Osinib 80MG (Osimertinib)

Product Name : Osinib
Generic Name : Osimertinib
Formulation : Capsule
Available Pack Size : Box of 30 tablets
Available Strengths : 80mg
Registrations : Export Only

Product Information

Osinib (Osimertinib) 80mg is a third-generation, irreversible EGFR tyrosine kinase inhibitor (EGFR-TKI) used to treat EGFR mutation-positive Non-Small Cell Lung Cancer (NSCLC), including tumours with exon 19 deletions, exon 21 L858R mutations, and the T790M resistance mutation. It works by irreversibly binding to mutant EGFR proteins at concentrations roughly 9-fold lower than those needed to affect normal, wild-type EGFR, blocking the abnormal signalling that drives tumour cell growth while sparing healthy tissue to a greater extent than earlier-generation EGFR inhibitors. Manufactured by Drug International Ltd., Bangladesh and globally supplied by Mediaid Pharmacy with worldwide shipping.

Basic Product Information of Osinib (Osimertinib) 80mg

Brand Name Osinib (Osimertinib)
Generic Name Osimertinib (as Osimertinib Mesylate) INN, 80mg
Drug Class Third-Generation, Irreversible EGFR Tyrosine Kinase Inhibitor (EGFR-TKI)
Available Strength 80mg
Formulation Film-Coated Tablet
Pack Size 30 Tablets per Box
Primary Indication EGFR Mutation-Positive Non-Small Cell Lung Cancer (Exon 19 Deletion, Exon 21 L858R, and T790M Resistance Mutation)
Regulatory Approvals USFDA Approved (First-Line and T790M-Positive NSCLC). EMA Approved.
Originator Brand Tagrisso by AstraZeneca
Manufacturer Drug International Ltd., Dhaka, Bangladesh
Global Supplier Mediaid Pharmacy, Worldwide Shipping Available
Registration Status Export Only – Manufactured for International Markets
Storage Conditions Store below 30 degrees Celsius. Protect from moisture and light. Keep out of the reach of children.

How Osinib (Osimertinib) Works

Osinib contains Osimertinib, a third-generation, irreversible inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. In certain non-small cell lung cancers, mutations in the EGFR gene, most commonly exon 19 deletions and the exon 21 L858R substitution, cause the receptor to signal continuously, driving uncontrolled tumour cell growth and survival.

Osimertinib binds irreversibly to these mutant EGFR forms, including the T790M resistance mutation that commonly develops after treatment with earlier-generation EGFR-TKIs, at approximately 9-fold lower concentrations than are needed to affect normal, wild-type EGFR. By selectively shutting down mutant EGFR signalling, Osinib halts tumour proliferation, and its favourable penetration of the central nervous system makes it particularly useful for patients with brain metastases, a frequent complication of EGFR-mutated NSCLC.

Because of this mutant-selective mechanism, Osinib is classified as a targeted therapy rather than conventional chemotherapy, allowing it to act on cancer cells more precisely while producing a different, generally more manageable side-effect profile. It is taken as a convenient once-daily oral tablet.

Indications for Osinib (Osimertinib)

Osinib (Osimertinib) is indicated for the following conditions:

First-Line Metastatic NSCLC

For the first-line treatment of adult patients with metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an approved test.

T790M-Positive NSCLC

For adult patients with metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after prior EGFR-TKI therapy.

Benefits of Osinib (Osimertinib) 80mg

Strong CNS Penetration

Osinib shows strong penetration into the central nervous system, making it particularly effective against brain metastases, a common and difficult-to-treat complication of EGFR-mutated NSCLC.

Convenient Once-Daily Dosing

Osinib is taken as a single oral tablet once daily, offering a simple, convenient regimen compared to intravenous chemotherapy schedules.

Effective Against Resistance Mutations

Unlike first and second-generation EGFR-TKIs, Osinib retains activity against the T790M resistance mutation, extending treatment options for patients who have progressed on earlier therapy.

Affordable Alternative to Tagrisso

Osinib contains the same active ingredient as Tagrisso by AstraZeneca, at a significantly lower cost, making long-term targeted lung cancer therapy financially accessible for patients worldwide.

Improved Survival Outcomes

Clinical trials of Osimertinib demonstrated significant improvements in progression-free and overall survival compared to earlier-generation EGFR-TKIs.

Backed by a Pioneering Manufacturer

Produced by Drug International Ltd., a long-established Bangladeshi manufacturer with a five-decade history and a strong track record in advanced oral solid dosage production.

How to Take Osinib (Osimertinib)

Route: Oral, taken by mouth. Tablets should be swallowed whole and not chewed, crushed, dissolved, or divided.

Standard dose: 80mg (one tablet) once daily, taken at approximately the same time each day, until disease progression or unacceptable toxicity, exactly as directed by the prescribing oncologist.

