Lepirudin (Injection)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you have kidney disease, liver disease, blood vessel disorders, or if you have recently had surgery or dental work.
• Some medical conditions may make using lepirudin dangerous because it increases your risk of bleeding. These conditions include any type of bleeding in your body (such as a bleeding ulcer), or a bleeding disorder such as hemophilia. Other conditions include uncontrolled high blood pressure, a bacterial infection of the heart, or a history of strokes.
• You may bleed and bruise more easily while you are using this medicine. Be extra careful to avoid injuries until the effects of the medicine have worn off. Stay away from situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Avoid picking your nose. If you need to blow your nose, blow it gently.
• Watch for any bleeding from open areas such as around your injection site. Also check for blood in your urine or stools. Tell your doctor right away if you have any bleeding or injuries.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you get the injection.
• Serious side effects can occur even up to several weeks after you have stopped receiving this medicine. Check with your doctor right away if you have any unusual side effects while you are using this medicine or after you stop using this medicine.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools.
• Chest pain, shortness of breath, or coughing up blood.
• Fever, chills, cough, sore throat, and body aches.
• Increased menstrual bleeding.
• Nosebleeds or bleeding from your gums.
• Pain, redness, bleeding, or irritation where the needle is placed.
• Red or dark brown urine.
• Sudden or severe headache, problems with vision, speech, or walking.
• Unusual bleeding, bruising, or weakness.
• Vomiting of blood or material that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Nausea or vomiting.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Introduction

Lepirudin (lep-i-ROO-din)

Treats or prevents blood clots. This medicine is an anticoagulant.

Brand Name(s)

Refludan

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• Usually, you will get a dose of the medicine right away. Then you will continue to get the medicine for about 2 to 10 days, depending on how well you respond to the treatment.
• During this time, you will be watched closely to make sure the medicine is working and is not causing unwanted side effects.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using other medicines to dissolve blood clots (such as streptokinase or Streptase®), a blood thinner (such as warfarin or Coumadin®), or pain or arthritis medicine (such as aspirin, ibuprofen, naproxen, Advil®, Aleve®, Ecotrin®, or Motrin®).