Osimertinib 80 mg

Disclaimer: Before purchasing any medicine, always verify whether there is a valid drug license.

Osimertinib 80 mg is an oral anticancer medicine containing osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). It is used in selected patients with EGFR-mutated non-small cell lung cancer (NSCLC). Osimertinib is designed to selectively inhibit certain activating EGFR mutations and the EGFR T790M resistance mutation while having activity against wild-type EGFR at clinically relevant exposures.

The established originator/reference brand for osimertinib is TAGRISSO, developed by AstraZeneca. AstraZeneca discovered and developed osimertinib and commercialized Tagrisso as the reference product. The U.S. Food and Drug Administration granted Tagrisso its initial approval in 2015, followed by European authorization in 2016.

Osimertinib 80 mg is also supplied under different brand names and by different manufacturers in various countries. A product containing osimertinib should not automatically be described as identical to Tagrisso solely because it contains the same active ingredient. Manufacturer, formulation, regulatory authorization, quality standards, packaging, and legal status may differ between products.

Everest Pharmaceuticals Ltd. About the Manufacturer

Everest Pharmaceuticals Ltd. is a pharmaceutical manufacturer based in Bangladesh. The company is involved in the development, production, and marketing of pharmaceutical products, including medicines used in specialized therapeutic areas.

Everest Pharmaceuticals focuses on manufacturing quality medicines for the healthcare market and offers a range of products, including treatments used in oncology and other medical fields. Its product portfolio includes various generic medicines formulated for patients and healthcare providers.

Company Name: Everest Pharmaceuticals Ltd.

Industry: Pharmaceutical Manufacturing

Country: Bangladesh

Business Activities: Manufacturing, marketing, and distribution of pharmaceutical products

Product Areas: Includes specialized and general pharmaceutical medicines

Quality Focus: Product manufacturing and quality-control processes are intended to support medicine quality, safety, and regulatory compliance.

For product-specific information, it is important to check the official packaging, product insert, batch details, and manufacturer information, as formulations and regulatory status may vary by product and market.

Head Office: Everest Pharmaceuticals Ltd. is located at Rahman’s Regnum Centre (10th & 11th floor), 191/1 Tejgaon Commercial Area, Dhaka-1208, Bangladesh.

Manufacturing Plant: Everest Pharmaceuticals Limited B-33, 45 & 46, BSCIC, Kanchpur, Narayanganj–1430, Bangladesh.

Topic	Information
Generic name	Osimertinib
Active substance	Osimertinib
Common salt form	Osimertinib mesylate
Stated strength	80 mg
Dosage form	Tablet
Route	Oral
Drug class	Third-generation EGFR tyrosine kinase inhibitor
Therapeutic area	Oncology
Main disease area	Non-small cell lung cancer
Key biomarker	EGFR mutation status
Reference/originator brand	TAGRISSO
Reference-product company	AstraZeneca
Specific generic manufacturer	Depends on the brand and market
Product-specific authorization	Should be verified against applicable regulatory documentation

Incepta Pharmaceuticals Ltd. About the Manufacturer

Incepta Pharmaceuticals Ltd. is one of Bangladesh’s leading pharmaceutical companies, established in 1999. The company is engaged in the research, development, manufacturing, and distribution of a broad range of pharmaceutical products for both the local and international markets.

Head Office

Incepta Pharmaceuticals Ltd.
40 Shahid Tajuddin Ahmed Sarani
Tejgaon I/A, Dhaka-1208
Bangladesh

About the Manufacturer of Tagrix 80 mg

Tagrix 80 mg (Osimertinib) is manufactured by Beacon Pharmaceuticals PLC, a pharmaceutical company based in Bangladesh. Established in 2006, Beacon has built a diverse portfolio of generic medicines, with a particular focus on oncology and other specialized treatments.

The company operates dedicated manufacturing facilities for oncology products and produces a range of medicines, including conventional chemotherapy agents, targeted therapies, and immunotherapy products. Its manufacturing operations are designed around pharmaceutical quality standards and Good Manufacturing Practice (GMP) requirements.

