Reteplase, recombinant (Intravenous route)
- Powder for Solution
Blood Modifier Agent
Tissue Plasminogen Activator
Uses of This Medicine:
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 immediately after symptoms of a heart attack occur .
This medicine is available only with your doctor's prescription .
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of reteplase in the pediatric population. Safety and efficacy have not been established .
No information is available on the relationship of age to the effects of reteplase in geriatric patients. However, the risk of serious bleeding from this medicine may be more likely in elderly patients .
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alteplase, Recombinant
- Dabigatran Etexilate
- Heparin Sodium
- Pentosan Polysulfate Sodium
- Protein C, Human
- Reteplase, Recombinant
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding problems or a history of bleeding in any part of the body or
- Blood vessel problems (aneurysm) or
- Brain disease or tumor or
- High blood pressure, uncontrolled or
- Stroke, history of or
- Surgery or injury to the brain or spine, recent—This medicine should NOT be used in these conditions .
- Blood clots, history of or
- Diabetic eye problems (hemorrhagic retinopathy) or
- Heart infections (pericarditis, endocarditis) or
- Injections into a blood vessel or
- Kidney disease, severe or
- Liver disease, severe or
- Placement of any tube into the body or
- Surgery or injury of any kind, major and recent—The chance of serious bleeding may be increased .
- Heart rhythm problems—This condition may get worse.
- High cholesterol, history of—The chance of having a serious side effect may be increased .
Proper Use of This Medicine:
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 .
Precautions While Using This Medicine:
Reteplase can cause bleeding that usually is not serious. However, serious bleeding may occur in some people. 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 on your own, unless your doctor tells you it is all right to do so.
Watch for any bleeding or oozing on your skin, such as around the place of injection or where blood was drawn from your arm. Also, check for blood in your urine or bowel movements. If you have any bleeding or injuries, tell your doctor or nurse right away .
Side Effects of This Medicine:
- More common
- Bleeding at 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
- Blurred vision
- difficult or labored breathing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- fast heartbeat
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shortness of breath
- skin rash
- tightness in chest
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
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.
Last Updated: 11/4/2014