Torisel is indicated for the treatment of adult patients with relapsed and/or refractory Mantle Cell Lymphoma (MCL)

Subtype:

Mantle Cell Lymphoma (MCL)

License:

EMA

Class:

mTOR inhibitors

R/R

SmPChttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000799/WC500039912.pdf

1. Approved Labelling

Torisel is indicated for the treatment of adult patients with relapsed and/or refractory Mantle Cell Lymphoma (MCL).

2. Treatment Regimen

Torisel must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.

The vial of Torisel concentrate must first be diluted with 1.8 ml of diluent withdrawn from the supplied vial to achieve a concentration of temsirolimus of 10 mg/ml. Withdraw the required amount of the temsirolimus-diluent mixture (10 mg/ml) and then inject rapidly into sodium chloride 9 mg/ml (0.9%) solution for injection.

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.

Treatment with Torisel should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

The recommended dosing regimen of Torisel 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.

3. AE/Warnings

Please see section 4.4 of the SmPC.

 

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