Pluvicto 27 mCi/mL (1,000 MBq/mL) intravenous solution

Generic name:
Lutetium lu 177 vipivotide tetraxetan - injection

Brand name(s)
Pluvicto

This medication is used to treat prostate cancer. Lutetium Lu 177 vipivotide tetraxetan is a radioactive drug. It works by attaching to certain cancer cells and causing them to die.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 6 weeks for up to 6 doses.

The dosage is based on your medical condition, lab tests, and response to treatment.

Drink plenty of fluids before and after treatment with this medication and urinate as often as possible to lessen damage to your bladder. Ask your doctor for more details.

To reduce radiation exposure to others after receiving this medication, avoid close contact (less than 3 feet) with people for 2 days and with children and pregnant women for 7 days. Do not have sexual activity for 7 days. Also, sleep in a different bedroom from other people for 3 days, from children for 7 days, and from pregnant women for 15 days. If you have any questions, ask your doctor or pharmacist.

Dizziness, tiredness, headache, nausea, vomiting, diarrhea/constipation, abdominal pain, change in how food tastes, dry mouth, or decreased appetite may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney damage (such as change in amount of urine)

This medication decreases bone marrow function, a severe (possibly fatal) effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms:

• unusual tiredness
• pale skin
• signs of infection (such as sore throat that doesn't go away, fever, chills, painful/burning urination)
• easy bruising/bleeding

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using lutetium Lu 177 vipivotide tetraxetan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney problems

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using lutetium Lu 177 vipivotide tetraxetan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may affect the ability to have children. Talk to your doctor for details.

Lutetium Lu 177 vipivotide tetraxetan should not be used by women, especially during pregnancy or breastfeeding. It may harm an unborn or breastfeeding baby. Men with female partners of childbearing age should ask about reliable forms of birth control while using this medication and for 14 weeks after the last dose. Consult your doctor if you have any questions about this medication.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, kidney/liver function, blood mineral levels) should be done before you start receiving this medication and while you are using it. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.