Drug Info: T: Thrombolytic Agents (Systemic)

Some commonly used brand names are:

In the U.S.—

In Canada—

Other commonly used names are: Anisoylatedplasminogen-streptokinase activator complex; APSAC;tissue-type plasminogen activator (recombinant); t-PA;rt-PA.

• Thrombolytic --Alteplase, Recombinant;Anistreplase; Reteplase, Recombinant; Streptokinase;Urokinase

Thrombolytic agents are used to dissolve blood clots thathave formed in certain blood vessels. These medicines areusually used when a blood clot seriously lessens the flow ofblood to certain parts of the body.

Thrombolytic agents are also used to dissolve blood clotsthat form in tubes that are placed into the body. The tubesallow treatments (such as dialysis or injections into a vein)to be given over a long period of time.

These medicines are to be given only by or under thedirect supervision of a doctor.

These medicines are available in the following dosageforms:

• Parenteral
• Alteplase, Recombinant
  • Injection (U.S. and Canada)
• Anistreplase
  • Injection (U.S. and Canada)
• Reteplase, Recombinant
  • Injection (U.S.)
• Streptokinase
  • Injection (U.S. and Canada)
• Urokinase
  • Injection (U.S. and Canada)

In deciding to use a medicine, the risks of using themedicine must be weighed against the good it will do. This isa decision you and your doctor will make. For thrombolyticagents, the following should be considered:

Allergies—Tell your doctor if you haveever had any unusual or allergic reaction to alteplase,anistreplase, streptokinase, or urokinase. Also tell yourhealth care professional if you are allergic to any othersubstances, such as foods, preservatives, or dyes.

Pregnancy—Tell your doctor if you arepregnant or if you have recently had a baby.

There is a slight chance that use of a thrombolytic agentduring the first five months of pregnancy may cause amiscarriage. However, both streptokinase and urokinase havebeen used in pregnant women and have not been reported tocause this problem. Also, studies in pregnant women (forstreptokinase) and studies in animals (for urokinase) havenot shown that these medicines cause either miscarriage orharm to the fetus (including birth defects). Studies on birthdefects with alteplase and anistreplase have not been done ineither pregnant women or animals.

Breast-feeding—It is not known whetherthrombolytic agents pass into the breast milk. Although mostmedicines pass into breast milk in small amounts, many ofthem may be used safely while breast-feeding. Mothers who aretaking any of these medicines and who wish to breast-feedshould discuss this with their doctor.

Children—Studies on these medicineshave been done only in adult patients, and there is nospecific information comparing the use of thrombolytic agentsin children with use in other age groups. However,streptokinase has occasionally been used in children todissolve blood clots in certain blood vessels. Bleeding maybe more likely to occur in children, who are usually moresensitive than adults to the effects of streptokinase.

Older adults—The need for treatmentwith a thrombolytic agent (instead of other kinds oftreatment) may be increased in elderly patients with bloodclots. However, the chance of bleeding may also be increased.It is especially important that you discuss the use of thismedicine with your doctor.

Other medicines—Although certainmedicines should not be used together at all, in other casestwo different medicines may be used together even if aninteraction might occur. In these cases, your doctor may wantto change the dose, or other precautions may be necessary.Before you receive a thrombolytic agent, it is especiallyimportant that your doctor know if you are taking any of thefollowing:

• Anticoagulants (blood thinners) or
• Aspirin or
• Cefamandole (e.g., Mandol) or
• Cefoperazone (e.g., Cefobid) or
• Cefotetan (e.g., Cefotan) or
• Dipyridamole (e.g., Persantine)
• Divalproex (e.g., Depakote) or
• Enoxaparin (e.g., Lovenox) or
• Heparin or
• Indomethacin (e.g., Indocin) or
• Inflammation or pain medicine (except narcotics)or
• Phenylbutazone (e.g., Butazolidin) or
• Plicamycin (e.g., Mithracin) or
• Sulfinpyrazone (e.g., Anturane) or
• Thrombolytic agents, other or
• Ticlopidine (e.g., Ticlid) or
• Valproic acid (e.g., Depakene)—The chance ofbleeding may be increased

Also, tell your doctor if you have had an injection ofanistreplase or streptokinase within the past year. If youhave, these medicines may not work properly if they are givento you again. Your doctor may decide to use alteplase orurokinase instead.

