alteplase, Activase, TPA
GENERIC NAME: alteplase
BRAND NAME: 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),
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 to be mixed with sterile water for injection at concentrations of 50 mg/50 mL and 100mg/100 mL.
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.
DOSING: Alteplase is injected intravenously. Depending on the
condition being treated, it is given once quickly or as a brief infusion
over 30 to 60 minutes.
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 medicines include warfarin (Coumadin), aspirin,
and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin), naproxen
(Naprosyn), and nabumetone (Relafen). Specific platelet inhibitors, for example, clopidogrel
(Plavix) do not appear to interact with alteplase and increase the risk of bleeding.
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. Most commonly, such bleeding is minor, but
significant, even fatal bleeding has been reported.
Reference: FDA Prescribing Information
Last Editorial Review: 12/19/2000 4:23:00 PM
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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