DIRECT THROMBIN INHIBITORS

DK-7419
GN-1600
MCI-9038
MD-805
(2R,4R)-4-methyl-1-[(S)-N(2)-{[(RS)-1,2,3,4-tetrahydro-3-methyl-8- quinolyl]sulfonyl}arginyl]pipecolic acid
C23-H36-N6-O5-S
CAS 74863-84-6 (anhydrous argatroban)
CAS 141396-28-3 (argatroban monohydrate)
BG-8967
Hirulog
C98-H138-N24-O33
CAS 128270-60-0
Dabigatran etexilate
Dabigatran etexilate mesylate
C34-H41-N7-O5 CH4-O3-S
CAS 211914-51-1 (Dabigatran)
CAS 211915-06-9 (Dabigatran etexilate)
CGP-39393
63-Desulfohirudin
Desulfatohirudin
Hirudo medicinalis isoform HV1
C287-H440-N80-O110-S6
CAS 120993-53-5
Efegatran
Hirudine
Inogatran
HBW-023
Hirudin, rekombiniert
Hirudo medicinalis isoform HV 1
Lepirudina
Lepirudine
Lepirudinum
rDNA-Hirudin
r-Hirudin
1-L-Leucine-2-L-threonine-63-desulfohirudin
C287-H440-N80-O111-S6
CAS 138068-37-8
Ro 46-6240
Melagatran
CAS 192939-46-1

ARGATROBAN

DK-7419
GN-1600
MCI-9038
MD-805
(2R,4R)-4-methyl-1-[(S)-N(2)-{[(RS)-1,2,3,4-tetrahydro-3-methyl-8- quinolyl]sulfonyl}arginyl]pipecolic acid
C23-H36-N6-O5-S
CAS 74863-84-6 (anhydrous argatroban)
CAS 141396-28-3 (argatroban monohydrate)

BG-8967
Hirulog
C98-H138-N24-O33
CAS 128270-60-0

Dabigatran etexilate
Dabigatran etexilate mesylate
C34-H41-N7-O5 CH4-O3-S
CAS 211914-51-1 (Dabigatran)
CAS 211915-06-9 (Dabigatran etexilate)

CGP-39393
63-Desulfohirudin
Desulfatohirudin
Hirudo medicinalis isoform HV1
C287-H440-N80-O110-S6
CAS 120993-53-5

Efegatran

Hirudine

Inogatran

HBW-023
Hirudin, rekombiniert
Hirudo medicinalis isoform HV 1
Lepirudina
Lepirudine
Lepirudinum
rDNA-Hirudin
r-Hirudin
1-L-Leucine-2-L-threonine-63-desulfohirudin
C287-H440-N80-O111-S6
CAS 138068-37-8

Ro 46-6240

Melagatran
CAS 192939-46-1

IDENTIFIERS

CAS REGISTRY NUMBER

128270-60-0(Bivalirudin)
138068-37-8(Lepirudin)

MOLECULAR FORMULA

ARGATROBAN: C23-H36-N6-O5-S.H2O
DABIGATRAN ETEXILATE MESYLATE: C34-H41-N7-O5 CH4-O3-S (Prod Info PRADAXA(R) oral capsules, 2011)
DESIRUDIN: C287-H440-N80-O110-S6

ERG GUIDE NUMBER

Editor's Note: An ERG guide with information appropriate to this material does not exist.

USES/FORMS/SOURCES

USES

ARGATROBAN is an anticoagulant used for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. It is also indicated for use in patients undergoing percutaneous coronary interventions with or at a risk for heparin-induced thrombocytopenia (Prod Info argatroban intravenous injection, 2014).
BIVALIRUDIN is an anticoagulant used in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty in conjunction with taking aspirin. It is also used in patients undergoing percutaneous coronary interventions and either have or at risk for heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome (Prod Info ANGIOMAX(R) intravenous injection, 2016).
DABIGATRAN is an oral direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It is also used to treat deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have received parenteral anticoagulants for 5 to 10 days, to decrease the risk of recurrent DVT and PE, and to prevent DVT and PE in patients who underwent hip replacement surgery (Prod Info PRADAXA(R) oral capsules, 2015).
DESIRUDIN is used for deep vein thrombosis prophylaxis, which may lead to pulmonary embolism, in patients undergoing elective hip replacement surgery (Prod Info IPRIVASK(R) subcutaneous injection, 2014).
LEPIRUDIN is used for anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease in order to prevent further thromboembolic complications (Prod Info Refludan (R), 2002).

