Allogeneic Processed Thymus Tissue Implant

What is this medication?

ALLOGENEIC PROCESSED THYMUS TISSUE (al oh juh NEE ik pros sesd THAHY muhs TI shoo) is made from donor thymus tissue. It treats congenital athymia. It is not a cure for congenital athymia.

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 problems
• upcoming vaccine
• an unusual or allergic reaction to allogeneic processed thymus tissue, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This product is placed into a muscle. It is placed by a health care provider.

Talk to your health care provider about the use of this product in children. While it may be given to children as young as 1 month 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. Thymus tissue is not for regular use.

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.

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

Talk to your health care provider 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 health care provider if you have received this product. Talk to your health care provider 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 health care provider 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.

What side effects may I notice from receiving this medication?

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

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• kidney injury (trouble passing urine or change in the amount of urine)
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low magnesium levels (fast, irregular heartbeat; muscle cramp or pain; muscle weakness; tremors; seizures)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• seizures
• trouble breathing
• unusual bruising or bleeding

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

• diarrhea
• hair loss

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.