Gefitinib Accord
EGFR Tyrosine Kinase Inhibitor for Non-Small Cell Lung Cancer
Quick Facts About Gefitinib Accord
Key Takeaways About Gefitinib Accord
- Targeted therapy for EGFR-mutant NSCLC: Gefitinib is specifically designed for non-small cell lung cancers that carry activating EGFR mutations (e.g., exon 19 deletions or exon 21 L858R substitution)
- Once-daily oral dosing: Taken as a single 250 mg tablet daily at the same time, with or without food, making it convenient compared to intravenous chemotherapy
- Watch for lung problems: Interstitial lung disease (ILD) is a rare but potentially life-threatening side effect – report any new or worsening shortness of breath, cough, or fever immediately
- Common skin and GI effects: Diarrhoea, acne-like skin rash, nausea, and loss of appetite are very common but usually manageable with supportive care
- Avoid during pregnancy and breastfeeding: Gefitinib may harm the unborn baby; effective contraception is required during treatment, and breastfeeding must be stopped
What Is Gefitinib Accord and What Is It Used For?
Gefitinib Accord contains the active substance gefitinib, which belongs to a class of cancer medicines called EGFR tyrosine kinase inhibitors. It is used to treat adults with non-small cell lung cancer (NSCLC) that has specific activating mutations in the epidermal growth factor receptor (EGFR) gene.
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 80–85% of all lung cancer diagnoses worldwide. Within this broad category, a subset of patients – approximately 10–15% in Western populations and up to 40–50% in East Asian populations – harbour activating mutations in the epidermal growth factor receptor (EGFR) gene. These mutations cause the EGFR protein to become permanently switched on, driving uncontrolled cell growth, survival, and tumour progression.
Gefitinib works by selectively blocking the EGFR tyrosine kinase. It does this by binding to the ATP-binding site of the EGFR protein, thereby preventing the receptor from sending growth signals to the cancer cell. When the EGFR signalling pathway is blocked, cancer cell proliferation slows or stops, and in many cases the tumour shrinks significantly. This targeted mechanism of action means that gefitinib is most effective in patients whose tumours are driven by specific EGFR mutations, particularly exon 19 deletions and the exon 21 L858R point mutation, which together account for approximately 85–90% of all sensitising EGFR mutations.
Clinical trials have demonstrated that gefitinib offers significant benefits over traditional platinum-based chemotherapy in patients with EGFR-mutant NSCLC. The landmark IPASS trial (Iressa Pan-Asia Study) and subsequent studies such as WJTOG3405 and NEJ002 showed that gefitinib significantly improved progression-free survival and quality of life compared with carboplatin-paclitaxel chemotherapy in this molecularly selected patient population. Response rates with gefitinib in EGFR-mutant NSCLC typically range from 60–80%, compared with 30–40% with conventional chemotherapy.
Gefitinib Accord is a generic formulation of gefitinib, containing the same active substance and dose as the originator product. It has been approved by the European Medicines Agency (EMA) based on demonstrated bioequivalence, meaning it delivers the same amount of active substance to the body at the same rate as the reference product. The availability of generic formulations helps improve access to this important targeted therapy for patients with EGFR-mutant lung cancer.
Before starting treatment with gefitinib, your doctor will arrange a molecular test on your tumour tissue or blood (liquid biopsy) to confirm the presence of an activating EGFR mutation. This test is essential because gefitinib is only effective in tumours driven by these specific mutations. The most common testing methods include PCR-based assays and next-generation sequencing (NGS).
What Should You Know Before Taking Gefitinib Accord?
Before starting Gefitinib Accord, inform your doctor about all your medical conditions, particularly any history of lung problems or liver disease. Do not take this medicine if you are allergic to gefitinib or if you are breastfeeding.
