Osimertinib
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Molecule Summary
| Uses | Non-Small Cell Lung Cancer |
| Therapy | Anti-Neoplastic |
| Side Effects | Diarrhoea, Rash, Dry Skin, Nail Changes |
Assurance
available
Regulated
Molecule Description
Osimertinib is an anticancer medicine. It is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It treats non-small cell lung cancer (NSCLC) whose tumours carry a specific EGFR gene mutation. It targets and slows cancer cell growth to help control disease spread.
Osimertinib is given orally as a tablet with or without food, as prescribed by the doctor. Common side effects include low blood cell count, low platelet count, diarrhea, dry skin, decreased appetite, rash, and itching, among others.
This is a prescription medicine and must be taken only on a doctor's advice.
Osimertinib is a prescription-only medicine and should be used strictly under medical supervision. The treatment plan is decided by the treating doctor based on the condition being treated, your body response and the other medicines you are receiving. Do not change, stop or repeat a dose on your own.
Before starting Osimertinib, tell your doctor about all your existing medical conditions, especially heart, liver or kidney problems, and about every medicine, vitamin, supplement and herbal product you take. Tell your doctor if you are pregnant, planning a pregnancy or breastfeeding. Regular blood tests and clinical check-ups are usually needed during treatment so that side effects are picked up early.
Uses
- Osimertinib as a monotherapy is Indicated For The Adjuvant Treatment After Complete Tumour Resection In Patients With Non-Small Cell Lung Cancer (Nsclc).
Contraindications
When should one not use Osimertinib
- If you are allergic to Osimertinib or any other ingredient of the medicine.
Side effects
Common side effects of this drug are:
- Common side effects may include:
- Low white blood cell counts
- Low platelet counts
- Diarrhoea
- Dry skin
- Rash
- Stomatitis (mouth sores or inflammation inside the mouth)
- Paronychia (inflammation around the nails)
- Decreased appetite
- Itching
- Serious side effects
- New or worsening cough, shortness of breath or fever: These may be signs of lung inflammation (interstitial lung disease or pneumonitis), which can be serious.
- Fast or irregular heartbeat, dizziness, light-headedness or fainting: These may be signs of a heart-rhythm problem.
- Shortness of breath, swelling of the ankles or legs, or unusual tiredness: These may be signs of reduced heart-pumping function.
- Eye pain, redness, blurred vision, sensitivity to light or excessive watering of the eyes: These may indicate an eye problem, including keratitis.
- Widespread rash, blistering or peeling of the skin, particularly with sores involving the mouth or eyes: Seek urgent medical attention because this may indicate a serious skin reaction.
- Fever, unusual bruising or bleeding, unusually pale skin, infection, tiredness or weakness: These may indicate a serious blood-cell problem, including aplastic anaemia.
Precautions and Warnings
Pregnancy
Breast Feeding
Driving
Alcohol
Other General Warnings
Talk to your doctor if
- If you have lung or breathing problems.
- If you have heart problems, including prolonged QTc or an abnormal heart rhythm.
- If you have abnormal electrolyte levels, such as low potassium, calcium or magnesium.
- If you have a history of eye problems.
- Tell your doctor about all medicines, vitamins, supplements and herbal products you are taking, particularly medicines that may affect the heart rhythm.
- Your doctor will arrange the appropriate EGFR mutation testing to confirm that osimertinib is suitable for your type of NSCLC before treatment.
- If you become pregnant while taking osimertinib.
- Report any new or worsening cough, shortness of breath or fever promptly.
- If you develop a fast or irregular heartbeat, dizziness or fainting.
- Report new eye pain, redness, blurred vision, sensitivity to light or excessive watering of the eyes.
- Seek urgent medical attention for widespread rash, blistering or peeling skin.
- Attend all blood tests and other monitoring appointments recommended by your doctor. ECG or heart-function monitoring may be required in patients with particular risk factors.
Mode of Action
How Does It Work?
Osimertinib contains osimertinib, which is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It blocks EGFR activity, which controls cancer cell growth and division.
Interactions
Interactions with other medicines
- Avoid using osimertinib with CYP3A inducer medicines may decrease osimertinib absorption.
- Avoid using osimertinib with breast cancer resistant protein (BCRP) or P-glycoprotein (P-gp) substrate as it can result in increased the exposure of the substrate compared to when used alone.
- Osimertinib may interact with other medicinal products as well hence, please share complete information with your doctor of all the medicines you are taking.
Interactions with food items
No specific food interactions have been established for Osimertinib. Follow any dietary advice given by your doctor or pharmacist during treatment.
Dosage
Overdose
In the event of an overdose, report to your doctor immediately.
Missed a Dose
Report to your doctor immediately. Do not take extra doses to compensate for missed doses.
Frequently Asked Questions (FAQs)
Articles
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References:
- DailyMed. Osimertinib prescribing information. 2026 [Cited 17th Sep 2026]
- electronic medicines compendium (emc). Osimertinib Summary of Product Characteristics. 2026 [Cited 17th Sep 2026]
- Central Drugs Standard Control Organisation (CDSCO). Drugs@CDSCO [Internet]. New Delhi: Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. 2026 [Cited 17th Sep 2026]
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