FONDAPARINUX SODIUM- fondaparinux sodium injection
Dr. Reddy’s Laboratories Inc.
WARNING: SPINAL/EPIDURAL HEMATOMAS
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- use of indwelling epidural catheters
- concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
- a history of traumatic or repeated epidural or spinal puncture
- a history of spinal deformity or spinal surgery
- Optimal timing between the administration of fondaparinux sodium and neuraxial procedures is not known.
Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary.
Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis. [see Warnings and Precautions (5.1) and Drug Interactions (7)]
1 INDICATIONS AND USAGE
1.1 Prophylaxis of Deep Vein Thrombosis
Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
- in patients undergoing hip fracture surgery, including extended prophylaxis;
- in patients undergoing hip replacement surgery;
- in patients undergoing knee replacement surgery;
- in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
1.2 Treatment of Acute Deep Vein Thrombosis
Fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.
1.3 Treatment of Acute Pulmonary Embolism
Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
2 DOSAGE AND ADMINISTRATION
Do not mix other medications or solutions with fondaparinux sodium injection. Administer fondaparinux sodium injection only subcutaneously. Discard unused portion.
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:
- 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.
- 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.
- Remove the syringe from the injection site keeping your finger on the plunger (Figure 3).
- 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).
- Immediately discard the syringe into the sharps container (Figure 5).
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