Contraindications
You should not take Gefitinib Accord if any of the following apply:
- Allergy to gefitinib or any of the other ingredients in the tablet (including lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulphate, and magnesium stearate)
- Breastfeeding – you must stop breastfeeding before starting gefitinib treatment, as the drug may pass into breast milk and harm the nursing infant
Warnings and Precautions
Talk to your doctor, pharmacist, or nurse before taking Gefitinib Accord if you have or have had any of the following conditions:
- Lung problems (other than your cancer) – some lung conditions, including pulmonary fibrosis and prior radiation pneumonitis, may increase the risk of developing interstitial lung disease (ILD) during gefitinib treatment. ILD has been reported in approximately 1% of patients and can be fatal. Your doctor should be contacted immediately if you develop new or worsening shortness of breath, cough, or fever
- Liver disease – gefitinib is extensively metabolised by the liver. Pre-existing hepatic impairment may lead to higher drug levels and increased risk of liver-related side effects. Your doctor will monitor your liver function with regular blood tests during treatment
During treatment with gefitinib, your doctor will perform regular monitoring, including liver function tests (ALT, AST, bilirubin) and assessment of your kidney function. It is important to attend all scheduled blood test appointments to ensure any changes are detected and managed early.
Children and Adolescents
Gefitinib Accord is not intended for use in children and adolescents under 18 years of age. The safety and efficacy of gefitinib have not been established in the paediatric population, and there is no relevant indication for its use in this age group.
Pregnancy and Breastfeeding
Gefitinib Accord should not be used during pregnancy unless clearly necessary and the potential benefit justifies the potential risk to the foetus. Based on its mechanism of action and preclinical data, gefitinib may cause harm to the developing baby. Women of childbearing potential should use effective contraception during treatment and for at least one month after the last dose.
If you become pregnant while taking Gefitinib Accord, inform your doctor immediately. Your oncologist will discuss the risks and benefits with you and help determine the most appropriate course of action, which may include discontinuation of the drug if alternatives are available.
Breastfeeding is contraindicated during treatment with Gefitinib Accord. It is not known whether gefitinib or its metabolites are excreted in human breast milk, but based on the pharmacological properties of the drug, a risk to the breastfed infant cannot be excluded. You must stop breastfeeding before starting treatment.
Driving and Operating Machinery
Gefitinib may cause weakness (asthenia) and visual disturbances in some patients. If you experience these effects, you should exercise caution when driving or operating machinery. You are personally responsible for assessing whether you are fit to drive or perform tasks that require alertness. The effects of the medication – including side effects – should be considered alongside other factors that may impair your ability. Consult your doctor or pharmacist if you are unsure.
Important Information About Ingredients
Gefitinib Accord tablets contain lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. The tablets also contain sodium, but less than 1 mmol (23 mg) per dose, meaning they are essentially sodium-free.
How Does Gefitinib Accord Interact with Other Drugs?
Gefitinib can interact with several important medications, including certain anti-epileptics, antibiotics, antifungals, acid-reducing drugs, and blood thinners. Always tell your doctor about all medications you are taking, including herbal supplements and over-the-counter products.
Gefitinib is primarily metabolised in the liver by the cytochrome P450 enzyme CYP3A4. Consequently, drugs that inhibit or induce CYP3A4 can significantly affect gefitinib blood levels. Additionally, drugs that alter gastric pH can reduce the absorption of gefitinib, as the drug requires an acidic environment for optimal dissolution and absorption. The following tables summarise the most clinically important interactions.
Major Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Rifampicin | Antibiotic (TB treatment) | Strong CYP3A4 inducer that reduces gefitinib plasma concentrations by up to 83%, potentially eliminating its anticancer effect | Avoid concurrent use; if unavoidable, consider increasing gefitinib dose to 500 mg/day under close monitoring |
| Phenytoin | Anti-epileptic | Strong CYP3A4 inducer that significantly decreases gefitinib levels | Avoid concurrent use; alternative anti-epileptics should be considered |
| Carbamazepine | Anti-epileptic | Strong CYP3A4 inducer that reduces gefitinib effectiveness | Avoid concurrent use; consider levetiracetam or valproate as alternatives |
| Warfarin | Anticoagulant | Gefitinib may increase the anticoagulant effect and risk of bleeding, including elevated INR | Monitor INR frequently; dose adjustment of warfarin may be required |
Moderate Interactions
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Itraconazole | Antifungal | CYP3A4 inhibitor that increases gefitinib blood levels by approximately 80% | Use with caution; monitor closely for increased side effects |
| Proton pump inhibitors (omeprazole, esomeprazole, etc.) | Acid-reducing agents | Sustained increase in gastric pH reduces gefitinib absorption and blood levels | Avoid concurrent use if possible; consider H2 antagonists with appropriate timing instead |
| H2 receptor antagonists (ranitidine, famotidine) | Acid-reducing agents | Increase gastric pH and reduce gefitinib absorption | Take gefitinib 6 hours after or 6 hours before the H2 antagonist |
| Antacids (aluminium/magnesium hydroxide) | Acid-neutralising agents | Temporarily increase gastric pH, reducing gefitinib absorption | Do not take antacids within 2 hours before or 1 hour after gefitinib |
| Barbiturates | Sedatives/anti-epileptics | CYP3A4 inducers that may reduce gefitinib effectiveness | Avoid concurrent use if possible; consider alternatives |
| St. John’s Wort (Hypericum perforatum) | Herbal supplement | CYP3A4 inducer that may significantly reduce gefitinib levels | Do not use St. John’s Wort during gefitinib treatment |
It is essential that you inform your doctor about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Your oncology team will review potential interactions and adjust your treatment plan as needed. Never start or stop any medication without first consulting your doctor.
