Activase (Alteplase) Patient Information: Side Effects and Drug Images at RxList

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May 22, 2012

Activase

Stroke »

What is a stroke?

Brain cell function requires a constant delivery of oxygen and glucose from the bloodstream. A stroke, or cerebrovascular accident (CVA), occurs when blood supply to part of the brain is disrupted, causing brain cells to die. Blood flow can be compromised by a variety of mechanisms.

Blockage of an artery

Narrowing of the small arteries within the brain can cause a lacunar stroke, (lacune means "empty space"). Blockage of a single arteriole can affect a tiny area of brain causing that tissue to die (infarct).
Hardening of the arteries (atherosclerosis) leading to the brain. There are four major blood vessels that supply the brain with blood. The anterior circulation of the brain that controls most motor activity, sensation, thought, speech, and emotion is supplied by the carotid arteries. The posterior circulation, which supplies the brainstem and the cer...

Read the Stroke article »

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ACTIVASE®
(alteplase)
A Recombinant Tissue Plasminogen Activator

DRUG DESCRIPTION

Activase® (Alteplase) 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. The manufacturing process involves the secretion of the enzyme alteplase into the culture medium by an established mammalian cell line (Chinese Hamster Ovary cells) into which the cDNA for alteplase has been genetically inserted. Fermentation is carried out in a nutrient medium containing the antibiotic gentamicin, 100 mg/L. However, the presence of the antibiotic is not detectable in the final product.

Phosphoric acid and/or sodium hydroxide may be used prior to lyophilization for pH adjustment.

Activase (alteplase) is a sterile, white to off-white, lyophilized powder for intravenous administration after reconstitution with Sterile Water for Injection, USP.

Quantitative Composition of the Lyophilized Product
	100 mg Vial	50 mg Vial
Alteplase	100 mg (58 million IU)	50 mg (29 million IU)
L-Arginine	3.5 g	1.7 g
Phosphoric Acid	1 g	0.5 g
Polysorbate 80	≤ 11 mg	≤ 4 mg
Vacuum	No	Yes

Biological potency is determined by an in vitro clot lysis assay and is expressed in International Units as tested against the WHO standard. The specific activity of Activase (alteplase) is 580,000 IU/mg.

Last reviewed on RxList: 5/9/2008
This monograph has been modified to include the generic and brand name in many instances.