WASKYRA

ETUVETIDIGENE AUTOTEMCEL (E tue ve TI di jeen AW toe TEM sel) treats Wiskott-Aldrich syndrome. It works by helping your body make healthy blood and immune cells. This reduces the number of infections and bleeding episodes you have. It is a gene therapy.

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

This medication is infused into a vein. It is given by your care team in a hospital or clinic setting.
This therapy uses your own stem cells. Your care team will give you other medications as part of your treatment. Before therapy, your care team will give you a medication that helps move your stem cells from your bone marrow to the blood stream, so they can collect them. This is called mobilization. These cells will be used to make your treatment. Shortly before you receive treatment, you will receive another medication that helps prepare your body for the stem cell transplant. This is called conditioning.
Talk to your care team about the use of this medication in children. While it may be given to children as young as 6 months 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.

-Live virus vaccines
-Some antivirals for HIV or hepatitis

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.

Your condition will be monitored carefully while you are receiving this medication.
You may need blood work done while you are taking this medication.
This medication can cause serious infusion reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Follow the directions from your care team.
This medication may increase your risk of getting an infection. 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.
Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication.
If you need an HIV test, talk to your care team about which test to use. This medication may cause a false-positive result if certain tests are used.
Do not donate blood, organs, tissues, or cells any time after receiving this treatment.
Carry the Patient Wallet Card with you at all times. Show it to all members of your care team.
This medication is made using human and other animal-based substances. There is a risk that it may contain bacteria, viruses, or fungi. Donors are screened carefully and all substances are tested. Talk to your care team if you have questions about the risk of infection.
Talk to your care team if you or your partner may be pregnant. This medication has not been well studied during pregnancy. You will need a negative pregnancy test before starting treatment. Contraception is recommended during treatment and for at least 6 months after treatment. Your care team can help you find the option that works for you. Talk to your care team if you plan to become pregnant after receiving this medication.
If your partner can get pregnant, use a condom during sex during treatment and for at least 6 months after treatment.
Talk to your care team before breastfeeding. There are benefits and risks to taking medications while breastfeeding. Your care team can help you find the option that works for you.

This does not apply. This medication is not for regular use.

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
-Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
-Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
-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 red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
-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):
-Cough
-Diarrhea
-Nosebleed
-Runny or stuffy nose
-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.

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.