Acellular Tissue Engineered Vessel Implant

What is this medication?

ACELLULAR TISSUE ENGINEERED VESSEL (ay SEL yuh lr TI shoo en juh NEERD veh sl) treats injury to an artery in the arm or leg. It works by replacing or repairing the injured part of the blood vessel. This restores blood flow to the arm or leg and prevents amputation.

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

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

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

• An unusual or allergic reaction to acellular tissue engineered vessel, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This implant is placed in your arm or leg by your care team in a hospital setting.

Talk to your care team about the use of this implant 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 medication?

Interactions are not expected.

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 when you first receive this implant. Visit your care team for regular checks on your progress. Tell your care team right away if you have bleeding, swelling, worsening pain, or change in the color of the skin around your implant site.

You may need blood work done after the implant is placed.

This implant is made using human cells and other animal-based substances. There is a small risk that it may contain bacteria or viruses, such as hepatitis or HIV. Donors are screened carefully and all substances are tested. Talk to your care team if you have questions about the risk of infection.

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—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• 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.

Where should I keep my medication?

This implant is placed in a hospital. It will not be stored at home before use.

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.