medicine every day for as long as your doctor prescribes. If you do not take this medicine as prescribed by your doctor, your cancer may recur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, GIOTRIF can cause side effects, although not everyone gets them.
Contact your doctor as soon as possible if you experience any of the serious side effects listed below. In some cases, your doctor may need to discontinue treatment and reduce your dose or stop treatment:
Diarrhea (very often, may affect more than 1 in 10 people). If diarrhea lasts for more than 2 days, or if it is more severe, it may cause dehydration (often may affect up to 1 in 10 people), low blood potassium (often) and worsening of kidney function (often). Diarrhea can be treated. At the first signs of diarrhea, start drinking lots of fluids. Contact your doctor immediately and start appropriate diarrhea treatment as soon as possible. You should have a diarrhea medicine before you start taking GIOTRIF;
Skin rash (very common). It is important that rash treatment is started early. Tell your doctor if a rash occurs. If rash treatment does not help and rash gets worse (for example, if your skin gets white or bubbles), you should tell your doctor right away. He may decide to discontinue your treatment with GIOTRIF. An outbreak may appear or worsen on parts of the body that are exposed to the sun. Sun protection is recommended with protective clothing and sunscreen;
Inflammation of the lung (uncommon, may affect up to 1 in 100 people) called “interstitial lung disease”. Immediately report to
Contact your doctor as soon as possible if you experience any of the above symptoms.
Other side effects listed below have also been reported:
Very common side effects (may affect more than 1 in 10 people):
Aphtha and inflammation in the mouth;
Bleeding from the nose.
Common side effects (may affect up to 1 in 10 people):
Pain, redness, swelling or scaling of the skin of the palms and soles;
Increased levels of liver enzymes (aspartate aminotransferase and alanine aminotransferase), blood tests;
Inflammation of the lining of the bladder accompanied by a burning sensation during urination and frequent urgent need for urination (cystitis);
Perversion of taste (dysgeusia);
Stomach pain, indigestion, heartburn;
Inflammation of the lips;
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store GIOTRIF
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton, pouch and blister after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture and light.
Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What GIOTRIF contains
The active substance is: amphotin. Each film-coated tablet contains 40 mg of ampatinib (as dilamate).
The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica (E551), crospovidone type A, magnesium stearate (E470b), hypromellose (E464), macrogol 400, titanium dioxide (E171), talc (E553b) Polysorbate 80 (E433), indigo carmine (E132) aluminum hydroxide.
What GIOTRIF looks like and contents of the pack
GIOTRIF 40 mg film-coated tablets are light blue and round. On one side there is a debossed embossment – code “T40”, and on the other is the emblem of the company “Boehringer Ingelheim”.
GIOTRIF film-coated tablets are supplied in packs containing 1, 2 or 4 perforated single dose blisters. Each blister contains 7 x 1 film-coated tablets and is packed together with a sachet with a desiccant in an aluminum bag.
Not all packs may be marketed.