EPOGEN Solution for injection (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

Amgen Inc

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1. Indications and Usage

1.1 Anemia Due to Chronic Kidney Disease Epogen is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for ...

2. Dosage and Administration

2.1 Important Dosing Information Evaluation of Iron Stores and Nutritional Factors Evaluate the iron status in all patients before and during treatment. Administer supplemental iron therapy when serum ...

3. Dosage Forms and Strengths

Injection: 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL of Epogen as a clear and colorless liquid in single-dose vials 20,000 Units/2 mL (10,000 Units/mL) and 20,000 Units/mL of ...

4. Contraindications

Epogen is contraindicated in patients with: Uncontrolled hypertension [see Warnings and Precautions (5.3)]. Pure red cell aplasia (PRCA) that begins after treatment with Epogen or other. ...

5. Warnings and Precautions

5.1 Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism In controlled clinical trials of patients with CKD comparing higher hemoglobin targets (13-14 g/dL) to lower targets (9-11.3 ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the label: Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ...

6.1. Clinical Trials 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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Epogen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

6.3. Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed ...

8.1. Pregnancy

Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women [see Contraindications (4)]. When therapy with Epogen is needed during pregnancy, ...

8.2. Lactation

Risk Summary Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in lactating women [see Contraindications (4), Warnings and Precautions (5.9)]. Advise a lactating woman ...

8.4. Pediatric Use

The multiple-dose vials are formulated with benzyl alcohol and are contraindicated for use in neonates and infants [see Contraindications (4), Warnings and Precautions (5.9)]. When therapy with ...

8.5. Geriatric Use

Of the 4553 patients who received Epogen in the 6 studies for treatment of anemia due to CKD not receiving dialysis, 2726 (60%) were age 65 years and over, while 1418 (31%) were 75 years and over. Of the ...

10. Overdosage

Epogen overdosage can cause hemoglobin levels above the desired level, which should be managed with discontinuation or reduction of Epogen dosage and/or with phlebotomy, as clinically indicated [see ...

11. Description

Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian ...

12.1. Mechanism of Action

Epogen stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.

12.2. Pharmacodynamics

Epogen increases the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. The rate of hemoglobin increase varies ...

12.3. Pharmacokinetics

In adult and pediatric patients with CKD, the elimination half-life (t1/2) of plasma erythropoietin after intravenous administration of Epogen ranged from 4 to 13 hours. After subcutaneous administration, ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Epogen has not been evaluated. Epogen was not mutagenic or clastogenic under the conditions tested: Epogen was negative in the in vitro bacterial reverse mutation ...

14. Clinical Studies

14.1 Patients With Chronic Kidney Disease Adult Patients on Dialysis Patients with chronic kidney disease on dialysis: ESA effects on rates of transfusion: In clinical studies of patients with CKD ...

16.1. How Supplied

Epogen (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation): 2,000 Units/mL (NDC 55513-126-10), ...

16.2. Storage and Handling

Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Do not use Epogen that has been shaken or frozen. Store Epogen vials in the original carton until use to protect from light.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Inform patients: Of the increased risks of mortality, serious cardiovascular reactions, ...