According to the manufacturer’s product information, Tagrix 80 mg contains osimertinib 80 mg and is supplied as a tablet. The product forms part of Beacon’s oncology portfolio and was developed as a generic version of osimertinib.

• Manufacturer: Beacon Pharmaceuticals PLC
• Country: Bangladesh
• Product: Tagrix 80 mg
• Active Ingredient: Osimertinib
• Strength: 80 mg
• Dosage Form: Tablet
• Manufacturing Location: Mymensingh, Bangladesh
• Business Address: Beacon Pharmaceuticals PLC Business Centre, 9/B/2 Toyenbee Circular Road, Motijheel, Dhaka-1223, Bangladesh

Beacon’s oncology-focused manufacturing capabilities support its production of specialized medicines such as Tagrix 80 mg for patients and markets in Bangladesh and internationally.

Osimert 80 mg (Osimertinib)

Osimert 80 mg contains osimertinib, a targeted anticancer medicine in the EGFR tyrosine kinase inhibitor (TKI) class. It is primarily used for certain forms of EGFR mutation-positive non-small cell lung cancer (NSCLC). Treatment selection depends on the tumor’s EGFR mutation status confirmed through appropriate testing.

Osicent 80 mg (Osimertinib)

Incepta Pharmaceuticals Ltd.’s Osicent 80 mg is a prescription tablet containing osimertinib, a targeted anticancer medicine known as an EGFR tyrosine kinase inhibitor (TKI). Incepta’s product information confirms that each Osicent 80 tablet contains 80 mg of osimertinib equivalent.

Tagrix 80 mg (Osimertinib)

Tagrix 80 mg is a prescription oncology medicine containing osimertinib, an EGFR tyrosine kinase inhibitor. It is manufactured by Beacon Pharmaceuticals Limited, Bangladesh. Beacon lists Tagrix 80 mg as a film-coated tablet containing osimertinib mesylate equivalent to 80 mg of osimertinib.

What is osimertinib?

Osimertinib is a targeted oral anticancer medicine belonging to the EGFR tyrosine kinase inhibitor class. EGFR is a receptor involved in signaling pathways that regulate cell growth and survival. Certain EGFR gene mutations can cause persistent signaling that contributes to the development and progression of NSCLC.

Osimertinib irreversibly inhibits selected mutant forms of EGFR, including common sensitizing mutations and the T790M resistance mutation. This targeted mechanism distinguishes osimertinib from conventional cytotoxic chemotherapy.

What is osimertinib 80 mg used for?

Osimertinib is used in specific EGFR-mutated NSCLC treatment settings. Depending on the applicable regulatory labeling, it may be used for:

• Certain patients with locally advanced or metastatic NSCLC whose tumors contain EGFR exon 19 deletions or exon 21 L858R substitutions.

• Patients with EGFR T790M-positive advanced NSCLC following previous EGFR-directed treatment, where this indication remains applicable under the relevant local authorization.

• Selected patients with EGFR-mutated NSCLC in the postoperative/adjuvant setting.

• Selected patients with unresectable, stage III EGFR-mutated NSCLC following definitive platinum-based chemoradiotherapy, where approved by the applicable regulator.

The exact indication depends on the country, regulatory authority, disease stage, prior treatment and EGFR mutation status. Therefore, information approved in one jurisdiction should not automatically be assumed to apply in another.

Why EGFR testing is important

Osimertinib is a biomarker-directed therapy. Treatment selection depends on identifying an appropriate EGFR alteration using a validated diagnostic test.

Common clinically relevant EGFR alterations include:

• Exon 19 deletions

• Exon 21 L858R substitutions

• EGFR T790M, particularly in previously treated disease where the applicable indication includes this resistance mutation

Testing should be performed using an appropriate tumor or other validated specimen according to the relevant diagnostic and regulatory requirements.

How does osimertinib work?

EGFR is a receptor tyrosine kinase located on the surface of cells. When activated by appropriate signals, EGFR can trigger intracellular pathways involved in proliferation, survival and other cellular functions.

Some EGFR mutations cause abnormal or excessive EGFR signaling. Osimertinib forms an irreversible covalent interaction with susceptible mutant EGFR proteins, inhibiting their kinase activity.