According to the US Food and Drug Administration, Baxter Healthcare Corporation has made a decision to discontinue Refludan(R) (lepirudin (rDNA)) for Injection. No further product will be distributed after May 31, 2012.

MELAGATRAN/XIMELAGATRAN are investigational drugs used for anticoagulation purposes. Ximelagatran is a prodrug for the active metabolite melagatran and is the first oral direct thrombin inhibitor. It is pending FDA approval, although it has been approved for use in France (Hrebickova et al, 2003).

FORMS

ARGATROBAN is available as 250 mg/2.5 mL single use vial for intravenous infusion (Prod Info argatroban intravenous injection, 2014).
BIVALIRUDIN is available as a 250 mg vial containing a white lyophilized cake. When reconstituted with sterile water it is a clear to opalescent, colorless to slightly yellow solution (Prod Info ANGIOMAX(R) intravenous injection, 2016).
DABIGATRAN is available in 75 mg, 110 mg, and 150 mg capsules for oral use (Prod Info PRADAXA(R) oral capsules, 2015).
DESIRUDIN is available as a 15 mg (15.75 mg/vial) containing a white, freeze-dried powder with a pre-filled syringe containing a diluent (Mannitol USP 3% in Water for Injection) (Prod Info IPRIVASK(R) subcutaneous injection, 2014).
LEPIRUDIN is available as a 50 mg vial containing a white, freeze-dried powder (Prod Info Refludan (R), 2002).

According to the US Food and Drug Administration, Baxter Healthcare Corporation has made a decision to discontinue Refludan(R) (lepirudin (rDNA)) for Injection. No further product will be distributed after May 31, 2012.

SOURCES

BIVALIRUDIN is a synthetic agent derived from an amino acid peptide (Prod Info ANGIOMAX(R) intravenous injection, 2016).
DESIRUDIN is protein which is derived from yeast by recombinant DNA technology (Prod Info IPRIVASK(R) subcutaneous injection, 2014).
LEPIRUDIN is a synthetic recombinant hirudin derived from yeast cells (Prod Info Refludan (R), 2002).

-CLINICAL EFFECTS

GENERAL CLINICAL EFFECTS

USES: Direct thrombin inhibitors (DTIs) are used as anticoagulants. Argatroban, bivalirudin, desirudin, and lepirudin are used parenterally and are indicated for adjuvant anticoagulation for percutaneous cardiac interventions or as a substitution for heparin/low-molecular-weight heparins in cases of heparin-induced thrombocytopenia. Dabigatran etexilate is an oral medication approved for treatment of venous thromboembolism and stroke prophylaxis in atrial fibrillation.

PHARMACOLOGY: These agents directly inhibit thrombin, leading to inhibition of clot formation and stabilization.

TOXICOLOGY: The toxic effects are extensions of the pharmacologic effects and primarily include bleeding complications.

EPIDEMIOLOGY: Overdose data are limited. One patient, a 66-year-old man, ingested 9 g dabigatran in a suicide attempt and subsequently developed hypotension, bradycardia, and coagulopathy. Inpatient medication errors may occur in 1% to 2% of patients receiving DTIs. The incidence of overdose is likely to increase as new DTIs are approved for in-hospital parenteral use and oral anticoagulation indications.

WITH POISONING/EXPOSURE

MILD TO MODERATE TOXICITY: Bleeding complications that do not lead to cardiovascular compromise may be considered mild or moderate.
SEVERE TOXICITY: Bleeding complications that lead to hypotension or difficulty with oxygen delivery can be considered severe. Intracranial hemorrhage, hemothorax, cardiac tamponade, retroperitoneal hemorrhage, or massive gastrointestinal hemorrhage may occur even at therapeutic doses of DTIs. Allergic reactions have been reported.

