Retisert餂?
(fluocinolone acetonide intravitreal implant)
MATERIAL SAFETY DATA SHEET
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Effective Date: 6/2/05 Supersedes: None
Section 1: CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Product Name: Retisert餂? For Information: (9-011) 353-51-859631
(fluocinolone acetonide intravitreal implant) 0.59 mg For Emergency: 1-800-535-5053 or
Product Code: NDC 24208-416-01 1-352-323-3500
Chemical Family: Corticosteroid
Manufactured By: Bausch & Lomb - Ireland
Address: Unit 424/425
Industrial Estate
Waterford, Ireland
Section 2: COMPOSITION / INFORMATION ON INGREDIENTS
OCCUPATIONAL EXPOSURE LIMITS / GUIDELINES
OSHA PEL ACGIH TLV NIOSH REL IRELAND HSE
CAS # COMPONENT NAME % w/w TWA /STEL TWA /STEL TWA /STEL TWA /STEL TWA /STEL UNITS
Tablet Core
Active:
1
67-73-2 Fluocinolone Acetonide <6 NE NE NE NE NE NE NE NE NE NE NA
Inactives:
9002-89-5 Polyvinyl Alcohol (98% hydrolyzed) <5 NE NE NE NE NE NE NE NE NE NE NA
2 3
232-674-9 Microcrystalline Cellulose < 20 15*5** NE 10 NE 10*5** NE 10*4** 20 10*4** 20 mg/m
557-04-0 Magnesium Stearate <1 NE NE NE NE NE NE NE NE NE NE NA
7732-18-5 Purified Water <2 NE NE NE NE NE NE NE NE NE NE NA
Polymer Coating:
9002-89-5 Polyvinyl Alcohol (98% hydrolyzed) < 10 NE NE NE NE NE NE NE NE NE NE NA
NA Silicone Elastomer < 45 NE NE NE NE NE NE NE NE NE NE NA
NA Silicone Adhesive < 20 NE NE NE NE NE NE NE NE NE NE NA
Suture tab:
9002-89-5 Polyvinyl Alcohol (98% hydrolyzed) < 20 NE NE NE NE NE NE NE NE NE NE NA
1. Bausch & Lomb, Inc. has adopted an Occupational Exposure Limit, as established by SafeBridge Consultants, Inc., of 0.04 ug/m3 as an 8-hour TWA.
.
* Total Dust (as cellulose) ** Respirable Dust (as cellulose)
N/E: Not Established TWA: 8-Hour Time-Weighted Average
N/A: Not Applicable STEL: Short-Term Exposure Limit
OSHA: Occupational Safety & Health Administration C: Ceiling Limit
NIOSH: National Institute for Occupational Safety & Health REL: Recommended Exposure Limit
3
ACGIH: American Conference of Governmental Industrial Hygienists MG/M : Milligrams Per Cubic Meter
PPM: Parts Per Million
Retisert餂?
MATERIAL SAFETY DATA SHEET
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Section 3: HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW
Retisert餂? is a surgically implanted drug delivery system composed of a white to
off white central core consisting of 0.59 mg of fluocinolone acetonide (FA)
compressed into a tablet. The tablet is encased in a silicone elastomer cup
containing a release orifice and attached to a yellowish to light brown suture tab.
It is intended for the treatment of non-infectious posterior uveitis. It is
anticipated that implant contents may irritate skin, eyes, mucous membranes,
and other contaminated tissues. This product is contraindicated in individuals
with known or suspect hypersensitivity to any of the ingredients of this
preparation and to other corticosteroids. Use only in accordance with product
literature.
PRECAUTIONS:
Retisert餂? is a surgical implant, indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment
of the eye, and must be used in accordance with product literature. The active drug substance in this implant is a synthetic
corticosteroid (fluocinolone acetonide). This product is contraindicated in individuals with known or suspect
hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
The toxicological properties of this material have not been fully characterized; therefore, laboratory control systems and
work practices should be in place to minimize the potential for skin contact, eye contact, ingestion, and inhalation in the
event that the integrity of this implant becomes compromised or damaged. It is anticipated that implant contents may
irritate skin, eyes, and mucous membranes.
