Active Ingredient: Temsirolimus
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:
Intravenous
75 - 175 mg
From 75 To 175 mg once every 7 day(s)
175 mg
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 level | Starting dose 175 mg | Continuing dosea 75 mg |
|---|---|---|
| -1 | 75 mg | 50 mg |
| -2 | 50 mg | 25 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:
| ANC | Platelets | Dose of temsirolimus |
|---|---|---|
| ≥1,0 × 109/l | ≥50 × 109/l | 100% of planned dose |
| <1,0 × 109/l | <50 × 109/l | Holda |
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.
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.
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