WITH THERAPEUTIC USE

ADVERSE EFFECTS: COMMON: Hemorrhage, dyspepsia, back pain, nausea, vomiting, and diarrhea. LESS COMMON: Anemia, fever, hematomas, hematuria, gastrointestinal and rectal bleeding, epistaxis, intracranial bleeding, hypotension, cardiac arrest, dyspnea, cardiac dysrhythmias, abnormal hepatic and renal function, and hemothorax. RARE: Acute allergic reactions and formation of antihirudin antibodies have also been reported.

Editor's Note: An ERG guide with information appropriate to this material does not exist.

-FIRST AID

FIRST AID AND PREHOSPITAL TREATMENT

ORAL OVERDOSE: Administer activated charcoal within 1 to 2 hours of oral overdose with dabigatran etexilate to prevent absorption from the gastrointestinal tract (van Ryn et al, 2010).

ACTIVATED CHARCOAL

PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION

Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).

In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).

CHARCOAL DOSE

Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).

Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).

ADVERSE EFFECTS/CONTRAINDICATIONS

Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).

-RANGE OF TOXICITY

MINIMUM LETHAL EXPOSURE

ARGATROBAN

ANIMAL STUDIES: Single intravenous doses of 200, 124, 150 and 200 mg/kg were lethal to mice, rats, rabbits, and dogs, respectively (Prod Info Argatroban, 2003).

MAXIMUM TOLERATED EXPOSURE

ARGATROBAN

CASE REPORT: Following a successful mitral valve repair surgery, a 65-year-old man with ischemic and valvular heart disease was inadvertently given a large intravenous bolus of argatroban over a 1-hour period (approximately 225 mg; approximately 3.6 mg/kg) instead of 0.3 mcg/kg/min. Laboratory tests revealed an increase in aPTT and INR to levels exceeding the instrument range, followed by a gradual decline to the therapeutic target range over the next 2 days. In addition, his platelet count fell from 131 x 10(3)/mcL to 82 x 10(3)/mcL. A small amount of blood was found in the patient's stool; however, no evidence of blood in tracheal aspirates, urine, or at the wound or arterial/venous access sites was observed (Knoblauch et al, 2005).
CASE REPORT: A 74-year-old critically ill man with heparin-induced thrombocytopenia (HIT) accidentally received argatroban 125 mg over 1 hour (26 mcg/kg/min). Anticoagulant effect peaked one hour after exposure (PT greater than 50 seconds, PTT greater than 150 seconds). Although treatment with fresh frozen plasma (9 units total) was effective, the argatroban clearance was prolonged and PTT continued to be prolonged for 2 days after the overdose. He did not experience any bleeding complications (Yee & Kuter, 2006).

DABIGATRAN

No toxic dose has been established; however, in a phase II dose finding trial, patients were given a maximum of 600 mg (300 mg twice daily) with no major bleeding events reported. The incidence of total bleeding events was 13.3% (n=14 of 105)(Ezekowitz et al, 2007).
CASE REPORT: A 57-year-old woman showed no evidence of acute bleeding after intentionally ingesting 11.25 grams of dabigatran and an unknown amount of alprazolam, although initial laboratory studies indicated a slightly elevated INR of 1.3 (reference range 0.9 to 1.1) an activated partial thromboplastin time of 48.8 seconds (reference range 26.8 to 37.1 seconds), and a thrombin clot time measured at greater than 120 seconds (reference range 1.6 to 24.3 seconds). With supportive care, the patient's clinical course was uneventful with no signs of blood loss or evidence of a hematoma. On hospital day 4, she was transferred to an inpatient psychiatric unit for follow-up (Woo et al, 2013).
CASE REPORT: An 81-year-old man, with a history of atrial fibrillation, hypertension, macular degeneration, and moderate renal insufficiency (creatinine clearance of 52 mL/min), intentionally ingested 1650 mg of dabigatran (15 110-mg capsules). Laboratory data at admission (approximately 150 minutes post-ingestion) revealed an activated partial thromboplastin time (aPTT) of 79 seconds (normal 23 to 37 seconds), an INR of 3.3, a serum creatinine of 1.33 mg/dL, and a creatinine clearance of 44 mL/min. The patient showed no signs of acute bleeding. With conservative supportive treatment, including gastric lavage and activated charcoal decontamination, and administration of fresh frozen plasma, IV fluids, and furosemide, his coagulation parameters gradually improved, and he was discharged four days later without complications (Mumoli et al, 2015).
CASE REPORTS: Two women, a 55-year-old and a 21-year-old, presented to the ED after ingesting 1500 mg and 11,000 mg of dabigatran, respectively. Laboratory data revealed INRs of 4.8 and 3.6 international units, respectively (reference range, 0.9 to 1.3 international units), prothrombin times of 51 sec and 28.2 sec, respectively, aPTT 128 sec and 177 sec, respectively (normal 26 to 37 sec), and a thrombin clotting time of greater than 180 sec in both patients (normal less than 21 sec). Renal function was normal in both patients. Initial plasma dabigatran levels, measured approximately 3 hours post-ingestion, were greater than 1000 ng/mL and 750 ng/mL, respectively. The coagulation parameters gradually normalized approximately 3 days post-ingestion (Vlad et al, 2016).

