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Activase

Last reviewed on RxList: 9/22/2020

What Is Activase and how is it used?

Activase (alteplase) is an enzyme, which works to break up and dissolve blood clots that can block arteries, used in the treatment of an acute heart attack or pulmonary embolism.

What are side effects of Activase?

The most common side effect of Activase is bleeding, including gastrointestinal bleeding, genitourinary bleeding, bruising, nosebleed, and bleeding gums. Other side effects of Activase include:

DESCRIPTION

Activase is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. Activase is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP.

Table 6 : Quantitative Composition of the Lyophilized Product

100 mg Vial50 mg Vial
Alteplase100 mg (58 million IU)50 mg (29 million IU)
L-Arginine3.5 g1.7 g
Phosphoric Acid1 g0.5 g
Polysorbate 8010 mg5 mg
VacuumNoYes

Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units (IU).

The reconstituted preparation results in a colorless to pale yellow transparent solution containing Activase 1 mg/mL at approximately pH 7.3. The osmolality of this solution is approximately 215 mOsm/kg.

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