Afatinib (Giotrif and Gilotrif)

Afatinib at a glance

Afatinib belongs to a group called tyrosine kinase inhibitors, or TKIs. It blocks growth signals involving the EGFR family of proteins. Giotrif and Gilotrif are verified brand names in the sources reviewed; your pack may use another name. This guide does not establish which brands are available or approved in India.

Treatment is usually once daily, at a consistent time, on an empty stomach. Your prescription determines the strength. A commonly recommended starting dose is 40 mg daily, but kidney function, side effects and the product instructions can change that decision. Never increase, reduce or alternate doses yourself.

Diarrhoea, skin rash, mouth soreness and inflammation around the nails are particularly important. Early treatment can prevent these problems becoming more serious. Before the first tablet, have your hospital contact details and a written diarrhoea-management plan ready.

How afatinib works

Proteins on and inside cells pass messages that influence growth and survival. EGFR is one of these signalling proteins. Some cancer cells depend on abnormal signalling through this system. Afatinib attaches to and inhibits members of the ErbB receptor family, including EGFR, helping interrupt those messages.

A targeted medicine is selected for a biological reason; it is not automatically suitable for every person with the same diagnosis. It can also affect healthy tissues that use these pathways. This helps explain why a medicine directed at cancer can cause changes in the bowel lining, skin, mouth and eyes.

Your team assesses benefit through your symptoms, examination and planned investigations. The presence of a rash is not a substitute for that assessment. Having few side effects does not, by itself, show that treatment has failed.

How your team decides whether it is suitable

Afatinib is used for selected non-small cell lung cancers, including cancers with particular EGFR mutations and certain squamous lung cancers that have progressed after platinum chemotherapy. The decision brings together the precise diagnosis, pathology findings, relevant molecular results, previous treatments and your general health. When selection depends on an EGFR alteration, the exact alteration and the reliability of the test matter; the words “EGFR positive” alone do not explain every treatment decision. Ask what your report shows and how it supports the proposed plan.

Your clinician also considers existing breathing difficulties, liver or kidney disease, eye problems and your ability to manage daily oral treatment. Previous severe diarrhoea, poor intake or low body weight may affect the monitoring and support you need. Tell the team about practical barriers, such as swallowing difficulty or uncertainty about meal timing, before treatment starts.

Ask what treatment is intended to achieve, how benefit will be assessed and what would lead to a change. These answers are individual. Another person's tablet strength or treatment duration should not be used to judge your own prescription.

Before your first dose

Your team normally reviews blood tests, including kidney and liver function, and checks your medicines. Explain your usual bowel pattern and any current diarrhoea. Report dry eyes, previous corneal inflammation, contact-lens use, lung inflammation, heart disease and previous stomach or bowel ulcers or diverticular disease. These details help identify problems requiring closer observation.

Take an up-to-date list of prescriptions, over-the-counter medicines, vitamins, Ayurvedic preparations and other supplements. Include medicines taken only occasionally, especially painkillers and antibiotics. Do not assume a product is compatible because it is described as natural.

Before leaving the clinic, confirm the tablet strength, daily time, food instructions and missed-dose rule for your pack. Have the prescribed anti-diarrhoea medicine available and know when to begin it and when to call. Ask for advice on moisturiser, mouth care and a suitable sunscreen.

Discuss pregnancy prevention, breastfeeding and fertility before starting. Tell your team about any allergy or unusual inherited sugar intolerance: Giotrif contains lactose. A pharmacist can check the exact ingredients of your supplied product.

Taking afatinib

Dose and treatment schedule

Afatinib is usually taken every day. Treatment commonly continues while it is providing benefit and its adverse effects remain manageable. Your clinician may temporarily withhold treatment and later prescribe a lower strength when side effects occur. A supervised break is a treatment adjustment, not something to compensate for with extra tablets.

The US label recommends a lower starting dose of 30 mg in severe kidney impairment. The European label takes a different approach, with close monitoring and adjustment for tolerability. Some European prescriptions may also use 50 mg after an assessment of tolerability. These are prescribing decisions; follow the dose on your own plan.

Food and swallowing

Take the tablet with water. Food instructions differ between the reviewed products. European Giotrif instructions require no food for at least three hours before the dose and at least one hour afterwards. US Gilotrif and the reviewed US generic instructions say at least two hours after food or at least one hour before food. Ask your pharmacist to write the correct window for your pack; do not switch between these rules yourself.

Swallow tablets whole rather than chewing or crushing them. If swallowing is difficult, discuss this before missing doses. The European Giotrif information permits a specific dispersion method: put the whole tablet in approximately 100 mL of still drinking water, without crushing it; stir occasionally for up to 15 minutes until small particles remain; drink immediately; then rinse the glass with approximately 100 mL of water and drink that too. No other liquid should be used. A gastric-tube method is also described. Use either method only after the pharmacist confirms it for your product and teaches you how to prepare the dose.