Carcinogenicity Ratings for CAS128270-60-0 :

ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
EPA (U.S. Environmental Protection Agency, 2011): Not Listed
IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
MAK (DFG, 2002): Not Listed
NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

Carcinogenicity Ratings for CAS138068-37-8 :

ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
EPA (U.S. Environmental Protection Agency, 2011): Not Listed
IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
MAK (DFG, 2002): Not Listed
NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

TOXICITY AND RISK ASSESSMENT VALUES

EPA IRIS

EPA Risk Assessment Values for CAS128270-60-0 (U.S. Environmental Protection Agency, 2011):

Not Listed

EPA Risk Assessment Values for CAS138068-37-8 (U.S. Environmental Protection Agency, 2011):

Not Listed

TOXICITY VALUES

ARGATROBAN
- LD50- (INTRAVENOUS)DOG:
- LD50- (INTRAPERITONEAL)MOUSE:
- LD50- (INTRAVENOUS)MOUSE:
- LD50- (ORAL)MOUSE:
- LD50- (SUBCUTANEOUS)MOUSE:
- LD50- (INTRAPERITONEAL)RAT:
- LD50- (INTRAVENOUS)RAT:
- LD50- (ORAL)RAT:
- LD50- (SUBCUTANEOUS)RAT:
HIRUDIN
- LD50- (INTRAVENOUS)UNASSIGNED:
- TDLo- (INTRAVENOUS)GUINEA_PIG:

-STANDARDS AND LABELS

WORKPLACE STANDARDS

ACGIH TLV Values for CAS128270-60-0 (American Conference of Governmental Industrial Hygienists, 2010):

Not Listed

ACGIH TLV Values for CAS138068-37-8 (American Conference of Governmental Industrial Hygienists, 2010):

Not Listed

AIHA WEEL Values for CAS128270-60-0 (AIHA, 2006):

Not Listed

AIHA WEEL Values for CAS138068-37-8 (AIHA, 2006):

Not Listed

NIOSH REL and IDLH Values for CAS128270-60-0 (National Institute for Occupational Safety and Health, 2007):

Not Listed

NIOSH REL and IDLH Values for CAS138068-37-8 (National Institute for Occupational Safety and Health, 2007):

Not Listed

OSHA PEL Values for CAS128270-60-0 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):

Not Listed

OSHA PEL Values for CAS138068-37-8 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):

Not Listed

OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS128270-60-0 (U.S. Occupational Safety and Health Administration, 2010):

Not Listed

OSHA List of Highly Hazardous Chemicals, Toxics, and Reactives for CAS138068-37-8 (U.S. Occupational Safety and Health Administration, 2010):

Not Listed

ENVIRONMENTAL STANDARDS

EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS128270-60-0 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA CERCLA, Hazardous Substances and Reportable Quantities for CAS138068-37-8 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS128270-60-0 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA CERCLA, Hazardous Substances and Reportable Quantities, Radionuclides for CAS138068-37-8 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA RCRA Hazardous Waste Number for CAS128270-60-0 (U.S. Environmental Protection Agency, 2010b):

Not Listed
Editor's Note: The D, F, and K series waste numbers and Appendix VIII to Part 261 -- Hazardous Constituents were not included. Please refer to 40 CFR Part 261.

