Pharmacy & Therapeutics - September 2008 - (Page CB16)

The beneficial effect of enoxaparin on the primary end point was consistent across key subgroups including age, gender, infarct location, history of diabetes, history of prior myocardial infarction, fibrinolytic agent administered, and time to treatment with study drug (see Figure 1); however, it is necessary to interpret such subgroup analyses with caution. Figure 1. Relative Risks of and Absolute Event Rates for the Primary End Point at 30 Days in Various Subgroups * 16 HOW SUPPLIED/STORAGE AND HANDLING Lovenox is available in two concentrations [see Tables 26 and 27]: Table 26 100 mg/mL Concentration Anti-Xa Package Label Activity2 Size Color (per carton) Dosage Unit / Strength1 NDC # 0075- Prefilled Syringes3 30 mg / 0.3 mL 3000 IU 10 syringes Medium Blue 0624-30 40 mg / 0.4 mL 4000 IU 10 syringes Yellow 0620-40 Graduated Prefilled Syringes3 60 mg / 0.6 mL 6000 IU 10 syringes Orange 0621-60 80 mg / 0.8 mL 8000 IU 10 syringes Brown 0622-80 100 mg / 1 mL 10,000 IU 10 syringes Black 0623-00 Multiple-Dose Vial4 300 mg / 3.0 mL 30,000 IU 1 vial Red 0626-03 1 Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Lovenox 30 and 40 mg prefilled syringes, and 60, 80, and 100 mg graduated prefilled syringes each contain 10 mg enoxaparin sodium per 0.1 mL Water for Injection. 2 Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard. 3 Each Lovenox syringe is affixed with a 27 gauge x 1/2 inch needle. 4 Each Lovenox multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative. Table 27 150 mg/mL Concentration Anti-Xa Package Syringe Activity2 Size Label (per carton) Color Dosage Unit / Strength1 NDC # 0075- * The primary efficacy end point was the composite of death from any cause or myocardial re-infarction in the first 30 days. The overall treatment effect of enoxaparin as compared to the unfractionated heparin is shown at the bottom of the figure. For each subgroup, the circle is proportional to the number and represents the point estimate of the treatment effect and the horizontal lines represent the 95 percent confidence intervals. Fibrinspecific fibrinolytic agents included alteplase, tenecteplase and reteplase. Time to treatment indicates the time from the onset of symptoms to the administration of study drug (median, 3.2 hours). The beneficial effect of enoxaparin on the primary end point observed during the first 30 days was maintained over a 12 month follow-up period (see Figure 2). Figure 2 - Kaplan-Meier plot - death or myocardial re-infarction at 30 days - ITT population Graduated Prefilled Syringes 3 120 mg / 0.8 mL 12,000 IU 10 syringes Purple 2912-01 150 mg / 1 mL 15,000 IU 10 syringes Navy Blue 2915-01 1 Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Lovenox 120 and 150 mg graduated prefilled syringes contain 15 mg enoxaparin sodium per 0.1 mL Water for Injection. 2 Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard. 3 Each Lovenox graduated prefilled syringe is affixed with a 27 gauge x 1/2 inch needle. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not store the multiple-dose vials for more than 28 days after the first use. Keep out of the reach of children. 17 PATIENT COUNSELING INFORMATION Patients should be told that it may take them longer than usual to stop bleeding, that they may bruise and/or bleed more easily when they are treated with Lovenox, and that they should report any unusual bleeding or bruising to their physician [see Warnings and Precautions (5.1, 5.5)]. Patients should inform physicians and dentists that they are taking Lovenox and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.3)]. Patients should inform their physicians and dentists of all medications they are taking, including those obtained without a prescription [see Drug Interactions (7)]. sanofi-aventis U.S. LLC Bridgewater, NJ 08807 Multiple-dose vials are also manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27835 © 2007 sanofi-aventis U.S. LLC LOV-OCT07-F-Aa There is a trend in favor of enoxaparin during the first 48 hours, but most of the treatment difference is attributed to a step increase in the event rate in the UFH group at 48 hours (seen in Figure 2), an effect that is more striking when comparing the event rates just prior to and just subsequent to actual times of discontinuation. These results provide evidence that UFH was effective and that it would be better if used longer than 48 hours. There is a similar increase in endpoint event rate when enoxaparin was discontinued, suggesting that it too was discontinued too soon in this study. The rates of major hemorrhages (defined as requiring 5 or more units of blood for transfusion, or 15% drop in hematocrit or clinically overt bleeding, including intracranial hemorrhage) at 30 days were 2.1% in the enoxaparin group and 1.4% in the unfractionated heparin group. The rates of intracranial hemorrhage at 30 days were 0.8% in the enoxaparin group 0.7% in the unfractionated heparin group. The 30-day rate of the composite endpoint of death, myocardial re-infarction or ICH (a measure of net clinical benefit) was significantly lower in the enoxaparin group (10.1%) as compared to the heparin group (12.2%). 10

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Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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