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(reteplase, recombinant) Lyophilized Powder for Intravenous Bolus Injection


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® contains 355 of the 527 amino acids of native tPA (amino acids 1-3 and 176-527). Retavase® 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® and is not comparable with units used for other thrombolytic agents.

Retavase® 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® is supplied as a 10.4 unit vial to ensure sufficient drug for administration of each 10 unit injection. Each single-use vial contains:

Reteplase 18.1 mg
Tranexamic Acid 8.32 mg
Dipotassium Hydrogen Phosphate 136.24 mg
Phosphoric Acid 51.27 mg
Sucrose 364.0 mg
Polysorbate 80 5.20 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...

Read All Potential Side Effects and See Pictures of Retavase »

Last reviewed on RxList: 5/31/2016
This monograph has been modified to include the generic and brand name in many instances.

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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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