POTENTIAL HEALTH EFFECTS
EYE:
Non-irritating to the external surfaces of the eyes when used as directed. Implant contents are irritating to the eyes.
SKIN:
Non-irritating to the skin and mucous membranes when used as directed. Implant contents may cause allergic skin
reaction.
INGESTION:
Ingestion of the implant contents (i.e., through poor hygiene practices) may be harmful.
INHALATION:
If dusts of this material are inhaled, they may cause irritation of the nose and upper respiratory system. Symptoms of
such over exposure may include sneezing, coughing, and nasal congestion.
.
CHRONIC HEALTH EFFECTS
Refer to Section 11. The toxicological properties of this product have not been fully characterized.
Retisert餂?
MATERIAL SAFETY DATA SHEET
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Section 3: HAZARDS IDENTIFICATION (cont.)
TARGET ORGANS:
The toxicological properties of this material have not been fully investigated
Section 4: FIRST AID MEASURES
EYES:
In the event that the implant contents come in contact with the outside of the eye, immediately flush with plenty of water
for at least 15 minutes. Seek medical attention.
SKIN:
In the event that the implant contents come in contact with the skin, immediately wash with soap and flush with copious
amounts of water for at least 15 minutes while removing contaminated clothing and shoes. Wash clothing separately
before reuse. Seek medical attention.
INGESTION:
If this product is swallowed, obtain medical attention immediately.
INHALATION:
If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Seek
medical attention immediately.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE:
This product is contraindicated in individuals with known or suspect hypersensitivity to any of the ingredients of this
preparation and to other corticosteroids.
RECOMMENDATIONS TO PHYSICIANS:
Treat symptoms and eliminate overexposures.
Section 5: FIRE FIGHTING MEASURES
FLAMMABLE PROPERTIES:
Flash Point:
Not Flammable.
Autoignition Temperature:
Not Applicable.
Flammable Limits (in air by volume %):
Not Applicable
Retisert餂?
MATERIAL SAFETY DATA SHEET
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Section 5: FIRE FIGHTING MEASURES (cont.)
EXTINGUISHING MEDIA:
Use water spray or fog, foam, carbon dioxide, or dry chemical.
HAZARDOUS COMBUSTION PRODUCTS:
This material must be substantially pre-heated before ignition can occur. When involved in a fire, this material may
decompose and produce irritating vapors and toxic compounds (including carbon monoxide, carbon dioxide, and nitrogen
and sulfur oxides
SPECIAL FIRE FIGHTING INSTRUCTIONS:
Fire fighters must wear Self-Contained Breathing Apparatus and full protective equipment.
Section 6: ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE:
Undamaged Implants:
Use proper personal protection (refer to Section 8). Collect product and place in a suitable container and seal tightly.
Dispose of in accordance with Section 13.
Damaged Implants (with exposed contents):
Trained personnel using pre-planned procedures should respond to releases involving damaged or compromised
implants.
Proper protective equipment including PVC or other plastic gloves, safety glasses, and a disposable laboratory coat
should be used for cleaning up a damaged implant with exposed contents. Provide adequate ventilation. In the event that
dust is generated, a NIOSH-certified air-purifying respirator with HEPA cartridges may be permissible under certain
circumstances where airborne concentrations are expected to exceed exposure limits and when adequate oxygen is
present. Use a positive pressure air-supplied respirator if there is any potential for an uncontrolled release or any other
circumstances where air-purifying respirators may not provide adequate protection.
