Lutetium Lu 177 Vipivotide Tetraxetan Injection

What is this medication?

LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN (loo-TEE-shee-uhm vye PIV oh tide te TRAX e tan) treats prostate cancer. It works by slowing down the growth 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): PLUVICTO

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 counts (white cells, platelets, or red blood cells)
• An unusual or allergic reaction to lutetium Lu 177 vipivotide tetraxetan, other medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medicine is injected into a vein. It is given in a hospital or clinic setting.

Talk to your care team about the use of this medicine 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 your appointment.

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?

This medicine 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 medicine 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 medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medicines 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 medicine.

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.

Avoid sexual activity for 7 days after receiving this medicine. After this, males who get this medicine must use a condom during treatment and for 14 weeks after stopping the medicine during sex with females who can get pregnant. If you get a woman pregnant, there is potential for serious harm to an unborn child. Tell your care team right away if you think your partner might be pregnant.

This medicine may make it more difficult to father a child. Talk to your care team if you are concerned about your fertility.

Sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, and from pregnant women for 15 days. Limit other close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days.

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
• High potassium level—muscle weakness, fast or irregular heartbeat
• 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 of skin or eyes, unusual weakness or fatigue
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Low red blood cell count—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• 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):

• Constipation
• Dry mouth
• 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.

Where should I keep my medication?

This medicine 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.