Activase contains the active ingredient alteplase, a tissue plasminogen activator produced via recombinant DNA technology. It is formulated as a lyophilized powder that, after reconstitution with Sterile Water for Injection, can be administered intravenously. The reconstituted solution contains Activase at a concentration of 1 mg/mL.

How should I use this medication?

This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication 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.

Where should I keep my medication?

This medication is given in a hospital or clinic. It 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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• Bleeding in the brain—severe headache, stiff neck, confusion, dizziness, change in vision, numbness or weakness of the face, arm, or leg, trouble speaking, trouble walking, vomiting
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain

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.

What should I tell my care team before I take this medication?

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

• Bleeding disorder
• Bleeding in the brain
• Blood clots
• Bleeding or bleeding problems
• Cancer
• Have had a heart attack or stroke
• Head injury
• Heart or blood vessel conditions
• High blood pressure
• Liver disease
• Recent surgery
• Stomach ulcers
• An unusual or allergic reaction to alteplase, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Aminocaproic acid
• Apixaban
• Defibrotide
• Tranexamic acid
• Warfarin

This medication may also interact with the following:

• Other medications that prevent or treat blood clots, such heparin

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 medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need blood work done while you are taking this medication.