Lutathera has lutetium Lu 177 dotatate as its active ingredient, which is a radiolabeled somatostatin analog. It is available as an injection with a dosage strength of 370 MBq/mL (10 mCi/mL) and is intended for intravenous use. Key inactive ingredients include acetic acid, sodium acetate, gentisic acid, sodium hydroxide, ascorbic acid, and sodium chloride.

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.

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.

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.

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

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?

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

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. Be sure to follow the directions from your care team.

There will be radiation from this medication in your urine for up to 30 days. Follow the directions from your care team to decrease the risk of radiation exposure to other people you live with or may come in contact with.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 7 months after stopping treatment for people who can get pregnant or 4 months after stopping treatment for people with partners who can get pregnant. Talk to your care team about reliable forms of contraception.

Do not breast-feed while taking this medication or for 2.5 months after the last dose.

This medication may cause infertility. Talk with your care team if you are concerned about your fertility.

Be careful brushing and 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.

Call your care team for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This medication decreases your body's ability to fight infections. Try to avoid being around people who are sick.

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

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

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