close

  
Filter options:

Freebase Commons Common /common

  • Fondaparinux sodium (Apotex), manufactured drug form of Fondaparinux sodium, 10mg/0.8mL fondaparinux sodium injectable solution, NDC 60505-6081

Freebase Commons Business /business

Freebase Commons Medicine /medicine

Section name Section URI Prominent warning Highlight text Subject manufactured drug Section LOINC code
  • true
  • 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 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 (5.5) and Drug Interactions (7).]
  • -
  • 34066-1
  • false
  • Fondaparinux Sodium Solution is a Factor Xa inhibitor (anticoagulant) indicated for: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. (1.1) Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin. (1.2, 1.3)
  • -
  • 34067-9
  • false
  • Prophylaxis of deep vein thrombosis: Fondaparinux Sodium Solution 2.5 mg subcutaneously once daily after hemostasis has been established. The initial dose should be given no earlier than 6 to 8 hours after surgery and continued for 5 to 9 days. For patients undergoing hip fracture surgery, extended prophylaxis up to 24 additional days is recommended. (2.1, 2.2) Treatment of deep vein thrombosis and pulmonary embolism: Fondaparinux Sodium Solution 5 mg (body weight 100 kg) subcutaneously once daily. Treatment should continue for at least 5 days until INR 2 to 3 achieved with warfarin sodium. (2.3) Do not use as intramuscular injection. For subcutaneous use, do not mix with other injections or infusions.
  • -
  • 34068-7
  • false
  • Single-dose, prefilled syringes containing 2.5 mg, 5 mg, 7.5 mg, or 10 mg of fondaparinux. (3)
  • -
  • 43678-2
  • false
  • Fondaparinux Sodium Solution is contraindicated in the following conditions: (4) Severe renal impairment (creatinine clearance <30 mL/min) in prophylaxis or treatment of venous thromboembolism. Active major bleeding. Bacterial endocarditis. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium. Body weight <50 kg (venous thromboembolism prophylaxis only).
  • -
  • 34070-3
  • false
  • Use with caution in patients who have conditions or are taking concomitant medications that increase risk of hemorrhage. (5.1) Bleeding risk is increased in renal impairment and in patients with low body weight <50 kg. (5.2, 5.3) Thrombocytopenia can occur with administration of Fondaparinux Sodium Solution. (5.4) Periodic routine complete blood counts (including platelet counts), serum creatinine level, and stool occult blood tests are recommended (5.6) The packaging (needle guard) contains dry natural rubber and may cause allergic reactions in latex sensitive individuals (5.7)
  • -
  • 43685-7
  • false
  • The most common adverse reactions associated with the use of Fondaparinux Sodium Solution are bleeding complications. (6.1) Mild local irritation (injection site bleeding, rash, and pruritus) may occur following subcutaneous injection. (6.2) Anemia, insomnia, increased wound drainage, hypokalemia, dizziness, hypotension, confusion, bullous eruption, hematoma, post-operative hemorrhage, and purpura may occur. (6.4) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-667-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • -
  • 34084-4
  • false
  • Discontinue agents that may enhance the risk of hemorrhage prior to initiation of therapy with Fondaparinux Sodium Solution unless essential. If co-administration is necessary, monitor patients closely for hemorrhage. (7)
  • -
  • 34073-7
  • false
  • Safety and effectiveness of Fondaparinux Sodium Solution in pediatric patients have not been established. Because the risk for bleeding during treatment with Fondaparinux Sodium Solution is increased in adults who weigh <50 kg, bleeding may be a particular safety concern for use of Fondaparinux Sodium Solution in the pediatric population. (4, 5.3) Because elderly patients are more likely to have reduced renal function, Fondaparinux Sodium Solution should be used with caution in these patients. (8.5) The risk of bleeding is increased with reduced renal or hepatic function. (8.6, 8.7)
  • -
  • 43684-0
  • false
  • -
  • -
  • 34088-5

Comments

Hide