With food: Can be taken with or without food, at any time of the day.

Missed dose: If a dose is missed by more than 12 hours, skip that dose and take the next dose at its normal scheduled time; do not double up doses.

Dose reduction for toxicity: If a dose reduction is required to manage adverse reactions such as QTc prolongation, rash, diarrhoea, or other toxicity, the dose may be reduced to a lower strength once daily, as directed by the prescribing physician.

Renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. Osinib is not recommended for patients with severe or end-stage renal impairment.

Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. Osinib is not recommended for patients with severe hepatic impairment due to a lack of safety data.

Strong CYP3A4 inducers: Concomitant use should be avoided where possible, as these (including rifampin, phenytoin, carbamazepine, and St. John’s Wort) may decrease Osimertinib plasma concentrations. If unavoidable, dose increases may be considered under close physician supervision.

Paediatric use: The safety and efficacy of Osinib in children and adolescents have not been established. No data are currently available.

Prescription Medication. Treatment with Osinib should not be initiated without confirmed EGFR mutation status from an approved test. Interstitial lung disease/pneumonitis has occurred in a small proportion of patients and requires permanent discontinuation if confirmed. Avoid use in patients with congenital long QT syndrome, and use with caution in patients with cardiac risk factors, requiring baseline and periodic assessment of left ventricular ejection fraction (LVEF) and ECG (QTc interval). Osinib may affect the ability to drive or operate machinery in some patients. Always follow your prescribing oncologist’s instructions.

Monitoring and Dosage Adjustments

Regular monitoring is essential during Osinib treatment. Your healthcare provider will monitor for interstitial lung disease (ILD) and pneumonitis, occurring in around 3.3% of patients, assessing for new or worsening respiratory symptoms such as shortness of breath, cough, or fever. Monitoring also includes left ventricular ejection fraction (LVEF) at baseline and periodically thereafter, ECG monitoring for QTc prolongation in patients with risk factors, and periodic blood counts and liver function tests. The most common adverse reactions leading to dose reduction or interruption are QTc prolongation and neutropenia. Report any breathlessness, chest pain, palpitations, or unusual fatigue to your doctor immediately.

Drug Interactions and Important Information

Avoid concomitant use of Osinib with strong CYP3A inducers such as rifampicin, phenytoin, carbamazepine, and St. John’s Wort, as these significantly reduce Osimertinib plasma exposure and may reduce efficacy. Avoid concomitant use with drugs that are sensitive substrates of CYP3A, BCRP, or CYP1A2 with a narrow therapeutic index, including but not limited to fentanyl, cyclosporine, quinidine, ergot alkaloids, phenytoin, and carbamazepine, as Osinib may increase or decrease the plasma concentration of these drugs. If no alternative exists, monitor patients more closely for adverse reactions.

Use caution when combining Osinib with other medicines known to prolong the QTc interval. Women of childbearing potential must use effective contraception during treatment and for at least 6 weeks after the final dose; men should use effective contraception during treatment and for at least 4 months after the final dose. Always inform your physician of all medications, supplements, and herbal products you are currently taking before starting Osinib.

Side Effects and Precautions

Common Side Effects

Diarrhoea (approximately 42% of patients)

Rash (approximately 41%) and dry skin (approximately 31%)

Nail toxicity, or paronychia (approximately 25%)

Stomatitis (mouth inflammation)

Fatigue

Decreased appetite

Serious Warnings and Precautions

Interstitial lung disease (ILD)/pneumonitis (approximately 3.3% of patients), which can be fatal. Discontinue permanently if confirmed.

QTc interval prolongation, which may lead to life-threatening arrhythmia. Avoid in congenital long QT syndrome.

Cardiomyopathy with reduced left ventricular ejection fraction.

Serious adverse reactions including pneumonia and pulmonary embolism, reported in 2% or more of patients.

Embryo-foetal toxicity. Not recommended during pregnancy or breastfeeding.

Who Should Use Osinib (Osimertinib)?

Osinib is suitable for adult patients diagnosed with locally advanced or metastatic Non-Small Cell Lung Cancer whose tumours carry EGFR exon 19 deletions, exon 21 L858R mutations, or the T790M resistance mutation, confirmed by an approved EGFR mutation test on tissue or blood (liquid biopsy). It is prescribed by medical oncologists and thoracic oncology specialists experienced in biomarker-guided cancer therapy. A thorough medical assessment including EGFR mutation testing, cardiac evaluation (ECG and LVEF), and renal and liver function is required before initiating treatment.

Manufacturer: Drug International Ltd.

