Epoetin alfa
Epoetin alfa (Epogen, Procrit, both manufactured by Amgen) is available as a preservative-free, citrate-buffered injection solution in 1-mL single-dose vials containing 2000, 3000, 4000, or 10,000 units/mL of epoetin alfa.4030; 4031 Each mL also contains albumin human 2.5 mg, citric acid 0.06 mg, sodium chloride 5.9 mg, and sodium citrate 5.8 mg in water for injection.4030; 4031
Epoetin alfa (Procrit) is also available as a preservative-free, phosphate-buffered injection solution in 1-mL single-dose vials containing 40,000 units/mL of epoetin alfa.4031 Each mL also contains albumin human 2.5 mg, citric acid 0.0068 mg, sodium chloride 5.8 mg, sodium citrate 0.7 mg, sodium phosphate dibasic anhydrate 1.8 mg, and sodium phosphate monobasic monohydrate 1.2 mg in water for injection.4031
Epoetin alfa (Epogen, Procrit) is also available with benzyl alcohol as a preservative as a 10,000 units/mL injection solution in 2-mL multiple-dose vials, or a 20,000 units/mL injection solution in 1-mL multiple-dose vials.4030; 4031 Each mL contains epoetin alfa 10,000 or 20,000 units with benzyl alcohol 1%, albumin human 2.5 mg, sodium chloride 8.2 mg, citric acid 0.11 mg, and sodium citrate 1.3 mg in water for injection.4030; 4031
Epoetin alfa-epbx
Epoetin alfa-epbx (Retacrit) is biosimilar to epoetin alfa (Epogen, Procrit).4034 Epoetin alfa-epbx (Retacrit) is available as a preservative-free injection solution in 1-mL single-dose vials containing 2000, 3000, 4000, 10,000, or 40,000 units/mL of epoetin alfa-epbx.4034 Each mL also contains calcium chloride dihydrate 0.01 mg, glycine 7.5 mg, isoleucine 1 mg, leucine 1 mg, L-glutamic acid 0.25 mg, phenylalanine 0.5 mg, polysorbate 20 0.1 mg, and threonine 0.25 mg with sodium chloride, sodium phosphate dibasic anhydrous, and sodium phosphate monobasic monohydrate (2.2, 5.7, and 1.5 mg, respectively, in the 40,000-units/mL solution and 2.4, 4.9, and 1.3 mg, respectively, in all other strengths of the preservative-free solutions) in water for injection.4034 Sodium hydroxide and hydrochloric acid may have been added for pH adjustment.4034
Epoetin alfa-epbx (Retacrit) is also available with benzyl alcohol as a preservative as a 10,000 units/mL injection solution in 2-mL multiple-dose vials, and a 20,000 units/mL injection solution in 1-mL multiple-dose vials.4034 Each mL contains epoetin alfa-epbx 10,000 or 20,000 units with benzyl alcohol 8.5 mg, L-methionine 0.45 mg, polysorbate 20 0.04 mg, sodium phosphate dibasic anhydrous 0.09 mg, sodium phosphate monobasic monohydrate 2.67 mg, and sucrose 60 mg in water for injection.4034 Sodium hydroxide and hydrochloric acid may have been added for pH adjustment.4034
pH
Epoetin alfa (Epogen, Procrit) single-dose vials (preservative-free): 6.6 to 7.2.4030; 4031
Epoetin alfa (Epogen, Procrit) multiple-dose vials (with benzyl alcohol): 5.8 to 6.4.4030; 4031
Epoetin alfa-epbx (Retacrit) single-dose vials (preservative-free): 7 to 7.5.4034
Epoetin alfa-epbx (Retacrit) multiple-dose vials (with benzyl alcohol): 5.6 to 6.6.4034
Tonicity
Epoetin alfa injection is isotonic.4030; 4031
Trade Name(s)
Epogen, Procrit, Retacrit
Epoetin alfa products are administered by intravenous or subcutaneous injection.4030; 4031; 4034 In general, injection solutions should not be diluted; however, for subcutaneous injection, epoetin alfa (Epogen, Procrit) preservative-free solutions may be diluted in a syringe at the time of administration using aseptic technique with an equal quantity (1:1 ratio) of bacteriostatic sodium chloride 0.9% containing benzyl alcohol 0.9% to help minimize discomfort at the subcutaneous injection site.4030; 4031; 4032 The manufacturer of Epogen/Procrit states allowing the vials to reach room temperature prior to subcutaneous injection may decrease some of the pain associated with subcutaneous administration.4032
Epoetin alfa injection products are clear, colorless solutions.4030; 4031; 4034 Intact vials should be stored at 2 to 8°C in the original carton to protect from light.4030; 4031; 4034 Do not shake or freeze; solutions that have been shaken or frozen should not be used.4030; 4031; 4034 Although refrigerated storage is required, epoetin alfa (Epogen, Procrit) in intact single-dose and multiple-dose vials showed no significant degradation or loss of activity when exposed to elevated temperatures not exceeding 30°C for up to 72 hours, protected from light.4032 Manufacturer data indicate that epoetin alfa-epbx (Retacrit) in multiple-dose vials was stable after exposure to 25°C for 24 hours followed by storage at 2 to 8°C for 6 weeks.4035 In addition, epoetin alfa-epbx (Retacrit) in single-dose vials was stable for up to 1 month at 25°C.4035
Multiple-dose vials contain a preservative and, after initial vial entry, should be stored at 2 to 8°C and discarded after 21 days.4030; 4031; 4034
Single-dose vials contain no preservative; after initial vial entry, vials should not be re-entered and any unused portion should be discarded.4030; 4031; 4034
Usually, epoetin alfa should not be diluted and transferred to new containers or admixed with other drugs and solutions because of possible protein loss from adsorption to PVC containers and tubing. However, when 10,000-unit/mL single-use product is diluted in the original vial with benzyl alcohol-preserved sodium chloride 0.9% injection to a concentration of 4000 units/mL for subcutaneous use, it is stated to be stable for at least 12 weeks stored at 5 and 30°C. Furthermore, the final benzyl alcohol concentration of 0.54% enabled the dilution to pass the USP preservative effectiveness test.1905 Restriction of this dilution to 28 days used as a multiple-dose vial has been recommended.1906 Higher concentrations of epoetin alfa (e.g., 5000 units/mL), which would have lower benzyl alcohol concentrations, were found to fail the preservative effectiveness test.1905
Syringes
Epoetin alfa (Procrit) 40,000-units/mL in single-dose vials drawn into plastic 1-mL tuberculin syringes (Becton-Dickinson) with 25 gauge needles was reported to be stable for 3 weeks at either 4°C or 27 to 30°C, protected from light.4033
Epoetin alfa (Procrit) 10,000 units/mL in 2-mL multiple-dose vials drawn into plastic 1-mL tuberculin syringes (Becton-Dickinson) was reported to undergo no significant degradation or loss of activity in 24 hours at 2 to 8°C.4033
Epoetin alfa (Amgen) 20,000 units/1 mL was packaged in 1-mL hubless Medsaver (Becton Dickinson) plastic syringes and stored under refrigeration for six weeks. No loss of epoetin alfa biological activity was found.2472
For a list of references cited in the text of this monograph, search the monograph titled References.