Side Effects of Kinlytic (urokinase)

Kinlytic (urokinase) is a thrombolytic medication used to break up blood clots in the lungs. Urokinase is an enzyme (protein) that disrupts the clotting cycle and breaks down blood clots lodged in the lungs in people with pulmonary embolism. 

Common side effects of Kinlytic include:

• bleeding,
• decreased hematocrit,
• chest pain,
• increased heart rate,
• fever, chills,
• nausea, and
• vomiting. 

Serious side effects of Kinlytic include:

• anaphylaxis reactions.

Drug interactions of Kinlytic include other medications that alter platelet function and increase risk of bleeding such as:

• aspirin,
• nonsteroidal anti-inflammatory drugs (NSAIDs),
• warfarin,
• enoxaparin,
• clopidogrel, and
• cilostazol. 

There are no adequate studies done on Kinlytic to determine safe and effective use in pregnant women. Kinlytic should be only used during pregnancy if clearly needed. 

It is unknown if Kinlytic enters breast milk. It is best to be cautious before using it in breastfeeding mothers.

Side effects of urokinase are:

• bleeding,
• decreased hematocrit,
• chest pain,
• increased heart rate,
• fever,
• chills,
• nausea,
• vomiting, and
• anaphylaxis reactions.

The most serious adverse reactions reported with Kinlytic (urokinase injection) administration include:

• fatal hemorrhage and
• anaphylaxis.

Bleeding

Bleeding is the most frequent adverse reaction associated with Kinlytic and can be fatal.

In controlled clinical studies using a 12-hour infusion of urokinase for the treatment of pulmonary embolism (UPET and USPET),3,5,6 bleeding resulting in at least a 5% decrease in hematocrit was reported in 52 of 141 urokinase-treated patients.

Significant bleeding events requiring transfusion of greater than 2 units of blood were observed during the 14-day study period in 3 of 141 urokinasetreated patients in these studies.

Multiple bleeding events may have occurred in an individual patient. Most bleeding occurred at sites of external incisions and vascular puncture, with lesser frequency in gastrointestinal, genitourinary, intracranial, retroperitoneal, and intramuscular sites.

Sources of Information on Adverse Reactions

There are limited well-controlled clinical studies performed using urokinase. The adverse reactions described in the following sections reflect both the clinical use of Kinlytic (urokinase injection) in the general population and limited controlled study data.

Because post-marketing reports of adverse reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.

Allergic Reactions

Rare cases of fatal anaphylaxis have been reported. In controlled clinical trials, allergic reaction was reported in 1 of 141 patients ( < 1%).

The following allergic-type reactions have been observed in clinical trials and/or post-marketing experience:

• bronchospasm,
• orolingual edema,
• urticaria,
• skin rash, and
• pruritus.

Infusion reaction symptoms include:

• hypoxia,
• cyanosis,
• dyspnea,
• tachycardia,
• hypotension,
• hypertension,
• acidosis,
• fever and/or chills/rigors,
• back pain,
• vomiting, and
• nausea.

Other Adverse Reactions

Other adverse events occurring in patients receiving Kinlytic (urokinase injection) therapy in clinical studies, regardless of causality, include:

• myocardial infarction,
• recurrent pulmonary embolism,
• hemiplegia,
• stroke,
• decreased hematocrit,
• substernal pain,
• thrombocytopenia, and
• diaphoresis.

Additional adverse reactions reported from post-marketing experience include cardiac arrest, vascular embolization (cerebral and distal) including:

• cholesterol emboli,
• cerebral vascular accident,
• pulmonary edema,
• reperfusion ventricular arrhythmias and
• chest pain.

A cause and effect relationship has not been established.

Immunogenicity

The immunogenicity of Kinlytic (urokinase injection) has not been studied.

Anticoagulants and agents that alter platelet function (such as aspirin, other non-steroidal antiinflammatory agents, dipyridamole, and GP IIb/IIIa inhibitors) may increase the risk of serious bleeding.

Administration of Kinlytic (urokinase injection) prior to, during, or after thrombolytic agents may increase the risk of serious bleeding.

Because concomitant use of Kinlytic (urokinase injection) with agents that alter coagulation, inhibit platelet function, or are thrombolytic may further increase the potential for bleeding complications, careful monitoring for bleeding is recommended.

The interaction of Kinlytic (urokinase injection) with other drugs has not been studied and is not known.