Retavase

DRUG DESCRIPTION

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:

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 805.20 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...

Read All Potential Side Effects and See Pictures of Retavase »


Retavase Patient Information Including Side Effects

Brand Names: Retavase

Generic Name: retaplase (Pronunciation: RE te plase)

  • What is retaplase (Retavase)?
  • What are the possible side effects of retaplase (Retavase)?
  • What is the most important information I should know about retaplase (Retavase)?
  • What should I discuss with my health care provider before I receive retaplase (Retavase)?
  • How is retaplase given (Retavase)?
  • What happens if I miss a dose (Retavase)?
  • What happens if I overdose (Retavase)?
  • What should I avoid after receiving retaplase (Retavase)?
  • What other drugs will affect retaplase (Retavase)?
  • Where can I get more information?

What is retaplase (Retavase)?

Retaplase is a thrombolytic (THROM-bo-LIT-ik) drug that is used to dissolve blood clots.

Retaplase is used to improve heart function and prevent congestive heart failure or death in people who have had a heart attack.

Retaplase may also be used for other purposes not listed in this medication guide.

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 stop);
  • darkening or purple discoloration of your fingers or toes;
  • blood in your urine;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • bleeding from needle punctures (such as from needles used in blood tests or in giving injection) injections; or
  • pale skin, easy bruising, or any bleeding that will not stop.

Less serious side effects may include:

  • nausea;
  • vomiting; or
  • fever.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about retaplase (Retavase)?

You should not receive this medication if you are allergic to retaplase, or if you have a bleeding disorder, a brain tumor or aneurysm, uncontrolled high blood pressure, a history of stroke or blood clots, or recent brain or spinal injury or surgery.

Before using retaplase, tell your doctor if you have kidney or liver disease, eye complications caused by diabetes, an infection of the lining of your heart, or if you have had any recent surgery, injury, or major bleeding.

Tell your doctor if you take aspirin, a blood thinner such as warfarin (Coumadin), or any medications to prevent blood clots, such as abciximab (ReoPro), dipyridamole (Persantine), and others.

Tell your doctor at once if you have a serious side effect such as sudden numbness or weakness, confusion, problems with speech or vision, chest pain, sudden cough, wheezing, rapid breathing, fast or slow heart rate, darkening or purple discoloration of your fingers or toes, blood in your urine or stools, pale skin, easy bruising, or any bleeding that will not stop.

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