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Wyeth Oncology Products

Wyeth oncology products include TORISEL® (temsirolimus) injection, NEUMEGA® (oprelvekin), and MYLOTARG®(gemtuzumab ozogamicin for Injection).

Products

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  • MYLOTARG® (gemtuzumab ozogamicin for Injection)
    Rethink first relapse.

    • MYLOTARG is indicated for the treatment of patients with CD33+ acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. The safety and efficacy of MYLOTARG in patients with poor performance status and organ dysfunction has not been established.

    The effectiveness of MYLOTARG is based on overall response (OR) rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival, compared to any other treatment.

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

    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 PDF, including Boxed Warning, for NEUMEGA® (oprelvekin) (with 1 mL Sterile Water for Injection diluent, USP in pre-filled syringe).

    Please see full Prescribing Information PDF, including Boxed Warning, for NEUMEGA® (oprelvekin) (with 1 mL Sterile Water for Injection diluent, USP in vial).

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

 

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 and laboratory abnormalities 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 PDF for TORISEL.

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

MYLOTARG Important Safety Information

WARNINGS: MYLOTARG should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients. There are no controlled trials demonstrating efficacy and safety using MYLOTARG in combination with other chemotherapeutic agents. Therefore, MYLOTARG should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when MYLOTARG is used at recommended doses.

HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS, PULMONARY EVENTS: MYLOTARG administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events have been fatal. In most cases, infusion-related symptoms occurred during the infusion or within 24 hours of administration of MYLOTARG and resolved. MYLOTARG infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of MYLOTARG treatment should be strongly considered for patients who develop anaphylaxis, pulmonary edema, or acute respiratory distress syndrome. Since patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome, physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/μL prior to administration of MYLOTARG. (See WARNINGS.)

HEPATOTOXICITY: Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported in association with the use of MYLOTARG as a single agent, as part of a combination chemotherapy regimen, and in patients without a history of liver disease or hematopoietic stem-cell transplant (HSCT). Patients who receive MYLOTARG either before or after HSCT, patients with underlying hepatic disease or abnormal liver function, and patients receiving MYLOTARG in combinations with other chemotherapy are at increased risk for developing VOD, including severe VOD. Death from liver failure and from VOD has been reported in patients who received MYLOTARG. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD. These symptoms can include: rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations in bilirubin and/or liver enzymes. However, careful monitoring may not identify all patients at risk or prevent the complications of hepatotoxicity. (See WARNINGS and ADVERSE REACTIONS sections.)

  • MYLOTARG is contraindicated in patients with a known hypersensitivity to gemtuzumab ozogamicin or any of its components. MYLOTARG may cause fetal harm when administered to a pregnant woman. MYLOTARG could be excreted in human breast milk and could therefore cause serious adverse reactions in nursing infants. The reported rate of Grade 3 or 4 thrombocytopenia, neutropenia, anemia, and bleeding were 99%, 98%, 52%, and 13%, respectively. Thirty percent of patients experienced severe infections, including opportunistic infections. The most frequent severe infections included sepsis (17%) and pneumonia (8%).
  • The most common adverse events (>20%) were fever (82%), nausea (68%), chills (66%), vomiting (58%), thrombocytopenia (50%), leukopenia (47%), headache (37%), asthenia (36%), abdominal pain (32%), diarrhea (32%), epistaxis (28%), dyspnea (26%), hypokalemia (26%), sepsis (26%), anorexia (25%), stomatitis (25%), liver function tests abnormal (24%), constipation (23%), anemia (22%), local reaction (22%), herpes simplex (21%), and hypotension (20%).
  • MYLOTARG can produce a postinfusion symptom complex of fever and chills, and less commonly hypotension and dyspnea during the first 24 hours after administration. Patients should receive diphenhydramine 50 mg po and acetaminophen 650-1000 mg po 1 hour before MYLOTARG administration. Two additional doses of acetaminophen 650-1000 mg po every 4 hours may be given. Fever and chills were commonly reported despite premedication with diphenhydramine and acetaminophen. Vital signs should be monitored during infusion and for 4 hours following infusion. Methylprednisolone given prior to MYLOTARG infusion may ameliorate infusion-related symptoms.
  • Severe pulmonary events leading to death have been reported infrequently with the use of MYLOTARG in the postmarketing setting. Signs, symptoms and clinical findings include dyspnea, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia and acute respiratory distress syndrome. Patients with symptomatic intrinsic lung disease may also be at greater risk of severe pulmonary reactions.
  • Severe myelosuppression will occur in all patients given the recommended dose of this agent. Careful hematologic monitoring is required. Systemic infections should be treated.

Please see full Prescribing Information PDF, including Boxed Warning, for MYLOTARG.

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

NEUMEGA Important Safety Information

Allergic Reactions Including Anaphylaxis
NEUMEGA has caused allergic or hypersensitivity reactions, including anaphylaxis. Administration of NEUMEGA should be permanently discontinued in any patient who develops an allergic or hypersensitivity reaction (see WARNINGS, CONTRAINDICATIONS, ADVERSE REACTIONS and ADVERSE REACTIONS, Immunogenicity).
  • 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 PDF, including Boxed Warning, for NEUMEGA® (oprelvekin) (with, 1mL Sterile Water for Injection diluent, USP in pre-filled syringe).

Please see full Prescribing Information PDF, including Boxed Warning, for NEUMEGA® (oprelvekin) (with, 1mL Sterile Water for Injection diluent, USP in vial).

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

 

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