Drug International Ltd. is a long-established pharmaceutical manufacturer based in Dhaka, Bangladesh, incorporated in 1974 and one of the country’s pioneering companies in oral solid dosage manufacturing. Drug International was the first company in Bangladesh to formulate medicines in soft gelatin capsule form, and continues to lead in this area today. Operating under WHO cGMP guidelines, the company manufactures a broad portfolio spanning tablets, capsules, injectables, and other dosage forms, and exports its products to markets around the world. Osinib is one of Drug International’s oncology products, offering a bioequivalent alternative to Tagrisso by AstraZeneca at a fraction of the cost.

Global Supplier: Mediaid Pharmacy with Worldwide Shipping

Mediaid Pharmacy is a trusted global supplier of specialty and oncology medications. We ensure Osinib (Osimertinib) is accessible to patients and healthcare providers worldwide through reliable worldwide shipping. Whether you are located in South Asia, the Middle East, Africa, Europe, or beyond, Mediaid Pharmacy provides fast and reliable delivery with full order support. Contact us directly via WhatsApp, phone, or WeChat for pricing, availability, and delivery enquiries.

Why Choose Osinib (Osimertinib) from Mediaid Pharmacy?

Osinib represents a major advancement in the targeted treatment of EGFR-mutated lung cancer. As the generic equivalent of Tagrisso by AstraZeneca, it delivers the same active ingredient, Osimertinib, with the same proven mutant-selective EGFR-inhibition mechanism at a dramatically more affordable price. Manufactured by Drug International Ltd., one of Bangladesh’s longest-established pharmaceutical companies, and distributed globally by Mediaid Pharmacy, Osinib gives patients worldwide access to high-quality targeted lung cancer therapy without the financial burden of brand-name alternatives. For patients and physicians seeking a proven, affordable, and accessible Osimertinib option with worldwide delivery, Osinib from Mediaid Pharmacy is the trusted choice.

Frequently Asked Questions About Osinib (Osimertinib)

What is Osinib (Osimertinib) used for?

Osinib (Osimertinib) is a third-generation EGFR-TKI used as first-line treatment for adult patients with metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, and for patients with T790M mutation-positive NSCLC whose disease has progressed after prior EGFR-TKI therapy. It works by blocking the abnormal EGFR signalling that drives tumour growth, with strong activity against brain metastases.

How should I take Osinib (Osimertinib)?

Osinib is taken orally once daily, with or without food, at approximately the same time each day. The standard dose is 80mg (one tablet) once daily. Always follow your physician’s exact instructions.

What strength is Osinib (Osimertinib) available in?

Osinib is available in an 80mg film-coated tablet, supplied in a box of 30 tablets. The 80mg strength is the standard recommended dose for most adult patients with EGFR-mutated NSCLC.

Is Osinib the same as Tagrisso (Osimertinib by AstraZeneca)?

Yes. Osinib is the generic equivalent of Tagrisso. Both contain the same active ingredient, Osimertinib, in the same dosage form and strength. Osinib is manufactured by Drug International Ltd. in Bangladesh and delivers the same clinical mechanism as Tagrisso at a significantly lower cost, making it a more accessible option for patients worldwide.

What are the side effects of Osinib (Osimertinib)?

Common side effects include diarrhoea, rash, dry skin, nail toxicity, mouth inflammation, fatigue, and decreased appetite. Serious but less common risks include interstitial lung disease, QTc prolongation, and reduced heart function. Always consult your physician for a complete assessment of your individual risks and benefits before starting treatment.

Can Osinib be used with other medications?

Osinib should not be combined with strong CYP3A inducers such as rifampicin, phenytoin, or carbamazepine, as these reduce its effectiveness. Caution is needed with sensitive CYP3A, BCRP, or CYP1A2 substrate medications with a narrow therapeutic index, and with other medicines that prolong the QTc interval. Always inform your physician of all medications, supplements, and herbal products you are taking before starting Osinib.

Is Osinib (Osimertinib) safe during pregnancy or breastfeeding?

No. Osinib is not recommended during pregnancy or breastfeeding, as it can cause foetal harm. Women of childbearing potential must use effective contraception during treatment and for at least 6 weeks after the final dose, and men should use contraception for at least 4 months after their final dose. Please consult your physician before starting treatment if you are pregnant, planning to become pregnant, or breastfeeding.

Can I order Osinib (Osimertinib) online with worldwide shipping?

Yes. Mediaid Pharmacy supplies Osinib (Osimertinib) 80mg globally with worldwide shipping. Contact us via WhatsApp, phone, or WeChat at +8801773428128 or email us at info@mediaidpharmacy.com to enquire about pricing, availability, and delivery to your country.

Order Osinib (Osimertinib) 80mg with Worldwide Shipping

Phone / WhatsApp / WeChat: +8801773428128 | Email: info@mediaidpharmacy.com

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