Giotrif 40 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

GIOTRIF 40 mg Film-coated Tablets

afatinib

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What GIOTRIF is and what it is used for
2. What you need to know before taking GIOTRIF
3. How to take GIOTRIF
4. Possible side effects
5. How to store GIOTRIF
6. Contents of the pack and other information

1. What GIOTRIF is and what it is used for

GIOTRIF is a medicine that contains the active substance afatinib. It works by blocking the activity of a group of proteins called the ErbB family (including EGFR [Epidermal Growth Factor Receptor or ErbB1], HER2 [ErbB2], ErbB3 and ErbB4]. These proteins are involved in the growth and spread of cancer cells and may be affected by changes (mutations) in the genes that produce them. By blocking the activity of these proteins, this medicine can inhibit the growth and spread of cancer cells.

This medicine is used alone to treat adult patients with a specific type of lung cancer (non-small cell lung cancer):

• characterized by a change (mutation) in the EGFR gene. Your doctor may prescribe GIOTRIF as your first treatment or if previous chemotherapy has been insufficient.
• squamous type if previous treatment with chemotherapy has been insufficient.

2. What you need to know before starting to take GIOTRIF

Do not take GIOTRIF

• if you are allergic to afatinib or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• if you are a woman, weigh less than 50 kg, or have kidney problems. If any of these apply to you, your doctor may monitor you more closely, as side effects may be more severe.
• if you have a history of lung inflammation (interstitial lung disease).
• if you have liver problems. Your doctor may perform liver tests. Treatment with this medicine is not recommended if you have severe liver disease.
• if you have a history of eye disorders such as severe dry eye, inflammation of the clear outer layer of the front of the eye (cornea), or ulcers on the outer part of the eye, or if you wear contact lenses.
• if you have a history of heart problems. Your doctor may monitor you more closely.

Inform your doctor immediately while taking this medicine:

• if you develop diarrhea. It is important to start treatment at the first signs of diarrhea.
• if you develop a skin rash. It is important to start treatment for the rash as soon as possible.
• if you experience new or sudden worsening of shortness of breath, possibly accompanied by cough or fever. These could be symptoms of lung inflammation (interstitial lung disease), which can be life-threatening.
• if you experience severe stomach or intestinal pain, fever, chills, nausea, vomiting, or abdominal stiffness or swelling, as these could be symptoms of a tear in the stomach or intestinal wall ("gastrointestinal perforation"). Also, inform your doctor if you have previously had gastrointestinal ulcers or diverticular disease, or if you are receiving concomitant treatment with anti-inflammatory drugs (NSAIDs) (used to relieve pain and swelling) or steroids (used for inflammation and allergies), as this may increase the risk.
• if you experience redness and severe eye pain or worsening of these symptoms, increased tearing, blurred vision, and/or sensitivity to light. You may require urgent treatment.

See also section 4 "Possible side effects".

Children and adolescents

Use of GIOTRIF is not recommended in children and adolescents. Do not administer this medicine to children or adolescents under 18 years of age.

Other medicines and GIOTRIF

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including herbal medicines and over-the-counter medicines.

In particular, the following medicines, if taken before GIOTRIF, may increase GIOTRIF levels in the blood and therefore the risk of side effects. Therefore, these medicines should be taken as far apart as possible from GIOTRIF. Ideally, a gap of 6 hours (for medicines taken twice daily) or 12 hours (for medicines taken once daily) should be left between taking GIOTRIF:

• Ritonavir, ketoconazole (except in shampoo), itraconazole, erythromycin, nelfinavir, and saquinavir, used to treat various types of infections.
• Verapamil, quinidine, and amiodarone, used to treat heart conditions.
• Cyclosporine A and tacrolimus, medicines that affect the immune system.

The following medicines may reduce the effectiveness of GIOTRIF:

• Carbamazepine, phenytoin, and phenobarbital, used to treat seizures.
• St. John’s wort (Hypericum perforatum), a herbal medicine used to treat depression.
• Rifampicin, an antibiotic used to treat tuberculosis.

Ask your doctor if you are unsure about when to take these medicines.

GIOTRIF may increase blood levels of other medicines, including the following:

• Sulfasalazine, used to treat inflammation/infection.
• Rosuvastatin, used to lower cholesterol.

Inform your doctor before taking these medicines together with GIOTRIF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must avoid becoming pregnant while taking this medicine. If you could become pregnant, you should use adequate contraception during treatment and for at least 1 month after taking the last dose of this medicine. This is because there is a risk of harm to the unborn baby.

If you become pregnant while taking this medicine, inform your doctor immediately. Your doctor will decide with you whether to continue treatment.

Seek advice from your doctor if you plan to become pregnant after taking the last dose of this medicine, as your body may not have completely eliminated the medicine.

Breastfeeding

You must not breastfeed while taking this medicine, as a risk to the breastfed infant cannot be ruled out.

Driving and using machines

If you experience treatment-related symptoms affecting your vision (e.g., redness and/or eye irritation, dry eyes, watery eyes, sensitivity to light) or your concentration and reaction ability, you are advised not to drive or use machines until the side effects have resolved (see section 4 Possible side effects).

GIOTRIF contains lactose

This medicine contains a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take GIOTRIF

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose is 40 mg once daily.

Your doctor may adjust (increase or decrease) your dose depending on how well you tolerate this medicine.

