"SILVER SPRING, MD â€” The US Food and Drug Administration (FDA) is warning of several treatment-related serious adverse events in association with implantable left ventricular assist devices (LVADs) in heart-failure patients.
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A Recombinant Tissue Plasminogen Activator
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.
|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|
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.
Additional Activase Information
- Activase Drug Interactions Center: alteplase iv
- Activase Side Effects Center
- Activase FDA Approved Prescribing Information including Dosage
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