During the first several months following initiation of Epogen, monitor patients closely for premonitory neurologic symptoms. In pediatric patients with CKD on dialysis, the pattern of adverse reactions was similar to that found in adults. There was no significant difference in the number of patients transfused between Epogen (9% 300 Units/kg, 6% 100 Units/kg) and placebo (13%) in the > 13 to ≤ 15 g/dL hemoglobin stratum. Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in lactating women [see Contraindications (4), Warnings and Precautions (5.9)]. Keep the needle in the vial. 0000010887 00000 n In each trial, the potential benefit of ESA therapy was offset by worse cardiovascular safety outcomes resulting in an unfavorable benefit-risk profile [see Warnings and Precautions (5.1)].

Do you wish to proceed? A pharmacokinetic study comparing 150 Units/kg subcutaneous 3 times weekly to 40,000 Units subcutaneous weekly dosing regimen was conducted for 4 weeks in healthy subjects (n = 12) and for 6 weeks in anemic cancer patients (n = 32) receiving cyclic chemotherapy. Epogen is indicated in pediatric patients, ages 1 month to 16 years of age, for the treatment of anemia associated with CKD requiring dialysis. If the syringe package is undamaged, open the package and remove the syringe. 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery. 55513-126-01, For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. Intravenous route recommended for patients on hemodialysis (, Patients on Zidovudine due to HIV-infection: 100 Units/kg 3 times weekly (, Patients with Cancer on Chemotherapy: 40,000 Units weekly or 150 Units/kg 3 times weekly (adults); 600 Units/kg intravenously weekly (pediatric patients ≥ 5 years) (, Surgery Patients: 300 Units/kg per day daily for 15 days or 600 Units/kg weekly (, Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other erythropoietin protein drugs (, Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women  (, Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit (, Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer (, Hypertension: Control hypertension prior to initiating and during treatment with Epogen (, Seizures: Epogen increases the risk for seizures in patients with CKD (, PRCA: If severe anemia and low reticulocyte count develop during Epogen treatment, withhold Epogen and evaluate for PRCA (, Serious Allergic Reactions: Discontinue Epogen and manage reactions (, Severe Cutaneous Reactions: Discontinue Epogen (, 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 (, Patients on Zidovudine due to HIV-infection: Adverse reactions in ≥ 5% of Epogen-treated patients in clinical studies were pyrexia, cough, rash, and injection site irritation (, Patients with Cancer on Chemotherapy: Adverse reactions in ≥ 5% of Epogen-treated 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 (, 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 (. Do not reuse the single-dose vials, syringes, or needles. x�b```b``���������ǀ |@16� ���Y]�:��圔K�����b Patients on Cancer Chemotherapy, 2.6 It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. Treatment with Epogen 300 Units/kg significantly (p = 0.024) reduced the risk of allogeneic RBC transfusion in patients with a pretreatment hemoglobin of > 10 to ≤ 13 g/dL; 5/31 (16%) of patients treated with Epogen 300 Units/kg, 6/26 (23%) of patients treated with Epogen 100 Units/kg, and 13/29 (45%) of placebo-treated patients were transfused. Among 778 patients enrolled in the 3 clinical studies of Epogen for the treatment of anemia due to concomitant chemotherapy, 419 received Epogen and 359 received placebo. 