Torisel
From Kidney Cancer Resource
Overview
Torisel is the Trade/Marketing name for the drug Temsirolimus - produced by Wyeth
For full prescribing detail see the website http://www.torisel.com/
To see Wyeth's articles on Torisel Click Here
EUROPEAN PUBLIC ASSESSMENT REPORT - TORISEL
- Summary for the public
Details
<< About TORISEL >>
TORISEL is an mTOR inhibitor. Inhibition of mTOR in treated cancer cells blocked the translation of genes that regulate the cell cycle. In in vitro studies using renal cancer cell lines, TORISEL inhibited the activity of mTOR and resulted in reduced levels of certain cell growth factors involved in the development of new blood vessels, such as vascular endothelial growth factor.
TORISEL is approved for the treatment of advanced RCC in the United States, European Union and other markets, based on results of a phase 3 clinical study that demonstrated that TORISEL improves overall survival for patients with advanced RCC compared with interferon-alpha.
An application for the use of TORISEL for the treatment of relapsed and/or refractory MCL is currently under review with the European Medicines Agency (EMEA). TORISEL received Orphan Medicinal Product designation for the treatment of MCL in the European Union in November 2006.
<< Important Safety Information >>
Hypersensitivity reactions manifested by symptoms, including, but not limited to anaphylaxis, dyspnea, flushing and chest pain have been observed with TORISEL.
Serum glucose, serum cholesterol and triglycerides should be tested before and during treatment with TORISEL.
The use of TORISEL is likely to result in hyperglycemia and hyperlipemia. This may result in the need for an increase in the dose of, or initiation of, insulin and/or oral hypoglycemic agent therapy and/or lipid-lowering agents, respectively.
The use of TORISEL may result in immunosuppression. Patients should be carefully observed for the occurrence of infections, including opportunistic infections.
Cases of interstitial lung disease, some resulting in death, have occurred. Some patients were asymptomatic and others presented with symptoms. Some patients required discontinuation of TORISEL and/or treatment with corticosteroids and/or antibiotics.
Cases of fatal bowel perforation occurred with TORISEL. These patients presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea and/or acute abdomen.
Cases of rapidly progressive and sometimes fatal acute renal failure not clearly related to disease progression occurred in patients who received TORISEL.
Due to abnormal wound healing, use TORISEL with caution in the perioperative period.
Patients with central nervous system tumors (primary CNS tumor or metastases) and/or receiving anticoagulation therapy may be at an increased risk of developing intracerebral bleeding (including fatal outcomes) while receiving TORISEL.
Live vaccinations and close contact with those who received live vaccines should be avoided.
Patients and their partners should be advised to avoid pregnancy throughout treatment and for 3 months after TORISEL therapy has stopped.
The most common (incidence greater than or equal to 30%) adverse reactions observed with TORISEL are: rash (47%), asthenia (51%), mucositis (41%), nausea (37%), edema (35%), and anorexia (32%). The most common laboratory abnormalities (incidence greater than or equal to 30%) are anemia (94%), hyperglycemia (89%), hyperlipemia (87%), hypertriglyceridemia (83%), elevated alkaline phosphatase (68%), elevated serum creatinine (57%), lymphopenia (53%), hypophosphatemia (49%), thrombocytopenia (40%), elevated AST (38%), and leukopenia (32%).
Most common Grades 3/4 adverse events included asthenia (11%), dyspnea (9%), hemoglobin decreased (20%), lymphocytes decreased (16%), glucose increased (16%), phosphorus decreased (18%) and triglycerides increased (44%).
Strong inducers of CYP3A4/5 (e.g., dexamethasone, rifampin) and strong inhibitors of CYP3A4 (e.g., ketoconazole, atazanavir) may decrease and increase concentrations of the major metabolite of TORISEL, respectively. If alternatives cannot be used, dose modifications of TORISEL are recommended.
