Osimert 80 mg (Generic Osimertinib) – Everest Pharmaceuticals

Medically Reviewed by: Dr. Daria Kwaśniewska

Last Updated: April 12, 2026

Name: Osimert

Generic Availability: Osimertinib

Strength: 80 mg

Classification: Prescription Only Medicine

Indication: T790M mutation non-small cell lung cancer

  • Medically Reviewes by Dr. Daria Kwaśniewska
  • WHO-GMP standards
  • Instant Online Verification

Description

DK
Dr. Daria Kwaśniewska ESMO Certified Consultant Medical Oncologist
Reviewed June 2026
⚠ Prescription required. For informational purposes only. Meds For Cancer is a Named Patient Program facilitator — not a retail pharmacy. A valid oncologist prescription is mandatory before any order is processed.

Is Osimert 80 mg right for your situation?

Review these criteria with your oncologist before enquiring
✔ You may be a candidate if
  • Confirmed EGFR-mutated NSCLC (exon 19 deletion or L858R) on molecular testing
  • EGFR T790M-positive disease after progression on an earlier EGFR inhibitor
  • Need a WHO-GMP generic alternative to Tagrisso® (AstraZeneca)
  • Hold a valid oncologist prescription
✖ May NOT be suitable if
  • No confirmed EGFR mutation (biomarker testing is mandatory before starting)
  • Severe pre-existing interstitial lung disease
  • Pregnant, planning pregnancy, or breastfeeding
  • Significant uncontrolled cardiac arrhythmia or QTc prolongation

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What is Osimert 80 mg?

Osimert 80 mg is a generic formulation of Osimertinib — a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) — manufactured by Everest Pharmaceuticals Ltd. under WHO-GMP certified conditions in Bangladesh. Each tablet contains 80 mg of osimertinib, the same active molecule found in Tagrisso® (AstraZeneca), and is dispensed under the Named Patient Program for patients requiring a quality-assured, affordable alternative.

Osimertinib is uniquely effective both as a first-line treatment for EGFR-mutated NSCLC and as a second-line treatment after resistance to earlier-generation EGFR inhibitors via the T790M mutation. It also has the strongest CNS penetration of any approved EGFR inhibitor.

Generic nameOsimertinib
Reference brandTagrisso® (AstraZeneca)
ManufacturerEverest Pharmaceuticals Ltd.
StandardWHO-GMP Certified
Drug classEGFR Inhibitor (3rd generation, irreversible)
Dosage formTablet — 80 mg
Pack size30 tablets per pack
RouteOral · once daily
PrescriptionRequired — oncologist only

How Osimertinib Works

In EGFR-mutated NSCLC, mutations such as exon 19 deletions or L858R cause the EGFR receptor to become permanently switched on, driving uncontrolled tumour growth. Osimertinib selectively and irreversibly binds to mutant EGFR, including the T790M resistance mutation that commonly emerges after treatment with first- or second-generation EGFR inhibitors.

Osimertinib was engineered specifically to spare wild-type (normal) EGFR while potently inhibiting mutant EGFR — this selectivity reduces skin and gastrointestinal toxicity compared to earlier EGFR inhibitors. It also crosses the blood-brain barrier more effectively than any other approved EGFR TKI, making it especially valuable for patients with CNS metastases. In the FLAURA trial, frontline osimertinib reduced the risk of disease progression or death by 54% versus first-generation EGFR inhibitors. NCCN guidelines list osimertinib as a Category 1 preferred agent for both first-line and T790M-positive EGFR-mutated NSCLC. View NCCN NSCLC Guidelines →

What to Expect: First 30 Days

Osimertinib is generally one of the better-tolerated targeted therapies, with a milder side-effect profile than earlier EGFR inhibitors. Most patients adjust well within the first month.

  • Week 1: Many patients feel relatively normal initially, though mild fatigue is common as your body adjusts to the new daily dose.
  • Weeks 2–3: Skin changes — dry skin or a mild acne-like rash — commonly emerge during this window, along with a possible mild decrease in appetite. These are usually manageable with supportive skin care.
  • Week 4: Your body has generally adjusted to the routine by now. Your oncologist will typically schedule a check-in to review side effects and discuss early imaging to assess response.

Side Effects

Osimertinib is generally well-tolerated, with most side effects mild and manageable. Always report new or worsening symptoms to your oncologist promptly.

