Thenox Warnings

General warning: Do not administer intramuscularly. Not to be used interchangeably (unit to unit) with heparin or any other low molecular weight heparins. Due to the different in molecular weight, anti-Xa activity, etc.
Epidural or Spinal anesthesia or lumbar puncture: Neuraxial anesthesia or spinal puncture may result in epidural or spinal hematomas and subsequently long-term or permanent paralysis. Factors that can increase the risk of developing epidural or spinal hematomas include use of indwelling epidural catheters: concomitant use of other drug that affect hematostasis, such as NSAIDs, platelet inhibitors and anticoagulants. A history of traumatic or repeated epidural or spinal punctures and a history of spinal deformity or spinal surgery.
Clinicians should carefully consider in: The benefit and risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
The timing of spinal catheter placement and removal in relation to anticoagulant use, considering both the dosage and pharmacokinetic properties of the anticoagulant. Insertion or removal of epidural catheter or lumbar puncture is best performed when the anticoagulant effect of enoxaparin is minimal. In patients receiving low dosage of enoxaparin sodium (30 mg once or twice daily or 40 mg once daily), insertion or removal of a spinal catheter should be delayed for at least 12 hours after a dose of enoxaparin. In patients receiving higher dosage of enoxaparin sodium (0.75 mg/kg twice daily, 1 mg/kg twice daily or 1.5 mg/kg once daily), a delay of at least 24 hours is recommended between the enoxaparin dose and catheter placement/removal.
Monitoring frequently for sign and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Clinicians should adhere precisely to the recommended dosing interval for enoxaparin. Recommendations for the timing of sheath removal is based on the method of post-PCI arterial closure. If the closure device is used, the sheath may be removed immediately. If manual compression is used, the sheath should be removed 6 hours after the last dose of enoxaparin. If the treatment with enoxaparin is to be continued, the next scheduled dose should be given no sooner than 6-8 hours after sheath removal.
Hemorrhage: Enoxaparin should be used with extreme caution in patients with an increased risk of hemorrhage (e.g., congenital or acquired bleeding disorders; active ulceration and angiodysplastic GI disease; hemorrhagic stroke; recent brain, spinal or ophthalmic surgery; uncontrolled arterial hypertension; history of recent GI ulceration; diabetic retinopathy).
History of Heparin-induced thrombocytopenia (HIT): Enoxaparin should be used with extreme caution or avoid in patients with a history of HIT, especially if administered within 100 days of HIT episode.
Thrombocytopenia of any degree should be monitored closely, and enoxaparin should be discontinued if platelet count fall below 100,000/mm³. For patients with HIT with or without thrombosis, nonheparin anticoagulants such as lepirudin or argatroban are recommended; continued use of a low molecular weight heparin is contraindicated.
Patients with mechanical prosthetic heart valves: The use of enoxaparin for prophylaxis of thromboembolism in patients with mechanical prosthetic heart valves has not been adequately studied and a clinical consensus regarding optimal therapy remains to be established.
Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism. If enoxaparin is used in pregnant women with mechanical prosthetic heart valves, frequent monitoring of peak and trough anti-factor Xa concentrations and adjustment of enoxaparin sodium dosage may be necessary.
The ACC/AHA suggest that the dosage of a low molecular weight heparin should be adjusted to maintain anti-factor Xa levels of 0.7-1.2 units/mL 4 hours after administration in pregnant women with mechanical prosthetic heart valves and that a low molecular weight heparin should not be used in such women unless anti-factor Xa levels are monitored 4-6 hours after administration of the drug.
Sensitivity reactions: Hypersensitivity reactions, including anaphylactoid reactions, pruritus, urticaria, vesiculobullous and rare cases of hypersensitivity cutaneous vesiculitis have occurred.