EPOGEN®

Safety Data Sheet

Revision Number: 5 Date Issued 09-Jan-2020

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE

COMPANY/UNDERSTANDING
1.1 Product identifier
Product Name: EPOGEN®
Common Name: Epoetin alpha
Chemical Name: Recombinant human erythropoietin
Synonyms: Epoetin alpha, r-HuEPO

1.2 Relevant identified uses of the substance or mixture and uses advised against
Recommended Use: Pharmaceutical
Uses advised against: No information available

Manufacturer: Emergency Telephone Number:

Amgen Inc. Chemtrec
One Amgen Center Drive NORTH AMERICA 1-800-424-9300,
Thousand Oaks, California 91320-1799 INTERNATIONAL 1-703-527-3887
1-805-447-7233
1-805-447-1000

2. HAZARDS IDENTIFICATION

Emergency Overview
Pharmaceutical product intended for clinical and commercial manufacturing purposes only. Product contains epoetin
alfa, a recombinant form of erythropoietin. Dosage form contents may pose a health hazard only if exposure occurs
to contents, e.g., after spill or leak. Repeated overexposure in manufacturing or from a significant spill may
potentially cause effects seen in patients administered the drug such as increased hematocrit and blood pressure.
Avoid inhalation, skin contact, eye contact, and ingestion. Does not meet GHS Classification Criteria and therefore is
not classified.

2.1 - Classification of the drug substance or mixture (drug product in final form, not applicable)
REGULATION (EC) No 1272/2008

Does not meet GHS Classification Criteria and therefore is not classified.

2.2 Label elements

Does not meet GHS Classification Criteria and therefore is not classified.

2.3 Other Hazards No information available

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 EPOGEN®
Safety Data Sheet
Revision Number: 5 Date Issued 09-Jan-2020
3. COMPOSITION/INFORMATION ON INGREDIENTS
3.1 Substances
Ingredients: Epoetin alfa drug product has three approved formulations: a single-dose citrate
formulation, a multidose citrate formulation, and a single-dose phosphate formulation:

- Single-dose citrate Epoetin alfa drug product is formulated at 2,000 U/mL, 3,000
U/mL,4,000 U/mL and 10,000 U/mL in 0.25% human serum albumin (HSA), sodium citrate
and sodium chloride.
- Multidose citrate Epoetin alfa drug product is formulated at 10,000 U/mL and 20,000
U/mL in 0.25% HSA, sodium citrate, sodium chloride and 1% benzyl alcohol.
- Single-dose phosphate Epoetin alfa drug product is formulated at 40,000 U/mL in 0.25%
HSA, sodium citrate, sodium phosphate and sodium chloride.

Chemical Name: Recombinant human erythropoietin

CAS-No: 113427-24-0

4. FIRST AID MEASURES

4.1 Description of first-aid measures
Eye Contact: In the case of contact with eyes, rinse immediately with plenty of water and seek medical
advice.

Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothes and
shoes. Consult a physician if necessary.

Inhalation: Move to fresh air. If symptoms persist, call a physician.

Ingestion: If symptoms persist, call a physician. Do not induce vomiting without medical advice. Never
give anything by mouth to an unconscious person.

Notes to Physician: Treat symptomatically.

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 EPOGEN®
Safety Data Sheet
Revision Number: 5 Date Issued 09-Jan-2020
5. FIRE-FIGHTING MEASURES

5.1 Extinguishing media

Flammable Properties: Not applicable/aqueous solution.

Extinguishing Media: Use extinguishing measures that are appropriate to local circumstances and the
surrounding environment.

5.2 Special hazards arising from the substance or mixture

Hazardous Combustion Products: None

5.3 Advice for firefighters

Protective Equipment and As in any fire, wear self-contained breathing apparatus pressure-demand, NIOSH
Precautions for Firefighters: (approved) and full protective gear.

6. ACCIDENTAL RELEASE MEASURES

6.1 Personal precautions, protective equipment and emergency procedures
Spill Procedures: If material is released or spilled, cordon off spill area. Take proper precautions to minimize
exposure by using appropriate personal protective equipment in cleaning up a spill. If in
powder form, wet down spilled material to minimize airborne dispersion. Soak up material
with absorbent e.g., paper towels, and wash spill area thoroughly with appropriate cleaning
materials. Dispose of collected material in accordance with applicable waste disposal
regulations. Avoid release to the environment.

7. HANDLING AND STORAGE

7.1 Precautions for Safe Handling
Handling and Storage: Avoid contact with skin, eyes or clothing. Do not eat, drink or smoke in work areas. Use
adequate ventilation to minimize exposure. Wash hands, face and other potentially
exposed areas immediately after handling this material. Remove contaminated clothing
prior to entering eating areas. Clean protective equipment thoroughly after each use. Store
in a well ventilated area.

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 EPOGEN®
Safety Data Sheet
Revision Number: 5 Date Issued 09-Jan-2020
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1 Control parameters
Occupational Exposure Limit: No exposure guidelines established by ACGIH, NIOSH or OSHA. Amgen recommends an
occupational exposure limit (OEL) of 30 µg/m3 as an 8-hour time weighted average over a
40-hour work week. The OEL is designed as an acceptable airborne concentration of a
substance for which it is believed that workers may be repeatedly exposed day after day
without adverse health effects. Epoetin alpha has been classified per Amgen's Hazard
Classification System as an Occupational Exposure Band 3 compound (20 µg/m3 - 100
µg/m3).

Engineering Controls: When practicable, handle material in enclosed processes or in processes with effective
local exhaust ventilation or within a chemical hood.

8.2 Exposure controls

Personal Protective Equipment

Eye/face Protection: Wear safety glasses with side shields, chemical splash goggles, or safety glasses with side
shields and a full-face shield to prevent contact with eyes. The choice of protection should
be based on the job activity and potential for exposure to the eyes and face.