Its activity includes important EGFR alterations such as:

• EGFR exon 19 deletions

• EGFR exon 21 L858R

• EGFR T790M

By inhibiting mutant EGFR signaling, osimertinib can interfere with molecular pathways that support the growth and survival of EGFR-mutated cancer cells.

Osimertinib and EGFR T790M

The T790M mutation became clinically important because it can produce resistance to earlier-generation EGFR TKIs.

Osimertinib was specifically developed to address mutant EGFR signaling, including T790M-mediated resistance. Its development therefore represented an important advance in targeted treatment for patients whose EGFR-mutated NSCLC had developed this resistance mechanism.

The relevance of T790M testing depends on the treatment setting and the current regulatory indication in the applicable jurisdiction.

Originator and Reference Product

The established originator/reference brand for osimertinib is TAGRISSO, developed by AstraZeneca.

AstraZeneca was responsible for the discovery and development of osimertinib and subsequently developed Tagrisso as the reference medicinal product. Tagrisso received its initial U.S. approval in 2015, establishing the medicine as an important targeted treatment for selected EGFR-mutated NSCLC.

The European Union subsequently authorized Tagrisso in 2016.

Reference-product distinction

It is important to distinguish between:

• Originator/developer: AstraZeneca, which discovered and developed osimertinib.

• Reference product: Tagrisso.

• Generic or alternative product: A later product containing osimertinib that may be manufactured by another company.

• Manufacturer: The company responsible for manufacturing the particular product.

• Marketing authorization holder: The entity legally responsible for the medicinal-product authorization in a particular jurisdiction.

• Distributor: A company involved in commercial distribution.

A generic osimertinib product should not be represented as Tagrisso unless its regulatory and commercial documentation specifically establishes that relationship.

Osimertinib 80 mg dosage

The 80 mg once-daily regimen is an established osimertinib dose for several labeled treatment settings. However, the appropriate regimen depends on the specific indication, treatment setting, patient characteristics and local prescribing information.

Treatment may require modification or interruption when clinically significant adverse reactions occur.

Patients should not increase, decrease, discontinue or restart osimertinib without instructions from their treating healthcare professional.

How is osimertinib taken?

Osimertinib is administered orally.

General administration principles include:

• Take the medicine exactly as prescribed.

• Take it once daily when an 80 mg once-daily regimen has been prescribed.

• Try to take it at approximately the same time each day.

• The tablet may generally be taken with or without food under established product labeling.

• Swallow the tablet according to the instructions supplied with the specific product.

• Do not change the dose independently.

The instructions accompanying the particular product should always be followed because formulations and regulatory labeling can vary.

Missed dose

If a dose is missed, patients should follow the instructions in the applicable prescribing information or contact their healthcare professional or pharmacist.

A missed dose should not normally be replaced by taking an additional dose unless specifically instructed by a healthcare professional.

Common side effects

Osimertinib can cause adverse reactions. Frequently reported reactions can include:

• Diarrhea

• Rash

• Dry skin

• Nail-related changes

• Decreased appetite

• Stomatitis

• Musculoskeletal pain

• Fatigue

• Cough

• Pruritus

The frequency and severity of adverse reactions can differ according to the treatment setting and individual patient factors.

Important and serious safety risks

Osimertinib has several clinically important safety considerations.

Interstitial lung disease and pneumonitis

Osimertinib can cause interstitial lung disease (ILD) or pneumonitis, which may be serious or life-threatening.

New or worsening respiratory symptoms, including:

• Shortness of breath

• Cough

• Fever

• Difficulty breathing

should be promptly discussed with a healthcare professional.

QTc interval prolongation

Osimertinib can prolong the QTc interval and may increase the risk of cardiac rhythm abnormalities in susceptible patients.

Healthcare professionals may consider ECG and electrolyte monitoring in patients with relevant risk factors.

Cardiomyopathy

Reduced left ventricular ejection fraction and other forms of cardiac dysfunction have been reported.

Patients with cardiac risk factors may require appropriate cardiac assessment and monitoring during treatment.

