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Affymax, Inc. (AFFY) Message Board

  • dinepat203 dinepat203 Feb 27, 2013 8:50 AM Flag

    0.2 % NOT A BIG DEAL - CHECK EPOGEN HAS 5-6%

    -----------------------WARNINGS AND PRECAUTIONS------------------------
    • Increased Mortality, Myocardial Infarction, Stroke, and
    Thromboembolism: Using ESAs to target a hemoglobin level of greater
    than 11 g/dLincreases the risk of serious adverse cardiovascular reactions
    and has not been shown to provide additional benefit (5.1 and 14.1). Use
    caution in patients with coexistent cardiovascular disease and stroke (5.1).
    • Increased Mortality and/or Increased Risk of Tumor Progression or
    Recurrence in Patients With Cancer (5.2 and 5.3).
    • Hypertension: Control hypertension prior to initiating and during treatment
    with Epogen (5.4).
    • Seizures: Epogen increases the risk for seizures in patients with CKD
    (5.5). Increase monitoring of these patients for changes in seizure
    frequency or premonitory symptoms (5.5).
    • PRCA: If severe anemia and low reticulocyte count develop during
    Epogen treatment, withhold Epogen and evaluate for PRCA (5.7).
    ------------------------------ADVERSE REACTIONS-------------------------------
    • Patients with CKD: Adverse reactions in ≥ 5% of Epogen-treated patients
    in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia,
    dizziness, medical device malfunction, vascular occlusion, and upper
    respiratory tract infection (6.1).
    • Zidovudine-treated HIV-infected Patients: Adverse reactions in ≥ 5% of
    Epogen-treated patients in clinical studies were pyrexia, cough, rash, and
    injection site irritation (6.1).
    • Cancer Patients on Chemotherapy: Adverse reactions in ≥ 5% of Epogentreated patients in clinical studies were nausea, vomiting, myalgia,
    arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash,
    hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia,
    and thrombosis (6.1).
    • Surgery Patients: Adverse reactions in ≥ 5% of Epogen-treated patients in
    clinical studies were nausea, vomiting, pruritus, headache, injection site
    pain, chills, deep vein thrombosis, cough, and hypertension (6.1).
    To report SUSPECTED ADVERSE REACTIONS, contact Amgen
    Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at
    1-800-FDA-1088

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    • 1 Clinical Trial Experience
      Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical
      trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates
      observed in practice.
      Patients with Chronic Kidney Disease
      Adult Patients
      Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, were used to identify
      the adverse reactions to Epogen. In these studies, the mean age of patients was 48 years (range: 20 to 80 years).
      One hundred and thirty-three (55%) patients were men. The racial distribution was as follows: 177 (73%) patients
      were white, 48 (20%) patients were black, 4 (2%) patients were Asian, 12 (5%) patients were other, and racial
      information was missing for 3 (1%) patients.
      Two double-blind, placebo-controlled studies, including 210 patients with CKD not on dialysis, were used to
      identify the adverse reactions to Epogen. In these studies, the mean age of patients was 57 years (range:
      24 to 79 years). One hundred and twenty-one (58%) patients were men. The racial distribution was as follows:
      164 (78%) patients were white, 38 (18%) patients were black, 3 (1%) patients were Asian, 3 (1%) patients were
      other, and racial information was missing for 2 (1%) patients.
      The adverse reactions with a reported incidence of ≥ 5% in Epogen-treated patients and that occurred at a
      ≥ 1% higher frequency than in placebo-treated patients are shown in the table below:14
      Table 3. Adverse Reactions in Patients With CKD on Dialysis
      Adverse Reaction Epogen-treated Patients
      (n = 148)
      Placebo-treated Patients
      (n = 96)
      Hypertension 27.7% 12.5%
      Arthralgia 16.2% 3.1%
      Muscle spasm 7.4% 6.3%
      Pyrexia 10.1% 8.3%
      Dizziness 9.5% 8.3%
      Medical Device
      Malfunction (artificial
      kidney clotting during
      dialysis)
      8.1% 4.2%
      Vascular Occlusion
      (vascular access
      thrombosis)
      8.1% 2.1%
      Upper respiratory tract
      infection 6.8% 5.2%
      An additional serious adverse reaction that occurred in less than 5% of epoetin alfa-treated dialysis patients and
      greater than placebo was thrombosis (2.7% Epogen and 1% placebo) [see Warnings and Precautions (5.1)].
      The adverse reactions with a reported incidence of ≥ 5% in Epogen-treated patients and that occurred at a
      ≥ 1% higher frequency than in placebo-treated patients are shown in the table below:
      Table 4. Adverse Reactions in Patients With CKD Not on Dialysis
      Adverse Reactions Epogen-treated Patients
      (n = 131)
      Placebo-treated Patients
      (n = 79)
      Hypertension 13.7% 10.1%
      Arthralgia 12.2% 7.6%
      Additional serious adverse reactions that occurred in less than 5% of epoetin alfa-treated patients not on dialysis and
      greater than placebo were erythema (0.8% Epogen and 0% placebo) and myocardial infarction (0.8% Epogen and
      0% placebo) [see Warnings and Precautions (5.1)].

 
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