Skin Protection: Use gloves or other appropriate personal protective equipment if skin contact with
formulation is possible. Wear lab coat or other protective over garment if splashing is
possible. The choice of protection should be based on the job activity and potential for skin
contact.

Respiratory Protection: When possible, handle material in enclosed processes or containers. If it is properly
handled with effective local exhaust ventilation or containment, respiratory protection may
not be needed. For procedures involving larger quantities or dust/aerosol generating
procedures such as weighing or a large transfer of liquids, an air-purifying respirator with
NIOSH approval for dusts and mists may be needed. The choice of protection should be
based on the job activity and the potential for exposure.

Other: Wash hands, face and other potentially exposed areas after handling material (especially
before eating, drinking or smoking). Clean protective equipment thoroughly after each use.

8.3 Environmental exposure controls

Environmental Exposure Controls Avoid release to the environment.

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 EPOGEN®
Safety Data Sheet
Revision Number: 5 Date Issued 09-Jan-2020
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance: Clear colorless
Physical State: Liquid
Molecular Weight: ~ 30,400 Daltons
Odor: No information available
Odor Threshold: No information available
pH: 6.1, 6.9
Melting Point: No information available
Boiling point 100 °C / 212 °F
Flash Point: Not applicable
Evaporation Rate: No information available
Lower explosive limit: No information available
Upper explosive limit: No information available
Vapor Pressure: No information available
Vapor Density (air = 1): Not applicable
Relative density: No information available
Water Solubility: No information available
Partition Coefficient (log Kow): No information available
Viscosity: No information available

10. STABILITY AND REACTIVITY

10.1 Reactivity No information available

10.2 Chemical stability Stable

10.3 Possibility of hazardous No information available

reactions

10.4 Conditions to avoid No Information available

10.5 Incompatible materials No information available

10.6 Hazardous No information available

decomposition products

10.7 Other information None

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 EPOGEN®
Safety Data Sheet
Revision Number: 5 Date Issued 09-Jan-2020
11. TOXICOLOGICAL INFORMATION

11.1 Information on toxicological effects

Acute Toxicity: No information available
Skin corrosion/irritation: Does not meet GHS Classification Criteria and therefore is not classified.
Serious eye damage/eye irritation: Does not meet GHS Classification Criteria and therefore is not classified.
Respiratory or skin sensitization: Does not meet GHS Classification Criteria and therefore is not classified.
Germ cell mutagenicity: Not genotoxic based on a battery of in vitro and in vivo studies. Based on data, the GHS
classification criteria are not met.
Carcinogenicity: Does not meet GHS Classification Criteria and therefore is not classified.
Reproductive toxicity: Does not meet GHS Classification Criteria and therefore is not classified.
STOT - single exposure: Does not meet GHS Classification Criteria and therefore is not classified.
STOT - repeated exposure: Does not meet GHS Classification Criteria and therefore is not classified.
Aspiration Hazard: No information available

12. ECOLOGICAL INFORMATION

12.1 Toxicity
Ecotoxicity effects: No information available

12.2 Persistence and degradability

Persistence/Degradability: No information available

12.3 Bioaccumulative potential

Bioaccumulation/ Accumulation: No information available

12.4 Mobility in soil

Mobility in Environmental Media: No information available

12.5 Results of PBT and vPvB assessment

Results of PBT and vPvB assessment: No information available

12.6 Other adverse effects

Other Adverse Effects: No information available

13. DISPOSAL CONSIDERATIONS

13.1 Waste treatment methods

Waste Disposal Method: Dispose of waste according to prescribed federal, state, local and competent authority
guidelines.

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 EPOGEN®
Safety Data Sheet
Revision Number: 5 Date Issued 09-Jan-2020
14. TRANSPORT INFORMATION
DOT: Not regulated by U.S. DOT, IATA, or IMDG.

15. REGULATORY INFORMATION

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
International Inventories

TSCA: -
EINECS/ELINCS -
DSL/NDSL -
PICCS: -
ENCS: -
CHINA: -
AICS: -
KECL: -

Legend
TSCA - United States Toxic Substances Control Act Section 8(b) Inventory
EINECS/ELINCS - European Inventory of Existing Commercial Chemical Substances/EU List of Notified Chemical Substances
DSL/NDSL - Canadian Domestic Substances List/Non-Domestic Substances List
PICCS - Philippines Inventory of Chemicals and Chemical Substances
ENCS - Japan Existing and New Chemical Substances
IECSC - China Inventory of Existing Chemical Substances
AICS - Australian Inventory of Chemical Substances
KECL - Korean Existing and Evaluated Chemical Substances

State Regulations

California Proposition 65: This product does not contain any Proposition 65 chemicals.

15.2 Chemical safety assessment

No CSA has been conducted.

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 EPOGEN®
Safety Data Sheet
Revision Number: 5 Date Issued 09-Jan-2020
16. OTHER INFORMATION

Revision Number: 5

To the best of our knowledge, the information provided here is accurate as of the date of the Safety Data Sheet (SDS). The
information is specific to the material that is the subject of this SDS and may not be valid when this material is used in
combination with any other materials or in any process. Each user should review the information provided here in the
context of the user’s intended manner of handling, using, processing, storing, transporting, and disposing of the
material.

This information is provided without warranty or guarantee of any kind, whether express, implied or statutory, including
without limitation warranty of fitness or merchantability for a particular purpose or noninfringement. No representation,
warranty, or guarantee is made, and no liability is assumed, with respect to the material or the information contained in
this SDS including without limitation its accuracy or completeness or the hazards of, or results obtained from, use of the
material or the information contained here. Caution should be used in the handling, using, processing, storing,
transporting, and disposing of the material.

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