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Osimertinib oral


Oral formulations containing osimertinib.

Drugs List

  • osimertinib 40mg tablets
  • osimertinib 80mg tablets
  • TAGRISSO 40mg tablets
  • TAGRISSO 80mg tablets
  • Therapeutic Indications


    Advanced/metastatic non-small cell lung cancer with EGFR T790M mutation
    Advanced/metastatic non-small cell lung cancer with EGFR-TK mutations

    First-line treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
    Locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small-cell lung cancer (NSCLC).


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    80mg once daily.

    Additional Dosage Information

    Dose adjustments
    QTc interval greater than 500msec on at least 2 separate ECGs
    Withhold until QTc interval is less than 481msec or recovery to baseline if baseline is greater than or equal to 481msec, then restart at a reduced dose of 40mg daily.

    QTc interval prolongation with signs/symptoms of serious arrhythmia
    Permanently discontinue treatment.

    Grade 3 or higher adverse reaction
    Withhold treatment for 3 weeks.

    Grade 3 or higher adverse reaction improves to grade 2 or below after 3 weeks without treatment
    Restart treatment at the same dose, 80mg or 40mg.

    Grade 3 or higher adverse reaction does not improve to grade 2 or below after 3 weeks without treatment
    Permanently discontinue treatment.

    Missed Doses
    If a dose is missed, it should be made up unless the next dose is due within 12 hours.


    Children under 18 years
    Long QT syndrome
    Severe hepatic impairment
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    History of treatment with anthracyclines
    Patients over 65 years
    Risk factors for cardiovascular disorder
    Weight below 50kg
    Congestive cardiac failure
    Electrolyte imbalance
    History of pneumonitis
    History of torsade de pointes
    Interstitial lung disease
    Renal impairment - creatinine clearance below 30 ml/minute

    Correct electrolyte disorders before treatment
    Refer patients with symptoms of keratitis to an ophthalmology specialist
    Confirm EGFR mutation status of tumour prior to treatment
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Perform ECG before and during treatment
    Consider interrupting treatment if QTc > 500msec
    Consider monitoring LVEF in patients who develop cardiac signs/symptoms
    Monitor serum electrolytes
    Patients with new pulmonary symptoms should be investigated
    Advise patient of signs and symptoms of Stevens-Johnson syndrome
    Advise patient to report any symptoms of interstitial lung disease
    Discontinue treatment if Stevens-Johnson Syndrome suspected
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Suspend treatment if pneumonitis is suspected
    Discontinue if evidence of interstitial lung disease
    Discontinue if grade 3 or greater adverse reaction does not improve
    Discontinue if treatment related pneumonitis is diagnosed
    Discontinue permanently if QTc prolongation and arrhythmias occur
    Suspend treatment if grade 3 or greater adverse reaction occurs
    Suspend treatment if interstitial lung disease is suspected
    Advise patient not to take St John's wort concurrently
    May cause impaired fertility
    Female: Non-hormonal contraception required until 2 months after treatment
    Male: Contraception required during and for 4 months after treatment

    Pregnancy and Lactation


    Osimertinib is contraindicated during pregnancy.

    Use of osimertinib during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Osimertinib is contraindicated during breastfeeding.

    Use of osimertinib when breastfeeding is contraindicated by the manufacturer. It is not known if the presence of osimertinib or its metabolites are excreted in human breast milk. Effects on exposed infants are unknown, however due to the potential for serious toxicity, it is recommended that breastfeeding is discontinued during treatment.

    Side Effects

    Blurred vision
    Corneal epithelium defect
    Corneal erosion
    Cutaneous vasculitis
    Dermatitis acneiform
    Dry skin
    Erythema multiforme
    Erythematous rash
    Eye pain
    Eyelid inflammation
    Eyelid pruritus
    Fixed drug eruption
    Formation of pustules
    General pruritus
    Increased susceptibility to infection
    Interstitial lung disease
    Macular rash
    Maculopapular rash
    Mouth ulcers
    Nail disorders
    Palmar-Plantar Erythrodysaesthesia syndrome
    Prolongation of QT interval
    Pruritic rash
    Punctate keratitis
    Pustular rash
    Reddening of eyes
    Reduced platelet count
    Sensitivity to light secondary to pupillary dilation
    Serum creatinine increased
    Skin fissures
    Stevens-Johnson syndrome


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2019

    Reference Sources

    Summary of Product Characteristics: Tagrisso 40 mg film-coated tablets. AstraZeneca UK Ltd. Revised May 2021.
    Summary of Product Characteristics: Tagrisso 80 mg film-coated tablets. AstraZeneca UK Ltd. Revised May 2021.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.