Allogeneic Processed Thymus Tissue Implant

What is this medication?

ALLOGENEIC PROCESSED THYMUS TISSUE (al oh juh NEE ik pros sesd THAHY muhs TI shoo) treats congenital athymia, a condition in which the thymus gland is missing or not developed. The thymus gland makes a type of white blood cells called T cells. T cells help your immune system protect your body from infection and disease. This implant works by helping your body make T cells.

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

COMMON BRAND NAME(S): RETHYMIC

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

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

• Infection
• Kidney disease
• Recent or upcoming vaccine
• An unusual or allergic reaction to allogeneic processed thymus tissue, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

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

Talk to your care team about the use of this product in children. While it may be used in children for selected conditions, precautions do apply.

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 have not been studied.

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 after you receive this product. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done after you receive this product.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer after you receive this product.

If you need to get vaccinated, tell your care team you have received this product. Talk to your care team to see if a different vaccination schedule is needed.

Your risk of getting an infection may still be increased after you receive this product. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This product is made from donated human tissue. There is a small risk that it may contain bacteria or viruses, such as hepatitis or HIV. All products are processed to kill most bacteria and viruses. 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
• Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
• Hemolytic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, dark urine, yellowing skin or eyes
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low magnesium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, tremors
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Rash, burning, and redness of the skin over the hands and feet that may spread, stomach pain or cramping, diarrhea, loss of appetite, weight loss, which may be signs of graft versus host disease
• Unusual bruising or bleeding

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

• Diarrhea
• Fever
• Skin rash

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 product 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.