Alteplase, recombinant (intravenous route)

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.

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.

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.

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 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

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.

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.

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