Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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 affected 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 specific type of cancer of the lung (non-small cell lung cancer): ¢ that is identified by a change (mutation) in the gene for EGFR. GIOTRIF can be prescribed to you as your first treatment or if prior chemotherapy treatment has been insufficient. * of squamous type if prior chemotherapy treatment has been insufficient.
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
N
Boehringer Ingelheim
monitor you more closely as the side effects may be more pronounced.
¢ if you have a history of lung inflammation (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, inflammation 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 first 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 inflammation 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-inflammatory drugs (NSAIDs) (used to treat pain relief and swelling) or steroids (used for inflammation 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 effects".
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.
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In particular, if taken before GIOTRIF, the following medicines may increase the blood levels of GIOTRIF and therefore the risk of side effects. 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, nelfinavir, saquinavir - used to treat different kinds of infections. ¢ Verapamil, quinidine, amiodarone - used to treat heart conditions. ¢ Cyclosporine A, tacrolimus - medicines that affect your immune system.
The following medicines may reduce the effectiveness 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 inflammation/ 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 affecting 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 effect disappears (see section 4 Possible side effects).
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.
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 difficulties 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 fill 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 effects 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 first 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.
Like all medicines, GIOTRIF can cause side effects, although not everybody gets them.
Contact your doctor as soon as possible if you suffer from any of the serious side effects listed below.
In some cases your doctor may need to interrupt treatment and reduce your dose or stop treatment:
¢ Diarrhoea (very common, may affect more than 1 in 10 people). Diarrhoea lasting more than 2 days or more severe diarrhoea may lead to fluid loss (Common, may affect up to 1 in 10 people), low blood potassium (common) and worsening kidney function (common). Diarrhoea can be treated. At the first signs of diarrhoea drink plenty of fluids. 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.
¢ Inflammation of the lungs (uncommon, may affect 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 inflammation Eye irritation or inflammation 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 effects have also been reported:
Very common side effects (may affect more than 1 in 10 people):
¢ Mouth sores and inflammation
¢ Nail infection
¢ Decreased appetite
¢ Bleeding from the nose
« Nausea
¢ Vomiting
¢ Itching
¢ Dry skin ----
Common side effects (may affect 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.
¢ Inflammation 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 inflammation
¢ Decreased weight
¢ Runny nose
¢ Muscle spasms
e Fever
¢ Nail problems
Uncommon side effects (may affect up to 1 in 100 people): ¢ Inflammation of the pancreas (pancreatitis) ¢ Occurrence of a tear in the wall of your stomach or intestines (gastrointestinal perforation) ¢ Abnormal growth of your eyelash (including misdirected growth that may lead to damage to the eye surface)
Rare side effects (may affect 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 effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
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.
What GIOTRIF contains
The active substance is afatinib. Each film-coated
tablet contains 30 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 30 mg film-coated tablets are dark blue
and round shaped. They are debossed with the code
"T30" on one side and the Boehringer Ingelheim company logo on the other.
GIOTRIF film-coated tablets are available in packs containing 1, 2 or 4 perforated unit dose blisters. Each blister contains 7 x 1 film-coated tablets and is packed in an aluminium pouch together with
a desiccant sachet that should not be swallowed.
Not all pack sizes may be marketed. Marketing Authorisation 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
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom Boehringer Ingelheim Ltd. Tel: +44 1344 424 600
This leaflet was last revised in 11/2025.
Giotrif 30 mg film-coated tablets comes as tablet containing 30 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Giotrif 30 mg film-coated tablets is afatinib dimaleate.
This leaflet reproduces the patient information leaflet approved for Giotrif 30 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
GIOTRIF as monotherapy is indicated for the treatment of
• Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s);
• Adult patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy (see section 5.1).
Treatment with GIOTRIF should be initiated and supervised by a physician experienced in the use of anticancer therapies.
EGFR mutation status should be established prior to initiation of GIOTRIF therapy (see section 4.4).
Posology
The recommended dose is 40 mg once daily.
This medicinal product should be taken without food. Food should not be consumed for at least 3 hours before and at least 1 hour after taking this medicinal product (see sections 4.5 and 5.2).
GIOTRIF treatment should be continued until disease progression or until no longer tolerated by the patient (see Table 1 below).