Keratitis and ocular effects

Eye-related adverse reactions can occur. Patients experiencing significant eye pain, redness, visual changes or other concerning ocular symptoms should seek medical assessment.

Skin and nail reactions

Rash, dry skin and nail toxicity are recognized adverse effects associated with osimertinib.

Diarrhea

Diarrhea is among the commonly reported adverse reactions. Persistent or severe diarrhea can contribute to dehydration and may require medical management.

Drug interactions

Osimertinib can interact with other medicines.

Particular attention may be required with medicines that:

• Strongly induce or inhibit relevant metabolic pathways.

• Prolong the QT interval.

• Affect cardiac rhythm.

• Alter electrolyte balance.

Patients should provide their healthcare professional with a complete list of prescription medicines, nonprescription medicines, supplements and herbal products before starting treatment.

Pregnancy and reproductive considerations

Osimertinib may cause fetal harm based on its pharmacologic and toxicologic properties.

Pregnancy considerations should therefore be discussed with a qualified healthcare professional before treatment. Appropriate contraception and reproductive counseling may be recommended according to the applicable prescribing information.

Patients who become pregnant during treatment should promptly contact their treating healthcare professional.

Breastfeeding

The applicable product information should be consulted regarding breastfeeding. Patients should discuss breastfeeding decisions with their healthcare professional before and during osimertinib treatment.

Monitoring during treatment

Depending on the clinical situation, monitoring may include:

• EGFR mutation status before treatment when required

• Assessment of treatment response

• Respiratory symptoms

• Cardiac function

• ECG monitoring when clinically appropriate

• Electrolytes

• Skin and nail effects

• Gastrointestinal symptoms

• Ocular symptoms

• Other laboratory or clinical assessments indicated by the patient’s condition

Monitoring requirements can vary according to the treatment indication and individual patient risk factors.

Osimertinib versus conventional chemotherapy

Osimertinib is a targeted anticancer therapy, not conventional cytotoxic chemotherapy.

Its activity depends on the presence of susceptible EGFR alterations. This biomarker-driven approach allows treatment to be directed toward a molecular feature of the tumor.

However, targeted therapy can still cause significant adverse reactions because the molecular pathways affected by the medicine can also have roles in normal tissues.

Osimertinib and Tagrisso

Tagrisso is the established reference/originator brand associated with osimertinib.

An osimertinib 80 mg product from another manufacturer may contain the same active pharmaceutical ingredient but should be distinguished from Tagrisso unless regulatory documentation establishes equivalence or another specific relationship.

Important product-specific details include:

• Manufacturer

• Manufacturing site

• Dosage form

• Excipients

• Regulatory authorization

• Packaging

• Batch information

• Storage requirements

• Market authorization holder

These details should be verified using the actual product packaging and applicable regulatory documentation.

Product Verification

Osimertinib 80 mg Verification Steps

• Inspect the packaging: Check that the carton and blister packaging are intact and free from signs of tampering. Confirm the product name, strength, batch/lot number, and expiry date. Official product information identifies the batch number and expiry date as important pack details.
• Match batch and expiry details: Make sure the batch/lot number and expiry information on the outer carton correspond with the information on the inner packaging. Do not use the medicine if the packaging is damaged or appears tampered with.
• Verify with the manufacturer: Contact the pharmaceutical manufacturer or its authorized local representative using contact information from the manufacturer’s official website or product packaging. Provide the brand name, strength, batch/lot number, expiry date, and distributor information and ask whether they can authenticate the product.
• Buy from a licensed pharmacy: Obtain osimertinib only from a legitimate, licensed pharmacy or authorized medicine supplier. Osimertinib 80 mg is a prescription oncology medicine, so authentication should be treated separately from determining whether the medicine is appropriate for a particular patient.
• Ask a pharmacist or treating oncologist: If the packaging, batch information, or source seems unusual, do not rely on appearance alone. Ask a qualified pharmacist or your treating oncology team to help verify it before use.

Important: A batch number by itself does not establish that a medicine is genuine. If you suspect counterfeit or tampered osimertinib, avoid taking it until the product has been verified by an appropriate pharmaceutical professional or manufacturer.

