Material Safety Data Sheet
Biogen, Inc. 24-Hour Emergency Phone:
14 Cambridge Center 1 (800) 262 4363
Cambridge, MA 02142 Biogen Environmental Health & Safety:
(617) 679-2000 1 (617) 679 2236
Section 1. Identification
Product Name: Interferon beta-1a (bulk intermediate)
Chemical Name: Interferon beta-1a (bulk intermediate)
CAS Number: 145258-61-3
Substance: Interferon beta-1a is produced by recombinant DNA
technology. Interferon beta-1a is a 166 amino acid
glycoprotein with a predicted molecular weight of
approximately 22,500 daltons. It is produced by
mammalian cells (Chinese Hamster Ovary cells) into
which human interferon beta gene has been introduced.
The amino acid sequence of AVONEX®, is identical to
that of natural human interferon beta.
Other Names or Code Numbers: AVONEX®, BG9418, recombinant human
interferon beta, r-HuIFN-b.AVONEX®, BG9418, BG9317,
BG9216, BG9015, recombinant human interferon beta,
r-HuIFN-b, Betaferon, recombinant human fibroblast
interferon.
Section 2. Composition / Information on Ingredients
Components % Optional OSHA PEL ACGIH TLV OTHER STANDARDS
Interferon beta-1a None None None
Finished Drug Product Human Serum Albumin, USP 15.0 mg
Excipient Materials: Sodium Chloride, USP 5.8 mg
Dibasic Sodium Phosphate, USP 5.7 mg
Monobasic Sodium Phosphate, USP 1.2 mg
Section 3. Hazards Identification
General Statement: Interferon beta-1a is a recombinant form of a
naturally occuring protein. The final product is sold
as a prescription injectable drug.
Carcinogen Status: OSHA: No NTP: No IARC: No
Carcinogen Statement: No carcinogenicity data for interferon beta-1a
are available in animals or humans.
Mutagenic Effects: Interferon beta-1a was not mutagenic when
tested in the Ames bacterial mutagenicity test and in
an in vitro cytogenetic assay in human lymphocytes in
the presence and absence of metabolic activation.
Teratogenic Effects: No information.
Reproductive Effects: The reproductive toxicity of interferon beta-1a
has not been been studied in humans. In pregnant
monkeys given interferon beta at 100 times the
recommended weekly human dose, no teratogenic or other
adverse effects on fetal development were observed.
Abortifacient activity was evident following 3 to 5
doses at this level. No abortifacient effects were
observed in monkeys treated at 2 times the recommended
weekly human dose. Menstrual irregularities were
observed in monkeys administered a dose 100 times the
recommended weekly human dose. Treatment of monkeys
with interferon beta at 2 times the recommended weekly
human dose had no effects on cycle duration or
ovulation.
Neurotoxic Effects: No specific studies have been performed to
evaluate neurotoxicity. However, in repeat dose
toxicity studies in rhesus monkeys, no signs of
neurotoxicity were evident at doses up to 50 mcg/kg (10
MU/kg).
The most common adverse events associated with exposure
of humans to interferon beta-1a by intravenous,
subcutaneous or intramuscular injection are flu-like
symptoms, muscle ache, fever, chills and asthenia.
Doses of up to 90 mcg (18 MU) have been administered
subcutaneously in clinical trials.
Single doses of 200 mcg/kg (40 MU/kg) in rats and mice
and 90 mcg/kg (18 MU/kg) in guinea pigs have been
administered with no observed toxicity. Recombinant
human interferon beta-1a was well tolerated in rhesus
monkeys following repeat subcutaneous administration up
to 50 mcg/kg (10 MU/kg), excluding expected fever and
antibody production to both human serum albumin and
recombinant human interferon beta. Slight, but
reversible decreases in platelets were observed in
monkeys at the 50 mcg/kg dose level.
Human Serum Albumin, USP used in the formulation of
Biogen's finished drug product, is derived from human
plasma. Final product has been heated for 10 hours at
60 °C. The Human Serum Albumin meets the requirements
of the USP, EP and 21 CFR Part 640.81(e).
Section 4. First Aid Measures
If Inhaled: Remove to fresh air. Get medical attention. If
breathing has stopped, give artificial respiration.
Treat symptomatically and supportively.
If Swallowed: Wash out with water.
In Case of Skin or Eye Contact: No data available. May cause
irritation; flush with copious amounts of freely
flowing running water. If irritation persists, seek
medical care.
Skin Absorption: Limited available data indicates that interferon
beta-1a is not absorbed across intact skin.
If Injected: No data available
Medical Conditions Aggravated by Exposure: No data available.
Section 5. Fire Fighting Measures
Flash Point: No data available
Flammable Limits: n/a
Extinguishing Media: Use water spray, CO2, ABC dry chemical or foam.
Special Fire Fighting Materials: No special procedures.
Unusual Fire and Explosion Hazards: No data available.
Section 6. Accidental Release Measures
Interferon beta-1a is not a hazardous material as defined by the U.S. EPA.
No data available. Wear gloves to clean up a spill. No other special
procedures should be necessary.
Section 7. Handling and Storage
No special safety precautions are required. For final product quality
assurance, vials must be stored in a 2 - 8 °C (36 - 46 °F) refrigerator.
Should refrigeration be unavailable, AVONEX® can be stored at 25 °C (77
°F) for a period of up to 30 days. DO NOT EXPOSE TO HIGH TEMPERATURES.
DO NOT FREEZE. Following reconstitution, it is recommended the product be
used as soon as possible within 6 hours stored at 2 - 8 °C (36 - 46 °F).
Section 8. Exposure Control / Personal Protection
Wear gloves, lab coat, and safety glasses to prevent skin and eye contact.
Section 9. Physical and Chemical Properties
Molecular Formula: 166 amino acid glycoprotein
Molecular Weight: approximately 22,500 daltons
Appearance/Odor: White to off-white lyophilized powder/odorless
Solubilities: Water, phospate buffered saline
Boiling Point: Approximately 100 °C
Melting Point: Approximately 0 °C
Vapor Pressure (mm HG): N/A
Vapor Density (Air = 1): N/A
Specific Gravity (H(2)0 = 1): N/A
pH:
Section 10. Stability and Reactivity
Interferon beta-1a is Stable
Hazardous Polymerization: Will Not Occur
Incompatible Materials: No data available
Conditions to Avoid: No special safety precautions required. See
above statement.
Hazard Decomposition Products: No data available.
Section 11. Toxicology Information
THE CHEMICAL, PHYSICAL AND TOXICOLOGICAL PROPERTIES OF INTERFERON BETA-1a
HAVE NOT BEEN THOROUGHLY INVESTIGATED.
Refer to Section 3.
Section 12. Ecological Information
No data available. Interferon beta-1a (bulk intermediate) is not a
regulated hazardous material.
Section 13. Disposal Considerations
Interferon beta-1a (bulk intermediate) is not a regulated hazardous
material. Follow federal, state and local environmental regulations for
disposal.
Section 14. Transport Information
DOT Proper Shipping Name: n/a
Hazard Class: n/a
ID #: n/a
Section 15. Regulatory Information
No data available.
Section 16. Other Information
MSDS Created: 2-May-96
Revised: 24-Apr-97
Prepared By: Susan B. Lee, CIH
Manager, Environmental Health and Safety
DISCLAIMER: The above mentioned data are based on Biogen's best present
knowledge of this product. Biogen cannot guarantee completeness or
accuracy of the information contained herein, and disclaims all liability
for incompleteness or inaccuracy of the information and for any claims of
damages arising from handling or use of this product.