Usual Adult Dose for Deep Vein Thrombosis - Prophylaxis

Initial dose: 15 mg subcutaneously 5 to 15 minutes prior to surgery (but after induction of regional block anesthesia, if used)
Maintenance dose: 15 mg subcutaneously every 12 hours

Duration of therapy: Up to 12 days (9 to 12 days on average) has been well tolerated in controlled clinical trials.

Comments: All patients should be evaluated for bleeding disorder risk before prophylactic administration of this drug.

Use: Prophylaxis of deep vein thrombosis (DVT) in patients undergoing elective hip replacement surgery.

Renal Dose Adjustments

Mild renal dysfunction (CrCl 61 to 90 mL/min): No adjustment recommended.

Moderate renal dysfunction (CrCl 31 to 60 mL/min): 5 mg subcutaneously every 12 hours; if activated partial thromboplastin time (aPTT) exceeds 2 times control, interrupt therapy until aPTT returns to less than 2 times control and resume therapy at a reduced dose guided by the initial degree of aPTT abnormality.

Severe renal dysfunction (CrCl less than 31 mL/min): 1.7 mg subcutaneously every 12 hours; if aPTT exceeds 2 times control, interrupt therapy until aPTT returns to less than 2 times control and consider further dose reductions guided by the initial degree of aPTT abnormality.

Liver Dose Adjustments

Use with caution

Dose Adjustments

If peak activated partial thromboplastin time (aPTT) exceeds 2 times control: Reduce the dose based on the degree of aPTT abnormality. If necessary, interrupt therapy until aPTT returns to less than 2 times control, at which time treatment can be resumed at a reduced dose.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to natural or recombinant hirudins
• Active bleeding
• Irreversible coagulation disorders

US BOXED WARNING:

• SPINAL/EPIDURAL HEMATOMAS: When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with selective inhibitors of thrombin such as this drug may be at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. Risk of spinal/epidural hematoma may be increased by use of indwelling spinal catheters for administration of analgesia, concomitant use of drugs that affect hemostasis (NSAIDs, platelet inhibitors, other anticoagulants), or traumatic or repeated epidural or spinal puncture. Patients should be monitored frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks prior to neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Patients should be sitting or lying down.
• Alternate administration between the left and right anterolateral and left and right posterolateral thigh or abdominal wall.
• Administer using deep subcutaneous injection. Introduce the entire length of the needle into a skin fold held between the thumb and forefinger (the skin fold should be held throughout the injection). To minimize bruising, avoid rubbing the injection site following injection completion.

Storage requirements:

• Protect from light.
• Once reconstituted, this drug may be used for up to 24 hours when stored at 25C (77F); excursions permitted to 15C to 30C (59F to 86F). Discard after 24 hours.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

Monitoring:

• Hematologic: Activated partial thromboplastin time (aPTT): Monitor daily in patients with increased risk of bleeding and/or renal impairment.
• Renal: Serum creatinine: Monitor daily in patients with renal impairment.

Patient advice: Advise patients to contact their healthcare provider immediately if they experience any signs or symptoms of neurological impairment (e.g., midline back pain, numbness or weakness in the lower limbs, bowel and/or bladder dysfunction).