Pronunciation:

ure-oh-KYE-nase

Brand Names:

• Abbokinase
• Kinlytic

Classifications:

Pharmacologic—

Tissue Plasminogen Activator

Uses of This Medicine:

Urokinase injection is used to dissolve blood clots that have formed in the lungs (pulmonary embolism).

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

This medicine is not available in the United States as of October 2010.

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 urokinase 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 urokinase injection in geriatric patients.

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Defibrotide

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.

• Acenocoumarol
• Alteplase, Recombinant
• Anistreplase
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Betrixaban
• Bivalirudin
• Certoparin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Edoxaban
• Enoxaparin
• Fondaparinux
• Heparin
• Lepirudin
• Nadroparin
• Parnaparin
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Protein C
• Reteplase, Recombinant
• Reviparin
• Rivaroxaban
• Streptokinase
• Tenecteplase
• Tinzaparin
• 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Bleeding problems or a history of bleeding in any part of the body or
• Blood vessel problems (e.g., aneurysm) or
• Brain disease or tumor or
• Hypertension (high blood pressure), uncontrolled or
• Stroke, recent (within two months) or
• Surgery or injury to the brain or spine, recent (within two months) or
• Trauma including CPR (cardiopulmonary resuscitation), recent—Should not be used in patients with these conditions.

• Blood clotting disorders or
• Diabetic eye problems (e.g., hemorrhagic retinopathy) or
• Heart disease or infections (e.g., endocarditis, mitral stenosis) or
• Injections into a blood vessel or
• Kidney disease, severe or
• Liver disease, severe or
• Placement of any tube into the body or
• Surgery or injury of any kind, major and recent—The chance of serious bleeding may be increased.

• High cholesterol, history of—The chance of having a serious side effect may be increased.

Proper Use of This Medicine:

A doctor 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:

Urokinase can cause bleeding that usually is not serious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow any instructions given by your doctor. Move around as little as possible, and do not get out of bed on your own, unless your doctor tells you it is all right to do so.

Watch for any bleeding or oozing on your skin, such as around the place of injection or where blood was drawn from your arm. Also, check for blood in your urine or bowel movements. If you have any bleeding or injuries, tell your doctor or nurse right away.

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 gums

coughing up blood

difficulty with breathing or swallowing

dizziness

headache

increased menstrual flow or vaginal bleeding

nosebleeds

paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

shortness of breath

Rare

Cough

fast heartbeat

hives or welts

itching skin

noisy breathing

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

redness of the skin

skin rash

tightness in the chest

unusual tiredness or weakness

wheezing

Incidence not known

Blue lips and fingernails

blurred vision

chest pain or discomfort

confusion

convulsions

coughing that sometimes produces a pink frothy sputum

difficult, fast, or noisy breathing, sometimes with wheezing

fainting

fast, irregular, pounding, or racing heartbeat or pulse

inability to speak

increased sweating

low blood pressure or pulse

numbness or tingling in the face, arms, or legs

pale skin

severe or sudden headache

severe or sudden weakness in the arm or leg on one side of the body

slurred speech

swelling in the legs and ankles

trouble with walking or speaking

unconsciousness

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.