What Is the Correct Dosage of Gefitinib Accord?
The recommended dose is one 250 mg tablet taken once daily at approximately the same time each day, with or without food. The tablet can be dissolved in water for patients who have difficulty swallowing.
Always take Gefitinib Accord exactly as your doctor has instructed. Do not change your dose or stop taking the medication without consulting your oncologist first. Gefitinib is a long-term treatment that is continued for as long as it continues to control your cancer and you do not experience unacceptable side effects.
Adults
EGFR-Mutant Non-Small Cell Lung Cancer
Standard dose: 250 mg (one tablet) once daily
Administration: Take at approximately the same time each day, with or without food
Duration: Continue treatment until disease progression or unacceptable toxicity, as determined by your oncologist
If you are also taking a strong CYP3A4 inducer (such as rifampicin or phenytoin) and your doctor has determined this cannot be avoided, the dose may be increased to 500 mg daily under close medical supervision. When the inducer is stopped, the gefitinib dose should be reduced back to 250 mg daily.
Children and Adolescents
Not Recommended
Gefitinib Accord is not intended for use in patients under 18 years of age. There is no relevant indication for gefitinib in the paediatric population, and safety and efficacy have not been established in this age group.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. Clinical trial data have shown that gefitinib has a similar safety and efficacy profile in patients over 65 years as in younger adults. However, elderly patients may be more susceptible to certain side effects such as interstitial lung disease, and close monitoring is warranted. Your oncologist will determine the most appropriate approach based on your overall health status and any other medications you are taking.
Difficulty Swallowing the Tablet
If you have difficulty swallowing the tablet whole, you can disperse it in half a glass of still (non-carbonated) water. Do not use any other liquid. Do not crush the tablet. Gently swirl the glass until the tablet has dispersed – this may take up to 20 minutes. Drink the liquid immediately once the tablet is fully dispersed. Rinse the glass thoroughly with another half glass of water and drink the rinse to ensure you receive the complete dose. The dispersed solution can also be administered through a nasogastric tube if needed.
Do not take antacids (medicines that reduce stomach acid) within 2 hours before or 1 hour after taking Gefitinib Accord. Antacids raise the pH in your stomach, which can significantly reduce the absorption of gefitinib and may decrease its effectiveness against your cancer.
Missed Dose
What you should do if you miss a dose depends on how long it is until your next scheduled dose:
- 12 hours or more until your next dose: Take the missed tablet as soon as you remember, then take your next dose at the usual time
- Less than 12 hours until your next dose: Skip the missed dose and take your next dose at the usual time
Do not take a double dose (two tablets at the same time) to make up for a missed dose. If you frequently forget your doses, consider setting a daily alarm or associating your tablet with a fixed daily routine.
Overdose
If you take more Gefitinib Accord than prescribed, or if a child accidentally ingests the medication, contact your doctor, hospital, or poison control centre immediately for assessment and advice. The most commonly reported adverse reactions associated with overdose include diarrhoea and skin rash. There is no specific antidote for gefitinib overdose; treatment is supportive and symptomatic. Your medical team will monitor you closely and manage any symptoms that arise.
What Are the Side Effects of Gefitinib Accord?
The most common side effects of Gefitinib Accord include diarrhoea, skin reactions (acne-like rash), nausea, vomiting, loss of appetite, weakness, mouth sores, and elevated liver enzymes. Serious but less common effects include interstitial lung disease and severe skin reactions.
