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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 Description

Osinib is a drug manufactured by Drugs International LTD (Bangladesh) with the main ingredient Osimertinib effective in adjuvant treatment after complete tumor resection in adult patients with non-small cell lung cancer.

Ingredients of Osinib

  • Osimertinib 80mg.

Dosage forms

  • Film-coated tablets.

Uses and indications of Osinib

Osinib as monotherapy is indicated for:

  • Adjuvant treatment after complete tumor resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exons 19 or exon 21 substitution mutation (L858R).
  • First-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.
  • Treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

How to use - Dosage of Osinib

  • How to use:
    • Medicines for oral use.
    • Dosage:
      • The recommended dose is 80mg osimertinib once a day (1 tablet).
      • Patients in the adjuvant setting should be treated until disease relapse or unacceptable toxicity occurs. Treatment durations of more than 3 years were not studied.
      • Patients with locally advanced or metastatic lung cancer should be treated until disease progression or unacceptable toxicity.

    Contraindications of Osinib

    • Contraindicated in patients with hypersensitivity to any ingredient in the drug, including pharmaceutical ingredients and excipients.

    Notes when using Osinib

    • Osimertinib may cause serious side effects on your heart, lungs, or vision.
    • Call your doctor at once if you have a fast or pounding heartbeat, swelling in your lower legs, cough, fever, trouble breathing, vision changes, eye pain, increased sensitivity to light, or if you feel light-headed head.
    • Tell your doctor if you have ever had:
      • respiratory disorders;
      • Electrolyte imbalance (such as high or low levels of calcium, potassium, or magnesium in the blood);
      • Eye problems;
      • Long QT syndrome (in you or a family member).
    • Osimertinib may harm an unborn baby if the mother or father is using osimertinib.
    • When using the drug, regular blood tests are required. Heart function may need to be tested with an electrocardiogram or ECG (sometimes called an EKG).
    • Osimertinib is usually taken until the body no longer responds to the drug.

    Use for pregnant or breastfeeding women

    • Women who are pregnant or breastfeeding should consult their doctor.

    For use by drivers and machine operators

    • Drivers and machine operators should consult a doctor.

    Osinib side effects

    • The most common adverse reactions (>20%) in all patients treated with Osimertinib were diarrhea (42%), rash (41%), dry skin (31%), and nail toxicity (25%). %).
    • The most common adverse reactions leading to dose reduction or interruption were: ECG QTc prolongation (2.2%) and neutropenia (1.9%).
    • Serious adverse reactions reported in 2% or more of patients were pneumonitis and pulmonary embolism.
    • Inform your doctor of any unwanted effects you encounter when using the drug.


    • Strong CYP3A4 sensor, thus affecting drugs metabolized through CYP3A4.
    • If concurrent use is unavoidable, increase the Osimertinib dose to 160 mg daily when coadministered with a strong CYP3A inducer. Continue Osimertinib 80mg 3 weeks after discontinuation of the strong CYP3A4 inducer.

    Missed dose and treatment

    • Take the dose as soon as you remember. Do not take a second dose to make up for a dose you may have missed. Just continue with the next dose.

    Overdose and treatment

    • If an overdose occurs, notify your doctor immediately, or if you see unusual symptoms, go to the hospital for timely treatment.


    • Dry, airy place, temperature below 30 degrees Celsius, avoid direct sunlight.
    • Keep out of reach of children.


    • Box of 30 tablets.