Active Ingredient: Osimertinib
Osimertinib as monotherapy is indicated for:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 80 milligrams osimertinib, once daily.
The recommended dose is 80 mg osimertinib once a day.
Patients with locally advanced or metastatic lung cancer should receive osimertinib treatment until disease progression or unacceptable toxicity.
If a dose of osimertinib is missed, the dose should be made up unless the next dose is due within 12 hours.
Dosing interruption and/or dose reduction may be required based on individual safety and tolerability. If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
Dose reduction guidelines for adverse reactions toxicities are provided in th following table.
Recommended dose modifications for osimertinib:
| Target organ | Adverse reactiona | Dose modification |
|---|---|---|
| Pulmonary | ILD/Pneumonitis | Discontinue osimertinib |
| Cardiac | QTc interval greater than 500 msec on at least 2 separate ECGs | Withhold osimertinib until QTc interval is less than 481 msec or recovery to baseline if baseline QTc is greater than or equal to 481 msec, then restart at a reduced dose (40 mg) |
| QTc interval prolongation with signs/symptoms of serious arrhythmia | Permanently discontinue osimertinib | |
| Cutaneous | Stevens-Johnson Syndrome and Toxic epidermal necrolysis | Permanently discontinue osimertinib |
| Blood and lymphatic system | Aplastic anaemia | Permanently discontinue osimertinib |
| Other | Grade 3 or higher adverse reaction | Withhold osimertinib for up to 3 weeks |
| If Grade 3 or higher adverse reaction improves to Grade 0-2 after withholding of osimertinib for up to 3 weeks | Osimertinib may be restarted at the same dose (80 mg) or a lower dose (40 mg) | |
| Grade 3 or higher adverse reaction that does not improve to Grade 0-2 after withholding for up to 3 weeks | Permanently discontinue osimertinib |
a Note: The intensity of clinical adverse events graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
ECGs: Electrocardiograms; QTc: QT interval corrected for heart rate
Osimertinib can be taken with or without food at the same time each day.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
