Pronunciation:

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

Brand Names:

• Activase
• Cathflo Activase

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Thrombolytic

Pharmacologic—

Tissue Plasminogen Activator

Uses of This Medicine:

Alteplase injection 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 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:

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.

Children—

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

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

Older adults—

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 geriatric-specific problems that would limit the usefulness of alteplase in the elderly.

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.

Other medicines—

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 not recommended. Your doctor may decide not to treat you with this medication or 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 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
• Anistreplase
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Benazepril
• Betrixaban
• Bivalirudin
• Captopril
• Certoparin
• Cilostazol
• Clopidogrel
• Curcumin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dipyridamole
• Edoxaban
• Enalapril
• Enalaprilat
• Enoxaparin
• Eptifibatide
• Fondaparinux
• Fosinopril
• Heparin
• Lepirudin
• Lisinopril
• Moexipril
• Nadroparin
• Nitroglycerin
• Parnaparin
• Pentosan Polysulfate Sodium
• Perindopril
• Phenindione
• Phenprocoumon
• Prasugrel
• Protein C
• Quinapril
• Ramipril
• Reteplase, Recombinant
• Reviparin
• Rivaroxaban
• Streptokinase
• Sulfinpyrazone
• Tenecteplase
• Ticlopidine
• Tinzaparin
• Tirofiban
• Trandolapril
• Treprostinil
• Turmeric
• 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 (eg, aneurysm or arteriovenous malformation) or
• Brain disease or tumor or
• Hypertension (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 (eg, hemorrhagic retinopathy) or
• Heart infections (eg, 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 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—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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 This Medicine:

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 This Medicine:

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

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

Rare

Chills

confusion

fainting

fast heartbeat

fever

lightheadedness

pain in the chest, groin, or legs, especially the calves

pain, redness, or swelling in the arm or leg

rapid, shallow breathing

severe, sudden headache

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

sudden, unexplained shortness of breath

vision changes

Incidence not known

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, itching, or skin rash

hoarseness

increased sweating

large, hive-like swelling on the mouth, lips, or tongue

loss of bladder control

muscle spasm or jerking of all extremities

nausea or vomiting

pain or discomfort in the arms, jaw, back, or neck

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

slow or irregular breathing or heartbeat

sudden loss of consciousness

sweating

swelling of the face, fingers, feet, lower legs, or ankles

unconsciousness

unusual tiredness or weakness

weight gain

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.