alteplase, Activase; Cathflo Activase; TPA

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GENERIC NAME: alteplase

BRAND NAME: Activase, Cathflo Activase, TPA

DRUG CLASS AND MECHANISM: Alteplase is an injectable drug, given directly into a vein, that is used to treat conditions caused by arterial blood clots including heart attacks, strokes, chest pain at rest (unstable angina), blood clots in the lungs (pulmonary thrombosis or embolus), and other less common conditions involving blood clots. Alteplase is an enzyme that occurs naturally in man and causes blood clots to dissolve. It is a man-made protein manufactured by recombinant DNA technology. The naturally occurring protein, known as tissue plasminogen activator (TPA), is made by ovarian cells from the Chinese hamster. The amount that is given to patients is far greater than the amount naturally made by the body itself. Alteplase was first approved for heart attacks in 1987. In 1996, it was approved for strokes.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Powder is mixed with sterile water for injection: 2, 50, and 100 mg vials.

STORAGE: The vials are stored at room temperature up to 80 F (30 C) or under refrigeration at 2-8 C (36-46 F). Once mixed with sterile water, it must be used immediately. Any drug not used must be thrown away.

PRESCRIBED FOR: Alteplase is used to treat persons with heart attacks (acute myocardial infarctions), strokes, chest pain at rest (unstable angina), blood clots in the lungs (pulmonary thrombosis or embolism), and other less common conditions involving blood clots. It is also used for clearing blood clots from blocked venous catheters.

DOSING: Alteplase is injected intravenously or directly into a clogged catheter.

For heart attacks the recommended dose is a 15 mg injection followed by 50 mg or 0.75 mg/kg (up to 50 mg) infused over 30 minutes then 35 mg or 0.5 mg/kg (up to 35 mg) over 60 minutes. The total dose is 100 mg. It also can be infused over 3 hours.

The dose for treating pulmonary embolism is 100 mg infused over 2 hours. The dose for treating acute ischemic stroke is 0.9 mg/kg infused over one hour not to exceed 90 mg. Clogged catheters are cleared by injecting 2 mg/2 ml solution into the clogged catheter.

DRUG INTERACTIONS: Alteplase breaks down clots and thereby interferes with the body's ability to stop bleeding. Therefore, drugs which also interfere with the body's ability to form blood clots (or the clot-promoting effects of platelets) increase the risk of bleeding in patients receiving alteplase. Such drugs include warfarin (Coumadin), aspirin, and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin), naproxen (Naprosyn), nabumetone (Relafen), and platelet inhibitors such as clopidogrel (Plavix).

PREGNANCY: Alteplase has been shown to cause damage to embryos of rabbits. No damage has been reported in humans. Physicians must carefully balance potential risks and possible benefits when prescribing alteplase to pregnant women.

NURSING MOTHERS: It is not known whether alteplase passes into breast milk.

SIDE EFFECTS: The most common and serious side effect with alteplase is bleeding. Minor bleeding is more common, but significant bleeding such as into the brain or fatal bleeding also occurs. Nausea, vomiting, and allergic reactions also occur.

Reference: FDA Prescribing Information


Last Editorial Review: 3/16/2012




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