Drotrecogin Alfa (Activated) for Injection Page 1 of 7
Drotrecogin Alfa (Activated)
for Injection
Eli Lilly and Company Effective Date: 18-Jul-2001
Material Safety Data Sheet
Section 1 - Chemical Product and Company
Manufacturer's Emergency Phone:
Manufacturer:
1-317-276-2000
Eli Lilly and Company
CHEMTREC:
Lilly Corporate Center
1-800-424-9300 (North America)
Indianapolis, IN 46285
1-703-527-3887 (International)
Common Name: Drotrecogin Alfa (Activated) for Injection
Chemical Name: Blood-coagulation factor XIVa
Synonym(s): 203638 Formulation; APC Vial; Blood-coagulation Factor XIVa Vial; Recombinant
Human Activated Protein C Vial; Recombinant Human Activated Protein C for Injection; rhAPC Vial
Trademarks(s): Bicade; Cyvade; Vicade; Xigris; Xigrys; Xygris; Xygrys; Zovant; Zyvast
Lilly Item Code(s): VL7559; VL7560; VL7561
See attached glossary for abbreviations.
Section 2 - Composition / Information on Ingredients
Ingredient CAS Concentration %
Drotrecogin Alfa (Activated) 42617-41-4 6-8
Excipients NA 92 - 94
Contains no hazardous components (one percent or greater) or carcinogens (one-tenth percent or
greater) not listed above.
Exposure Guidelines: Drotrecogin alfa (activated) - LEG 250 micrograms/m3 TWA (respirable) for 8
or 12 hours, 800 micrograms/m3 TWA (respirable) for 15 minutes STEG.
Section 3 - Hazards Identification
Appearance: White to off-white lyophilized powder
Physical State: Solid
Odor: Odorless
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Emergency Overview
Emergency Overview Effective Date: 18-Jul-2001
Lilly Laboratory Labeling Codes:
Health 0 Fire 1 Reactivity 0
Primary Physical and Health Hazards: Blood Effects.
Caution Statement: Effects of exposure to Drotrecogin Alfa (Activated) for Injection may include
delayed clotting.
Routes of Entry: Inhalation and skin contact.
Effects of Overexposure: Effects of exposure may include delayed clotting. Drotrecogin alfa
(activated) is not expected to be active orally.
Medical Conditions Aggravated by Exposure: Hemophilia and individuals on coumadin, heparin, or
other anticoagulant therapy.
Carcinogenicity: Drotrecogin alfa (activated) - No carcinogenicity data found. Not listed by IARC,
NTP, ACGIH, or OSHA.
Section 4 - First Aid Measures
Eyes: Hold eyelids open and flush with a steady, gentle stream of water for 15 minutes. See an
ophthalmologist (eye doctor) or other physician immediately.
Skin: Remove contaminated clothing and clean before reuse. Wash all exposed areas of skin with
plenty of soap and water. Get medical attention if irritation develops.
Inhalation: Move individual to fresh air. Get medical attention if breathing difficulty occurs. If not
breathing, provide artificial respiration assistance (mouth-to-mouth) and call a physician immediately.
Ingestion: Call a physician or poison control center. No first aid procedures are normally required.
Section 5 - Fire Fighting Measures
Flash Point: No applicable information found
UEL: No applicable information found
LEL: No applicable information found
Extinguishing Media: Use water, carbon dioxide, dry chemical, foam, or Halon.
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Unusual Fire and Explosion Hazards: As a finely divided material, may form dust mixtures in air
which could explode if subjected to an ignition source.
Hazardous Combustion Products: May emit toxic fumes when exposed to heat or fire.
Section 6 - Accidental Release Measures
Spills: Vacuum material with appropriate dust collection filter in place. Be aware of potential for dust
explosion when using electrical equipment. If vacuum is not available, lightly mist material and remove
by sweeping or wet wiping. Wear protective equipment, including eye protection, to avoid exposure
(see Section 8 for specific handling precautions).
Section 7 - Handling and Storage
Storage Conditions: Refrigerator: 2 to 8 C (36 to 46 F). Protect unreconstituted vials from light.
Section 8 - Exposure Controls / Personal Protection
See Section 2 for Exposure Guideline information.
Respiratory Protection: Use an approved respirator.
Eye Protection: Chemical goggles and/or face shield.
Ventilation: Laboratory fume hood or local exhaust ventilation.
Other Protective Equipment: Chemical-resistant gloves and body covering to minimize skin
contact. If handled in a ventilated enclosure, as in a laboratory setting, respirator and goggles or face
shield may not be required. Safety glasses are always required.
Section 9 - Physical and Chemical Properties
Appearance: White to off-white lyophilized powder
Odor: Odorless
Boiling Point: No applicable information found
Melting Point: No applicable information found
Specific Gravity: No applicable information found
pH: No applicable information found
Evaporation Rate: No applicable information found
Water Solubility: Soluble
Vapor Density: No applicable information found
Vapor Pressure: No applicable information found
Section 10 - Stability and Reactivity
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Stability: Stable at normal temperatures and pressures.
