Kinlytic™ (urokinase for injection) is a thrombolytic agent obtained
from human neonatal kidney cells grown in tissue culture. The principal active
ingredient of Kinlytic™ is the low molecular weight form of urokinase,
and consists of an A chain of 2,000 daltons linked by a sulfhydryl bond to a
B chain of 30,400 daltons. Kinlytic™ (urokinase injection) is supplied as a sterile lyophilized
white powder containing 250,000 international units urokinase per vial, mannitol
(25 mg/vial), Albumin (Human) (250 mg/vial), and sodium chloride (50 mg/vial).
Following reconstitution with 5 mL of Sterile Water for Injection, USP, Kinlytic™ (urokinase injection)
is a clear, slightly straw-colored solution; each mL contains 50,000 international
units of urokinase activity, 0.5% mannitol, 5% Albumin (Human), and 1% sodium
chloride (pH range 6.0 to 7.5).
Thin translucent filaments may occasionally occur in reconstituted Kinlytic™
vials (see DOSAGE AND ADMINISTRATION).
Kinlytic™ (urokinase injection) is for intravenous infusion only.
Kinlytic™ (urokinase injection) is produced from human neonatal kidney cells (see WARNINGS).
No fetal tissue is used in the production of Kinlytic™ (urokinase injection) . Kidney donations
are obtained exclusively in the United States from neonates (birth to 28 days)
for whom death has not been attributed to infectious causes and that have exhibited
no evidence of an infectious disease based in part, on an examination of the
maternal and neonatal donor medical records. The maternal and neonatal donor
screening process also identifies specific risk factors for known infectious
diseases and includes testing of sera for HBV, HCV, HIV-1, HIV-2, HTLV-I, HTLV-II,
CMV, and EBV. Donors with sera testing positive or associated with other risk
factors are excluded. During the manufacturing process, cells are tested at
multiple stages for the presence of viruses using in vitro and in
vivo tests that are capable of detecting a wide range of viruses. Cells
are also screened for HPV using a DNA detection-based test and for reovirus
using a polymerase chain reaction-based test. The manufacturing process used
for this product has been validated in laboratory studies to inactivate and/or
remove a diverse panel of spiked model enveloped and nonenveloped viruses, and
includes purification steps and a heat treatment step (10 hours at 60°C
in 2% sodium chloride). A single vial of Kinlytic™ contains urokinase
produced using cells derived from one or two donors.
What are the possible side effects of urokinase (Abbokinase, Kinlytic)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- easy bruising or bleeding (nosebleeds, bleeding gums, bleeding from a wound, incision, catheter, or needle injection );
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...
Read All Potential Side Effects and See Pictures of Kinlytic »
Last reviewed on RxList: 8/7/2008
This monograph has been modified to include the generic and brand name in many instances.