When to take GIOTRIF

• It is important that you take this medicine without food.
• Take this medicine at least 1 hour before eating, or
• If you have already eaten, wait at least 3 hours before taking this medicine.
• Take this medicine once daily at approximately the same time each day. This makes it easier to remember to take the medicine.
• Do not break, chew, or crush the tablet.
• Swallow the tablet whole with a glass of still water.

GIOTRIF must be taken by mouth. If you have difficulty swallowing the tablet, dissolve it in a glass of still water. Do not use any other liquids. Place the tablet in the water without crushing it and stir occasionally for about 15 minutes until the tablet has dissolved into very fine particles. Drink the liquid immediately. To ensure you have taken the entire dose, refill the glass with water and drink it as well.

If you are unable to swallow and have a gastric tube, your doctor may recommend administering the medicine through the tube.

If you take more GIOTRIF than you should

Contact your doctor or pharmacist immediately. You may experience more severe adverse effects, and your doctor may interrupt treatment and provide supportive therapy.

If you forget to take GIOTRIF

• If your next dose is more than 8 hours away, take the missed dose as soon as you remember.
• If your next dose is within the next 8 hours, skip the missed dose and take the next dose at your usual time. Then continue taking your tablets as before.

Do not take a double dose (two tablets at once instead of one) to make up for missed doses.

If you stop taking GIOTRIF

Do not stop taking this medicine without first consulting your doctor. It is important to take this medicine every day as long as your doctor prescribes it. If you do not take this medicine as prescribed, your cancer may start to grow again.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, GIOTRIF may cause adverse effects, although not everyone experiences them.

Immediately inform your doctor if you notice any of the following serious adverse effects. In some cases, your doctor may need to interrupt the treatment, reduce your dose, or stop treatment altogether:

• Diarrhoea (very common, may affect more than 1 in 10 patients).

Diarrhoea lasting more than 2 days or severe diarrhoea may lead to fluid loss (common, may affect up to 1 in 10 patients), low levels of potassium in the blood (common), and worsening of kidney function (common). Diarrhoea can be treated. As soon as the first symptoms of diarrhoea appear, drink plenty of fluids. Inform your doctor immediately and start appropriate anti-diarrhoeal treatment as soon as possible. You should have an anti-diarrhoeal medicine available before starting treatment with GIOTRIF.

• Skin rash (very common).

It is important to start treatment for the rash as early as possible. Inform your doctor as soon as a rash appears. If treatment for the rash is ineffective and the rash worsens (for example, if your skin begins to peel or blisters appear), inform your doctor immediately, as your doctor may decide to discontinue your treatment with GIOTRIF. The rash may appear or worsen in areas of the body exposed to sunlight. It is recommended to wear appropriate clothing and use sunscreen as protective measures against sunlight.

• Inflammation of the lungs (uncommon, may affect up to 1 in 100 patients), known as “interstitial lung disease”. Immediately inform your doctor if you notice new or suddenly worsening shortness of breath, possibly accompanied by cough or fever.

• Eye irritation or inflammation

Eye irritation or inflammation may occur (conjunctivitis/dry eye occurs commonly and keratitis occurs uncommonly). Inform your doctor if you experience sudden onset or worsening of eye symptoms such as eye pain, redness, or dry eyes.

If you experience any of these symptoms, inform your doctor as soon as possible.

The following adverse effects have also been reported:

Very common adverse effects (may affect more than 1 in 10 patients):

• Inflammation and sores in the mouth
• Nail infections
• Loss of appetite
• Nosebleeds
• Nausea
• Vomiting
• Itching
• Dry skin

Common adverse effects (may affect up to 1 in 10 patients):

• Pain, redness, swelling, or peeling of the skin on hands and feet
• Increased levels of the liver enzymes aspartate aminotransferase and alanine aminotransferase in blood tests
• Inflammation of the inner layer of the bladder with a burning sensation when urinating and a frequent and urgent need to urinate (cystitis)
• Taste disturbance (dysgeusia)
• Stomach pain, indigestion, heartburn
• Inflammation of the lips
• Weight loss
• Runny nose
• Muscle spasms
• Fever
• Nail problems

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Inflammation of the pancreas (pancreatitis)
• Development of a tear in the wall of your stomach or intestines (gastrointestinal perforation)
• Abnormal growth of eyelashes (including misdirected growth that may cause damage to the eye surface)

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Severe blistering or peeling of the skin (indicative of Stevens-Johnson syndrome and toxic epidermal necrolysis)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of GIOTRIF

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, the bag, and the blister after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect it from moisture and light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of GIOTRIF

• The active substance is afatinib. Each film-coated tablet contains 30 mg of afatinib (as dimaleate).
• The other components are monohydrate lactose, 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 aluminum lake (E132).

Appearance of the product and contents of the pack

GIOTRIF 30 mg are dark blue, round, film-coated tablets. They are marked with the code “T30” on one side and the Boehringer Ingelheim logo on the other.

GIOTRIF film-coated tablets are available in packaging containing 1, 2, or 4 single-dose perforated blisters. Each blister contains 7 x 1 film-coated tablets and is packed in an aluminum bag together with a desiccant sachet which must not be swallowed.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Boehringer Ingelheim France
100-104 Avenue de France
75013 Paris
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.euopa.eu.