Pronunciation:

lep-i-ROO-din

Brand Names:

• Refludan

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Anticoagulant

Pharmacologic—

Thrombin Inhibitor, Direct

Chemical—

Hirudin Related

Uses of This Medicine:

Lepirudin injection is used to decrease the clotting ability of the blood and to help prevent harmful clots from forming in the blood vessels. This medicine is used to treat or prevent blood clots in patients with bleeding problems caused by another medicine called heparin.

This medicine was available only with your doctor's prescription.

Baxter Healthcare Corporation has made a decision to discontinue Refludan (lepirudin (rDNA)) for Injection. No further product will be distributed from Bayer after May 31, 2012.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lepirudin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of lepirudin injection in geriatric patients.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alteplase, Recombinant
• Amtolmetin Guacil
• Anistreplase
• Apixaban
• Argatroban
• Aspirin
• Bivalirudin
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Clopidogrel
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyridamole
• Dipyrone
• Drotrecogin Alfa
• Enoxaparin
• Eptifibatide
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenofibrate
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Ibuprofen Lysine
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Reteplase, Recombinant
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Streptokinase
• Sulindac
• Tenecteplase
• Tenoxicam
• Tiaprofenic Acid
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Urokinase
• Valdecoxib
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bacterial endocarditis (heart infection) or
• Blood disease or bleeding problems or
• Blood vessel problems or
• Hypertension (high blood pressure), severe and uncontrolled or
• Kidney disease or
• Major surgery or procedure (e.g., biopsy, brain surgery), recent or
• Spinal anesthesia or
• Stomach or intestinal ulcer, active or
• Stroke, recent—Use with caution. The risk of bleeding may be increased.

• Liver disease (e.g., cirrhosis)—May increase the effect of this medicine in the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

This medicine will only be given to you while you are in the hospital. Before you leave the hospital, you may be switched to an oral medicine that works in a similar way. If you have any concerns about this, talk to your doctor.

It is very important that your doctor check you at regular visits after you leave the hospital for any problems or unwanted effects that may be caused by this medicine. Be sure to keep all appointments.

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.

This medicine may increase your chance of bleeding. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

Bleeding from puncture sites and wounds

blood in the urine

bloody or black, tarry stools

collection of blood under the skin

constipation

dark urine

deep, dark purple bruise

fever with or without chills

itching, pain, redness, or swelling

light-colored stools

loss of appetite

nausea and vomiting

pale skin

severe stomach pain

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

yellow eyes or skin

Less common

Bloody nose

chest pain or discomfort

cloudy urine

confusion

cough or hoarseness

decrease in urine output

difficult or labored breathing

dilated neck veins

dizziness

extreme fatigue

fainting

fast, slow, or irregular heartbeat

headache, sudden and severe

irregular breathing

lightheadedness

lower back or side pain

noisy breathing

painful or difficult urination

rapid, shallow breathing

shortness of breath

skin rash, hives, itching, or redness

sneezing

sore throat

swelling of the face, fingers, feet, or lower legs

tightness in the chest

troubled breathing

vaginal bleeding

weakness

weight gain

wheezing

Rare

Difficulty swallowing

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

tightness or swelling of the neck

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.