Donislecel Injection

What is this medication?

DONISLECEL (dou ni sle sel) treats type 1 diabetes. It works by giving your body donor beta cells that can make insulin. This reduces the need for external insulin.

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:

• Cancer
• Infection
• Kidney disease
• Liver disease
• Organ transplant
• Recent or upcoming vaccine
• An unusual or allergic reaction to donislecel, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is infused into a vein in the liver. 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.

What may interact with this medication?

• Live virus vaccines

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?

Visit your care team for regular checks on your progress. You may need blood work after receiving this medication.

Do not stop taking insulin after receiving this medication. Continue to take insulin and check your blood sugar (glucose) as instructed by 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.

Talk to your care team if you or your partner may be pregnant. The risk of receiving this treatment during pregnancy has not been studied. Other medications used with this treatment can cause serious birth defects if taken during pregnancy. You will need a negative pregnancy test before receiving treatment. Contraception is recommended before treatment is started and until you can no longer become pregnant. Your care team can help you find the option that works for you.

If your partner can get pregnant, contraception is recommended before and during treatment. Their care team can help them find the option that works for them.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

Medications used with this treatment may cause infertility. Talk to your care team if you are concerned about your fertility.

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
• 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
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• 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

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

• Diarrhea
• Nausea
• Stomach pain
• Unusual weakness or fatigue
• 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.

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.