Tnkase

Last updated on RxList: 3/9/2018
Tnkase Side Effects Center

Last reviewed on RxList 3/9/2018

TNKase (tenecteplase) is a tissue plasminogen activator (TPA) used to prevent death from a heart attack (acute myocardial infarction). TNKase works by causing the body to over-produce a substance called plasmin to dissolve unwanted blood clots. Common side effects of TNKase include:

TNKase is for intravenous administration only. The recommended total dose should not exceed 50 mg and is based upon patient weight. TNKase may interact with blood thinners, abciximab, alteplase, anistreplase, dipyridamole, eptifibatide, heparin, streptokinase, tirofiban, or urokinase. Tell your doctor all medications and supplements you use. During pregnancy, TNKase should be used only if prescribed. It may be harmful to a fetus. Before you receive this medication, tell your doctor if you are pregnant. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our TNKase (Tenecteplase) 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.

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Tnkase Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tenecteplase increases your risk of bleeding, which can be severe or life-threatening. Call your doctor or seek emergency medical attention if you have bleeding that will not stop. Bleeding may occur from a surgical incision, or from the skin where a needle was inserted during a blood test or while receiving injectable medication. You may also have bleeding on the inside of your body, such as in your stomach or intestines, kidneys or bladder, brain, or within the muscles.

Call your doctor at once if you have signs of bleeding inside your body, 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;
  • red or pink urine; or
  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Also call your doctor at once if you have:

  • swelling, rapid weight gain, little or no urinating;
  • darkening or purple discoloration of your fingers or toes;
  • very slow heartbeats, shortness of breath, feeling light-headed;
  • sudden severe back pain, muscle weakness, numbness or loss of feeling in your arms or legs,
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or
  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting.

Common side effects may include:

  • bleeding;
  • nausea, vomiting; or
  • fever.

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.

Read the entire detailed patient monograph for Tnkase (Tenecteplase)

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Tnkase Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in Section PRECAUTIONS of the label:

  • Hypersensitivity

Bleeding

The most frequent adverse reaction associated with TNKase is bleeding (see WARNINGS).

Should serious bleeding occur, concomitant heparin and antiplatelet therapy should be discontinued. Death or permanent disability can occur in patients who experience stroke or serious bleeding episodes.

For TNKase-treated patients in ASSENT-2, the incidence of intracranial hemorrhage was 0.9% and any stroke was 1.8%. The incidence of all strokes, including intracranial bleeding, increases with increasing age (see PRECAUTIONS: Geriatric Use).

In the ASSENT-2 study, the following bleeding events were reported (see Table 3).

Table 3
ASSENT-2
Non-ICH Bleeding Events

  TNKase
(n = 8461)
Accelerated
Activase
(n = 8488)
Relative Risk
TNKase/Activase
(95% CI)
Major bleedinga 4.7% 5.9% 0.78 (0.69, 0.89)
Minor bleeding 21.8% 23.0% 0.94 (0.89, 1.00)
Units of transfused blood
  Any 4.3% 5.5% 0.77 (0.67, 0.89)
  1-2 2.6% 3.2%
  > 2 1.7% 2.2%
a Major bleeding is defined as bleeding requiring blood transfusion or leading to hemodynamic compromise.

Non-intracranial major bleeding and the need for blood transfusions were lower in patients treated with TNKase.

Types of major bleeding reported in 1% or more of the patients were hematoma (1.7%) and gastrointestinal tract (1%). Types of major bleeding reported in less than 1% of the patients were urinary tract, puncture site (including cardiac catheterization site), retroperitoneal, respiratory tract, and unspecified. Types of minor bleeding reported in 1% or more of the patients were hematoma (12.3%), urinary tract (3.7%), puncture site (including cardiac catheterization site) (3.6%), pharyngeal (3.1%), gastrointestinal tract (1.9%), epistaxis (1.5%), and unspecified (1.3%).

Other Adverse Reactions

The following adverse reactions have been reported among patients receiving TNKase in clinical trials. These reactions are frequent sequelae of the underlying disease, and the effect of TNKase on the incidence of these events is unknown.

These events include cardiogenic shock, arrhythmias, atrioventricular block, pulmonary edema, heart failure, cardiac arrest, recurrent myocardial ischemia, myocardial reinfarction, myocardial rupture, cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation, thrombosis, embolism, and electromechanical dissociation. These events can be life-threatening and may lead to death. Nausea and/or vomiting, hypotension, and fever have also been reported.

Read the entire FDA prescribing information for Tnkase (Tenecteplase)

SLIDESHOW

Heart Disease: Symptoms, Signs, and Causes See Slideshow

© Tnkase Patient Information is supplied by Cerner Multum, Inc. and Tnkase Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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