Urokinase Other names: U-plasminogen activator Urokinase-type plasminogen activator precursor

There is a limited amount of data from the use of urokinase in pregnant women. Urokinase should not be given during pregnancy or in the immediate post-partum period unless clearly necessary.

It is unknown whether urokinase is excreted into human breast milk. Breast-feeding should be avoided during treatment with urokinase.

Fertility

No human data on the effect of urokinase on fertility are available.

Not relevant.

There are limited data available on the adverse effects of urokinase from controlled clinical trials. The adverse reactions described below reflect the available data from these clinical trials and the clinical use of urokinase in the general population, where it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure.

Haemorrhage:

The most frequent and severe adverse effect of urokinase therapy is haemorrhage. Severe spontaneous bleeding, including fatalities resulting from cerebral haemorrhage, has occurred during urokinase therapy. Less severe spontaneous bleeding has occurred approximately twice as frequently as that occurring during heparin therapy. Patients with pre-existing haemostatic defects have the greatest risk of spontaneous bleeding.

Moderate decreases in haematocrit not accompanied by clinically detectable bleeding have been reported in approximately 20% of patients receiving urokinase.

Embolism:

Embolic episodes may occur after fragments of clot have been released. Cholesterol embolisms have also been reported.

Hypersensitivity reactions:

Urokinase is reportedly non-antigenic but mild hypersensitivity reactions including urticaria, rash, bronchospasm and very rare cases of fatal anaphylaxis have been reported.

Infusion reactions:

Infusion reactions including fever and shaking chills (rigors) have been reported. Symptomatic treatment is usually sufficient to alleviate discomfort caused by urokinase-induced fever, however, acetylsalicylic acid should not be used.

Other infusion reactions include dyspnoea, cyanosis, hypoxemia, acidosis, back pain, and nausea and/or vomiting; these reactions generally occurred within one hour of beginning urokinase infusion.

The following frequency convention was used as a basis for the evaluation of undesirable effects:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)

Immune system disorders

Rare: Hypersensitivity reactions, including urticaria, dyspnoea, hypotension, flushing, rash

Very rare: Anaphylaxis

Nervous system disorders

Common: Stroke

Vascular disorders

Very common: Haemorrhage, including from puncture site and wound, Epistaxis, gingival bleeding, Thromboembolism, Embolism, including pulmonary embolism, Haematuria (microscopic)

Common: Gastrointestinal haemorrhage, intracranial haemorrhage, retroperitoneal haemorrhage, urogenital haemorrhage, muscle haemorrhage, Artery dissection, Cholesterol embolism

Uncommon: Intrahepatic haemorrhage

Rare: Vascular pseudoaneurysm, Haematuria (macroscopic)

Renal and urinary disorders

Uncommon: Renal failure

General disorders and administration site conditions

Common: Fever, chills

Investigations

Very common: Decrease in haematocrit without clinically detectable haemorrhage, Transient increase in transaminases