Like all medicines, Gefitinib Accord can cause side effects, although not everybody gets them. The frequency and severity of side effects vary between individuals and may change over the course of treatment. It is important to report any new or worsening symptoms to your oncology team promptly, as some side effects require immediate medical intervention while others can be managed with supportive care.
- Allergic reaction – swelling of the face, lips, tongue, or throat, difficulty swallowing, hives, or difficulty breathing
- Severe shortness of breath or sudden worsening of breathlessness, possibly with cough and fever – this may indicate interstitial lung disease (ILD), which affects about 1 in 100 patients and can be life-threatening
- Severe skin reactions affecting large areas of the body – redness, pain, ulcers, blisters, or peeling of the skin; lips, nose, eyes, and genitals may also be affected
- Signs of dehydration caused by prolonged or severe diarrhoea, vomiting, nausea, or loss of appetite
- Eye problems – pain, redness, watery eyes, light sensitivity, or vision changes, which may indicate a corneal ulcer
Very Common
May affect more than 1 in 10 people
- Diarrhoea
- Vomiting
- Nausea
- Skin reactions (acne-like rash, sometimes with itching, dry and/or cracked skin)
- Loss of appetite (anorexia)
- Weakness (asthenia)
- Red or sore mouth (stomatitis)
- Elevated alanine aminotransferase (ALT) in blood tests – if levels are too high, your doctor may ask you to stop treatment
Common
May affect up to 1 in 10 people
- Dry mouth
- Dry, red, or itchy eyes
- Red and sore eyelids
- Nail disorders (e.g., paronychia, brittle nails)
- Hair loss (alopecia)
- Fever (pyrexia)
- Bleeding (e.g., nosebleeds or blood in urine)
- Protein in the urine (proteinuria)
- Elevated bilirubin and aspartate aminotransferase (AST) in blood tests
- Increased creatinine levels (indicator of kidney function)
- Cystitis (burning sensation when urinating, frequent and urgent need to urinate)
Uncommon
May affect up to 1 in 100 people
- Interstitial lung disease (ILD) – inflammation of the lungs, which can be life-threatening; characterised by severe shortness of breath, cough, and fever
- Pancreatitis – severe pain in the upper abdomen with intense nausea and vomiting
- Hepatitis (liver inflammation) – symptoms may include general malaise with or without jaundice (yellowing of the skin and whites of the eyes); in some cases this has been fatal
- Gastrointestinal perforation (hole in the digestive tract)
- Palmar-plantar erythrodysaesthesia (hand-foot syndrome) – tingling, numbness, pain, swelling, or redness on the palms and soles
Rare
May affect up to 1 in 1,000 people
- Cutaneous vasculitis – inflammation of blood vessels in the skin, appearing as bruises or patches of non-blanching rash
- Haemorrhagic cystitis – burning sensation when urinating with frequent, urgent need to urinate and blood in the urine
If you experience any side effects, including any not listed above, tell your doctor, pharmacist, or nurse. Your oncology team can provide advice on managing side effects and may adjust your treatment if necessary. Reporting side effects also helps the ongoing monitoring of the medicine’s benefit-risk balance.
How Should You Store Gefitinib Accord?
Store Gefitinib Accord out of the sight and reach of children. No special storage conditions are required. Do not use this medicine after the expiry date printed on the packaging.
Keep this medicine out of the sight and reach of children. Store in the original packaging to protect from moisture and light. There are no special temperature requirements for storing Gefitinib Accord – it can be kept at room temperature.
Do not use this medicine after the expiry date stated on the carton and blister packaging after “EXP”. The expiry date refers to the last day of that month. If you have dispersed a tablet in water, the resulting solution should be used within 90 minutes. Do not save the dispersed solution for later use.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment and prevent accidental exposure to others.
What Does Gefitinib Accord Contain?
Each Gefitinib Accord tablet contains 250 mg of the active substance gefitinib, along with inactive ingredients including lactose monohydrate, microcrystalline cellulose, and various film-coating components.
The active substance is gefitinib. Each film-coated tablet contains 250 mg of gefitinib.
The other ingredients (excipients) are:
- Tablet core: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulphate, magnesium stearate
- Film coating: Poly(vinyl alcohol), macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172)
Appearance: Gefitinib Accord 250 mg tablets are brown, film-coated, round, biconvex tablets debossed with “LP100” on one side and plain on the other. Each tablet has a diameter of approximately 11.13 mm.
