GIOTRIF® 40 mg – patient leaflet, side effects, dosage

1. What GIOTRIF is and what it is used for

GIOTRIF is a medicine which 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 can be aff ected by changes (mutations) in the genes that produce them. By blocking the activity of these proteins this medicine can inhibit growth and spread of cancer cells.

This medicine is used on its own to treat adult patients with a specifi c type of cancer of the lung (non-small cell lung cancer):

• that is identifi ed by a change (mutation) in the

  gene for EGFR. GIOTRIF can be prescribed to you as your fi rst treatment or if prior chemotherapy treatment has been insuffi cient. ● of squamous type if prior chemotherapy

  treatment has been insuffi cient.

2. What you need to know before you take GIOTRIF

Do not take GIOTRIF

• if you are allergic to afatinib 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 female, have a low body weight

  of less than 50 kg or have kidney problems. If any of these apply to you, your doctor may monitor you more closely as the side eff ects may be more pronounced.

• if you have a history of lung infl ammation

  (interstitial lung disease).

• if you have liver problems. Your doctor may

  do some liver tests. Treatment with this medicine is not recommended if you have a severe liver disease.

• if you have a history of eye problems such

  as severe dry eyes, infl ammation of the transparent layer at the front of the eye (cornea) or ulcers involving the outer part of the eye, or if you use contact lenses.

• if you have a history of heart problems. Your

  doctor may want to monitor you more closely.

Inform your doctor immediately while taking this medicine:

• if you develop diarrhoea. Treatment at the fi rst

  signs of diarrhoea is important.

• if you develop skin rash. Early treatment of skin

  rash is important.

  • if you develop new or sudden worsening of

    shortness of breath, possibly with a cough or fever. These could be symptoms of an infl ammation of the lungs (interstitial lung disease) and can be life-threatening. ● if you have severe pain in your stomach or

    intestines, fever, chills, sickness, vomiting, or abdominal rigidity or bloating, as these could be symptoms of a tear in the wall of your stomach or intestines (‘gastrointestinal perforation’). Also, tell your doctor if you had gastrointestinal ulcers or diverticular disease in the past, or are concomitantly treated with anti-infl ammatory drugs (NSAIDs)

    (used to treat pain relief and swelling) or steroids (used for infl ammation and allergies), as this may increase this risk.

  • if you develop acute or worsening redness and

    pain in the eye, increased eye watering, blurred vision and/or sensitivity to light. You may need urgent treatment.

See also section 4 “Possible side eff ects”.

Children and adolescents

GIOTRIF is not recommended for use in children or adolescents. Do not give this medicine to children or 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 the blood levels of GIOTRIF and therefore the risk of side eff ects. They should therefore be taken as far apart in time as possible from GIOTRIF. This means preferably 6 hours (for medicines taken twice daily) or 12 hours (for medicines taken once daily) apart from GIOTRIF: ● Ritonavir, ketoconazole (except in shampoo),

itraconazole, erythromycin, nelfi navir, saquinavir - used to treat diff erent kinds of infections.

• Verapamil, quinidine, amiodarone - used to

  treat heart conditions.

• Cyclosporine A, tacrolimus - medicines that

  aff ect your immune system.

The following medicines may reduce the eff ectiveness

of GIOTRIF:

• Carbamazepine, phenytoin, phenobarbital -

  used to treat seizures.

• St. John’s wort (Hypericum perforatum), a

  herbal medicine to treat depression. ● Rifampicin, an antibiotic used to

  treat tuberculosis.

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

GIOTRIF may increase the blood levels of other medicines including but not limited to: ● Sulfasalazine, used to treat

infl ammation/infection.

• Rosuvastatin, used for lowering cholesterol.

Tell your doctor before taking these medicines together with GIOTRIF.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should avoid becoming pregnant while taking this medicine. If you could become pregnant, you should use adequate birth control methods during treatment and for at least 1 month after taking the last dose of this medicine. This is because there may be a risk that an unborn baby is harmed. If you become pregnant while receiving this medicine, you should immediately inform your doctor. Your doctor will decide with you whether treatment should be continued or not.

If you plan to become pregnant after taking the last dose of this medicine, you should ask your doctor for advice as your body may not have fully eliminated this medicine.

Breast-feeding

Do not breast-feed while taking this medicine as a risk to the breast-fed child cannot be excluded.

Driving and using machines

If you experience treatment-related symptoms aff ecting your eye sight (e.g. redness and/ or irritation of the eye, dry eye, tearing, light-sensitivity) or your ability to concentrate and react, it is recommended that you do not drive or use machines until the side eff ect disappears (see section 4 Possible side eff ects).

GIOTRIF contains lactose

This medicine contains a sugar called lactose. If you have been told by your doctor 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. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose is 40 mg each day. Your doctor may adjust (increase or decrease) your dose depending on how well you tolerate this medicine.

When to take GIOTRIF

• It is important to 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 about the

  same time each day. This makes it easier to remember to take this medicine.

• Do not break, chew or crush the tablet. ● Swallow the tablet whole with a glass of

  still water.

GIOTRIF is to be taken by mouth. If you have diffi culties swallowing the tablet, dissolve it in a glass of still water. No other liquids should be used. Drop the tablet into the water without crushing it, and occasionally stir for up to 15 min until the tablet is broken up into very small particles. Drink the liquid straight away. Then fi ll the glass again with water and drink it to make sure all medicine is taken.

