LOVENOX Solution for injection Ref.[10865] Active ingredients: Enoxaparin

Source: FDA, National Drug Code (US) Revision Year: 2020

Product description

Lovenox is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5.

Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons.

The molecular weight distribution is:

<2000 daltons	≤20%
2000 to 8000 daltons	≥68%
>8000 daltons	≤18%

STRUCTURAL FORMULA:

R₁ = H or SO₃Na and R₂ = SO₃ Na or COCH₃

R	X* = 15 to 25%		n=0 to 20
R	100-X	H	n=1 to 21

^* X = Percent of polysaccharide chain containing 1,6 anhydro derivative on the reducing end

Lovenox 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.

Lovenox 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection.

The Lovenox prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. The multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].

Dosage Forms and Strengths

Lovenox is a clear, colorless to pale-yellow solution available in two concentrations.

100 mg/mL Concentration
Single-Dose Prefilled Syringes	30 mg/0.3 mL, 40 mg/0.4 mL
Single-Dose Graduated Prefilled Syringes	60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL
Multiple-Dose Vial	300 mg/3 mL
150 mg/mL Concentration
Single-Dose Graduated Prefilled Syringes	120 mg/0.8 mL, 150 mg/1 mL

How Supplied

Lovenox is available in two concentrations (see Tables 26 and 27).

Table 26. 100 mg/mL Concentration:

Dosage Unit/Strength^*	Anti-Xa Activity^†	Package Size (per carton)	Label Color	NDC # 0075-
Single-Dose Prefilled Syringes^‡
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
Single-Dose Graduated Prefilled Syringes^‡
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 Vial^§
300 mg/3 mL	30,000 IU	1 vial	Red	0626-03

^* Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Lovenox 30 and 4 0 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.
^† Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard.
^‡ Each Lovenox prefilled syringe is for single, one-time use only and is affixed with a 27 gauge × 1/2-inch needle.
^§ Each Lovenox multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative.

Table 27. 150 mg/mL Concentration:

Dosage Unit/Strength^*	Anti-Xa Activity^†	Package Size (per carton)	Syringe Label Color	NDC # 0075-
Single-Dose Graduated Prefilled Syringes^‡
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

^* 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.
^† Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard.
^‡ Each Lovenox graduated prefilled syringe is for single, one-time use only and is affixed with a 27 gauge × 1/2-inch needle.

sanofi-aventis U.S. LLC, Bridgewater, NJ 08807,A SANOFI COMPANY

Drugs

Drug	Countries
LOVENOX	Austria, Canada, Germany, France, Tunisia, United States

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