Lutetium Lu 177 Dotatate Injection

What is this medication?

LUTETIUM LU 177 DOTATATE (loo TEE shee uhm loo 177 DOE ta tate) treats neuroendocrine tumors, a cancer of the cells that release hormones and other substances in your body. It works by releasing energy (radiation) to slow or stop the spread of cancer cells.

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

COMMON BRAND NAME(S): Lutathera

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

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

• Kidney disease
• Liver disease
• Low blood cell levels (white cells, platelets, or red cell counts)
• An unusual or allergic reaction to lutetium Lu 177 dotatate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is infused into a vein. 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. While it may be prescribed for children as young as 12 years 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?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

• Lanreotide
• Octreotide
• Steroid medications, such as prednisone or cortisone

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 while you are receiving this medication.

This medication may cause serious side effects or allergic 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.

You may need blood work done while you are taking this medication.

This medication releases radiation. There will be radiation in your urine for up to 30 days after your treatment. Follow the directions from your care team about how to use the bathroom, wash your clothes, and do other daily activities during this time. This will help protect the people you live and spend time with from radiation. Wash your hands often. Take showers often. This helps remove radiation from your skin so you don't spread it to things or people around you. Talk to your care team if you have any questions.

It is important to drink plenty of water before and after you receive this medication. Urinate often afterward. This helps reduce the amount of radiation your body is exposed to.

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.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

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. Serious fetal side effects can occur if you take this medication during pregnancy and for 7 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 7 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 2.5 months after the last dose.

This medication 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 or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Flushing, diarrhea, dizziness, feeling faint or lightheaded, blurry vision, wheezing or trouble breathing
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Infection—fever, chills, cough, or sore throat
• 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 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):

• Diarrhea
• Nausea
• Stomach pain
• 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.