Miscellaneous hematological agents:

Indications for FRAGMIN:

Prevention of ischemic complications in unstable angina and non-Q-wave MI with aspirin. Prevention of DVT in patients undergoing hip replacement or abdominal surgery or those with severely restricted mobility during acute illness at risk for thromboembolic complications. Extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or pulmonary embolism), to reduce the recurrence of VTE in cancer patients. Treatment of symptomatic VTE to reduce the recurrence of VTE in children.

Limitations of Use:

Not indicated for the acute treatment of VTE.

Adult:

Give by deep SC inj; rotate inj sites. Angina, MI: 120 IU/kg (max 10000 IU) every 12hrs until stabilized (usually 5–8 days), with aspirin 75–165mg once daily. Hip replacement, post-op start: 2500 IU 4–8hrs after surgery, then 5000 IU once daily (at least 6 hrs after 1st dose); hip replacement, pre-op start day of surgery: 2500 IU within 2hrs before surgery, then 2500 IU 4–8hrs after surgery, then 5000 IU once daily (at least 6hrs after previous dose); hip replacement pre-op evening before surgery: 5000 IU 10–14hrs before surgery, then 5000 IU 4–8hrs after surgery, then 5000 IU once daily (allow 24hrs between doses); for all hip replacement regimens: usually treat for 5–10 days; max up to 14 days post-op. Abdominal surgery: 2500 IU once daily (usually for 5–10 days) starting 1–2hrs pre-op; for high risk of thromboembolism (eg, malignancy): see full labeling. Severely restricted mobility: 5000 IU once daily (usually for 12–14 days). Extended treatment of VTE in cancer patients: 200 IU/kg once daily for the first 30 days, then 150 IU/kg once daily for months 2–6; max daily dose 18000 IU; dose reductions for thrombocytopenia or renal insufficiency: see full labeling.

Children:

<4wks: not established. Neonates/infants: use preservative-free formulation (syringes). Give by deep SC inj; rotate inj sites. Symptomatic VTE: 4wks–<2yrs: 150 IU/kg twice daily. 2–<8yrs: 125 IU/kg twice daily. 8–<17yrs: 100 IU/kg twice daily. Obtain anti-Xa level before 4th dose (4hrs after administration); adjust dose by increments of 25 IU/kg to achieve target anti-Xa level between 0.5–1 IU/mL.

Contraindications:

Active major bleeding. History of heparin-induced thrombocytopenia with/without thrombosis. Not for use in unstable angina, non-Q-wave MI, or for prolonged VTE prophylaxis in patients undergoing epidural/neuraxial anesthesia. Heparin or pork allergy.

Boxed Warning:

Spinal/epidural hematoma.

Warnings/Precautions:

Risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture; monitor for signs/symptoms of neurological impairment. Uncontrolled hypertension. Bleeding disorders. Acute ulcerative or angiodysplastic GI disease. Hemorrhagic stroke. Bacterial endocarditis. Recent brain, spinal, or eye surgery. Thrombocytopenia. Platelet dysfunction or defects. Obtain CBCs, platelets, blood chemistry, stool occult blood tests, anti-Xa levels (in children) during therapy. Severe renal or hepatic insufficiency. Diabetic retinopathy. Recent GI bleeding. Neonates/infants (gasping syndrome due to benzyl alcohol). Pregnancy: use preservative-free formulations. Nursing mothers.

Pharmacologic Class:

Low molecular weight heparin.

Interactions:

Increased bleeding risk with oral anticoagulants, platelet inhibitors, thrombolytics.

Adverse Reactions:

Bleeding, thrombocytopenia (monitor), inj site hematoma/pain, transient elevated transaminases.

How Supplied:

Prefilled/graduated syringes (w. needle)—10; Multidose vial—1 (95000 IU/3.8mL)

Pricing for FRAGMIN

10 syringes of 10000iu/ml carton (Qty: 7)
Appx. price $578
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