Reteplase, recombinant (Intravenous)

Reteplase is used to treat heart attacks by dissolving blood clots that have formed in the blood vessels of the heart. This medicine is used right after symptoms of a heart attack happen.

This medicine is available only with your doctor's prescription.

Reteplase can cause bleeding that is usually not serious. However, some people may experience serious bleeding. To help prevent serious bleeding, carefully follow any instructions given by your doctor. Move around as little as possible, and do not get out of bed by yourself unless your doctor says it is okay.

Watch for any bleeding or oozing on your skin, especially around the injection site or where blood was drawn from your arm. Also, check for blood in your urine or bowel movements. If you notice any bleeding or injuries, inform your doctor or nurse immediately.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how age affects the use of reteplase in children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how age affects the use of reteplase in older adults. However, elderly patients may have a higher risk of serious bleeding from this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the possible benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. If you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are considered significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or may change some of the other medicines you take.

• Defibrotide

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Acenocoumarol
• Alteplase, Recombinant
• Anistreplase
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Bivalirudin
• Certoparin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Edoxaban
• Enoxaparin
• Fondaparinux
• Heparin
• Lepirudin
• Nadroparin
• Parnaparin
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Protein C
• Reviparin
• Rivaroxaban
• Streptokinase
• Tenecteplase
• Tinzaparin
• Urokinase
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are considered significant but may not include all possible interactions.

Other Medical Problems

Other medical problems may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Bleeding problems or a history of bleeding anywhere in the body
• Blood vessel problems (aneurysm)
• Brain disease or tumor
• Uncontrolled high blood pressure
• History of stroke
• Recent surgery or injury to the brain or spine—This medicine should NOT be used in these situations.

• History of blood clots
• Diabetic eye problems (hemorrhagic retinopathy)
• Heart infections (pericarditis, endocarditis)
• Injections into a blood vessel
• Severe kidney disease
• Severe liver disease
• Placement of any tube into the body
• Recent major surgery or injury—The risk of serious bleeding may be increased.

• Heart rhythm problems—This condition may worsen.

• History of high cholesterol—The risk of having a serious side effect may be increased.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bleeding at the injection site
• Bleeding from the bladder, blood in urine
• Bloody or black, tarry stools
• Severe stomach pain
• Vomiting of blood or material that looks like coffee grounds

Less common

• Pale skin
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Rare

• Blurred vision
• Confusion
• Cough
• Difficult or labored breathing
• Difficulty swallowing
• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• Fast heartbeat
• Hives
• Itching
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Shortness of breath
• Skin rash
• Sweating
• Tightness in the chest
• Wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Retavase

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Blood Modifier Agent

Pharmacologic Class: Tissue Plasminogen Activator

Find detailed information on biosimilars for this medication.

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

• Is Activase the same as tPA?