Osimertinib oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing osimertinib.
Drugs List
Therapeutic Indications
Uses
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).
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
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.
Contraindications
Children under 18 years
Breastfeeding
Long QT syndrome
Pregnancy
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
Pregnancy
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.
Lactation
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
Acne
Alopecia
Blurred vision
Corneal epithelium defect
Corneal erosion
Cough
Cutaneous vasculitis
Dermatitis
Dermatitis acneiform
Diarrhoea
Dry skin
Dyspnoea
Eczema
Epistaxis
Erythema
Erythema multiforme
Erythematous rash
Eye pain
Eyelid inflammation
Eyelid pruritus
Fever
Fixed drug eruption
Folliculitis
Formation of pustules
General pruritus
Increased susceptibility to infection
Interstitial lung disease
Keratitis
Lacrimation
Leucopenia
Lymphocytopenia
Macular rash
Maculopapular rash
Mouth ulcers
Nail disorders
Neutropenia
Onychoclasis
Palmar-Plantar Erythrodysaesthesia syndrome
Paronychia
Pneumonitis
Prolongation of QT interval
Pruritic rash
Pruritus
Punctate keratitis
Pustular rash
Rash
Reddening of eyes
Reduced platelet count
Sensitivity to light secondary to pupillary dilation
Serum creatinine increased
Skin fissures
Stevens-Johnson syndrome
Stomatitis
Thrombocytopenia
Urticaria
Xeroderma
Xerosis
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
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.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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.