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Kinlytic

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Kinlytic

Kinlytic Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Kinlytic (urokinase) for Injection is a thrombolytic agent used to treat blood clots in the lungs. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include easy bruising or bleeding. Other side effects are uncommon, but can be severe such as fever, stroke, or trouble breathing. See your doctor if you have any side effects.

The loading dose of 4,400 international units per kilogram of Kinlytic injection is given at a rate of 90 mL per hour over a period of 10 minutes. This is followed with a continuous infusion of 4,400 international units per kilogram per hour at a rate of 15 mL for 12 hours. Kinlytic may interact with blood thinners, aspirin or NSAIDs (nonsteroidal anti-inflammatory drugs), or medications used to prevent blood clots. Tell your doctor all medications and supplements you use. Kinlytic is not expected to be harmful to a fetus. However, your doctor should know if you are pregnant before you receive this medication. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Kinlytic (urokinase) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Kinlytic in Detail - Patient Information: Side Effects

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 feeling;
  • sudden headache or problems with speech, vision, or balance;
  • fever, chills, flu symptoms, nausea, vomiting, back pain, or stomach pain;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite;
  • swelling, weight gain, feeling short of breath;
  • urinating less than usual or not at all;
  • red or purple discoloration of fingers or toes;
  • weak or shallow breathing, blue-colored lips or fingernails;
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or
  • pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Kinlytic (Urokinase Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Kinlytic FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reactions reported with Kinlytic™ (urokinase injection) administration include fatal hemorrhage and anaphylaxis (see WARNINGS).

Bleeding

Bleeding is the most frequent adverse reaction associated with Kinlytic™ 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 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 (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 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 (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 Kinlytic™ (urokinase injection) has not been studied.

Read the entire FDA prescribing information for Kinlytic (Urokinase Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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