Fondaparinux Sodium

Fondaparinux Sodium Manufacturers

• Apotex Corp.
  

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  Fondaparinux Sodium | Apotex Corp.

  

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  Do not mix other medications or solutions with Fondaparinux Sodium Solution. Administer Fondaparinux Sodium Solution only subcutaneously.

  2.1 Deep Vein Thrombosis Prophylaxis Following Hip Fracture, Hip Replacement, and Knee Replacement Surgery

  In patients undergoing hip fracture, hip replacement, or knee replacement surgery, the recommended dose of Fondaparinux Sodium Solution is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than 6 to 8 hours after surgery. Administration of Fondaparinux Sodium Solution earlier than 6 hours after surgery increases the risk of major bleeding. The usual duration of therapy is 5 to 9 days; up to 11 days of therapy was administered in clinical trials.

  In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (peri-operative and extended prophylaxis) was administered in clinical trials. [See Warnings and Precautions (5.6), Adverse Reactions (6), and Clinical Studies (14).]

  2.2 Deep Vein Thrombosis Prophylaxis Following Abdominal Surgery

  In patients undergoing abdominal surgery, the recommended dose of Fondaparinux Sodium Solution is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than 6 to 8 hours after surgery. Administration of Fondaparinux Sodium Solution earlier than 6 hours after surgery increases the risk of major bleeding. The usual duration of administration is 5 to 9 days, and up to 10 days of Fondaparinux Sodium Solution was administered in clinical trials.

  2.3 Deep Vein Thrombosis and Pulmonary Embolism Treatment

  In patients with acute symptomatic DVT and in patients with acute symptomatic PE, the recommended dose of Fondaparinux Sodium Solution is 5 mg (body weight <50 kg), 7.5 mg (body weight 50 to 100 kg), or 10 mg (body weight >100 kg) by subcutaneous injection once daily (Fondaparinux Sodium Solution treatment regimen). Initiate concomitant treatment with warfarin sodium as soon as possible, usually within 72 hours. Continue treatment with Fondaparinux Sodium Solution for at least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2 to 3). The usual duration of administration of Fondaparinux Sodium Solution is 5 to 9 days; up to 26 days of Fondaparinux Sodium Solution was administered in clinical trials. [See Warnings and Precautions (5.6), Adverse Reactions (6), and Clinical Studies (14).]

  2.4 Hepatic Impairment

  No dose adjustment is recommended in patients with mild to moderate hepatic impairment, based upon single-dose pharmacokinetic data. Pharmacokinetic data are not available for patients with severe hepatic impairment. Patients with hepatic impairment may be particularly vulnerable to bleeding during Fondaparinux Sodium Solution therapy. Observe these patients closely for signs and symptoms of bleeding. [See Clinical Pharmacology (12.4).]

  2.5 Instructions for Use

  Fondaparinux Sodium Solution is provided in a single-dose, prefilled syringe affixed with an automatic needle protection system. Fondaparinux Sodium Solution is administered by subcutaneous injection. It must not be administered by intramuscular injection. Fondaparinux Sodium Solution is intended for use under a physician’s guidance. Patients may self-inject only if their physician determines that it is appropriate and the patients are trained in subcutaneous injection techniques.

  Prior to administration, visually inspect Fondaparinux Sodium Solution to ensure the solution is clear and free of particulate matter.

  To avoid the loss of drug when using the prefilled syringe, do not expel the air bubble from the syringe before the injection. Administration should be made in the fatty tissue, alternating injection sites (e.g., between the left and right anterolateral or the left and right posterolateral abdominal wall).

  To administer Fondaparinux Sodium Solution:

  1. Wipe the surface of the injection site with an alcohol swab.

  2. Hold the syringe with either hand and use your other hand to twist the rigid needle guard (covers the needle) counter-clockwise. Pull the rigid needle guard straight off the needle (Figure 1). Discard the needle guard.

  3. Do not try to remove the air bubbles from the syringe before giving the injection.

  4. Pinch a fold of skin at the injection site between your thumb and forefinger and hold it throughout the injection.

  5. Hold the syringe with your thumb on the top pad of the plunger rod and your next 2 fingers on the finger grips on the syringe barrel. Pay attention to avoid sticking yourself with the exposed needle (Figure 2).

  6. Insert the full length of the syringe needle perpendicularly into the skin fold held between the thumb and forefinger (Figure 3).

  7. Push the plunger rod firmly with your thumb as far as it will go. This will ensure you have injected all the contents of the syringe (Figure 4).

  8. When you have injected all the contents of the syringe, the plunger should be released. The plunger will then rise automatically while the needle withdraws from the skin and retracts into the security sleeve. Discard the syringe into the sharps container.

  9. You will know that the syringe has worked when:

  • The needle is pulled back into the security sleeve and the white safety indicator appears above the upper body. • You may also hear or feel a soft click when the plunger rod is released fully.