• Allergic reaction to streptokinase, anistreplase, orurokinase (or history of)—Increased risk of an allergicreaction
• Blood disease, bleeding problems, or a history ofbleeding in any part of the body or
• Brain disease or tumor or
• Heart or blood vessel disease, including irregularheartbeat or
• High blood pressure or
• Liver disease (severe) or
• Stroke, especially with seizure (or history of)—Thechance of serious bleeding may be increased

• Streptococcal (“strep”) infection(recent)
• Surgery within the last two months—Anistreplase orstreptokinase may not work properly after a streptococcalinfection; your doctor may decide to use a differentthrombolytic agent

Also, tell your doctor if you have recently had any of thefollowing conditions:

• Falls or blows to the body or head or any other injuryor
• Injections into a blood vessel or
• Placement of any tube into the body or
• Surgery, including dental surgery—The chance ofserious bleeding may be increased

If you have recently had a baby, use of these medicines maycause serious bleeding.

Dosing—

The dose of these medicines will be different fordifferent patients. The dose you receive will depend on themedicine you receive and will be based on the condition forwhich you are receiving the medicine. In some cases, the dosewill also depend on your body weight.

Thrombolytic agents can cause bleeding that usually is notserious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow anyinstructions given by your health care professional. Also,move around as little as possible, and do not get out of bedon your own, unless your health care professional tells youit is all right to do so.

Along with its needed effects, a medicine may cause someunwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Tell your health care professional immediately if any ofthe following side effects occur:

• More common
  • Bleeding or oozing from cuts, gums, wounds, oraround the place of injection; fever; low bloodpressure
  
  

• Less common or rare
  • Agitation; bloating; blue or purple toes; blurredvision; bruising; changes in facial skin color ; chestpain or discomfort; chills; coma; confusion ; darkenedurine; decreased urine output; depression; dizziness;double vision; fast or irregular breathing; flushing orredness of skin; gangrenous fingers or toes; headache(mild or severe); hostility ; indigestion; irritability; lethargy; loss of appetite ; muscle cramps or spasms;muscle pain or stiffness; muscle twitching; nausea;nervousness; numbness or tingling in face, arms, legs;pain in side or abdomen, possibly radiating to theback; pain in toes; pain or discomfort in arms, jaw,back or neck; pounding in the ears; purplish red,net-like, blotchy spots on skin; rapid weight gain;seizures; shortness of breath, troubled breathing,tightness in chest, and/or wheezing ; skin rash, hives,or itching; slow or fast heartbeat; stupor; sweating;swelling of eyes, face, lips, or tongue ; swelling ofhands or ankles; trouble in speaking or walking;unusual tiredness or weakness; vomiting; weakness inarms or legs; yellow eyes or skin
  
  

• Frequency not determined
  • Bluish color of fingernails, lips, skin, palms, ornail beds ; cough; difficulty breathing ; drowsiness;faintness or lightheadedness when getting up from alying or sitting position suddenly ; fatigue; noisybreathing ; welts
  
  

• Symptoms of bleeding inside the body
  • Abdominal or stomach pain or swelling; back pain orbackaches; blood in urine; bloody or black, tarrystools; constipation ; coughing up blood; dizziness ;headaches (sudden, severe, or continuing); joint pain,stiffness, or swelling; muscle pain or stiffness(severe or continuing); nosebleeds; unexpected orunusually heavy bleeding from vagina; vomiting of bloodor material that looks like coffee grounds
  
  

Other side effects not listed above may also occur in somepatients. If you notice any other effects, check with yourdoctor.

Once a medicine has been approved for marketing for acertain use, experience may show that it is also useful forother medical problems. Although this use is not included inproduct labeling, alteplase may be used in certain patientswith the following condition:

• Peripheral arterial occlusive disease

Other than the above information, there is no additionalinformation relating to proper use, precautions, or sideeffects for this use.