Renal cell carcinoma

Active Ingredient: Temsirolimus

Indication for Temsirolimus

Population group: only adults (18 years old or older)

Temsirolimus is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors.

For this indication, competent medicine agencies globally authorize below treatments:

25 mg once a week

Route of admnistration


Defined daily dose

25 - 25 mg

Dosage regimen

From 25 To 25 mg once every 7 day(s)

Detailed description

The recommended dose of temsirolimus for advanced RCC is 25 mg administered by intravenous infusion over a 30- to 60-minute period once a week.

Treatment of suspected adverse reactions may require temporary interruption and/or dose reduction of temsirolimus therapy. If a suspected reaction is not manageable with dose delays, then temsirolimus may be reduced by 5 mg/week decrements.

Treatment of suspected adverse reactions may require temporary interruption and/or dose reduction of temsirolimus therapy according to the guidelines in the following tables. If a suspected reaction is not manageable with dose delays and/or optimal medical therapy, then the dose of temsirolimus should be reduced according to the dose reduction table below.

Dose reduction levels:

Dose reduction levelStarting dose 175 mgContinuing dosea 75 mg
-175 mg50 mg
-250 mg25 mg

a In the MCL clinical trial, up to two dose level reductions were allowed per patient.

Temsirolimus dose modifications based on weekly ANC and platelet counts:

ANCPlateletsDose of temsirolimus
≥1,0 × 109/l≥50 × 109/l100% of planned dose
<1,0 × 109/l<50 × 109/lHolda

a Upon recovery to ANC ≥1.0 × 109/l (1000 cells/mm³) and platelets to ≥50 × 109/l (50,000 cells/mm³), the doses should be modified to the next lower dose level according to the table above. If the patient cannot maintain ANC >1.0 × 109/l and platelets >50 × 109/l on the new dose reduction level, then the next lower dose should be given once the counts have recovered.
Abbreviation: ANC = absolute neutrophil count.

Dosage considerations

Patients should be given intravenous diphenhydramine 25 mg to 50 mg (or similar antihistamine) approximately 30 minutes before the start of each dose of temsirolimus.

Intravenous infusion over a 30- to 60-minute period.

Active ingredient


Temsirolimus is a selective inhibitor of mTOR (mammalian target of rapamycin). Temsirolimus binds to an intracellular protein (FKBP-12), and the protein/temsirolimus complex binds and inhibits the activity of mTOR that controls cell division. In vitro, at high concentrations (10-20 M), temsirolimus can bind and inhibit mTOR in the absence of FKBP-12. When mTOR activity is inhibited, its ability to phosphorylate, and thereby control the activity of protein translation factors (4E-BP1 and S6K, both downstream of mTOR in the P13 kinase/AKT pathway) that control cell division, is blocked.

Read more about Temsirolimus

Related medicines

Develop a tailored medication plan for your case, considering factors such as age, gender, and health history

Ask the Reasoner

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.