Fresenius Kabi USA LLC

11/08/2019 | Press release | Archived content

Fresenius Kabi Introduces Heparin Sodium Injection, USP Simplist® Prefilled Syringe in 5,000 USP units per 0.5 mL presentation

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.

"Fresenius Kabi is focused on expanding our Heparin and Simplist prefilled syringe portfolios with this Simplist Heparin prefilled syringe," said John Ducker, president and CEO of Fresenius Kabi USA. "By combining a small-volume presentation of Heparin with our other convenient ready-to-administer prefilled syringes, this product will support safe practices for this high-alert Medication."

In addition to this new prefilled syringe presentation, Fresenius Kabi also offers Heparin Sodium Injection, USP 5,000 units per 1 mL in a Simplist prefilled syringe along with Heparin Sodium in five freeflex® premix ready-to-administer containers and 11 vial presentations. To learn more about all Simplist ready-to-administer prefilled syringes please visit simplist-us.com.

According to the Institute for Safe Medication Practices (ISMP), high-alert medications are defined as "drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients."

About Simplist® Heparin Sodium Injection, USP

INDICATIONS AND USAGE

Heparin Sodium is an anticoagulant indicated for:

  • Prophylaxis and treatment of venous thromboembolism and pulmonary embolism
  • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease
  • Atrial fibrillation with embolization
  • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)
  • Prevention of clotting in arterial and cardiac surgery
  • Prophylaxis and treatment of peripheral arterial embolism
  • Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.

IMPORTANT SAFETY INFORMATION

Heparin Sodium is contraindicated in patients with history of Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT), known hypersensitivity to heparin or pork products, those whom suitable blood coagulation tests cannot be performed at appropriate intervals, and patients with uncontrolled bleeding states, except when this is due to disseminated intravascular coagulation.

Fatal Medication Errors: Heparin is supplied in various strengths. Fatal hemorrhages have occurred due to medication errors. Confirm choice of correct strength prior to administration.

Hemorrhage: Fatal cases have occurred. Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks.

Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT): Monitor for signs and symptoms and discontinue if indicative of HIT and HITT.

Coagulation Testing and Monitoring: When using a full dose heparin regimen, adjust the heparin dose based on frequent blood coagulation tests. Periodic platelet counts, hematocrits are recommended during the entire course of heparin therapy.

Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and HITT, injection site irritation, general hypersensitivity reactions, and elevations of aminotransferase levels.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions: Drugs that interfere with platelet aggregation may induce bleeding.

Use in Specific Populations:
Lactation: Advise females not to breastfeed.
Geriatric Use: A higher incidence of bleeding reported in patients, particularly women, over 60 years of age.

This Important Safety Information does not include all the information needed to use Heparin Sodium Injection, USP safely and effectively. Please see full prescribing information for Heparin Sodium Injection, USP at www.fresenius-kabi.com/us or https://tinyurl.com/y378zz4r.