Active Ingredient: Sotorasib
Sotorasib as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Oral, 960 milligrams sotorasib, once daily.
The recommended dose is 960 mg sotorasib once daily, at the same time each day.
Treatment with sotorasib is recommended until disease progression or unacceptable toxicity.
If less than 6 hours have passed since the scheduled time of dosing, the patient should take the dose as normal. If more than 6 hours have passed since the scheduled time of dosing, the patient must not take the dose. Treatment should be continued as prescribed the next day.
If vomiting occurs after taking sotorasib, the patient must not take an additional dose on the same day, and treatment must be continued as prescribed the next day.
Dosing should be modified based on sotorasib toxicity. Dose reduction levels are summarised in table 1. Dose modifications for adverse reactions are provided in table 2.
If toxicity events occur, a maximum of two dose reductions are permitted. Sotorasib must be discontinued if patients are unable to tolerate the minimum dose of 240 mg once daily.
Table 1. Recommended sotorasib dose reduction levels:
| Dose reduction level | Dose |
|---|---|
| Starting dose | 960 mg once daily |
| First dose reduction | 480 mg once daily |
| Second dose reduction | 240 mg once daily |
Table 2. Recommended dose modifications for sotorasib:
| Adverse reaction | Severitya | Dose modification |
|---|---|---|
| Hepatotoxicity | Grade 2 AST or ALT with symptoms or Grade ≥ 3 AST or ALT | • Stop treatment until recovered to ≤ grade 1 or to baseline grade • After recovery, resume treatment at the next dose reduction level |
| AST or ALT > 3 × ULN with total bilirubin > 2 × ULN, in the absence of alternative causes | • Permanently discontinue treatment | |
| Interstitial Lung Disease (ILD)/pneumonitis | Any grade | • Stop treatment if ILD/pneumonitis is suspected. • Permanently discontinue treatment if ILD/pneumonitis is confirmed. |
| Nausea, vomiting, or diarrhoea persisting despite supportive care (including anti-emetic or anti-diarrhoeal therapy) | Grade ≥ 3 | • Stop treatment until recovered to ≤ grade 1 or to baseline grade • After recovery, resume treatment at the next dose reduction level |
| Other medicinal product- related toxicity | Grade ≥ 3 | • Stop treatment until recovered to ≤ grade 1 or to baseline grade • After recovery, resume treatment at the next dose reduction level |
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
a Grading defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Co-administration of proton pump inhibitors (PPIs) or H2 receptor antagonists with sotorasib is not recommended. If treatment with an acid-reducing agent is required a local antacid may be used, sotorasib should be taken either 4 hours before or 10 hours after administration of a local antacid.
The tablets can be taken with or without food.
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.