Pack size: 30 × 1 tablets in PVC/PVDC-aluminium perforated unit dose blister packs, packed in a PET/aluminium pouch within a carton.
The marketing authorisation holder is Accord Healthcare B.V., Utrecht, Netherlands. The tablets are manufactured at several sites across Europe, including facilities in Barcelona (Spain), Budapest (Hungary), and Paola (Malta), ensuring reliable supply and quality control in compliance with EU Good Manufacturing Practice (GMP) standards.
Frequently Asked Questions About Gefitinib Accord
Gefitinib Accord is a generic version of the original branded product IRESSA. Both contain the same active substance (gefitinib 250 mg) and have been shown to be bioequivalent, meaning they deliver the same amount of drug to the body at the same rate. The European Medicines Agency (EMA) has approved Gefitinib Accord based on demonstrated bioequivalence studies. The main difference is typically the price, with generic formulations generally being more affordable than branded products.
Your doctor will order a molecular test on your tumour tissue (obtained through a biopsy) or blood sample (liquid biopsy). These tests analyse the DNA of your cancer cells to identify specific mutations in the EGFR gene. The most common sensitising mutations are exon 19 deletions and the exon 21 L858R point mutation. Results typically take 1–2 weeks. This testing is now considered standard of care for all patients diagnosed with advanced non-small cell lung cancer, regardless of smoking history.
Yes, Gefitinib Accord can be taken with or without food. Food does not significantly affect the absorption of gefitinib. However, it is important to take it at approximately the same time each day for consistent blood levels. Remember to avoid antacids within 2 hours before or 1 hour after taking the tablet, as they can reduce absorption.
Skin rash is one of the most common side effects of gefitinib and typically appears within the first few weeks of treatment. The rash is usually acne-like and may affect the face, chest, and back. In many cases, the development of a skin rash is associated with a better treatment response. Your doctor may recommend topical treatments (such as antibiotic creams or moisturisers) and oral antibiotics (such as doxycycline) for management. Do not stop taking gefitinib without consulting your oncologist, as the rash can usually be managed effectively. However, if you develop a severe skin reaction with blistering or peeling, seek immediate medical attention.
Gefitinib Accord is taken continuously for as long as it continues to control your cancer and you do not experience intolerable side effects. Treatment duration varies significantly between patients. Your oncologist will monitor your progress with regular imaging scans (typically every 2–3 months) and blood tests to assess how well the drug is working. If scans show that the cancer has progressed, your doctor will discuss the next steps, which may include switching to another targeted therapy or a different treatment approach. Never stop taking gefitinib on your own without consulting your medical team.
Interstitial lung disease (ILD) is a serious but uncommon side effect that affects approximately 1 in 100 patients taking gefitinib. Warning signs include: new or suddenly worsening shortness of breath that is not explained by your cancer, persistent dry cough, fever, and a general feeling of being unwell. These symptoms can develop at any time during treatment. If you experience any of these symptoms, stop taking gefitinib and contact your doctor or go to a hospital immediately. Early diagnosis and treatment of ILD are essential, as the condition can be fatal if not promptly managed.
References
This article is based on the following evidence-based sources. All medical claims are supported by peer-reviewed research, regulatory documents, and international clinical guidelines.
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- World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd List. Geneva: WHO; 2023.
- U.S. Food and Drug Administration (FDA). IRESSA (gefitinib) Prescribing Information. Reference ID: 4760397.
- Sequist LV, Waltman BA, Dias-Santagata D, et al. Genotypic and histological evolution of lung cancers acquiring resistance to EGFR inhibitors. Sci Transl Med. 2011;3(75):75ra26. doi:10.1126/scitranslmed.3002003
- Kudoh S, Kato H, Nishiwaki Y, et al. Interstitial lung disease in Japanese patients with lung cancer: a cohort and nested case-control study. Am J Respir Crit Care Med. 2008;177(12):1348–1357. doi:10.1164/rccm.200710-1501OC
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This article has been developed and reviewed by licensed physicians specialising in oncology, respiratory medicine, and clinical pharmacology. Our editorial team follows international best-practice guidelines including ESMO, NCCN, and WHO recommendations. All content is evidence-based and regularly updated to reflect the latest medical research and regulatory information.
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