Abbokinase (Urokinase) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The most serious adverse reactions reported with Abbokinase® administration include fatal hemorrhage and anaphylaxis (see WARNINGS).

BLEEDING

Bleeding is the most frequent adverse reaction associated with Abbokinase® and can be fatal (see WARNINGS).

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 urokinase-treated 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 Abbokinase® 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 (see WARNINGS). 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 (see WARNINGS).

Infusion reaction symptoms include hypoxia, cyanosis, dyspnea, tachycardia, hypotension, hypertension, acidosis, fever and/or chills/rigors, back pain, vomiting, and nausea (see WARNINGS).

OTHER ADVERSE REACTIONS

Other adverse events occurring in patients receiving Abbokinase® 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 (see WARNINGS), cerebral vascular accident, pulmonary edema, reperfusion ventricular arrhythmias and chest pain. A cause and effect relationship has not been established.

IMMUNOGENICITY

The immunogenicity of Abbokinase® has not been studied.

REPORTS OF SUSPECTED ABBOKINASE SIDE EFFECTS / ADVERSE REACTIONS

Possible Abbokinase side effects / adverse reactions in 48 year old male

Reported by a pharmacist from Spain on 2012-04-13

Patient: 48 year old male weighing 90.0 kg (198.0 pounds)

Reactions: Myositis, Drug Interaction

Suspect drug(s):
Acyclovir
    Dosage: 500 mg;tid;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-11
    End date: 2011-09-13

Hibor (Heparin Sodium /00027704/)
    Dosage: 2500 iu;qd;sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-07
    End date: 2011-09-30

Abbokinase
    Dosage: 100 kiu;qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-15
    End date: 2011-09-15

Omeprazole
    Dosage: 20 mg;qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-25
    End date: 2011-10-07

Allopurinol
    Dosage: 300 mg;qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-25
    End date: 2011-09-08

Enoxaparin Sodium
    Dosage: 20 mg;qd;sc
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-25
    End date: 2011-08-26

Meropenem
    Dosage: 1 mg;tid;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05
    End date: 2011-09-14

Levofloxacine (Levofloxacin)
    Dosage: 500 mg;qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-18
    End date: 2011-09-28

Orbenin (Cloxacillin Sodium)
    Dosage: 1000 mg;qid;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-31
    End date: 2011-09-16

Duphalac
    Dosage: 10 gm;qd;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-31
    End date: 2011-09-14

Targocid
    Dosage: 400 mg;qd;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-06
    End date: 2011-09-19

Polaramine
    Dosage: 12 mg;prn;po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-16
    End date: 2011-09-22

Ambisome
    Dosage: 250 mg;qd;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-16
    End date: 2011-09-26

Noxafil
    Dosage: po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-02
    End date: 2011-09-17

Acetaminophen
    Dosage: 1 gm;tid;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-25
    End date: 2011-09-08

Furosemide
    Dosage: 20 mg;qd;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-08
    End date: 2011-09-26

Cubicin
    Dosage: 350 mg;qd;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-10
    End date: 2011-09-14

Maxipime
    Dosage: 1 gm;tid;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-25
    End date: 2011-09-03

Tazocel (Pip/tazo)
    Dosage: 1 gm;qid;iv
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-14
    End date: 2011-09-19

Vesanoid
    Dosage: 50 mg;bid;po
    Administration route: Oral
    Indication: Acute Promyelocytic Leukaemia
    Start date: 2011-08-26
    End date: 2011-10-07