Prior to initiating cleanup, ensure that all sources of ignition have been eliminated. Exercise caution to avoid creating
dust. Use a vacuum equipped with HEPA filtration to vacuum up any visible particulate. DO NOT SWEEP. Wet a Kim
Wipe (or other suitable towelette) with a small amount of methanol to improve absorption of residual materials and
carefully wipe down the contaminated area. Rinse the area thoroughly with soapy water. Place all spill residues and
contaminated PPE in an appropriate, labeled container and seal. Dispose of in accordance with Section 13 of this
document.
Retisert餂?
MATERIAL SAFETY DATA SHEET
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Section 7: HANDLING AND STORAGE
STORAGE AND HANDLING PRACTICES:
Caution should be exercised in handling Retisert餂? in order to avoid damage to the implant, which may result in an increase
rate of drug release or inadvertent exposure to contents. Retisert餂? should be handled only by the suture tab, in
accordance with product literature.
Store in the original container at 15掳- 25掳 C (59掳-77掳F). Protect from freezing.
Section 8: EXPOSURE CONTROLS / PERSONAL PROTECTION
VENTILATON AND ENGINEERING CONTROLS:
No special ventilation requirements when used in accordance with product literature. Operations that may compromise
the integrity of the implant (crushing, cutting, etc.) must be conducted in a powder handling hood, with a verifiable airflow,
that is designed to accommodate potent drug compounds. Decontaminate work surfaces routinely to prevent
accumulation of dusts.
RESPIRATORY PROTECTION:
No respiratory protection required when handling implants in accordance with product literature.
EYE PROTECTION:
Use approved safety goggles or safety glasses.
HAND PROTECTION:
Handle implants in accordance with product literature. If an implant is damaged, use appropriate chemical resistant
gloves (i.e., PVC or other plastic glove materials).
ADDITIONAL PROTECTIVE CLOTHING & EQUIPMENT:
Disposable laboratory coat, emergency eye wash & shower units
Section 9: PHYSICAL AND CHEMICAL PROPERTIES
PHYSICAL PROPERTIES:
Appearance / Physical State: White to off-white tablet encased in a silicone elastomer cup
with a yellowish to light brown suture tab
Odor: Odorless
CHEMICAL PROPERTIES:
Boiling Point: Not Determined Melting Point: Not Determined
Vapor Pressure: Not Determined Vapor Density: Not Determined
Solubility (In Water): Insoluble Odor Threshold: Not Applicable
Solubility (In Methanol): Soluble Freezing Point: Not Determined
Evaporation Rate (n-BuAc=1) Not Applicable pH: Not Determined
Specific Gravity (H2O = 1): Not Determined Molecular Weight: Not Applicable
Retisert餂?
MATERIAL SAFETY DATA SHEET
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Section 10: STABILITY AND REACTIVITY
STABILITY:
Stable
INCOMPATIBLE MATERIALS AND CONDITIONS TO AVOID:
Avoid exposure to or contact with extreme temperatures, light, and incompatible chemicals.
HAZARDOUS POLYMERIZATION:
Will not occur.
HAZARDOUS DECOMPOSITION:
When exposed to extreme temperatures, this material may generate fluorine, magnesium oxide, carbon monoxide, carbon
dioxide, and nitrogen and sulfur oxides.
Section 11: TOXICOLOGICAL INFORMATION
RTECS No.: TU3830000
Fluocinolone Acetonide
ORL-RAT LD50: > 4 GM/KG
Toxicity Data:
ORL-MOUSE LD50: > 4 GM/KG
CARCINOGENICITY, MUTAGENICITY, REPRODUCTIVE EFFECTS:
Long-term animal studies have not been performed on Retisert餂? to evaluate the carcinogenic and mutagenic potential, or
the effect on fertility of fluocinolone acetonide.
Fluocinolone acetonide was not genotoxic in vitro in the Ames test, the mouse lymphoma TK assay, or in vivo in the
mouse bone marrow micronucleus assay.