EPA RCRA Hazardous Waste Number for CAS138068-37-8 (U.S. Environmental Protection Agency, 2010b):

Not Listed
Editor's Note: The D, F, and K series waste numbers and Appendix VIII to Part 261 -- Hazardous Constituents were not included. Please refer to 40 CFR Part 261.

EPA SARA Title III, Extremely Hazardous Substance List for CAS128270-60-0 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA SARA Title III, Extremely Hazardous Substance List for CAS138068-37-8 (U.S. Environmental Protection Agency, 2010):

Not Listed

EPA SARA Title III, Community Right-to-Know for CAS128270-60-0 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):

Not Listed

EPA SARA Title III, Community Right-to-Know for CAS138068-37-8 (40 CFR 372.65, 2006; 40 CFR 372.28, 2006):

Not Listed

DOT List of Marine Pollutants for CAS128270-60-0 (49 CFR 172.101 - App. B, 2005):

Not Listed

DOT List of Marine Pollutants for CAS138068-37-8 (49 CFR 172.101 - App. B, 2005):

Not Listed

EPA TSCA Inventory for CAS128270-60-0 (EPA, 2005):

Not Listed

EPA TSCA Inventory for CAS138068-37-8 (EPA, 2005):

Not Listed

LABELS

NFPA

NFPA Hazard Ratings for CAS128270-60-0 (NFPA, 2002):

Not Listed

NFPA Hazard Ratings for CAS138068-37-8 (NFPA, 2002):

Not Listed

-PERSONAL PROTECTION

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

PROTECTIVE CLOTHING

CHEMICAL PROTECTIVE CLOTHING. Search results for CAS 128270-60-0.

Specific recommendations and test data for this chemical were not found in the available manufacturers' product literature. A complete list of consulted manufacturers and references is presented below.

CHEMICAL PROTECTIVE CLOTHING. Search results for CAS 138068-37-8.

Specific recommendations and test data for this chemical were not found in the available manufacturers' product literature. A complete list of consulted manufacturers and references is presented below.

-PHYSICAL HAZARDS

FIRE HAZARD

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

FLAMMABILITY CLASSIFICATION

NFPA Flammability Rating for CAS128270-60-0 (NFPA, 2002):

Not Listed

NFPA Flammability Rating for CAS138068-37-8 (NFPA, 2002):

Not Listed

FIRE CONTROL/EXTINGUISHING AGENTS

Editor's Note: An ERG guide with information appropriate to this material does not exist.

NFPA Extinguishing Methods for CAS128270-60-0 (NFPA, 2002):

Not Listed

NFPA Extinguishing Methods for CAS138068-37-8 (NFPA, 2002):

Not Listed

EVACUATION PROCEDURES

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

AIHA ERPG Values for CAS128270-60-0 (AIHA, 2006):

Not Listed

AIHA ERPG Values for CAS138068-37-8 (AIHA, 2006):

Not Listed

DOE TEEL Values for CAS128270-60-0 (U.S. Department of Energy, Office of Emergency Management, 2010):

Not Listed

DOE TEEL Values for CAS138068-37-8 (U.S. Department of Energy, Office of Emergency Management, 2010):

Not Listed

AEGL Values for CAS128270-60-0 (National Research Council, 2010; National Research Council, 2009; National Research Council, 2008; National Research Council, 2007; NRC, 2001; NRC, 2002; NRC, 2003; NRC, 2004; NRC, 2004; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; United States Environmental Protection Agency Office of Pollution Prevention and Toxics, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; 62 FR 58840, 1997; 65 FR 14186, 2000; 65 FR 39264, 2000; 65 FR 77866, 2000; 66 FR 21940, 2001; 67 FR 7164, 2002; 68 FR 42710, 2003; 69 FR 54144, 2004):

