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ALIMTA
Version 1.4 Revision Date 02/11/2011 Print Date 03/23/2012
Company
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Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 317-276-2000 CHEMTREC: 1-800-424-9300
Item Code
VL7623, VL7640
Emergency Overview
Lilly Lab Labeling Code Health: 2 Fire: 1 Reactivity: 0 Special: Reproductive Hazard Primary Hazards: Mutagen, Irritant (eyes, skin), Blood, Bone Marrow, Reproductive Hazard Summary (Caution): May cause heritable genetic damage. May cause eye and skin irritation. May cause blood effects. May cause bone marrow effects. This product may cause adverse reproductive effects. Emergency Overview Form Colour Odour Special: R
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May irritate eyes. May irritate skin. Skin rash has been reported in patients not pretreated with a 1/9
ALIMTA
Version 1.4 Revision Date 02/11/2011 cortiosteroid (dexamethasone). Aggravated Medical Condition Primary Routes of Entry Additional Information : : : None known. Inhalation Skin Absorption Decreased fetal weight and viability have been reported in animal studies with pemetrexed disodium. The active ingredient, pemetrexed, is a folic acid antimetabolite, this class of compounds is known to cause developmental effects. Effects of overexposure to pemetrexed disodium may include bone marrow suppression resulting in decreased blood cell counts, inflammation of mucous membranes, skin rash, fatigue, fetal effects, and reproductive tissue changes. Patients are instructed to take folic acid and vitamin B12 to reduce treatment-related toxicity. Print Date 03/23/2012
Carcinogenicity NTP No component of this product present at levels greater than or equal to 0.1% is identified as a known or anticipated carcinogen by NTP. IARC No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. OSHA No component of this product present at levels greater than or equal to 0.1% is identified as a carcinogen or potential carcinogen by OSHA.
Skin contact
Eye contact
Ingestion
Pemetrexed disodium - If overdose occurs, general supportive measures should be instituted as deemed necessary by the treating physician. Management of pemetrexed overdose should include consideration of the use of leucovorin or thymidine rescue. 2/9
ALIMTA
Version 1.4 Revision Date 02/11/2011 Print Date 03/23/2012 Patients are instructed to take folic acid and vitamin B12 to reduce treatment-related toxicity.
Suitable extinguishing media Unusual Fire and Explosion Hazard. Special protective equipment for fire-fighters
Water Carbon dioxide (CO2) Dry chemical Dust may form explosive mixture in air. Hazardous decomposition products formed under fire conditions. Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes.
Use double pairs of latex disposable gloves which must be disposed of within an hour, goggles, impermeable body covering, and approved HEPA-filtered or supplied-air respirator. If material spills occur in production area, use either wet clean-up methods, ensuring that no airborne dusts or aerosols are formed, or appropriate vacuum cleaners having high efficiency particulate air (HEPA) filters. It is recommended that areas handling final finished product have cytotoxic spill kits available. Spill kits should include impermeable body covering, shoe covers, latex and utility latex gloves, goggles, approved HEPA respirator, disposable dust pan and scoop, absorbent towels, spill control pillows, disposable sponges, sharps container, disposable garbage bag, and a hazardous waste label.
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ALIMTA
Version 1.4 Revision Date 02/11/2011 Print Date 03/23/2012
For appropriate handling precautions in specific laboratory, manufacturing, or clinical health care operations, consult with a health and safety or technical services representative. In clinical health care settings, follow OSHA Technical Manual, Section VI, Chapter 2 - Controlling Occupational Exposure to Hazardous Drugs. This chapter covers protection of employees during cytotoxic drug preparation, administration, disposal, and the handling of human waste products potentially contaminated with cytotoxic drug substances. GENERAL: For all work environments, wear eye protection and ELIMINATE hand-to-eye contact. Avoid skin contact, wear gloves, and take other appropriate precautions. Engineering measures Extensive local exhaust, ventilated enclosure (HEPA-filtered balance enclosure, fume hood, or Class II or III vertical flow biosafety cabinet), or enclosed process equipment. Personal protective equipment Respiratory protection : When the exposure guidelines may be exceeded, use an approved HEPA-filtered or supplied-air respirator. Goggles Face-shield Chemical-resistant gloves and impermeable 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. In production settings, airline-supplied, hood-type respirators are preferred. Shower and change clothing if skin contact occurs.
