Activase - Alteplase, Recombinant (Intravenous Route)

    Activase – Alteplase, Recombinant (Intravenous Route)

    23
    0
    SHARE

    Description and Brand Names of Activase – Alteplase, Recombinant (Intravenous Route)

    US Brand Name

    1. Activase
    2. Cathflo Activase

    Descriptions

    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 .

    This product is available in the following dosage forms:

    • Powder for Solution

    Before Using Activase – Alteplase, Recombinant (Intravenous Route)

    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

    Breastfeeding

    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.

    Drug Interactions

    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.

    • Abciximab
    • Acenocoumarol
    • Alteplase, Recombinant
    • Anistreplase
    • Apixaban
    • Ardeparin
    • Argatroban
    • Aspirin
    • Benazepril
    • Bivalirudin
    • Captopril
    • Certoparin
    • Cilostazol
    • Clopidogrel
    • Dabigatran Etexilate
    • Dalteparin
    • Danaparoid
    • Desirudin
    • Dipyridamole
    • Enalapril
    • Enalaprilat
    • Enoxaparin
    • Eptifibatide
    • Fondaparinux
    • Fosinopril
    • Heparin Sodium
    • Lepirudin
    • Lisinopril
    • Moexipril
    • Nadroparin
    • Nitroglycerin
    • Parnaparin
    • Pentosan Polysulfate Sodium
    • Perindopril
    • Phenindione
    • Phenprocoumon
    • Prasugrel
    • Protein C, Human
    • Quinapril
    • Ramipril
    • Reteplase, Recombinant
    • Reviparin
    • Rivaroxaban
    • Streptokinase
    • Sulfinpyrazone
    • Tenecteplase
    • Ticlopidine
    • Tinzaparin
    • Tirofiban
    • Trandolapril
    • Treprostinil Sodium
    • Urokinase
    • Warfarin

    Other Interactions

    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 Activase – Alteplase, Recombinant (Intravenous Route)

    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

    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 .

    Side Effects of Activase – Alteplase, Recombinant (Intravenous Route)

    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:

    More common

    1. Bleeding from puncture sites and wounds
    2. bleeding gums
    3. coughing up blood
    4. difficulty with breathing or swallowing
    5. dizziness
    6. headache
    7. increased menstrual flow or vaginal bleeding
    8. nosebleeds
    9. paralysis
    10. prolonged bleeding from cuts
    11. red or black, tarry stools
    12. red or dark brown urine
    13. shortness of breath

    Rare

    1. Chills
    2. confusion
    3. fainting
    4. fast heartbeat
    5. fever
    6. lightheadedness
    7. pain in chest, groin, or legs, especially the calves
    8. pain, redness, or swelling in arm or leg
    9. rapid, shallow breathing
    10. severe, sudden headache
    11. slurred speech
    12. sudden loss of coordination
    13. sudden, severe weakness or numbness in arm or leg
    14. sudden, unexplained shortness of breath
    15. vision changes

    Incidence not determined

    1. Anxiety
    2. blue lips and fingernails
    3. blue or pale skin
    4. blurred vision
    5. chest pain or discomfort
    6. chest pain, possibly moving to the left arm, neck, or shoulder
    7. convulsions
    8. cool, sweaty skin
    9. cough
    10. coughing that sometimes produces a pink frothy sputum
    11. decreased urine output
    12. dilated neck veins
    13. extreme fatigue
    14. hives or welts
    15. hoarseness
    16. increased sweating
    17. itching
    18. large, hive-like swelling on mouth, lips, or tongue
    19. loss of bladder control
    20. low blood pressure or pulse
    21. muscle spasm or jerking of all extremities
    22. nausea or vomiting
    23. pain or discomfort in arms, jaw, back, or neck
    24. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    25. redness of skin
    26. skin rash
    27. slow or irregular breathing or heartbeat
    28. sudden loss of consciousness
    29. sweating
    30. swelling of face, fingers, feet, lower legs, or ankles
    31. tightness in chest
    32. troubled breathing
    33. unconsciousness
    34. unusual tiredness or weakness
    35. weight gain
    36. 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.