Reteplase (Recombinant) Solution for injection

What is this medicine?

RETEPLASE (RE te plays) is used to dissolve blood clots that form in certain blood vessels. This medicine is used when a blood clot in a heart artery causes a heart attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• aneurysm
• bleeding problems or problems with blood clotting
• diabetic retinopathy or bleeding problems of the eye
• endocarditis (infection of the heart valves)
• head injury, brain disease, or tumor
• high blood pressure
• infection
• irregular heartbeats
• kidney disease
• liver disease
• mitral stenosis
• recent biopsy, childbirth, surgery, or trauma (injury)
• recent history of stroke
• stomach ulcer or bleeding ulcer-an unusual or allergic reaction to reteplase, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• aminocaproic acid
• aprotinin
• tranexamic acid

This medicine may also interact with the following medications:

• antiplatelet drugs such as ticlopidine or clopidogrel
• aspirin and aspirin-like drugs
• medicines that treat or prevent blood clots like warfarin, heparin, enoxaparin, and dalteparin
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

You will be closely monitored to check your progress after you receive this medicine. Follow the advice of your doctor or health care professional exactly. You may need bed rest to minimize the risk of bleeding.

This medicine can make you bleed more easily. This effect can last for several days. Try to avoid damage to your teeth and gums when you brush or floss your teeth, and try to avoid any other injury to yourself.

Do not take aspirin, ibuprofen, or other nonprescription pain relievers during or for several days after treatment with this medicine unless otherwise told to do so by your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blood in the urine, stools, or vomit
• breathing problems
• chest pain or tightness
• constipation or black tarry stools
• fever
• severe headache
• slow or fast heart rate
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness, lightheadedness
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.