Not Listed

AEGL Values for CAS138068-37-8 (National Research Council, 2010; National Research Council, 2009; National Research Council, 2008; National Research Council, 2007; NRC, 2001; NRC, 2002; NRC, 2003; NRC, 2004; NRC, 2004; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; United States Environmental Protection Agency Office of Pollution Prevention and Toxics, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2009; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2008; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2007; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2005; National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances, 2006; 62 FR 58840, 1997; 65 FR 14186, 2000; 65 FR 39264, 2000; 65 FR 77866, 2000; 66 FR 21940, 2001; 67 FR 7164, 2002; 68 FR 42710, 2003; 69 FR 54144, 2004):

Not Listed

NIOSH IDLH Values for CAS128270-60-0 (National Institute for Occupational Safety and Health, 2007):

Not Listed

NIOSH IDLH Values for CAS138068-37-8 (National Institute for Occupational Safety and Health, 2007):

Not Listed

CONTAINMENT/WASTE TREATMENT OPTIONS

SUMMARY

Editor's Note: An ERG guide with information appropriate to this material does not exist.

SMALL LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

LARGE LEAK/SPILL

Editor's Note: An ERG guide with information appropriate to this material does not exist.

-PHYSICAL/CHEMICAL PROPERTIES

MOLECULAR WEIGHT

ARGATROBAN: 526.66 (Prod Info argatroban IV injection aqueous solution, 2011; Prod Info Argatroban intravenous injection solution, 2011)

BIVALIRUDIN: 2180 daltons (anhydrous free base peptide) (Prod Info ANGIOMAX(R) IV injection, 2010)

DABIGATRAN ETEXILATE: 627.75 (Prod Info PRADAXA(R) oral capsules, 2011)

DABIGATRAN ETEXILATE MESYLATE: 723.86 (Prod Info PRADAXA(R) oral capsules, 2011)

DESIRUDIN: 6963.52 (Prod Info Iprivask(R) subcutaneous injection powder, 2010)

LEPIRUDIN: 6979.5 daltons (Prod Info REFLUDAN(R) IV injection, 2006)

DESCRIPTION/PHYSICAL STATE

ARGATROBAN is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether (Prod Info Argatroban intravenous injection solution, 2011). The ready-to-use solution is a clear, colorless to pale yellow, aqueous solution (Prod Info argatroban IV injection aqueous solution, 2011).

BIVALIRUDIN vials contain a white lyophilized cake. The reconstituted solution is clear to opalescent, and colorless to slightly yellow (Prod Info ANGIOMAX(R) IV injection, 2010).

DABIGATRAN ETEXILATE MESYLATE is a yellow-white to yellow powder that is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL (Prod Info PRADAXA(R) oral capsules, 2011).

DESIRUDIN vials contain a white, freeze-dried powder (Prod Info Iprivask(R) subcutaneous injection powder, 2010).

LEPIRUDIN vials contain a white, freeze-dried powder (Prod Info REFLUDAN(R) IV injection, 2006).

ARGATROBAN: 3.2 to 7.5 (100 mg/mL solution after diluting to 1 mg/mL) (Prod Info Argatroban intravenous injection solution, 2011); approximately 8.8 (ready-to-use, 1 mg/mL solution) (Prod Info argatroban IV injection aqueous solution, 2011)

BIVALIRUDIN: 5 to 6 (reconstituted solution) (Prod Info ANGIOMAX(R) IV injection, 2010)

DESIRUDIN: 7.4 (reconstituted solution) (Prod Info Iprivask(R) subcutaneous injection powder, 2010)

LEPIRUDIN: approximately 7 (reconstituted solution) (Prod Info REFLUDAN(R) IV injection, 2006)

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National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances: Acute Exposure Guideline Levels (AEGLs) for Germane (Proposed). United States Environmental Protection Agency. Washington, DC. 2008j. Available from URL: http://www.regulations.gov/search/Regs/contentStreamer?objectId=0900006480963906&disposition=attachment&contentType=pdf. As accessed 2010-08-15.

National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances: Acute Exposure Guideline Levels (AEGLs) for Hexafluoropropylene (Proposed). United States Environmental Protection Agency. Washington, DC. 2006. Available from URL: http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064801ea1f5&disposition=attachment&contentType=pdf. As accessed 2010-08-15.

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DIRECT THROMBIN INHIBITORS

Classification | Information to evaluate chemical incidents

Information to evaluate chemical incidents

Information to evaluate chemical incidents

Information to evaluate chemical incidents