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

Iprivask 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. This medicine is for use after hip replacement surgery.

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

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

Iprivask 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Iprivask is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Iprivask is usually given every 12 hours for up to 12 days after your surgery. Follow your doctor's dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Iprivask must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Use only the syringe and needle provided with Iprivask.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need frequent medical tests.

Store the powder and diluent at cool room temperature away from moisture, heat, and light. After mixing Iprivask, store it at room temperature away from light, and use within 24 hours.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

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

• active or uncontrolled bleeding; or

• an irreversible blood clotting disorder.

Iprivask 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.

Tell your doctor if you have ever had:

• kidney disease; or

• cirrhosis or other liver disease.

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

• a bleeding disorder that is inherited or caused by disease;

• a hemorrhagic stroke;

• uncontrolled high blood pressure;

• bleeding inside your head;

• eye problems caused by diabetes;

• bleeding in your lungs, stomach, or intestines within the past 3 months;

• recent 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).

Tell your doctor if you are pregnant.

You should not breastfeed while using Iprivask.

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

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

Overdose may cause excessive bleeding.

Avoid rubbing your skin after injecting Iprivask, to prevent bruising.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Also seek emergency medical attention if you have symptoms of a spinal blood clot: back pain, numbness or muscle weakness in your lower body, or loss of bladder or bowel control.

Iprivask may cause serious side effects. Call your doctor at once if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums, heavy menstrual bleeding);

• pain, swelling, or drainage from a wound or where a needle was injected in your skin;

• bleeding from wounds or needle injections, any bleeding that will not stop;

• headache, dizziness, weakness, feeling like you might pass out;

• urine that looks red, pink, or brown; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Serious side effects may be more likely in adults who are 75 years or older.

Common side effects of Iprivask may include:

• nausea;

• vomiting; or

• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• abciximab, clopidogrel, dipyridamole, eptifibatide, ticlopidine, tirofiban;

• alteplase, reteplase, tenecteplase, urokinase;

• argatroban, bivalirudin, dabigatran, fondaparinux, lepirudin, rivaroxaban; or

• dalteparin, enoxaparin, heparin, tinzaparin.

This list is not complete. Other drugs may affect Iprivask, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.