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Tnkase

Tnkase Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

TNKase (Tenecteplase) is used to prevent death from a heart attack (acute myocardial infarction). It is a tissue plasminogen activator (TPA). It works by causing the body to over-produce a substance called plasmin to dissolve unwanted blood clots. Common side effects include bleeding, mild nausea, or dizziness.

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.

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.

Tnkase 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:

  • blood in your urine or stools;
  • nosebleed, coughing up blood;
  • bleeding from a recent injury or surgery incision;
  • bleeding around the IV needle;
  • fast, slow, or uneven heart rate; or
  • feeling like you might pass out.

Rare but serious side effects may include:

  • purple discoloration of your legs or toes;
  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • swelling, weight gain, feeling short of breath, urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
  • muscle pain or tenderness with fever or flu symptoms and dark colored urine;
  • pain or unusual sensations in your back;
  • numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use; or
  • loss of bowel or bladder control.

Less serious side effects may include mild nausea or dizziness.

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 Tnkase (Tenecteplase) »

What is Prescribing information?

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

Tnkase FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 (tenecteplase) -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 for 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 (tenecteplase) .

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%).

Allergic Reactions

Allergic-type reactions (e.g., anaphylaxis, angioedema, laryngeal edema,rash, and urticaria) have rarely ( < 1%) been reported in patients treated with TNKase (tenecteplase) .Anaphylaxis was reported in < 0.1% of patients treated with TNKase (tenecteplase) ; however, causality was not established. When such reactions occur, they usually respond to conventional therapy.

Other Adverse Reactions

The following adverse reactions have been reported among patients receiving TNKase (tenecteplase) in clinical trials. These reactions are frequent sequelae of the underlying disease, and the effect of TNKase (tenecteplase) 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) »

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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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