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In Business 29 Years - Since 1980		THE CURRENT TIME at LC Labs is:

R-7199 Rivaroxaban, >99%

[BAY-59-7939] [D07086] [Xarelto] [BAY 59-7939] [BAY59-7939]

M.W. 435.88

C19H18ClN3O5S

[366789-02-8]

M.I. 14:  10348

Storage:  Store at or below -20 ºC.  Solubility:  Soluble in DMSO at 12.5 mg/mL with slight warming; very poorly soluble in ethanol; very poorly soluble in water; maximum solubility in plain water is estimated to be about 20-50 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility.  Disposal:  A

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• Rivaroxaban is an oral anticoagulant and a direct inhibitor of coagulation Factor Xa.

• Rivaroxaban produces anticoagulant effects by inhibiting free and clot-bound factor Xa and thus preventing the conversion of factor II to factor IIa, resulting in decreased generation of thrombin.  Kubitza, D., et al.  "Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects."  Eur. J. Clin. Pharmacol. 61:  873-880 (2005).

• Rivaroxaban dose-dependently inhibited factor Xa activity from 20% to 61% at doses of 5 to 80 mg in 108 healthy white male volunteers.  The inhibition of factor Xa lasted for five to twelve hours with a maximum effect occurring one to four hours after administration.  Kubitza, D., et al.  "Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor." Clin. Pharmacol. Ther.  78: 412-421 (2005).

• Rivaroxaban is absorbed rapidly after oral administration, with bioavailability of 60% to 80% and peak concentrations at one to four hours.  Rivaroxaban is metabolized by hepatic cytochrome P450 isoenzyme 3A4.  The drug is excreted rapidly via a combination of renal, fecal and biliary routes.  The half-life of rivaroxaban is five to nine hours at doses ranging from 5 mg daily to 30 mg twice daily.  Kubitza, D., et al.  "Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects." Eur. J. Clin. Pharmacol.  61: 873-880 (2005).  Kubitza, D., et al.  "Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor."  Clin. Pharmacol. Ther. 78:  412-421 (2005).

• Once-daily oral rivaroxaban was safe and effective in thromboprophylaxis following total hip and knee arthoplasty.  Eriksson, B.I., et al.  "Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty."  N. Engl. J. Med. 358:  2765-2775 (2008).  Lassen M.R., et al.  "Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty." N. Engl. J. Med. 358:  2776-2786 (2008).

• Rivaroxaban is the active ingredient in the drug sold under the trade name Xarelto®.  This drug has been approved in at least one country for use in patients who have undergone elective total hip replacement or total knee replacement surgery to prevent venous thromboembolism.  NOTE:  The rivaroxaban product sold by LC Laboratories is NOT Xarelto® and is NOT for human use.

• Sold for laboratory or manufacturing purposes only; not for human, veterinary, food, or household use.

• This product is offered for R&D use in accordance with (i) 35 USC 271(e)+A13(1) in the U.S.; (ii) Section 69.1 of Japanese Patent Law in Japan; (iii) Section 11, No. 2 of the German Patent Act of 1981 in Germany; (iv) Section 60, Paragraph 5b of the U.K. Patents Act of 1977 in the U.K.; (v) Sections 55.2(1) and 55.2(6) and other common law exemptions of Canadian patent law; (vi) Section 68B of the Patents Act of 1953 in New Zealand together with the amendment of same by the Statutes Amendment Bill of 2002; (vii) such related legislation and/or case law as may be or become applicable in the aforementioned countries; and (viii) such similar laws and rules as may apply in various other countries.

• Not available in some countries; not available to some institutions; not available for some uses.