PLUVICTO is a radioligand therapeutic agent with the active ingredient lutetium Lu 177 vipivotide tetraxetan. It is available as a 1,000 MBq/mL (27 mCi/mL) sterile injection solution for intravenous use. Key inactive ingredients include acetic acid, sodium acetate, gentisic acid, sodium ascorbate, and pentetic acid. This formulation is typically used in radioligand therapies, though a specific purpose is not stated.

How should I use this medication?

This medication is injected 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. 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?

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—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 -Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet -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 to your care team if they continue or are bothersome): -Constipation -Dry mouth -Fatigue -Loss of appetite -Nausea

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 -Low blood cell levels, such as low white cells, red cells, or platelets -An unusual or allergic reaction to lutetium Lu 177 vipivotide tetraxetan, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Interactions are not expected.

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 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. After each dose, try to stay at least 3 feet away from people for 2 days. If those people are pregnant or a child, stay at least 3 feet away from them for 7 days. Sleep in a separate bedroom from others for 3 days. If you share a bedroom with a child, sleep in another room for 7 days. If you share a bedroom with a pregnant person, sleep in another room for 15 days. Avoid sexual activity for 7 days after each dose. 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. Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe. If your partner can get pregnant, use a condom during sex while taking this medication and for 14 weeks after the last dose. Avoid sexual activity for 7 days after each dose. This medication may cause infertility. Talk to your care team if you are concerned about your fertility.