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Temsirolimus parenteral


Infusion containing temsirolimus

Drugs List

  • temsirolimus 30mg/1.2ml concentrate for solution for infusion
  • TORISEL 30mg/1.2ml concentrate for solution for infusion
  • Therapeutic Indications


    Advanced renal cell carcinoma
    Relapsed or refractory mantle cell lymphoma

    First line treatment of patients with advanced renal cell carcinoma who have 3 to 6 prognostic factors.

    Treatment of adult patients with relapsed and/or refractory mantle cell lymphoma [MCL].


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    Intravenous antihistamine in standard doses should be given approximately 30 minutes before the start of each dose of temsirolimus (for example, 25 to 50 mg of diphenhydramine).

    Renal cell carcinoma
    25 mg infused intravenously over a 30 to 60 minute period once a week.

    Mantle cell lymphoma
    175 mg infused over a 30 to 60 minute period a once week for 3 weeks followed by weekly doses of 75 mg infused over a 30 to 60 minute period.

    Patients with Hepatic Impairment

    Renal cell carcinoma
    Mild to moderate hepatic impairment: No dose adjustment

    Severe hepatic impairment (total bilirubin > 3 times ULN with any abnormality of AST, or as defined by Child-Pugh Class C, baseline platelets equal to or greater than 100 times 10 to the power of 9 per litre): Reduce dose to 10 mg once a week..

    Additional Dosage Information

    Renal cell carcinoma
    If a suspected reaction is not manageable with dose delays, then the temsirolimus dose may be reduced by 5 mg/week decrements.

    Mantle cell lymphoma
    If a suspected adverse reaction is not manageable with dose delays and optimal medical therapy, then the dose of temsirolimus should be reduced as follows:

    Starting dose: 175 mg reduced to 75 mg and then to 50 mg if necessary
    Maintenance dose: 75 mg reduced to 50mg and then to 25 mg if necessary.

    Absolute neutrophil count (ANC) falls to less than 1 x 10 to the power of 9 per litre and platelets to less than 50 x 10 to the power of 9 per litre: Delay the next dose of temsirolimus until counts have recovered to at least 1 x 10 to the power of 9 per litre (ANC) and 50 x 10 to the power of 9 per litre (platelets) and dose at the next lower dosing level stated above.
    If counts cannot be maintained at these levels on the lower dose, then when counts have recovered the lowest dose should be given.


    To be administered as an intravenous infusion administered over 30 to 60 minutes after dilution.

    The use of an infusion pump is the preferred method of administration to ensure accurate delivery of the medicinal product.


    Children under 18 years
    Moderate hepatic impairment - if treating mantle cell lymphoma

    Precautions and Warnings

    Neutrophil count below 1.0 x 10 to the power of 9 / L
    Patients over 65 years
    Platelet count below 50 x 10 to the power of 9 / L
    Recent anticoagulant therapy
    Recent surgery
    Central nervous system neoplasm
    Diabetes mellitus
    Epileptic disorder
    Hepatic impairment
    Severe hepatic impairment & baseline platelets above 100x10 to power of 9
    Severe renal impairment

    Administration of live vaccines is not recommended
    Advise ability to drive/operate machinery may be affected by side effects
    Chest X-ray or CT advised prior to initiation, then as clinically indicated
    Premedication with antihistamine recommended
    Prophylaxis for pneumocystis jiroveci pneumonia recommended
    Treatment to be prescribed under the supervision of a specialist
    Contains alcohol
    Contains propylene glycol: may cause irritation
    Consult local policy on the safe use of anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor platelet count weekly
    Diabetic control may need adjustment
    Monitor blood glucose
    Monitor cholesterol and triglyceride levels
    Monitor for signs and symptoms of interstitial lung disease
    Monitor levels of hepatic enzymes and bilirubin
    Monitor neutrophil count weekly
    Monitor patient for infusion-associated reactions (IARs)
    Monitor patient for signs of serious infection
    Advise patient to report any new or worsening respiratory symptoms
    Advise patient to report excessive thirst or increased urination
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Immunosuppressive drugs may increase risk of malignancy
    Risk of developing opportunistic infections
    Discontinue if angioneurotic oedema occurs
    Interrupt treatment if severe infusion reaction occurs
    Advise patient not to take St John's wort concurrently
    Advise patient grapefruit products may increase plasma level
    Male: May cause infertility
    Male & female: Ensure adequate contraception during treatment
    Advise patient of risk of bleeding
    Advise patient on appropriate sun protection methods
    Advise patient to avoid exposure to sunlight and UV rays during treatment

    Hypersensitivity reactions, including anaphylactic reactions have occurred during temsirolimus administration. If a hypersensitivity reaction develops despite the antihistamine premedication the infusion should be stopped and the patient should be observed for 30 to 60 minutes. The treatment may be restarted at the discretion of the physician with the administration of an H1-receptor antagonist, if not previously administered and/or H2-receptor antagonist approximately 30 minutes before restarting the temsirolimus infusion. The infusion may then be resumed at a slower rate (up to 60 minutes).

    Both diabetic and non-diabetic patients have experienced an increase in blood glucose levels during temsirolimus treatment. Blood glucose should be monitored carefully during treatment and patients should be advised to report excessive thirst or any increase in the volume or frequency of urination.

    There have been cases of interstitial pneumonitis occurring in patients who received weekly intravenous temsirolimus. Therefore patients should be monitored for respiratory symptoms such as cough, dyspnoea and fever. It is also recommended, prior to treatment, that patients undergo baseline radiographic assessment by lung computed tomography scan or chest radiograph.

    Pregnancy and Lactation


    Temsirolimus is contraindicated during pregnancy.

    There are no adequate data from the use of temsirolimus in pregnant women.
    Studies in rats and rabbits have shown reproductive toxicity, embryo/foetotoxicity occurred in the forms of mortality and reduced foetal weights. The potential risk for humans is unknown.

    The effect of concurrent therapies must also be considered.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Temsirolimus is contraindicated in breastfeeding.

    It is not know whether temsirolimus is excreted in human breast milk. The excretion of temsirolimus in milk has not been studied in animals. However sirolimus (the main metabolite of temsirolimus) is excreted in the milk of lactating rats. It is not known whether sirolimus is excreted in human milk.

    Due to the potential for adverse reactions in nursing infants from temsirolimus, breastfeeding should be discontinued during therapy.

    The effect of concurrent therapies must also be considered.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal distension
    Abdominal pain
    Angioneurotic oedema
    Aphthous stomatitis
    Back pain
    Bowel perforation
    Cerebral haemorrhage
    Chest pain
    Decreased appetite
    Decreased glucose tolerance
    Dry skin
    Exfoliative dermatitis
    Febrile neutropenia
    Gastrointestinal bleeding
    Hypersensitivity reactions including anaphylaxis
    Increase in serum ALT/AST
    Interstitial lung disease
    Lacrimation disorder
    Nail disorders
    Oral pain
    Pericardial effusion
    Pleural effusion
    Pneumocystis jiroveci pneumonia
    Pulmonary embolism
    Renal failure
    Serum creatinine increased
    Stevens-Johnson syndrome
    Taste loss
    Upper respiratory tract infection
    Urinary tract infections
    Wound healing retarded


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2016

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 7 March 2016.

    Summary of Product Characteristics: Torisel concentrate for solution for infusion. Pfizer limited. Revised February 2017.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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