Desirudin Subcutaneous

Desirudin is used to prevent deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and can become lodged in the blood vessels of the lungs, causing a condition called pulmonary embolism. desirudin is used for several days after hip replacement surgery, while you are unable to walk. It is during this time that blood clots are most likely to form.

desirudin is available only with your doctor's prescription.

A nurse or other trained health professional will give you desirudin. desirudin is given as a shot under your skin, usually in the abdomen or thighs.

If you are using desirudin at home, your doctor will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your doctor if you have any problems using the medicine.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

Use only the brand of desirudin that your doctor prescribed. Different brands may not work the same way.

If the medicine in the vial (glass container) or prefilled syringe has changed color, or if you see particles in it, do not use it.

Put used syringes in a puncture-resistant, disposable container, or dispose of them as directed by your doctor.

Dosing

The dose of desirudin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of desirudin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For prevention of deep venous thrombosis (leg clots) after hip replacement surgery:
    • Adults—15 milligrams (mg) injected under the skin every 12 hours. The dose is 1.7 to 5 mg every 12 hours if you have a poorly performing kidney.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the unopened vials or prefilled syringes at room temperature, away from heat, moisture, and direct light. You may also store the mixed solution at room temperature and may be used up to 24 hours. Throw away any unused medicine after 24 hours.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bleeding gums
• collection of blood under the skin
• coughing up blood
• deep, dark purple bruise
• difficulty with breathing or swallowing
• dizziness
• headache
• increased menstrual flow or vaginal bleeding
• itching, pain, redness, or swelling
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• shortness of breath

• Changes in skin color, pain, tenderness, or swelling of the foot or leg
• cough
• fast heartbeat
• hives
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• wheezing
• wound secretion

• Blood in the urine
• blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• severe or sudden headache
• sudden loss of coordination
• sudden slurring of speech
• sweating
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
• trouble healing
• vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Nausea
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

This medication is used to prevent serious blood clots in the legs and/or lungs after certain types of surgery (such as hip replacement).

Desirudin is known as a "blood thinner" (anticoagulant). It works by blocking certain natural substances in the blood that cause clotting.

How to use Desirudin Solution, Reconstituted (Recon Soln)

Follow all directions for proper mixing. Do not mix with other medications. Consult your pharmacist for more details.

Gently swirl the medication to mix. Do not shake. Before using this product, check it visually for particles or discoloration. If either is present, do not use the liquid.

If you are giving the shots yourself, you will be trained by a health care professional on how to properly prepare, inject, and use this product. Sit or lie down when injecting this medication. Inject desirudin under the skin of the thigh or abdomen as directed by your doctor, usually twice a day. Do not inject into a muscle or a vein. To lessen irritation, change the injection site with each shot. To lessen bruising, do not rub the injection site after a shot.

Learn how to store and discard needles and medical supplies safely.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Dosage and length of treatment are based on your medical condition (such as kidney disease) and response to therapy. Do not use more than the recommended dose since this would increase your chance of bleeding.

See also Warning section.

Nausea or injection site reactions including mild irritation, pain, bruising, redness, a bump or swelling may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may rarely cause serious bleeding. Tell your doctor right away if any signs of serious bleeding occur, including: unusual bruising, severe stomach/abdominal pain, red/pinkish urine, black stools, vomit that looks like coffee grounds, severe headache, confusion, vision changes, unusual dizziness, fast/irregular heartbeat, chest pain, shortness of breath.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.