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Fresenius Kabi Introduces Four Presentations of Heparin Sodium in freeflex® Containers

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Fresenius Kabi announced today it has introduced four new presentations
of Heparin Sodium in the company's proprietary ready-to-administer freeflex®
containers. Fresenius Kabi introduced the advanced IV-container
technology in the United States in 2013, and has been expanding its
portfolio of convenient, ready-to-administer medicines in non-DEHP bags
as well as in prefilled syringes.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180801005074/en/

Fresenius Kabi Heparin Sodium is now available in four presentations in freeflex® containers. (Photo ...

Fresenius Kabi Heparin Sodium is now available in four presentations in freeflex® containers. (Photo: Business Wire)

Fresenius Kabi is a global health care company that specializes in
medicines and technologies for infusion, transfusion and clinical
nutrition.

"Clinicians continue to look for convenient, ready-to-administer
products to help minimize drug errors and assure patient safety," said
John Ducker, president and CEO of Fresenius Kabi USA. "We remain focused
on meeting these needs by expanding the number of products we offer in
both freeflex bags and prefilled syringes. With this most recent
offering we're also proud to offer the most comprehensive portfolio of
Heparin Sodium in the U.S."

Fresenius Kabi offers Heparin Sodium in 11 vial presentations and one
pre-filled syringe presentation, in addition to the new freeflex
offerings, which include:

  • Heparin Sodium in 0.45% NaCl freeflex 250 mL; 25,000 USP
    units per 250 mL
  • Heparin Sodium in 0.45% NaCl freeflex 500 mL; 25,000 USP
    units per 500 mL
  • Heparin Sodium in 5% Dextrose freeflex 250 mL; 25,000
    USP units per 250 mL
  • Heparin Sodium in 5% Dextrose freeflex 500 mL; 25,000
    USP units per 500 mL

Freeflex is a non-PVC, non-DEHP multilayer polyolefin film
flexible bag for infusion solutions with patented port technology, clear
labeling, a self-sealing septum and an oversized break-off cap that
indicates the directional flow of solutions.

INDICATIONS AND USAGE

Heparin Sodium is an anticoagulant indicated for:

  • Prophylaxis and treatment of venous thromboembolism and pulmonary
    embolism
  • 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
  • Anticoagulant use 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.

Thrombocytopenia: Can occur 2 to 20 days (average 5 to 9) following the
onset of heparin therapy. Monitor thrombocytopenia of any degree
closely. If the count falls below 100,000/mm3 or if recurrent
thrombosis develops, promptly discontinue heparin, evaluate for HIT and,
if necessary, administer an alternative anticoagulant.

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.

Heparin Resistance: Increased resistance to heparin is frequently
encountered in fever, thrombosis, thrombophlebitis, infections with
thrombosing tendencies, myocardial infarction, cancer, in postsurgical
patients, and patients with antithrombin III deficiency. Close
monitoring of coagulation tests is recommended in these cases.
Adjustment of heparin doses based on anti-Factor Xa levels may be
warranted.

Hypersensitivity Reactions: Heparin sodium is derived from animal
tissue, monitor for signs and symptoms of hypersensitivity when it is
used in patients with a history of allergy. Heparin Sodium in 5%
Dextrose Injection contains sodium metabisulfite, a sulfite that may
cause allergic-type reactions including anaphylactic symptoms and
life-threatening or less severe asthmatic episodes in certain
susceptible people.

Most common adverse reactions are hemorrhage, thrombocytopenia, HIT and
HITT, 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 coagulation, platelet
aggregation or drugs that counteract coagulation may induce bleeding.

Overdosage: Bleeding may result from heparin overdosage and may require
a neutralization of heparin effect.

This Important Safety Information does not include all the
information needed to use Heparin Sodium in 0.45% Sodium Chloride
Injection and Heparin Sodium in 5% Dextrose Injection safely and
effectively. Please click on the following link
https://tinyurl.com/y72s9xv6
for the full prescribing information for Heparin Sodium in 0.45%
Injection and Heparin Sodium in 5% Dextrose Injection or at
www.fresenius-kabi.com/us.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com/us)
is a global health care company that specializes in medicines and
technologies for infusion, transfusion and clinical nutrition. The
company's products and services are used to help care for critically and
chronically ill patients. The company's U.S. headquarters is in Lake
Zurich, Illinois. The company's global headquarters is in Bad Homburg,
Germany. For more information about Fresenius Kabi worldwide, please
visit www.fresenius-kabi.com.

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