Forgotten doses and vomiting

For European Giotrif, a forgotten dose may be taken on the same day if the next dose is more than eight hours away; otherwise skip it. US Gilotrif instructions say not to take a missed dose within twelve hours of the next dose. Follow the rule for your supplied tablets. Never double a dose. If the pack instructions and hospital plan differ, contact the pharmacist to resolve the discrepancy.

If you vomit after taking afatinib, do not take a replacement tablet. Resume at the next scheduled time unless your team gives other advice. Repeated vomiting or inability to drink needs prompt assessment. If you accidentally take extra tablets, contact your hospital immediately and have the pack and dose details available.

Storage and handling

Keep tablets in their original packaging, protected from moisture and light, out of children's reach. Keep a bottle tightly closed and retain any supplied desiccant; do not swallow it. Follow its temperature instructions; US Gilotrif specifies 20–25°C (68–77°F), with permitted short excursions as described in its label. Do not transfer tablets to an organiser without asking the pharmacist. Return unused medicine through your treatment service or pharmacy.

Checks during treatment

Appointments review both cancer control and treatment tolerance. Keep a brief record of doses, bowel movements, rash, mouth soreness and problems eating or drinking. Reporting a change early gives the team a better opportunity to treat it before dehydration or a severe reaction develops.

Blood tests check liver and kidney function and may include electrolytes, the minerals affected by fluid loss. Tests may be brought forward after diarrhoea, vomiting or reduced intake. Report reduced urine rather than waiting for your next planned blood test.

An eye examination may be needed for new symptoms. Heart-function testing may be considered when there is significant cardiac history, risk factors or new symptoms; it is not a fixed requirement for everyone. Scans and other assessments follow your individual cancer plan. There is no single blood-test or scan timetable suitable for every patient.

Common side effects and practical care

Diarrhoea

Diarrhoea often starts early, particularly in the first two weeks. Begin the anti-diarrhoea medicine exactly as your team has instructed at the first loose stool, and let them know. Loperamide is commonly prescribed, but the dose and maximum daily amount must come from your care plan. Do not keep increasing it independently.

Drink regularly according to your team's advice and any fluid restriction. Small meals may be easier; temporarily avoiding foods that make symptoms worse can help. Keep a record of stool frequency compared with your normal pattern, any night-time episodes, fluid intake and urine output.

Call promptly if diarrhoea is increasing, wakes you at night, comes with cramps, or is not controlled by the prescribed medicine. Contact the hospital if it has not improved within 24 hours of treatment, or sooner if your plan says so. Do not wait for 48 hours just because a prescribing label uses that duration in its dose-adjustment rules. Blood in the stool, fever, dizziness, very little urine or inability to drink requires urgent advice.

Rash, dry skin and itching

An acne-like rash can occur, often on the face and upper body. Report it early so the team can choose appropriate creams or other treatment. Use gentle washing, an unperfumed moisturiser and sun protection. Ordinary acne remedies may irritate this rash and should not be started without advice.

Protect exposed skin with clothing and a suitable high-factor sunscreen. Do not pick or scrub affected areas. A painful, extensive or rapidly worsening rash needs prompt review; blistering, peeling or sores involving the eyes or mouth require urgent assessment. These features are different from a mild dry rash.

Sore mouth and changes in eating

Mouth ulcers or inflammation can make food and drinks uncomfortable. Gentle toothbrushing and the mouth-care routine recommended by your team are useful. Soft, bland foods may be easier than rough, acidic or spicy foods. Ask for pain relief and prescribed rinses rather than struggling to eat.

Report white patches, marked soreness, swallowing difficulty or reduced drinking. Infection may need different treatment from uncomplicated soreness. Appetite loss, altered taste and nausea can also reduce intake. Ask for a dietitian if weight is falling; do not use the fasting window around the tablet as a reason to skip meals throughout the day.

Nails, hands and feet

The skin around a nail can become swollen, tender or infected. Report pain, discharge or redness promptly. Keep nails protected and avoid trauma to the cuticles. Sore or cracked palms and soles can interfere with walking or everyday tasks; tell the team before discomfort becomes disabling. Treatment and, sometimes, a dose adjustment may help.

Other effects

Nausea, vomiting, nosebleeds, a runny nose or urinary irritation may occur. Persistent or heavy bleeding needs prompt assessment. Burning urine or urinary frequency should be reported because infection needs to be considered. Fatigue can have several causes, including illness, poor sleep, reduced intake or dehydration; mention a new or substantial change rather than assuming it is unavoidable.

Less common but important problems

Lung inflammation

Afatinib can cause serious inflammation of lung tissue, sometimes called interstitial lung disease or pneumonitis. New or worsening breathlessness, cough or fever needs urgent assessment. Infection and the cancer itself can cause similar symptoms, so a diagnosis cannot be made at home. The treating team should withhold afatinib while suspected lung inflammation is investigated. Confirmed treatment-related interstitial lung disease requires permanent discontinuation.

