Intravas 40

• Deep Vein Thrombosis (DVT): Treatment of DVT with or without pulmonary embolism.
• Pulmonary Embolism (PE): Treatment of PE associated with DVT.
• Unstable Angina & Non-Q-Wave Myocardial Infarction: Prevention of ischemic complications when administered concurrently with aspirin.
• Prophylaxis (Prevention): Prevention of venous thromboembolism in patients undergoing abdominal surgery, hip or knee replacement surgery, and medical patients with severely restricted mobility during acute illness.
• Hemodialysis: Prevention of thrombus formation in the extra-corporeal circulation during hemodialysis.

Adult Dose:

• Deep Vein Thrombosis (Treatment - Inpatient): 1 mg/kg SC q12hr OR 1.5 mg/kg SC qDay (in conjunction with warfarin).
• Deep Vein Thrombosis (Treatment - Outpatient): 1 mg/kg SC q12hr (in conjunction with warfarin).
• Unstable Angina & Non-Q-Wave MI: 1 mg/kg SC q12hr + aspirin (100-325 mg/day).
• Acute STEMI (<75 years): 30 mg IV bolus + 1 mg/kg SC, then 1 mg/kg SC q12hr.
• Acute STEMI (>75 years): No IV bolus; 0.75 mg/kg SC q12hr (not to exceed 75 mg/dose for first 2 doses).
• Abdominal Surgery (Prophylaxis): 40 mg SC qDay; initiate 2 hr preoperatively.
• Hip or Knee Replacement (Prophylaxis): 30 mg SC q12hr OR 40 mg SC qDay; initiate 12-24 hr postoperatively.
• Medical Patients with Restricted Mobility (Prophylaxis): 40 mg SC qDay.
• Hemodialysis: 100 anti-Xa IU/kg; high-risk patients: 50-75 anti-Xa IU/kg.

Renal Dose:

• CrCl <30 mL/min: Prophylaxis: 30 mg SC qDay; Treatment: 1 mg/kg SC qDay.
• CrCl 30-50 mL/min: Use with caution; monitor for signs of bleeding.

Common Side Effects (1-10%):

• Hemorrhage/Bleeding (1-4%)
• Elevation of serum aminotransferases (6%)
• Fever (5-8%)
• Local site reactions (2-5%)
• Thrombocytopenia (3%)
• Nausea (3%)
• Anemia (2%)
• Ecchymosis/Bruising (3%)

Rare Side Effects (<1%):

• Atrial fibrillation
• Heart failure
• Pulmonary edema
• Pneumonia

Potentially Fatal: Hemorrhagic complications.

Other: Neuraxial hematomas (with concurrent use of spinal/epidural anesthesia).

Precautions:

• Do not administer by intramuscular route.
• Increased risk of bleeding; carefully monitor for signs/symptoms of bleeding.
• Low body weight (<45 kg for women, <57 kg for men): Increased exposure with prophylactic dosage; monitor carefully.
• Platelet count should be measured before initiation and regularly during treatment.
• Caution with spinal/epidural anesthesia; risk of neuraxial hematoma.
• Caution in patients with history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or ophthalmologic surgery.
• Use with caution during pregnancy.