Product Information

Product characteristic	Information
Product	Osimertinib 80 mg
Active ingredient	Osimertinib
Salt commonly used	Osimertinib mesylate
Strength	80 mg
Dosage form	Tablet
Route	Oral
Drug class	Third-generation EGFR TKI
Main therapeutic area	Oncology
Major disease area	EGFR-mutated NSCLC
Reference brand	TAGRISSO
Originator/developer	AstraZeneca
Initial U.S. approval of reference product	2015
Initial EU authorization of reference product	2016
Specific generic manufacturer	Requires product-specific verification
Product-specific regulatory status	Requires verification

Important Medical Disclaimer

Osimertinib is a prescription anticancer medicine and should be used only under appropriate medical supervision.

The information on this website is intended for general educational purposes and does not replace professional medical advice, diagnosis, prescribing information or individualized treatment planning.

Do not start, stop, increase or decrease osimertinib based solely on information published on a website. Treatment selection should take into account EGFR mutation status, cancer stage, previous treatment, other medicines, organ function and the applicable regulatory indication.

For authoritative treatment instructions, patients and healthcare professionals should consult the latest official prescribing information applicable to their country.

Michael R
The product information for Osimertinib 80 mg was clear and easy to understand. I especially appreciated the detailed explanation of EGFR mutations, dosage, possible side effects, and safety information.
David K
Very helpful information about osimertinib. The FAQ section answered many of the questions I had about how osimertinib works, T790M, EGFR testing, and the difference between generic osimertinib and Tagrisso.
David K
I found the information well organized and useful. The explanations about osimertinib 80 mg, available brands, treatment settings, and potential side effects made it much easier to understand the medicine.

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FAQs

How does osimertinib work?
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Osimertinib is an EGFR tyrosine kinase inhibitor that irreversibly blocks selected mutant EGFR proteins, helping inhibit abnormal signaling involved in the growth and survival of certain EGFR-mutated cancer cells.

How long does osimertinib stay in the body?
+

Osimertinib has an estimated mean plasma half-life of approximately 48 hours. Its relatively long half-life supports the standard once-daily dosing schedule.

Can osimertinib be used for EGFR-mutated lung cancer?
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Yes. Osimertinib is used in selected patients with EGFR-mutated non-small cell lung cancer (NSCLC). The appropriate treatment setting depends on the specific EGFR alteration, disease stage and previous treatment.

Can osimertinib be used after lung cancer surgery?
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Yes. Osimertinib may be used as adjuvant treatment after complete tumor resection in eligible patients whose NSCLC has certain EGFR mutations, including exon 19 deletions or exon 21 L858R mutations.

Can osimertinib be used for stage III NSCLC?
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Osimertinib is approved in certain settings for unresectable stage III EGFR-mutated NSCLC following concurrent or sequential platinum-based chemoradiation, depending on the applicable regulatory authorization.

Can osimertinib be used for metastatic NSCLC?
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Yes. Osimertinib is used for selected patients with advanced or metastatic NSCLC containing certain EGFR mutations. Treatment selection should be based on appropriate molecular testing and medical assessment.

Does osimertinib work against the EGFR T790M mutation?
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Yes. Osimertinib was developed to inhibit mutant EGFR, including the T790M resistance mutation that can occur after treatment with some earlier EGFR tyrosine kinase inhibitors.

Can osimertinib cause skin problems?
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Yes. Skin-related effects such as rash, dry skin and nail changes can occur during osimertinib treatment. Patients should discuss persistent or severe skin reactions with their healthcare professional.

Can osimertinib cause diarrhea?
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Yes. Diarrhea is a commonly reported adverse reaction with osimertinib. Persistent or severe diarrhea should be discussed with the treating healthcare professional because dehydration and other complications can occur.

Should osimertinib treatment be monitored by a doctor?
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Yes. Osimertinib is prescription cancer therapy and requires appropriate medical supervision. Monitoring may include assessment of treatment response, adverse reactions, heart function, lung symptoms and other factors according to the patient’s clinical situation.