Severe skin reactions

Blisters, peeling skin, a spreading painful rash or sores on the mouth or eyes may indicate a severe reaction. Seek immediate medical advice and do not take another dose until the treating team has assessed the situation. Severe reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis, can require hospital treatment. The specialist will stop afatinib if either is suspected; confirmed severe reactions can require permanent discontinuation.

Eye and corneal problems

Pain, marked redness, light sensitivity, blurred vision or excessive watering can signal corneal inflammation, called keratitis. Contact the team urgently for assessment; an eye specialist may be needed. Afatinib should be withheld while suspected keratitis is investigated. Confirmed ulcerative or persistent keratitis can require stopping treatment, as decided by the specialist. Do not drive with affected vision. Tell clinicians about contact-lens use and previous severe dry eye.

Liver injury and dehydration-related kidney problems

Blood tests may detect liver changes before symptoms occur. Yellow skin or eyes, dark urine, unusual bruising or persistent upper-abdominal discomfort should be reported promptly. Severe diarrhoea or vomiting can lead to dehydration and impaired kidney function; very little urine, dizziness or inability to drink needs urgent assessment.

Heart symptoms

Seek prompt assessment for new swelling of the ankles or legs, palpitations, sudden weight gain or worsening exercise tolerance. These can be signs of a heart problem and should not be dismissed as ordinary treatment fatigue. Severe breathlessness or collapse requires emergency care. Your clinician decides whether heart testing and a treatment change are needed.

Serious abdominal symptoms

Rarely, a hole can develop in the stomach or bowel wall, called gastrointestinal perforation. Severe or persistent abdominal pain, particularly with fever, vomiting or a swollen abdomen, requires urgent medical assessment. Do not treat this as ordinary indigestion or simply take more anti-diarrhoea medicine. Previous bowel disease and certain accompanying medicines can increase concern.

Other medicines, supplements and vaccinations

Afatinib can interact with medicines that affect a transport protein called P-glycoprotein. Examples include some antibiotics and antifungals, ritonavir, ciclosporin, verapamil and amiodarone. Other medicines, including rifampicin and certain seizure medicines, can reduce afatinib exposure. St John's wort can also interfere. Have every new medicine checked before starting it.

European information sometimes recommends separating interacting medicines from afatinib; US information may instead require a clinician-directed dose change. Do not assume that spacing tablets makes an interaction safe. Your pharmacist needs the precise medicines, doses and timing to choose an appropriate plan.

Tell the team about ibuprofen and other anti-inflammatory painkillers, corticosteroids and any other cancer treatment because these can be relevant to bowel-perforation risk. Do not suddenly stop a prescribed steroid. Ask before taking supplements or remedies for diarrhoea, rash or indigestion.

Discuss vaccinations with your oncology team, including whether a proposed vaccine is live and whether other treatment affects immunity. The timing depends on your overall treatment and health. Bring your vaccination record when seeking advice.

Everyday life during treatment

Build the tablet and its food window into a routine that still allows adequate meals and fluids. A phone reminder and a written dose record can reduce uncertainty. If another person helps with medicines, agree how each dose will be recorded so it is not given twice.

Plan outings with access to drinking water, toilets and your hospital contact details, particularly early in treatment. Protect skin from sun exposure. Choose activity according to how you feel and seek advice if breathlessness or weakness is new. Do not drive if vision, dizziness or concentration makes it unsafe.

Tell your dentist and other clinicians that you take afatinib. Before an operation or procedure, ask the oncology team whether any treatment adjustment is needed; do not borrow a stopping schedule intended for another targeted medicine. If work, travel or treatment costs make daily dosing difficult, raise this early so the team can help plan continuity.

Fertility, pregnancy and breastfeeding

Afatinib can harm a developing baby. Tell your team immediately if pregnancy occurs or is suspected. Discuss effective contraception before treatment. The reviewed US information specifies contraception during treatment and for at least two weeks afterwards for women who can become pregnant; European Giotrif specifies at least one month afterwards. Confirm the duration for your product and any accompanying treatment.

Vomiting or severe diarrhoea can affect reliance on an oral contraceptive. Ask your oncology team or contraception clinician what additional protection is needed; do not assume that taking the pill at another time solves the problem.

Do not breastfeed during treatment. US information also says not to breastfeed for two weeks after the last dose; European information does not give a specific restart interval. Obtain an individual restart plan rather than interpreting that absence as immediate permission.

Effects on human fertility are not fully known. Discuss preservation options before treatment if future parenthood matters to you. Ask for advice relevant to either partner and the whole treatment plan; do not assume that reduced fertility prevents pregnancy.

After treatment stops or changes

Keep following the team's plan for lingering side effects, blood tests and contraception. Skin, nail, mouth or bowel problems may need ongoing care. New serious symptoms still need assessment after the last tablet; mention when you last took afatinib.

If treatment is paused, ask who will authorise restarting and at what strength. Do not restart leftover tablets because symptoms improve. If it is permanently stopped, return unused supplies through the recommended pharmacy route and update your medicine list. Keep a record of important reactions for future treatment discussions.

Frequently asked questions