Wyeth Oncology

Wyeth Oncology Products

Our oncology products include

• TORISEL™ (temsirolimus) injection

  TORISEL is a mammalian target of rapamicin (mTOR) inhibitor indicated for the treatment of advanced renal cell carcinoma (RCC).

  Please see Important Safety Information, below.
  Please see full Prescribing Information for TORISEL.

  Document is in PDF (portable document format). PDF files require Adobe® Reader®; click here to download this free program.

• NEUMEGA^® (oprelvekin)
  Delayed once. NEUMEGA next.

  NEUMEGA is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.

  Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle.

  NEUMEGA is not indicated following myeloablative chemotherapy. The safety and effectiveness of NEUMEGA have not been established in pediatric patients.

  Please see Important Safety Information, including Boxed Warning, below.
  Please see full Prescribing Information , including Boxed Warning, for NEUMEGA.

  Document is in PDF (portable document format). PDF files require Adobe® Reader®; click here to download this free program.

mTOR Signaling Pathway

The mTOR signaling pathway is recognized as an important mediator in advanced renal cell carcinoma.¹

Learn more about mTOR Signaling Pathway.

Oncology Resources

Find information on clinical trials, treatment guidelines, advocacy, patient support, and practice management in our listings of Professional Oncology Resources.

TORISEL 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 ≥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 ≥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 (eg, dexamethasone, rifampin) and strong inhibitors of CYP3A4 (eg, 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 full Prescribing Information for TORISEL.

Document is in PDF (portable document format). PDF files require Adobe® Reader®; click here to download this free program.

NEUMEGA Important Safety Information

• Serious adverse reactions have been associated with NEUMEGA
  administration, including allergic or hypersensitivity reactions and
  anaphylaxis. NEUMEGA is known to cause serious fluid retention that
  can result in peripheral edema, dyspnea, pulmonary edema, capillary
  leak syndrome, atrial arrhythmias (some with strokes), dilutional
  anemia, and exacerbation of pre-existing pericardial or
  pleural effusions.
• NEUMEGA should be used with caution in patients with congestive
  heart failure (CHF), at risk of developing CHF, or with a history of
  heart failure. Other more common adverse events include mild to
  moderate fluid retention, tachycardia, conjunctival redness, and
  papilledema. Changes in visual acuity and/or visual field defects
  ranging from blurred vision to blindness can occur in patients with
  papilledema taking NEUMEGA.
• In post-marketing surveillance, ventricular arrhythmias have
  been reported.
• Dose adjustments are recommended for patients with severe renal
  impairment.
• In randomized studies, most adverse events were
  reversible within several days following discontinuation of NEUMEGA.

Please see full Prescribing Information, including Boxed Warning, for NEUMEGA.

Document is in PDF (portable document format). PDF files require Adobe® Reader®; click here to download this free program.

Reference:

1. TORISEL™ Kit (temsirolimus) Prescribing Information, Wyeth Pharmaceuticals Inc.

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