TORISEL 30 mg concentrate and diluent for solution for infus - Ireland[爱尔兰药品]

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TORISEL 30 mg concentrate and diluent for solution for infus

2013-12-29 17:36:10 来源: 作者: 【大中小】浏览:638次评论:0条

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

TORISEL^® 30 mg concentrate and diluent for solution for infusion.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial of TORISEL concentrate contains 30 mg temsirolimus.

After first dilution of TORISEL 30 mg concentrate with 1.8 ml of withdrawn diluent, the concentration of temsirolimus is 10 mg/ml (see section 4.2).

Excipients:

1 vial TORISEL 30 mg concentrate contains 474 mg anhydrous ethanol.

1.8 ml of the diluent, provided contains 358 mg anhydrous ethanol.

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Concentrate and diluent for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless to light-yellow solution, essentially free from visible particulates.

The diluent is a clear to slightly turbid, light-yellow to yellow solution, essentially free from visible particulates.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Renal cell carcinoma

TORISEL is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1).

Mantle cell lymphoma

TORISEL is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma [MCL] (see section 5.1).

4.2 Posology and method of administration

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.

For instructions on preparation and to help ensure correct dosing, see section 6.6.

Posology

Patients should be given intravenous diphenhydramine 25 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. No special dose modification is required for any of the populations that have been studied (gender, elderly).

Renal cell carcinoma

The recommended dose of temsirolimus for advanced renal cell carcinoma administered intravenously is 25 mg infused over a 30- to 60-minute period once weekly (see section 6.6 for instructions on dilution, administration and disposal).

Management 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.

Mantle cell lymphoma

The recommended dosing regimen of temsirolimus for mantle cell lymphoma is 175 mg, infused over a 30-60 minute period once weekly 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.

Management 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 Dose^a 75 mg
-1	75 mg	50 mg
-2	50 mg	25 mg
^aIn the MCL Clinical Trial, up to two dose level reductions were allowed per patient.