Incompatibility: May react with strong oxidizing agents (e.g., peroxides, permanganates, nitric acid,
etc.).
Hazardous Decomposition: May emit toxic fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Section 11 - Toxicological Information
Acute Exposure
No data available for mixture or formulation. Data for ingredient(s) or related material(s) are
presented.
Oral: No applicable information found.
Skin: No applicable information found.
Inhalation: No applicable information found.
Intravenous: Drotrecogin alfa (activated)- Monkey, median lethal dose between 5 mg/kg and 25 mg/kg,
hemorrhage, vascular inflammation, thrombus, embolism, decreased activity.
Skin Contact: No applicable information found.
Eye Contact: Drotrecogin alfa (activated)- Cell culture test, nonirritant
Chronic Exposure
No data available for mixture or formulation. Data for ingredient(s) or related material(s) are
presented.
Target Organ Effects: Drotrecogin alfa (activated) - Blood effects (hemorrhage due to delayed clotting
time).
Reproduction: No studies available for drotrecogin alfa (activated). Fertility and teratology studies
conducted with a similar recombinant activated Protein C molecule reported no adverse maternal,
reproductive, or developmental changes.
Sensitization: Drotrecogin alfa (activated) - Monkey, intravenous, negative hypersensitivity.
Mutagenicity: Drotrecogin alfa (activated) - Negative in chromosomal aberration and mouse
micronucleus assays.
Section 12 - Ecological Information
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No applicable ecological information found.
Section 13 - Disposal Considerations
Waste Disposal: Dispose of any cleanup materials and waste residue according to all applicable laws
and regulations.
Section 14 - Transport Information
Regulatory Organizations:
DOT: Not Regulated
ICAO/IATA: Not Regulated
IMO: Not Regulated
Section 15 - Regulatory Information
Below is selected regulatory information chosen primarily for possible Eli Lilly and Company
usage. This section is not a complete analysis or reference to all applicable regulatory
information. Please consider all applicable laws and regulations for your country/state.
U.S. Regulations
Drotrecogin alfa (activated)
TSCA - No
CERCLA - Not on this list
SARA 302 - Not on this list
SARA 313 - Not on this list
OSHA Substance Specific - No
EU Regulations
EC Classification
Not assigned an overall EC classification.
Section 16 - Other Information
MSDS Sections Revised: MSDS Name and sections 1, 2, 3, 7, 11, and 15.
Emergency Overview Sections Revised: New caution.
As of the date of issuance, we are providing available information relevant to the handling of this
material in the workplace. All information contained herein is offered with the good faith belief that it
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is accurate. THIS MATERIAL SAFETY DATA SHEET SHALL NOT BE DEEMED TO CREATE
ANY WARRANTY OF ANY KIND (INCLUDING WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE). In the event of an adverse incident associated with this
material, this safety data sheet is not intended to be a substitute for consultation with appropriately
trained personnel. Nor is this safety data sheet intended to be a substitute for product literature which
may accompany the finished product.
For additional information contact:
Eli Lilly and Company
Hazard Communication
317-277-6029
GLOSSARY:
ACGIH = American Conference of Governmental Industrial Hygienists
AIHA = American Industrial Hygiene Association
BEI = Biological Exposure Index
CAS Number = Chemical Abstract Service Registry Number
CERCLA = Comprehensive Environmental Response Compensation and Liability Act (of 1980)
CHAN = Chemical Hazard Alert Notice
CHEMTREC = Chemical Transportation Emergency Center
DOT = Department of Transportation
EC = European Community
EINECS = European Inventory of Existing Chemical Substances
ELINCS = European List of New Chemical Substances
EPA = Environmental Protection Agency
HEPA = High Efficiency Particulate Air (Filter)
IARC = International Agency for Research on Cancer
ICAO/IATA = International Civil Aviation Organization/International Air Transport Association
IEG = Lilly Interim Exposure Guideline
IMO = International Maritime Organization
Kow = Octanol/Water Partition Coefficient
LEG = Lilly Exposure Guideline
LEL = Lower Explosive Limit
MSDS = Material Safety Data Sheet
MSHA = Mine Safety and Health Administration
NA = Not Applicable, except in Section 14 where NA = North America
NADA = New Animal Drug Application
NAIF = No Applicable Information Found
NCI = National Cancer Institute
NIOSH = National Institute for Occupational Safety and Health
NOS = Not Otherwise Specified
NTP = National Toxicology Program
OSHA = Occupational Safety and Health Administration
PEL = Permissible Exposure Limit (OSHA)
RCRA = Resource Conservation and Recovery Act
RQ = Reportable Quantity
RTECS = Registry of Toxic Effects of Chemical Substances
SARA = Superfund Amendments and Reauthorization Act
STEG = Lilly Short Term Exposure Guideline
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STEL = Short Term Exposure Limit
TLV = Threshold Limit Value (ACGIH)
TPQ = Threshold Planning Quantity
TSCA = Toxic Substances Control Act
TWA = Time Weighted Average/8 Hours Unless Otherwise Noted
UEL = Upper Explosive Limit
UN = United Nations
WEEL = Workplace Environmental Exposure Level (AIHA)
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