TNKase Side Effects

Generic name: tenecteplase

Note: This document contains side effect information about tenecteplase. Some of the dosage forms listed on this page may not apply to the brand name TNKase.

Some side effects of TNKase may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tenecteplase: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking tenecteplase (the active ingredient contained in TNKase) 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.

For Healthcare Professionals

Applies to tenecteplase: intravenous powder for injection

Hematologic

Major hematological side effects including hematoma (1.7%), gastrointestinal bleeding (>1%), urinary tract bleeding (<1%), puncture site bleeding (<1%), retroperitoneal bleeding (<1%), respiratory tract bleeding (<1%), and unspecified bleeding (<1%) have been reported. Intracranial hemorrhage (ICH) has also been reported. In one study, ICH occurred in 1%, 1.9%, and 3.8% of patients treated with 30, 40, and 50 mg of tenecteplase (the active ingredient contained in TNKase) respectively (patients were also receiving heparin).

Minor hematological side effects including hematoma (12.3%), urinary tract bleeding (3.7%), pharyngeal (3.1%), gastrointestinal tract bleeding (1.9%), epistaxis (1.5%), and unspecified bleeding (1.3%) have been reported.

Cardiovascular

Cardiovascular side effects including cardiogenic shock, arrhythmias, atrioventricular block, heart failure, cardiac arrest, recurrent myocardial ischemia, myocardial reinfarction, myocardial rupture, cardiac tamponade, pericarditis, pericardial effusion, mitral regurgitation, thrombosis, electromechanical dissociation, and hypotension have been reported.

Local

Local side effects including bleeding from the puncture side have been reported.

Respiratory

Respiratory side effects including pulmonary edema have been reported.

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