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• Mylan Institutional Llc
  

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  Fondaparinux Sodium | Topco Associates Llc

  

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  • adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctor

  To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Replace cap tightly to maintain child resistance.

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• Dr. Reddy’s Laboratories Limited
  

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  Fondaparinux Sodium | Dr. Reddy's Laboratories Limited

  

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  Do not mix other medications or solutions with fondaparinux sodium injection. Administer fondaparinux sodium injection only subcutaneously.

  2.1 Deep Vein Thrombosis Prophylaxis Following Hip Fracture, Hip Replacement, and Knee Replacement Surgery

  In patients undergoing hip fracture, hip replacement, or knee replacement surgery, the recommended dose of fondaparinux sodium injection is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than 6 to 8 hours after surgery. Administration of fondaparinux sodium injection earlier than 6 hours after surgery increases the risk of major bleeding. The usual duration of therapy is 5 to 9 days; up to 11 days of therapy was administered in clinical trials.

  In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (peri-operative and extended prophylaxis) was administered in clinical trials. [See Warnings and Precautions (5.6), Adverse Reactions (6), and Clinical Studies (14)].

  2.2 Deep Vein Thrombosis Prophylaxis Following Abdominal Surgery

  In patients undergoing abdominal surgery, the recommended dose of fondaparinux sodium injection is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than 6 to 8 hours after surgery. Administration of fondaparinux sodium injection earlier than 6 hours after surgery increases the risk of major bleeding. The usual duration of administration is 5 to 9 days, and up to 10 days of fondaparinux sodium injection was administered in clinical trials.

  2.3 Deep Vein Thrombosis and Pulmonary Embolism Treatment

  In patients with acute symptomatic DVT and in patients with acute symptomatic PE, the recommended dose of fondaparinux sodium injection is 5 mg (body weight <50 kg), 7.5 mg (body weight 50 to 100 kg), or 10 mg (body weight >100 kg) by subcutaneous injection once daily (fondaparinux sodium treatment regimen). Initiate concomitant treatment with warfarin sodium as soon as possible, usually within 72 hours. Continue treatment with fondaparinux sodium injection for at least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2 to 3). The usual duration of administration of fondaparinux sodium injection is 5 to 9 days; up to 26 days of fondaparinux sodium injection was administered in clinical trials. [See Warnings and Precautions (5.6), Adverse Reactions (6), and Clinical Studies (14)].

  2.4 Hepatic Impairment

  No dose adjustment is recommended in patients with mild to moderate hepatic impairment, based upon single-dose pharmacokinetic data. Pharmacokinetic data are not available for patients with severe hepatic impairment. Patients with hepatic impairment may be particularly vulnerable to bleeding during fondaparinux sodium therapy. Observe these patients closely for signs and symptoms of bleeding. [See Clinical Pharmacology (12.4).]

  2.5 Instructions for Use

  Fondaparinux sodium injection is provided in a single-dose, prefilled syringe affixed with an active needle protection system. Fondaparinux sodium is administered by subcutaneous injection. It must not be administered by intramuscular injection. Fondaparinux sodium injection is intended for use under a physician’s guidance. Patients may self-inject only if their physician determines that it is appropriate and the patients are trained in subcutaneous injection techniques.  Prior to administration, visually inspect fondaparinux sodium injection to ensure the solution is clear and free of particulate matter. The following instructions are specific to the Preventis TM injection system and may differ from the directions for other injection systems.

  To avoid the loss of drug when using the prefilled syringe, do not expel the air bubble from the syringe before the injection. Administration should be made in the fatty tissue, alternating injection sites (e.g., between the left and right anterolateral or the left and right posterolateral abdominal wall).

  To administer fondaparinux sodium: 

  STEP 1: 

  Wipe the surface of the injection site with an alcohol swab. Remove the needle shield by pulling it straight off the syringe (Figure 1). Discard the needle shield.

  STEP 2: 

  Do not try to remove the air bubbles from the syringe before giving the injection. Pinch a fold of skin at the injection site between your thumb and forefinger and hold it throughout the injection time. Hold the syringe with your thumb on the top pad of the plunger and keep your index and middle fingers on the finger-grips of the syringe barrel. Pay attention to avoid pricking yourself with the exposed needle. Insert the full length of the syringe needle perpendicularly into the skin fold held between the thumb and forefinger (Figure 2). Push the plunger to the bottom of the syringe. This will ensure you have injected all the contents of the syringe.

  STEP 3: 

  Remove the syringe from the injection site keeping your finger on the plunger (Figure 3).

  STEP 4:

  Orient the needle away from you and others, and activate the safety shield by firmly pushing the plunger. The protective sleeve will automatically cover the needle and an audible "click" will be heard to confirm shield activation (Figure 4).

  STEP 5: 

  Immediately discard the syringe into the sharps container (Figure 5).

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