Desirudin

Desirudin is an anticoagulant (thrombin inhibitor) that helps prevent the formation of blood clots.

Desirudin is used to prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. Desirudin is for use after hip replacement surgery.

Desirudin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have active or uncontrolled bleeding, or an irreversible blood clotting disorder.

Desirudin can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural), especially if you are also using other drugs that can affect blood clotting, including blood thinners or NSAIDs (ibuprofen, Advil, Aleve, and others). This type of blood clot can lead to long-term or permanent paralysis.

Get emergency medical help if you have symptoms of a spinal cord blood clot such as back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

You should not use this medicine if you are allergic to desirudin, bivalirudin, or lepirudin, or if you have:

• active or uncontrolled bleeding; or
• an irreversible blood clotting disorder.

Desirudin can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term or permanent paralysis, and may be more likely to occur if:

• you have a spinal cord injury;
• you have a spinal catheter in place;
• you have a history of spinal surgery or repeated spinal taps;
• you are taking an NSAID (nonsteroidal anti-inflammatory drug)--ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or
• you are using a blood thinner (warfarin, Coumadin) or other medicines to treat or prevent blood clots.

To make sure desirudin is safe for you, tell your doctor if you have:

• kidney disease; or
• cirrhosis or other liver disease.

Desirudin may cause you to bleed more easily, especially if you have:

• a bleeding disorder that is inherited or caused by disease;
• a history of hemorrhagic stroke;
• uncontrolled high blood pressure;
• bleeding inside your head;
• eye problems caused by diabetes;
• if you have had bleeding in your lungs, stomach, or intestines within the past 3 months;
• if you have recently had surgery, an organ transplant, or biopsy of an organ; or
• if you take steroid medicine (prednisone, dexamethasone, and others), or a salicylate (aspirin, choline salicylate, diflunisal, magnesium salicylate, salsalate, and others).

FDA pregnancy category C. It is not known whether desirudin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether desirudin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Serious side effects have been reported with desirudin including the following:

Spinal/Epidural Hematoma. In patients who receive desirudin and need to have spinal or epidural anesthesia at the same time, there is a risk of accumulating blood in the subdural or epidural space in the spine, called a hematoma. This is a serious condition that requires immediate medical attention. Alert your physician if you develop back pain, tingling, numbness (especially in the lower limbs), muscle weakness, or the inability to hold in urine or stool.

Increased risk of bleeding. Desirudin increased the risk of major bleeding in certain patients. Tell your doctor if you have any signs of bleeding or bruising, or if you have or have had any of the following:

• kidney disease
• recent major surgery
• organ biopsy in the last month
• history of hemorrhagic stroke
• bleeding that occurred inside your skull or in your eyes
• recent ischemic stroke
• severe uncontrolled high blood pressure
• an infection of the heart's inner lining or heart valves, called bacterial endocarditis
• a disorder that affects bleeding, such as hemophilia, Von Willebrand disease, sickle cell disease, or liver disease

You should not receive desirudin if you:

• are allergic to desirudin or to any of its ingredients 
• have had an allergic reaction to similar medications such as bivalirudin (Angiomax)
• have an active bleed
• have a disorder that affects your ability to clot blood that cannot be reversed

Before receiving desirudin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to desirudin or to any of its ingredients
• have had an allergic reaction to bivalirudin (Angiomax) in the past
• have kidney problems
• have liver problems
• have had recent major surgery
• have had an organ biopsy in the last month
• have a history of hemorrhagic stroke
• have or have had bleeding that occurred inside your skull or in your eyes
• have had a recent ischemic stroke
• have severe uncontrolled high blood pressure
• have an infection of the heart's inner lining or heart valves, called bacterial endocarditis
• have a disorder that affects bleeding, such as hemophilia, Von Willebrand disease, sickle cell disease, or liver disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Epidural or spinal hematomas, which may result in long-term or permanent paralysis, may occur in patients who are anticoagulated with selective thrombin inhibitors and are undergoing neuraxial anesthesia or spinal puncture. The risk of developing these hematomas is increased with the use of indwelling epidural catheters and concomitant use of drugs affecting hemostasis. Monitor patients frequently for neurological impairment and treat immediately if neurological compromise is noted. Consider risks/benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

Call your doctor for instructions if you miss a dose of desirudin.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause excessive bleeding.

Usual Adult Dose for Deep Vein Thrombosis -- Prophylaxis:

15 mg subcutaneously every 12 hours with the initial dose given up to 5 to 15 minutes prior to surgery, but after induction of regional block anesthesia (if used).

Up to 12 days administration (9 to 12 days on average) of desirudin has been well tolerated in controlled clinical trials.

Anticoagulant; biosynthetic 65-amino acid peptide analog of naturally occurring hirudin.1 2 3

Thromboprophylaxis in Hip-Replacement Surgery

Prevention of postoperative DVT, which may lead to PE in patients undergoing elective total hip-replacement surgery.1 2 3 4

Lower rates of venous thromboembolism with desirudin compared with either heparin or low molecular weight heparin.1 2 3 17

• Importance of patients informing clinician of prior exposure to a hiridun agent.1

• Risk of serious bleeding or hemorrhage.1

• Importance of reporting any signs of bleeding.1

• Importance of patients informing clinician of history of bleeding disorders or impaired renal function.1

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• CGP-39393
• Desulfato-Hirudin
• Desulfatohirudin
• Desulphatohirudin
• r-Hirudin
• Recombinant Desulfatohirudin
• Recombinant Hirudin

Note: Initial dose may be given up to 5 to 15 minutes prior to surgery (after induction of regional anesthesia, if used); has been administered for up to 12 days (average: 9 to 12 days) in clinical trials

DVT prophylaxis: SubQ: 15 mg every 12 hours; interrupt therapy if aPTT exceeds 2 times control; resume at a reduced dose (based on the degree of aPTT abnormality) when aPTT is <2 times control

Attach enclosed vial adapter to vial containing desirudin. Attach provided syringe containing diluent to adapter on vial. Slowly push plunger down to transfer entire contents of syringe into vial. Do not remove syringe from vial adapter. Gently swirl solution; powder will dissolve within 10 seconds. Resultant solution concentration is 31.5 mg/mL (15.75 mg/0.5 mL provides a 15 mg dose). Turn vial upside down; withdraw appropriate dose amount back into syringe. Remove syringe from vial. Attach enclosed Eclipse™ needle; pull pink lever down and uncap needle; ready for injection. After injection, flip up pink lever to cover needle until it snaps into place; dispose of syringe appropriately.

Do not administer IM; for deep SubQ administration only. Administration should be alternated between the left and right anterolateral and left and right posterolateral thigh or abdominal wall. Insert whole needle length into a skin fold held between the thumb and forefinger; the skin fold should be held throughout the injection. Do not rub injection site.