Common · Usually Manageable

  • Dry skin or acne-like rash
  • Diarrhoea
  • Nail changes (brittle or inflamed)
  • Mouth sores
  • Fatigue
  • Decreased appetite
  • Low blood cell counts

Serious · Report Immediately

  • Interstitial lung disease / pneumonitis
  • QTc prolongation (heart rhythm changes)
  • Cardiomyopathy / heart failure
  • Keratitis (eye inflammation)
  • Severe skin reactions
⚠ Call your doctor immediately if you experience:
  • New or worsening breathlessness, cough, or fever (possible pneumonitis)
  • Severe, watery diarrhoea that doesn’t stop
  • Eye pain, redness, or vision changes

How to Take Osimert 80 mg

Standard dose: 1 tablet (80 mg) once daily, with or without food.

  • 1
    Once daily at the same time — consistency improves steady-state drug levels.
  • 2
    Swallow tablet whole with a glass of water. Do not chew or crush.
  • 3
    If swallowing is difficult: drop the tablet into a small glass of plain (non-carbonated) water — do not crush or chew it — stir until it disperses, then drink immediately. Rinse the glass with a little more water and drink that too, to ensure the full dose is taken.
  • 4
    Never stop without your oncologist’s instruction — discontinuing without guidance risks rapid disease progression.
  • 5
    Storage: below 30°C, protected from moisture and light, out of reach of children.

Caregiver Guidance

  • Track side effects in a simple journal — especially skin rashes and diarrhoea — so you can report them accurately at appointments.
  • Monitor breathing closely — pay attention to any new shortness of breath or persistent cough and contact the oncologist if you notice changes.
  • Support daily adherence — set a phone alarm or use a pill organiser to make sure a dose is never missed.

If the Medicine Stops Working

Over time, EGFR-mutated cancer cells can develop resistance to osimertinib through several mechanisms, including the C797S mutation, MET amplification, or transformation to small cell lung cancer histology. If disease progression is detected on routine scans, your oncologist will typically order a repeat biopsy or liquid biopsy to characterise the resistance mechanism, then determine the next-line strategy — which may include chemotherapy, a clinical trial, or combination targeted therapy depending on the specific resistance pattern identified.

Frequently Asked Questions

Do I need any tests before starting Osimert?
Yes. Osimertinib is only used when a confirmed EGFR mutation is present, identified through a molecular test on tumour tissue or a blood-based liquid biopsy. If you are being considered as second-line treatment after a different EGFR inhibitor, your oncologist will also test specifically for the T790M resistance mutation.
Can Osimert treat brain metastases?
Yes — osimertinib has the strongest CNS penetration of any approved EGFR inhibitor. It crosses the blood-brain barrier effectively and has demonstrated significant activity against brain metastases, which are common in EGFR-mutated NSCLC.
How long do I need to take Osimert?
You will generally take osimertinib continuously for as long as it controls your cancer and side effects remain manageable. Many patients remain on treatment for a year or more. Your oncologist will reassess your response regularly through imaging.
Can I stop if my scans look clear and I feel well?
No, you should never stop taking osimertinib without your oncologist’s explicit approval. Stopping treatment, even if scans look clear, can allow the cancer to rebound quickly because the medication is suppressing rather than eliminating the cancer cells.
Is hair loss common with Osimert?
No. Unlike traditional chemotherapy, complete hair loss is rare with osimertinib, though some patients notice mild hair thinning. This is one of the notable quality-of-life advantages of targeted therapy over conventional chemotherapy.
Can I take Osimert with my other medications?
Osimertinib can interact with certain medications, including some heart rhythm drugs (due to QTc prolongation risk) and strong CYP3A4 inducers/inhibitors. Always provide your oncologist and pharmacist with a complete list of everything you currently take, including over-the-counter medicines and supplements.
🛡 Named Patient Program — Regulatory Framework

Meds For Cancer operates as a Named Patient Program (NPP) facilitator. Under this framework, WHO-GMP certified medicines are made available to individual patients with a confirmed medical need and a valid oncologist prescription, in countries where the branded product is unavailable or unaffordable.

This service does not constitute retail pharmacy dispensing. A prescription review is mandatory before any order is processed.

Clinical References
  • Soria JC, et al. Osimertinib in untreated EGFR-mutated advanced NSCLC (FLAURA). NEJM 2018;378:113–125.
  • Mok TS, et al. Osimertinib or platinum–pemetrexed in EGFR T790M-positive lung cancer (AURA3). NEJM 2017;376:629–640.
  • NCCN Clinical Practice Guidelines in Oncology: NSCLC. V5.2026.
  • Ramalingam SS, et al. Overall survival with osimertinib in untreated EGFR-mutated advanced NSCLC. NEJM 2020;382:41–50.

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