Nadroparin

Bleeding may occur at any site during therapy. Monitor patient closely for signs or symptoms of bleeding. Certain patients are at increased risk of bleeding. Risk factors include bacterial endocarditis; congenital or acquired bleeding disorders; active ulcerative or angiodysplastic GI diseases; severe uncontrolled hypertension; hemorrhagic stroke; use shortly after brain, spinal, or ophthalmology surgery; in patients treated concomitantly with other drugs known to cause bleeding (eg, platelet inhibitors); recent GI bleeding or ulceration; vascular disorder of the chorio-retina; thrombocytopenia or platelet defects; severe liver disease; hypertensive or diabetic retinopathy; in patients undergoing invasive procedures; and in the elderly. Discontinue if bleeding occurs. Protamine infusion may be necessary for serious bleeding (consult Protamine monograph for dosing recommendations).

Cutaneous necrosis preceded by purpura or infiltrated or painful erythematous blotches has been reported rarely; discontinue treatment immediately if suspected.

Monitor for hyperkalemia; can cause hyperkalemia possibly by suppressing aldosterone production. Most commonly occurs in patients with risk factors for the development of hyperkalemia (eg, renal dysfunction, concomitant use of potassium-sparing diuretics or potassium supplements, hematoma in body tissues).

Cases of thrombocytopenia including thrombocytopenia with thrombosis have occurred. Use with caution in patients with history of thrombocytopenia (drug-induced or congenital) or platelet defects; monitor platelet count closely. Use is contraindicated in patients with a history of confirmed or suspected heparin-induced thrombocytopenia (HIT) or positive in vitro test for antiplatelet antibodies in the presence of nadroparin. Discontinue therapy and consider alternative treatment if platelets are 3 and/or thrombosis develops. Disease-related concerns:

Use with caution in patients with severe arterial hypertension.

Use with caution in patients with history of GI ulceration; contraindicated in patients with active peptic ulceration.

Use with caution in patients with hepatic impairment (has not been studied); patients with hepatic failure are at an increased risk of bleeding.

Prosthetic valve thrombosis has been reported in patients receiving thromboprophylaxis therapy with LMWHs. Pregnant women may be at increased risk.

Use with caution in patients with renal impairment; primarily renally excreted. Dose reductions may be required. Use is contraindicated in severe renal impairment when treating thromboembolic disorders, unstable angina, and NSTEMI. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Use with caution in the elderly; dosage reduction may be needed.

There is no consensus for adjusting/correcting the weight-based dosage of LMWH for patients who are morbidly obese (BMI ≥40 kg/m2). The American College of Chest Physicians Practice Guidelines suggest consulting with a pharmacist regarding dosing in bariatric surgery patients and other obese patients who may require higher doses of LMWH (Gould 2012). Dosage form specific issues:

Packaging (needle cover of prefilled syringe) may contain natural latex rubber. Other warnings/precautions:

Do not administer intramuscularly.

Not to be used interchangeably (unit for unit) with heparin or any other LMWHs.

Risk of bleeding may be increased in patients undergoing knee surgery and receiving LMWHs. Consider risk versus benefit in this population.

Epidural or spinal hematomas, including subsequent long-term or permanent paralysis, may occur in patients anticoagulated with LMWH or heparinoids who are receiving neuraxial anesthesia (epidural or spinal anesthesia) or undergoing spinal puncture. Consider risk versus benefit prior to spinal procedures; risk is increased by concomitant agents which may alter hemostasis, the use of indwelling epidural catheters, a history of spinal deformity or spinal surgery, or a history of traumatic or repeated epidural or spinal punctures. Avoid lumbar puncture or spinal or epidural anesthesia for 12 hours following the last nadroparin prophylactic dose or 24 hours following the last nadroparin treatment dose. The timing of subsequent nadroparin doses following catheter removal should be based on careful risk assessment for thrombosis and bleeding. Longer intervals should be considered for patients with renal impairment (doubling the timing of catheter removal). Observe patient closely for bleeding and signs and symptoms of neurological impairment if therapy is administered. If spinal hematoma is suspected, diagnose and treat immediately; spinal cord decompression may be considered although it may not prevent or reverse neurological sequelae.