Activase

Generic Name: alteplase, recombinant (Intravenous route)

AL-te-plase, ree-KOM-bi-nant

Commonly used brand name(s):

In the U.S.

• Activase
• Cathflo Activase

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Thrombolytic

Pharmacologic Class: Tissue Plasminogen Activator

Uses For Activase

Alteplase is used to dissolve blood clots that have formed in the blood vessels. It is used immediately after symptoms of a heart attack occur to improve patient survival. It is also used after symptoms of a stroke and to treat blood clots in the lungs (pulmonary embolism) .

Alteplase is used to dissolve blood clots in tubes (catheters) that are placed in large blood vessels (central venous access devices) .

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

Before Using Activase

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:

Allergies

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.

Pediatric

Heart attack, stroke, pulmonary embolism—Appropriate studies have not been performed on the relationship of age to the effects of alteplase in the pediatric population. Safety and efficacy have not been established .

Central venous access devices—Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of alteplase in children .

Geriatric

Heart attack, stroke, pulmonary embolism—No information is available on the relationship of age to the effects of alteplase in geriatric patients .

Central venous access devices—Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of alteplase in the elderly .

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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.

• Abciximab
• Acenocoumarol
• Alteplase, Recombinant
• Ancrod
• Anisindione
• Anistreplase
• Antithrombin III Human
• Ardeparin
• Argatroban
• Bivalirudin
• Certoparin
• Cilostazol
• Clopidogrel
• Dalteparin
• Danaparoid
• Defibrotide
• Dermatan Sulfate
• Desirudin
• Dicumarol
• Enoxaparin
• Eptifibatide
• Fondaparinux
• Heparin
• Lamifiban
• Lepirudin
• Nadroparin
• Nitroglycerin
• Parnaparin
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Reteplase, Recombinant
• Reviparin
• Sibrafiban
• Streptokinase
• Tenecteplase
• Tinzaparin
• Tirofiban
• Urokinase
• Warfarin
• Xemilofiban

Interactions with Food/Tobacco/Alcohol

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 (e.g., aneurysm or arteriovenous malformation) or
• Brain disease or tumor or
• High blood pressure, uncontrolled or
• Stroke, history of or
• Surgery or injury to the brain or spine, recent (within three months)—This medicine should NOT be used in these conditions .

• Blood clots, history of or
• Diabetic eye problems (e.g. hemorrhagic retinopathy) or
• Heart infections (e.g., pericarditis or endocarditis) or
• Injections into a blood vessel or
• Kidney disease, severe or
• Liver disease, severe or
• Placement of any catheter (tube) into the body or
• Surgery or injury of any kind, major and recent—The chance of serious bleeding may be increased .

• Catheter (tube) infection or
• Deep venous thrombosis (blood clots in the legs) or
• High cholesterol, history of—The chance of having a serious side effect may be increased .

• Heart rhythm problems—This condition may get worse .

Proper Use of alteplase, recombinant

This section provides information on the proper use of a number of products that contain alteplase, recombinant. It may not be specific to Activase. Please read with care.

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

Precautions While Using Activase

Alteplase 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 .

Activase Side Effects

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:

• Bleeding from puncture sites and wounds
• bleeding gums
• coughing up blood
• difficulty with breathing or swallowing
• dizziness
• headache
• increased menstrual flow or vaginal bleeding
• nosebleeds
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• shortness of breath

• Chills
• confusion
• fainting
• fast heartbeat
• fever
• lightheadedness
• pain in chest, groin, or legs, especially the calves
• pain, redness, or swelling in arm or leg
• rapid, shallow breathing
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in arm or leg
• sudden, unexplained shortness of breath
• vision changes

• Anxiety
• blue lips and fingernails
• blue or pale skin
• blurred vision
• chest pain or discomfort
• chest pain, possibly moving to the left arm, neck, or shoulder
• convulsions
• cool, sweaty skin
• cough
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• dilated neck veins
• extreme fatigue
• hives or welts
• hoarseness
• increased sweating
• itching
• large, hive-like swelling on mouth, lips, or tongue
• loss of bladder control
• low blood pressure or pulse
• muscle spasm or jerking of all extremities
• nausea or vomiting
• pain or discomfort in arms, jaw, back, or neck
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of skin
• skin rash
• slow or irregular breathing or heartbeat
• sudden loss of consciousness
• sweating
• swelling of face, fingers, feet, lower legs, or ankles
• tightness in chest
• troubled breathing
• unconsciousness
• unusual tiredness or weakness
• weight gain
• 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.

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