Mantle cell lymphoma

Active Ingredient: Temsirolimus

Indication for Temsirolimus

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

Temsirolimus is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).

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

75-175 mg once a week

Route of admnistration


Defined daily dose

75 - 175 mg

Dosage regimen

From 75 To 175 mg once every 7 day(s)

Loading dose

175 mg

Detailed description

The recommended dosing regimen of temsirolimus for MCL is 175 mg, infused over a 30-60 minute period once a week for 3 weeks followed by weekly doses of 75 mg, infused over a 30-60 minute period. The starting dose of 175 mg was associated with a significant incidence of adverse events and required dose reductions/delays in the majority of patients. The contribution of the initial 175 mg doses to the efficacy outcome is currently not known.

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

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