PREGNANCY, TERATOGENIC EFFECTS: PREGNANCY CATEGORY C.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage
levels. Fluocinolone acetonide, when administered subcutaneously at a dose of 0.13 mg/kg/day (approximately 10,000
times the daily clinical dose of Retisert餂?), during days 6 to 18 of pregnancy in the rabbit, induced abortion at the end of the
third and at the beginning of the fourth gestational week. When administered subcutaneously to rats and rabbits during
gestation at a maternal toxic dose 50 碌g/kg/day (approximately 4,000 times the clinical dose or Retisert餂?), fluocinolone
acetonide caused abortions and malformations in a few surviving fetuses.
There are no adequate and well-controlled studies in pregnant women. Retisert餂? should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus.
Refer to product literature for additional information.
The toxicological effects of Retisert餂? have not been fully characterized.
Retisert餂?
MATERIAL SAFETY DATA SHEET
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Section 12: ECOLOGICAL INFORMATION
No data available on the environmental impact of this product.
Section 13: DISPOSAL CONSIDERATIONS
Waste disposal must be in accordance with appropriate Federal, State and local regulations.
Section 14: TRANSPORT INFORMATION
US DOT IATA IMO RID/ADR Canadian TDG
Shipping Name: Not Regulated* Not Regulated No information No information No information
available available available
Hazard Class: NA NA
UN Number: NA NA
Package Group: NA NA
There are no unreasonable risks (health, safety, or property), that this product would pose when transported in commerce.
Hazard class definitions (49 CFR, Part 173) are not applicable to this product.
Section 15: REGULATORY INFORMATION
FDA Designations:
Prescription Medication Only
NDC 24208-416-01 (0.59 mg)
OSHA HAZARD COMMUNICATION STANDARD (29 CFR 1910.1200):
Retisert餂? contents are considered hazardous under the Occupational Safety & Health Administration Hazard
Communication Standard.
CERCLA (Comprehensive Response Compensation, and Liability Act):
(Fluocinolone acetonide) Not Listed
SARA TITLE III (Superfund Amendments and Reauthorization Act):
鈥? SECTION 302 (Extremely Hazardous Substances): (Fluocinolone acetonide) Not Listed
鈥? SECTION 311/312 HAZARD CLASS(s): (Fluocinolone acetonide) Acute, Chronic
鈥? SECTION 313 (Toxic Chemicals): (Fluocinolone acetonide) Not Listed
TOXIC SUBSTANCE CONTROL ACT (TSCA):
CAS# 67-73-2, Fluocinolone Acetonide, is listed on the TSCA Inventory.
CAS# 9002-89-5, Polyvinyl Alcohol (98% hydrolyzed), is listed on the TSCA Inventory
CAS# 232-674-9, Microcrystalline Cellulose, is listed on the TSCA Inventory.
CAS# 557-04-0, Magnesium Stearate, is listed on the TSCA Inventory.
Retisert餂?
MATERIAL SAFETY DATA SHEET
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Section 15: REGULATORY INFORMATION (cont.)
CALIFORNIA PROPOSITION 65:
This product contains no listed substances known to the State of California to cause cancer, birth defects or other
reproductive harm, at levels that would require a warning under the statute.
Section 16: OTHER INFORMATION
LABEL PRECAUTIONARY STATEMENTS:
WARNING! THE TOXICOLOGICAL PROPERTIES OF THIS PRODUCT HAVE NOT BEEN FULLY INVESTIGATED.
USE ONLY IN ACCORDANCE WITH PRODUCT LITERATURE.
To the best of our knowledge, the information contained herein is accurate. However, neither Bausch & Lomb
Incorporated nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All
materials may present unknown hazards and should be used with caution. Although certain hazards are described
herein, we cannot guarantee that these are the only hazards that exist. NO WARRANTY, EXPRESS OR IMPLIED, OF
MERCHANTABILITY, FITNESS OR OTHERWISE IS MADE. In no event shall Bausch & Lomb Incorporated nor any of
its subsidiaries be liable for any special, incidental or consequential damages.
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