55513-478-01, Instruct patients who self-administer Epogen of the: Manufactured by: 0000005467 00000 n In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. Increased mortality was observed in a randomized, placebo-controlled study of Epogen in adult patients who were undergoing CABG surgery (7 deaths in 126 patients randomized to Epogen versus no deaths among 56 patients receiving placebo). In clinical studies at starting doses of 50 to 150 Units/kg 3 times weekly, adult patients responded with an average rate of hemoglobin rise as presented in Table 8. Then draw air into the syringe by pulling back on the plunger. Following initiation and titration of Epogen, approximately 25% of patients on dialysis required initiation of or increases in antihypertensive therapy; hypertensive encephalopathy and seizures have been reported in patients with CKD receiving Epogen. An increased incidence of deep venous thrombosis (DVT) in patients receiving epoetin alfa undergoing surgical orthopedic procedures was demonstrated [see Adverse Reactions (6.1)]. • Dispose of the used syringe and needle as described below. Median overall survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC alone group (HR 1.07, 95% CI: 0.97, 1.18). Be sure the tip of the needle is in the Epogen liquid. 0 (current), epoetin alfa 10000 UNT/ML Injectable Solution [Epogen], EPO 10000 UNT/ML Injectable Solution [Epogen], Epogen (epoetin alfa 10,000 UNT/ML) Injectable Solution, Epogen (epoetin alfa 20,000 UNT per 2 ML) Injectable Solution, ERYTHROPOIETIN 10000 UNT/ML Injectable Solution [Epogen], 1 ML epoetin alfa 2000 UNT/ML Injection [Epogen], 1 ML ERYTHROPOIETIN 2000 UNT/ML Injection [Epogen], 1 ML epoetin alfa 3000 UNT/ML Injection [Epogen], 1 ML ERYTHROPOIETIN 3000 UNT/ML Injection [Epogen], 1 ML epoetin alfa 4000 UNT/ML Injection [Epogen], 1 ML ERYTHROPOIETIN 4000 UNT/ML Injection [Epogen], epoetin alfa 20000 UNT/ML Injectable Solution [Epogen], EPO 20000 UNT/ML Injectable Solution [Epogen], Epogen (epoetin alfa 20,000 UNT/ML) Injectable Solution, ERYTHROPOIETIN 20000 UNT/ML Injectable Solution [Epogen], 1 ML ERYTHROPOIETIN 2000 UNT/ML Injection, 1 ML ERYTHROPOIETIN 4000 UNT/ML Injection, epoetin alfa 10,000 UNT/ML Injectable Solution, epoetin alfa 10000 UNT/ML Injectable Solution, ERYTHROPOIETIN 10000 UNT/ML Injectable Solution, 1 ML ERYTHROPOIETIN 3000 UNT/ML Injection, epoetin alfa 20,000 UNT/ML Injectable Solution, epoetin alfa 20000 UNT/ML Injectable Solution, ERYTHROPOIETIN 20000 UNT/ML Injectable Solution, epoetin alfa 10,000 UNT in 1 ML Injection, 1 ML ERYTHROPOIETIN 10000 UNT/ML Injection, epoetin alfa 10,000 UNT per 1 ML Injection, 1 ML epoetin alfa 10000 UNT/ML Injection [Epogen], 1 ML ERYTHROPOIETIN 10000 UNT/ML Injection [Epogen], Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery (, In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy (, In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure (, In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion (, In patients scheduled for surgery who are willing to donate autologous blood (, In patients undergoing cardiac or vascular surgery (, As a substitute for RBC transfusions in patients who require immediate correction of anemia (, Evaluate iron status before and during treatment and maintain iron repletion. Of the 1085 patients who received Epogen, 582 (54%) were age 65 years and over, while 245 (23%) were 75 years and over. If your anemia caused by chemotherapy treatment can be managed by RBC transfusion. In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. Epogen is contraindicated in patients with: Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in: The design and overall results of the 3 large trials comparing higher and lower hemoglobin targets are shown in Table 1. In double-blind, placebo-controlled studies of 3 months duration involving approximately 300 zidovudine-treated patients with HIV-infection, adverse reactions with an incidence of ≥ 1% in patients treated with Epogen were: The data below were obtained in Study C1, a 16-week, double-blind, placebo-controlled study that enrolled 344 patients with anemia secondary to chemotherapy.       • Double-check that the correct amount of Epogen is in the syringe. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.

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+ How we made $200K with 4M downloads.

How we made $200K with 4M downloads.