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Hygiene measures
ALIMTA
Version 1.4 Flash point Lower explosion limit Upper explosion limit : No data available : No data available : No data available Revision Date 02/11/2011 Water solubility Water solubility log Pow Print Date 03/23/2012 : 101.5 g/l(pH 7), (as free acid) : 89.4 g/l(pH 9), (as free acid) : <1
Hazardous reactions
No data available
Acute toxicity (other routes of administration) Intravenous - LD50 (male rat) 1,332 mg/kg Pemetrexed Disodium Convulsions. Heptahydrate: Intravenous - LD50 (female rat) > 1,574 mg/kg Convulsions. Mortality. Skin irritation Pemetrexed Disodium Heptahydrate: Eye irritation Pemetrexed Disodium Heptahydrate: Sensitisation 5/9
rabbit, Irritant
ALIMTA
Version 1.4 Pemetrexed Disodium Heptahydrate: Repeated dose toxicity Pemetrexed Disodium Heptahydrate: Revision Date 02/11/2011 Print Date 03/23/2012 No test data available. Skin rash has been reported in patients not pretreated with a cortiosteroid (dexamethasone).
Decreased testes weights with decreased sperm production and decreased red blood cells were reported in mice with intraperitoneal exposure for 6 weeks. Intravenous exposure in dogs for up to 6 months resulted in mortality, decreased white blood cell counts, mild anemia, and intestinal lesions.
Administration to pregnant mice resulted in decreased fetal weight, incomplete ossification of some skeletal structures, and cleft palate. Male reproductive toxicity characterized by reduced fertility, hypospermia, and testicular atrophy was observed when given to male mice.
Clastogenic in the in vivo micronucleus assay in the mouse. Results in genetic toxicity assays (in vitro): Negative.
Patients are instructed to take folic acid and vitamin B12 to reduce treatment-related toxicity.
EC50 / 72 h / Pseudokirchneriella subcapitata (green algae): 17 mg/l (yield) (as free acid) NOEC / 72 h / Pseudokirchneriella subcapitata (green algae): 4 mg/l 6/9
ALIMTA
Version 1.4 Revision Date 02/11/2011 Print Date 03/23/2012 (yield) (as free acid) EC50 / 72 h / Pseudokirchneriella subcapitata (green algae): 63 mg/l (average specific growth rate) (as free acid) NOEC / 72 h / Pseudokirchneriella subcapitata (green algae): 11 mg/l (average specific growth rate) (as free acid) Effects on micro-organisms Pemetrexed Disodium Heptahydrate
EC50 / 3 h / Respiration inhibition of activated sludge: > 1,000 mg/l (highest concentration tested) (as free acid) NOEC / 3 h / Respiration inhibition of activated sludge: 1,000 mg/l (highest concentration tested) (as free acid)
EC50 / 48 h/ Daphnia magna (Water flea) : 462.0 mg/l (as free acid) NOEC / 48 h/ Daphnia magna (Water flea) : 91.8 mg/l (as free acid)
EC50/ 21 d / Daphnia magna (Water flea) : 1.8 mg/l (reproduction) (as free acid) LOEC/ 21 d / Daphnia magna (Water flea) : 2.1 mg/l (as free acid) NOEC/ 21 d / Daphnia magna (Water flea) : 1.2 mg/l (as free acid)
Lilly Aquatic Exposure Guideline Drinking Water: 0.045 g/l Pemetrexed Disodium Heptahydrate (as disodium salt) Chronic Exposure of Aquatic Organisms: 1 g/l (as disodium salt) Acute Exposure of Aquatic Organisms: 16 mg/l (as disodium salt)
Hydrolysis: <10% degradation at 50C for 5 days in pH4, 7, and 9 buffers Ready Biodegradability: 20% of theoretical C was released as CO2 over 29 day incubation Biodegradation (sludge): >99% disappearance when incubated with 1.5 g/L sludge solids (24 hrs) Degradation in sludge: After 1 hr incubation 90% of pemetrexed had disappeared. Numerous degradation peaks were observed by HPLC/RAM. 18.4% applied radioactivity evolved as 14 CO2 over the 28-day study. Degradation in water-sediment systems: DT50 (days): <0.5 7/9
ALIMTA
Version 1.4 Revision Date 02/11/2011 Print Date 03/23/2012 Over 100 day study, 8.1 to 14.3% AR evolved as 14 CO2 Non extractable radioactive residues at Day 100: 100: 26.9% to 39.8% of applied radioactivity.Three major degradation products observed over 100 day study all of which were degraded over the duration of the study. Bioaccumulation Pemetrexed Disodium Heptahydrate
Refer to Section 9.
California Prop. 65 This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm. US. EPA Emergency Planning and Community Right-To-Know Act (EPCRA) SARA Title III Section 313 Toxic Chemicals (40 CFR 372.65) - Supplier Notification Required SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313. US. EPA Emergency Planning and Community Right-To-Know Act (EPCRA) SARA Title III Section 302 Extremely Hazardous Substance (40 CFR 355, Appendix A) SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
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ALIMTA
Version 1.4 Revision Date 02/11/2011 Print Date 03/23/2012
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