Kinlytic

DRUG DESCRIPTION

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...

Read All Potential Side Effects and See Pictures of Kinlytic »


Kinlytic Patient Information Including Side Effects

Brand Names: Abbokinase, Kinlytic

Generic Name: urokinase (Pronunciation: URE oh KYE nase)

  • What is urokinase (Kinlytic)?
  • What are the possible side effects of urokinase (Kinlytic)?
  • What is the most important information I should know about urokinase (Kinlytic)?
  • What should I discuss with my health care provider before I receive urokinase (Kinlytic)?
  • How is urokinase given (Kinlytic)?
  • What happens if I miss a dose (Kinlytic)?
  • What happens if I overdose (Kinlytic)?
  • What should I avoid while receiving urokinase (Kinlytic)?
  • What other drugs will affect urokinase (Kinlytic)?
  • Where can I get more information?

What is urokinase (Kinlytic)?

Urokinase is a man-made product developed using a protein that occurs naturally in the kidneys. Urokinase is a thrombolytic agent that works by dissolving blood clots.

Urokinase is used to treat blood clots in the lungs.

Urokinase may also be used for other purposes not listed in this medication guide.

What are the possible side effects of urokinase (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 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.

What is the most important information I should know about urokinase (Kinlytic)?

You should not use this medication if you are allergic to urokinase, or if you have internal bleeding, a brain tumor or aneurysm, hemophilia or other bleeding disorder, arterial hypertension, or if you have had a recent stroke, surgery, organ transplant, or medical emergency .

Before you receive urokinase, tell your doctor if you have liver or kidney disease, diabetes, heart problems, if you are pregnant or recently gave birth, a history of stroke or stomach bleeding.

Tell your caregivers at once if you have a serious side effect such as easy bruising or bleeding, blood in your stools, coughing up blood, chest pain, sudden problems with vision or speech, swelling, discoloration of your fingers or toes, severe stomach pain, weak or shallow breathing, fever, chills, or flu symptoms.

Before you receive urokinase, tell your doctor if you are using a blood thinner such as warfarin (Coumadin), aspirin or an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), and others, or any medication used to prevent blood clots such as Kabikinase, Plavix, Ticlid, Persantine, Streptase, and others.

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