St. John's Wort may decrease TORISEL plasma concentrations, and grapefruit juice may increase plasma concentrations of the major metabolite of TORISEL, and therefore both should be avoided.
The combination of TORISEL and sunitinib resulted in dose-limiting toxicity (Grade 3/4 erythematous maculopapular rash, and gout/cellulitis requiring hospitalization).
<< Please see TORISEL full Prescribing Information at Click Here . Wyeth Pharmaceuticals>>
Side Effects
Video
a short video can be seen from Wf TV9 just Click Here
Articles
MedicalNewsToday (KC) 25-Sep-08
- Life-Extending Kidney Cancer Drug Commended For Health Benefit And Innovation
HEATON-HARRIS, Chris 26-Aug-08
- PRESS RELEASE - Chris HEATON-HARRIS MEP continued support....
DAVIES, David (KC) 26-Aug-08
- PRESS RELEASE - David T.C. DAVIES MP (Monmouthshire) continued support....
Yours Magazine (KC) 26-Aug-08
- The Living Nightmare 'I'm not ready to die'....
BBC (KC) 26-Aug-08
The Times (KC) 26-Aug-08
James Whale Press Release 25-Aug-08
- James Whale Press Release....
Echo (KC) 26-Aug-08
- Backlash over axe for specialist drugs cash....
Oxford Mail (KC) 26-Aug-08
- Doctors back cancer drug protest....
Renal & Urology News (KC) 25-Aug-08
- Difficult RCC Cases Respond to New Drug....
Telegraph (KC) 25-Aug-08
- Senior doctor accuses Government of destroying NHS....
The Guardian (KC) 25-Aug-08
- Specialists question decision not to fund drugs for kidney cancer....
LINDER MYERS SOLICITORS 24-Aug-08 Press Release
- Kidney Cancer Jean Murphy - press release....
BBC (KC) 24-Aug-08
- Experts in drug 'ration' warning....
Sunday Times (KC) 24-Aug-08
- Cancer drugs due a review....
BBC (KC) 24-Aug-08
- Experts in drug 'ration' warning
Daily Mail (KC) 12-Aug-08
Belfast Telegraph (KC) 12-Aug-08
- NHS should not save lives if it costs too much: watchdog
MedicalNewsToday (KC) 10-Aug-08
The Times (KC) 08-Aug-08
Swansea Evening Post (KC) 08-Aug-08
- 'HOW CAN THEY PUT A PRICE ON LIFE?'
The Times (KC) 07-Aug-08 / 01
- Case Study: ‘After three tablets, my tumour shrank’
Bristol Evening Post (KC) 07-Aug-08
- NHS advised not to fund kidney cancer drugs
The Times (KC) 07-Aug-08
- £35,000-a-year kidney cancer drugs too costly for NHS
BBC (KC) 07-Aug-08
Daily Mail KC 07-Aug-08-02
- Nasty truth about NICE: It's the body that rations NHS drugs. But this leading cancer specialist says its decisions are deeply flawed
Daily Mail (KC) 07-Aug-08
The Sun (KC) 07-Aug-08
- 4 kidney cancer drugs are axed
The Times (KC) 20-Jul-08
Hays Pharma (KC) 02-Jun-08
- Wyeth starts new trials comparing Avastin & Torisel for kidney cancer treatment....
Fox Business (KC) 31-May-08
- New Data Show TORISEL Improves Progression-Free Survival for Patients With Relapsed/Refractory Mantle Cell Lymphoma
Torisel Articles 07-Dec-07
- Surviving Longer With Kidney Cancer
PharmaTimes (KC) 27-Nov-07
Torisel Articles 20-Sep-07
- About TORISEL(TM) (temsirolimus)
Torisel Articles 01-Sep-07
- Phase I/II trial of temsirolimus combined with interferon alfa
Torisel Articles 02-Jun-07
- Data for ASCO re: Torisel
Torisel Articles 31-May-07
- Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma.
Torisel Articles 30-May-07
- New England Journal Data on Torisel
References
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