If you are not able to swallow and have a gastric tube your doctor might suggest that the medicine is given to you via the tube.

If you take more GIOTRIF than you should

Contact your doctor or pharmacist immediately. You may experience increased side eff ects and your doctor may interrupt your treatment and provide supportive care.

If you forget to take GIOTRIF

• If your next scheduled dose is more than

  8 hours away, take the missed dose as soon as you remember.

• If your next scheduled dose is due within

  8 hours, skip the missed dose and take your next dose at the usual time. Then carry on taking your tablets at regular times as usual.

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

If you stop taking GIOTRIF

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

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

4. Possible side eff ects

Like all medicines, GIOTRIF can cause side eff ects, although not everybody gets them.

Contact your doctor as soon as possible if you suff er from any of the serious side eff ects listed below. In some cases your doctor may need to interrupt treatment and reduce your dose or stop treatment:

• Diarrhoea (very common, may aff ect more

  than 1 in 10 people).

  Diarrhoea lasting more than 2 days or more severe diarrhoea may lead to fl uid loss (common, may aff ect up to 1 in 10 people), low blood potassium (common) and worsening kidney function (common). Diarrhoea can be treated. At the fi rst signs of diarrhoea drink plenty of fl uids. Contact your doctor immediately and start appropriate antidiarrhoeal treatment as soon as possible. You should have antidiarrhoeal medicine available prior to taking GIOTRIF. ● Skin rash (very common).

  It is important to treat the rash early. Tell your doctor if a rash starts. If treatment for rash is not working and the rash is getting more severe (for example, you have peeling or blistering of the skin) you should notify your doctor immediately, since your doctor may decide to stop your treatment with GIOTRIF. Rash may occur or worsen in areas exposed to sun. Sun protection with protective clothing and sunscreen is recommended.

• Infl ammation of the lungs (uncommon, may

  aff ect up to 1 in 100 people) called “interstitial lung disease”. Tell your doctor immediately if you develop new or sudden worsening of shortness of breath, possibly with a cough or fever.

• Eye irritation or infl ammation

  Eye irritation or infl ammation may occur (conjunctivitis/dry eye occurs commonly and keratitis uncommonly). Tell your doctor if you have sudden or worsening of eye symptoms such as pain or redness or dry eye.

If you experience any of the symptoms above, contact your doctor as soon as possible.

The following other side eff ects have also been reported:

Very common side eff ects

(may aff ect more than 1 in 10 people): ● Mouth sores and infl ammation

• Nail infection
• Decreased appetite
• Bleeding from the nose
• Nausea
• Vomiting
• Itching
• Dry skin

Common side eff ects

(may aff ect up to 1 in 10 people):

• Pain, redness, swelling or peeling of the skin

  of your hands and feet

• Increased levels of the liver enzymes

  (aspartate aminotransferase and alanine aminotransferase) in blood tests. ● Infl ammation of the lining of the bladder with

  burning sensations during urination and frequent, urgent need to urinate (cystitis) ● Abnormal taste sensations (dysgeusia) ● Stomach pain, indigestion, heartburn ● Lip infl ammation

• Decreased weight
• Runny nose
• Muscle spasms
• Fever
• Nail problems

Uncommon side eff ects

(may aff ect up to 1 in 100 people):

• Infl ammation of the pancreas (pancreatitis) ● Occurrence of a tear in the wall of your

  stomach or intestines (gastrointestinal perforation)

Rare side eff ects

(may aff ect up to 1 in 1,000 people): ● Severe blistering or peeling of skin

(suggestive of Stevens-Johnson syndrome and toxic epidermal necrolysis)

Reporting of side eff ects

If you get any side eff ects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed on this leafl et. You can also report side eff ects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eff ects, you can help provide more information on the safety of this medicine.

5. How to store GIOTRIF

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

Do not use this medicine after the expiry date which is stated on the carton, the pouch and the 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.

If your medicine shows any signs of discolouration or deterioration, you should seek the advice of your pharmacist.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What GIOTRIF contains

• The active substance is afatinib. Each fi lm-coated tablet contains 40 mg of afatinib (as dimaleate).
• 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) aluminium lake.

What GIOTRIF looks like and contents of the pack

GIOTRIF 40 mg fi lm-coated tablets are light blue and round shaped. They are debossed with the code “T40” on one side and the Boehringer Ingelheim company logo on the other.

GIOTRIF fi lm-coated tablets are in packs containing 4 perforated unit dose blisters. Each blister contains 7 x 1 fi lm-coated tablets and is packed in an aluminium pouch together with a desiccant sachet that should not be swallowed.

Procured from within the EU and repackaged for the PL Holder:

Abacus Medicine Ltd., Abbey House,

282 Farnborough Road, Farnborough, GU14 7NA, United Kingdom

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173

D-55216 Ingelheim am Rhein

Germany

PL 45763/0681

POM

GIOTRIF^® is a registered trademark of Boehringer Ingelheim International GmbH

For any information about this medicine, please contact the local representative of the Product Licence Holder:

Abacus Medicine Ltd.

tel: +44(0)2036301244 email: MedInfo@abacusmedicine.co.uk or drugsafetyuk@abacusmedicine.co.uk

This leafl et was last approved on 13.02.2025.

Blind or partially sighted? Is this leafl et hard to see or read? Call 02036301310 or write to info@abacusmedicine.com to obtain the leafl et in a format suitable for you.