Dose escalation
A dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day starting dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other adverse reactions with CTCAE Grade > 1) in the first cycle of treatment (21 days for EGFR mutation positive NSCLC and 28 days for squamous NSCLC). The dose should not be escalated in any patients with a prior dose reduction. The maximum daily dose is 50 mg.
Dose adjustment for adverse reactions
Symptomatic adverse reactions (e.g. severe/persistent diarrhoea or skin related adverse reactions) may be successfully managed by treatment interruption and dose reductions or treatment discontinuation of GIOTRIF as outlined in Table 1 (see sections 4.4 and 4.8).
Table 1: Dose adjustment information for adverse reactions
| CTCAEa Adverse reactions | Recommended dosing | |
| Grade 1 or Grade 2 | No interruption b | No dose adjustment |
| Grade 2 (prolonged c or intolerable) or Grade ≥ 3 | Interrupt until Grade 0/1 b | Resume with dose reduction by 10 mg decrements d |
a NCI Common Terminology Criteria for Adverse Events
b In case of diarrhoea, anti-diarrhoeal medicinal products (e.g. loperamide) should be taken immediately and continued for persistent diarrhoea until loose bowel movements cease.
c > 48 hours of diarrhoea and/or > 7 days of rash
d If patient cannot tolerate 20 mg/day, permanent discontinuation of GIOTRIF should be considered
Interstitial Lung Disease (ILD) should be considered if a patient develops acute or worsening of respiratory symptoms in which case treatment should be interrupted pending evaluation. If ILD is diagnosed, GIOTRIF should be discontinued and appropriate treatment initiated as necessary (see section 4.4).
Missed dose
If a dose is missed, it should be taken within the same day as soon as the patient remembers. However, if the next scheduled dose is due within 8 hours then the missed dose must be skipped.
Use of P‑glycoprotein (P‑gp) inhibitors
If P‑gp inhibitors need to be taken, they should be administered using staggered dosing, i.e. the P‑gp inhibitor dose should be taken as far apart in time as possible from the GIOTRIF dose. This means preferably 6 hours (for P‑gp inhibitors dosed twice daily) or 12 hours (for P‑gp inhibitors dosed once daily) apart from GIOTRIF (see section 4.5).
Special populations
Patients with renal impairment
Exposure to afatinib was found to be increased in patients with moderate or severe renal impairment (see section 5.2). Adjustments to the starting dose are not necessary in patients with mild (eGFR 60-89 mL/min/1.73 m²), moderate (eGFR 30-59 mL/min/1.73 m²) or severe (eGFR 15-29 mL/min/1.73 m²) renal impairment. Monitor patients with severe renal impairment (eGFR 15-29 mL/min/1.73 m²) and adjust GIOTRIF dose if not tolerated.
GIOTRIF treatment in patients with eGFR < 15 mL/min/1.73 m² or on dialysis is not recommended.
Patients with hepatic impairment
Exposure to afatinib is not significantly changed in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2). Adjustments to the starting dose are not necessary in patients with mild or moderate hepatic impairment. This medicinal product has not been studied in patients with severe (Child Pugh C) hepatic impairment. Treatment in this population is not recommended (see section 4.4).
Paediatric population
There is no relevant use of GIOTRIF in the paediatric population in the indication of NSCLC. Treatment of children or adolescents with GIOTRIF was not supported by a clinical trial conducted in paediatric patients with other conditions (see sections 5.1 and 5.2). Safety and efficacy have not been established. Therefore, treatment of children or adolescents with this medicinal product is not recommended.
Method of administration
This medicinal product is for oral use. The tablets should be swallowed whole with water. If swallowing of whole tablets is not possible, these can be dispersed in approximately 100 mL of non-carbonated drinking water. No other liquids should be used. The tablet should be dropped into the water without crushing it, and stirred occasionally for up to 15 min until it is broken up into very small particles. The dispersion should be consumed immediately. The glass should be rinsed with approximately 100 mL of water which should also be consumed. The dispersion can also be administered through a gastric tube.
Hypersensitivity to afatinib or to any of the excipients listed in section 6.1.
