Aventis announced innovations that will help enhance ease of use, accuracy and safety in the dispensing and administration of its top-selling low-molecular-weight heparin, Lovenox (enoxaparin sodium injection). A new 300 mg/3 mL multiple-dose vial will begin shipping to pharmacies in March, and prefilled syringes equipped with an Automatic Safety Device and a sharper needle will begin shipping in the second half of the year.
The new multiple-dose vial meets a range of customer needs through enhanced dispensing accuracy and less product waste.
“It is very exciting to have this new multiple-dose vial for enoxaparin, because it allows us more flexibility in the way we manage our patients,” said James B. Groce III, PharmD, CACP, clinical pharmacy specialist-anticoagulation at The Moses H. Cone Memorial Hospital in Greensboro, NC, associate professor of pharmacy at Campbell University School of Pharmacy, and clinical assistant professor of medicine at the University of North Carolina School of Medicine. “This introduction should help not only larger pharmacies, but also smaller ones that may not be able to carry all dosing strengths of enoxaparin. Now, we can all provide this important and life-saving drug to meet each individual patient's specific dosing needs.”
Lovenox provides the broadest range of dosing options and indications among low-molecular-weight heparins to meet the various needs of pharmacists and patients. In addition to the new multiple-dose vial, Lovenox will continue to be supplied in 30 mg ampules; 30 mg and 40 mg prefilled syringes; and 60 mg, 80 mg, and 100 mg graduated prefilled syringes at the 100 mg/mL concentration. At the 150 mg/mL concentration, Lovenox is provided in 120 mg and 150 mg graduated prefilled syringes.
Pharmacies will begin receiving Lovenox prefilled syringes equipped with a new Automatic Safety Device, in compliance with the Needlestick Safety and Prevention Act and with OSHA requirements. The easy-to-use device allows for one-handed activation of the syringe and lets the user decide when to activate the needle guard. The device will not impact normal injection technique and, with a new, larger barrel, the syringes with the Automatic Safety Device also are easier to grip. Each package will include step-by-step instructions for Lovenox administration with the new safety device.
A new, sharper needle will be incorporated into the new syringe design. It will have five cuts, or bevels, compared with the current three cuts, thus reducing pain upon insertion and the incidence of hematoma, helping to improve patient comfort.
The No. 1-selling, low-molecular-weight heparin in the world, Lovenox was approved in the U.S. and Canada in 1993. It has been available in Europe since 1987 and is known under the brand names Lovenox, Clexane and Klexane. Lovenox is the only low-molecular-weight heparin approved by the U.S. Food and Drug Administration (FDA) for all of the following indications:
Prophylaxis of deep-vein thrombosis, which may lead to pulmonary embolism; in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness; in patients undergoing abdominal surgery who are at risk for thromboembolic complications; in patients undergoing hip replacement surgery, during and following hospitalization; in patients undergoing knee replacement surgery.
Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
Inpatient treatment of acute deep-vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium.
Outpatient treatment of acute deep-vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
Lovenox (enoxaparin sodium injection) cannot be used interchangeably with other low-molecular-weight heparins or unfractionated heparin, as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage.
When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins or heparinoids are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.
The risk of these events is increased by the use of postoperative indwelling epidural catheters or by the concomitant use of drugs affecting hemostasis. Patients should be frequently monitored for signs and symptoms of neurological impairment.
As with other anticoagulants, use with extreme caution in patients with conditions that increase the risk of hemorrhage. Unless otherwise indicated, agents that may affect hemostasis should be discontinued prior to Lovenox therapy. Bleeding can occur at any site during Lovenox therapy. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site.
Thrombocytopenia can occur with Lovenox. In patients with a history of heparin-induced thrombocytopenia, Lovenox should be used with extreme caution. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm3, Lovenox should be discontinued. Cases of heparin-induced thrombocytopenia have been observed in clinical practice.
The use of Lovenox is not recommended for thromboprophylaxis in patients with prosthetic heart valves.
Lovenox is contraindicated in patients with hypersensitivity to enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding.