Abbokinase

In the U.S.

• Abbokinase
• Kinlytic

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Thrombolytic

Pharmacologic Class: Tissue Plasminogen Activator

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.

Pediatric

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.

Geriatric

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

Pregnancy

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.

Interactions with 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
• 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
• Urokinase
• Warfarin

Interactions with Food/Tobacco/Alcohol

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.

This section provides information on the proper use of a number of products that contain urokinase. It may not be specific to Abbokinase. Please read with care.

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.

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.

Applies to urokinase: intravenous powder for injection

General

The most common and severe adverse reaction was hemorrhage, with puncture site being the most frequent location.[Ref]

Hematologic

Very common (10% or more): Bleeding resulting in at least 5% decrease in hematocrit (36.9%)
Common (1% to 10%): Significant bleeding events requiring transfusion of greater than 2 units of blood
Frequency not reported: Hemorrhage, hematocrit decreased without clinically detectable hemorrhage, fatal hemorrhage, hematocrit decreased, thrombocytopenia[Ref]

Cardiovascular

Common (1% to 10%): Hematoma, artery dissection, embolism, cholesterol embolism
Rare (less than 0.1%): Vascular pseudoaneurysm
Frequency not reported: Thromboembolism, wound hemorrhage, hypotension, flushing, cyanosis, tachycardia, hypertension, myocardial infarction
Postmarketing reports: Cardiac arrest, reperfusion ventricular arrhythmias[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal hemorrhage, retroperitoneal hemorrhage
Frequency not reported: Gingival hemorrhage, retroperitoneal hematoma, nausea, vomiting, orolingual edema[Ref]

Nervous system

Common (1% to 10%): Stroke, intracranial hemorrhage
Frequency not reported: Fatal intracranial hemorrhage, intracranial hematoma, hemiplegia
Postmarketing reports: Cerebral embolism, cerebral vascular accident[Ref]

Other

Common (1% to 10%): Fever, chills
Frequency not reported: Substernal pain
Postmarketing reports: Chest pain[Ref]

Genitourinary

Common (1% to 10%): Urogenital hemorrhage
Rare (less than 0.1%): Macroscopic hematuria
Frequency not reported: Microscopic hematuria[Ref]

Musculoskeletal

Common (1% to 10%): Muscle hemorrhage
Frequency not reported: Back pain[Ref]

Immunologic

Uncommon (0.1% to 1%): Allergic reaction
Rare (less than 0.1%): Hypersensitivity reactions, anaphylaxis
Very rare (less than 0.01%): Fatal anaphylaxis[Ref]

Hepatic

Uncommon (0.1% to 1%): Intrahepatic hemorrhage
Frequency not reported: Transient increase in transaminases[Ref]

Renal

Uncommon (0.1% to 1%): Renal failure[Ref]

Respiratory

Frequency not reported: Epistaxis, pulmonary embolism, dyspnea, hypoxemia, bronchospasm, recurrent pulmonary embolism
Postmarketing reports: Pulmonary edema[Ref]

Dermatologic

Frequency not reported: Urticaria, rash, pruritus, diaphoresis[Ref]

Local

Frequency not reported: Puncture site hemorrhage, puncture site hematoma, infusion reactions[Ref]

Metabolic

Frequency not reported: Acidosis[Ref]

Some side effects of Abbokinase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available

Caution is recommended; some authorities recommend avoiding breastfeeding during use of this drug. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.