Interactions with drug transport systems
Effects of P‑gp and breast cancer resistance protein (BCRP) inhibitors on afatinib
In vitro studies have demonstrated that afatinib is a substrate of P‑gp and BCRP. When the strong P‑gp and BCRP inhibitor ritonavir (200 mg twice a day for 3 days) was administered 1 hour before a single dose of 20 mg GIOTRIF, exposure to afatinib increased by 48% (area under the curve (AUC0-∞)) and 39% (maximum plasma concentration (Cmax)). In contrast, when ritonavir was administered simultaneously or 6 hours after 40 mg GIOTRIF, the relative bioavailability of afatinib was 119% (AUC0-∞) and 104% (Cmax) and 111% (AUC0-∞) and 105% (Cmax), respectively. Therefore, it is recommended to administer strong P‑gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) using staggered dosing, preferably 6 hours or 12 hours apart from GIOTRIF (see section 4.2).
Effects of P‑gp inducers on afatinib
Pre-treatment with rifampicin (600 mg once daily for 7 days), a potent inducer of P‑gp, decreased the plasma exposure to afatinib by 34% (AUC0-∞) and 22% (Cmax) after administration of a single dose of 40 mg GIOTRIF. Strong P‑gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital or St. John's wort (Hypericum perforatum)) may decrease exposure to afatinib (see section 4.4).
Effects of afatinib on P‑gp substrates
Based on in vitro data, afatinib is a moderate inhibitor of P‑gp. However, based on clinical data it is considered unlikely that GIOTRIF treatment will result in changes of the plasma concentrations of other P‑gp substrates.
Interactions with BCRP
In vitro studies indicated that afatinib is a substrate and an inhibitor of the transporter BCRP. Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Food effect on afatinib
Co‑administration of a high-fat meal with GIOTRIF resulted in a significant decrease of exposure to afatinib by about 50% in regard to Cmax and 39% in regard to AUC0-∞. This medicinal product should be administered without food (see sections 4.2 and 5.2).
Women of childbearing potential
As a precautionary measure, women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with GIOTRIF. Adequate contraceptive methods should be used during therapy and for at least 1 month after the last dose.
Pregnancy
Mechanistically, all EGFR targeting medicinal products have the potential to cause foetal harm.
Animal studies with afatinib did not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Studies in animals have shown no signs of teratogenicity up to and including maternally lethal dose levels. Adverse changes were restricted to toxic dose levels. However, systemic exposures achieved in animals were either in a similar range or below the levels observed in patients (see section 5.3).
There are no or limited amount of data from the use of this medicinal product in pregnant women. The risk for humans is thus unknown. If used during pregnancy or if the patient becomes pregnant while or after receiving GIOTRIF, she should be informed of the potential hazard to the foetus.
Breast‑feeding
Available pharmacokinetic data in animals have shown excretion of afatinib in milk (see section 5.3). Based on this, it is likely that afatinib is excreted in human milk. A risk to the breast-feeding child cannot be excluded. Mothers should be advised against breast-feeding while receiving this medicinal product.
Fertility
Fertility studies in humans have not been performed with afatinib. Available non-clinical toxicology data have shown effects on reproductive organs at higher doses. Therefore, an adverse effect of this medicinal product on human fertility cannot be excluded.
GIOTRIF has minor influence on the ability to drive and use machines. During treatment, ocular adverse reactions (conjunctivitis, dry eye, keratitis) have been reported in some patients (see section 4.8) which may affect patients ability to drive or use machines.
Symptoms
The highest dose of afatinib studied in a limited number of patients in Phase I clinical trials was 160 mg once daily for 3 days and 100 mg once daily for 2 weeks. The adverse reactions observed at these doses were primarily dermatological (rash/acne) and gastrointestinal events (especially diarrhoea). Overdose in 2 healthy adolescents involving the ingestion of 360 mg each of afatinib (as part of a mixed drug ingestion) was associated with adverse events of nausea, vomiting, asthenia, dizziness, headache, abdominal pain and elevated amylase (< 1.5 times ULN). Both individuals recovered from these adverse events.
Treatment
There is no specific antidote for overdose with this medicinal product. In cases of suspected overdose, GIOTRIF should be withheld and supportive care initiated.
If indicated, elimination of unabsorbed afatinib may be achieved by emesis or gastric lavage.
Ask anything about Giotrif 30 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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