Hibor Bemiparin Sodium Injection

1. Indications and Usage
Prophylaxis of Thromboembolic Complications:
Indicated for the prevention of thromboembolic complications in patients undergoing surgery (e.g., orthopedic surgery such as hip or knee replacement) or in medical patients at risk of venous thromboembolism (VTE).
Prevention of Clotting in Extracorporeal Circulation:
Indicated for the prevention of clotting in the extracorporeal circulation during hemodialysis sessions (typically lasting up to 4 hours) in patients without a risk of bleeding.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY. Must not be administered intramuscularly.
Recommended Dosage:
Surgical Prophylaxis: The recommended dose is 3,500 anti-Xa IU once daily. The first dose is typically administered 2 hours before surgery or 6 hours after surgery (or later depending on hemostasis).
Hemodialysis: For patients without bleeding risk:
Weight < 60 kg: 2,500 anti-Xa IU administered at the start of dialysis via the arterial line.
Weight ≥ 60 kg: 3,500 anti-Xa IU administered at the start of dialysis via the arterial line.
Administration Instructions:
Inject deeply subcutaneously. It is recommended to alternate injection sites on the abdominal wall (preferably the left or right anterolateral or posterolateral aspects).
3. Mechanism of Action
Low Molecular Weight Heparin (LMWH):
Bemiparin is obtained by depolymerization of heparin. It has an average molecular weight of approximately 3,600 Daltons.
Anticoagulant Activity:
It acts by binding to Antithrombin III (ATIII), inducing a conformational change that enhances its ability to inhibit Factor Xa. Bemiparin exhibits a high ratio of anti-Factor Xa activity to anti-Factor IIa (anti-thrombin) activity. It primarily exerts its anticoagulant effect through the selective inhibition of Factor Xa.
4. Safety and Warnings
Heparin-Induced Thrombocytopenia (HIT):
Contraindicated in patients with a confirmed or suspected history of HIT. Platelet counts should be monitored regularly during treatment.
Bleeding Risk:
Although the risk is generally lower than with unfractionated heparin, bleeding can occur. Use with caution in patients with a high risk of bleeding (e.g., active peptic ulcer, hemorrhagic stroke, uncontrolled hypertension).
Hyperkalemia:
Like other heparins, bemiparin can suppress aldosterone synthesis, leading to hyperkalemia, particularly in patients with diabetes, renal failure, or those taking potassium-sparing diuretics. Serum potassium should be monitored if treatment exceeds 7 days.
Spinal/Epidural Hematoma:
Risk of spinal or epidural hematoma exists if used concomitantly with neuraxial anesthesia (spinal/epidural) or spinal puncture.
5. Adverse Reactions
Most Common:
Bleeding (e.g., post-operative hemorrhage) and injection site reactions (ecchymosis, hematoma, pain).
Other Reported Reactions:
Thrombocytopenia, elevated liver enzymes (transaminases), hypersensitivity reactions (rash, pruritus), and anemia.
6. Drug Interactions
Anticoagulants and Antiplatelet Agents:
Concomitant use with oral anticoagulants (e.g., warfarin), thrombolytics, or antiplatelet agents (e.g., aspirin, clopidogrel, NSAIDs) may increase the risk of bleeding and is generally not recommended unless strictly supervised.
Potassium-Sparing Drugs:
Concomitant use with potassium-sparing diuretics or ACE inhibitors may increase the risk of hyperkalemia.
Dextran 40:
Concurrent use is not recommended as it may increase bleeding risk.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Bemiparin Sodium.
Available Strengths: Prefilled syringes (e.g., 2,500 anti-Xa IU/0.2 mL and 3,500 anti-Xa IU/0.2 mL).
Excipients: Water for injections, sodium hydroxide, and/or hydrochloric acid for pH adjustment.
Storage:
Store below 30°C. Do not freeze. Protect from light.