"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.
In a "...
Retavase® (Reteplase) is a non-glycosylated deletion mutein of tissue plasminogen activator (tPA), containing the kringle 2 and the protease domains of human tPA. Retavase® (reteplase) contains 355 of the 527 amino acids of native tPA (amino acids 1-3 and 176-527). Retavase® (reteplase) is produced by recombinant DNA technology in E.coli. The protein is isolated as inactive inclusion bodies from E.coli, converted into its active form by an in vitro folding process and purified by chromatographic separation. The molecular weight of Reteplase is 39,571 daltons.
Potency is expressed in units (U) using a reference standard which is specific for Retavase® (reteplase) and is not comparable with units used for other thrombolytic agents.
Retavase® (reteplase) is a sterile, white, lyophilized powder for intravenous bolus injection after reconstitution with Sterile Water for Injection, USP (without preservatives). Following reconstitution, the pH is 6.0 ± 0.3. Retavase® (reteplase) is supplied as a 10.4 unit vial to ensure sufficient drug for administration of each 10 unit injection. Each single-use vial contains:
|Tranexamic Acid||8.32 mg|
|Dipotassium Hydrogen Phosphate||136.24 mg|
|Phosphoric Acid||51.27 mg|
What are the possible side effects of retaplase (Retavase)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Tell your doctor at once if you have a serious side effect such as:
- sudden numbness or weakness, especially on one side of the body;
- sudden headache, confusion, problems with vision, speech, or balance;
- chest pain, sudden cough, wheezing, rapid breathing;
- fast, slow, or uneven heart rate;
- feeling like you might pass out;
- weak pulse, fainting, slow breathing (breathing may...
Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Retavase Information
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.
Get the latest treatment options.