Brand Name(s): Pluvicto^®

WHY is this medicine prescribed?

Lutetium Lu 177 vipivotide tetraxetan injection is used to treat a certain type of prostate cancer (cancer of a male reproductive gland) that has spread to other parts of the body and that has already been treated with other medications. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to cancer cells which damages and kills these cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lutetium Lu 177 vipivotide tetraxetan comes as a liquid to be given intravenously (into a vein) by a doctor or nurse in a hospital or clinic. It is usually injected slowly over 1 to 10 minutes or it may be infused slowly over up to 30 minutes. It may be given once every 6 weeks for up to 6 doses depending on how well your body responds to the medication and the side effects that you experience.

Your doctor will probably tell you to drink plenty of water before you receive lutetium Lu 177 vipivotide tetraxetan injection and to urinate as often as possible during the first hours after you receive a dose.

Your doctor may reduce your dose or temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with lutetium Lu 177 vipivotide tetraxetan.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving lutetium Lu 177 vipivotide tetraxetan injection,

• tell your doctor and pharmacist if you are allergic to lutetium Lu 177 vipivotide tetraxetan, any other medications, or any of the ingredients in lutetium Lu 177 vipivotide tetraxetan injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you often get any type of infection or if you think you may have any type of infection now. Also tell your doctor if have previously received radiation therapy or if you have or have ever had cancer; bleeding problems; anemia (a lower than normal number of red blood cells); abnormal blood levels of sodium, potassium, or calcium; or liver or kidney problems.

• you should know that lutetium Lu 177 vipivotide tetraxetan injection is for use only in men. If your female partner is not pregnant but could become pregnant, you and your partner must use birth control during your treatment and for 14 week after your final dose. If your partner becomes pregnant while you are receiving this medication, call your doctor. Lutetium Lu 177 vipivotide tetraxetan may harm the fetus.

• you should know that this medication may temporarily or permanently cause infertility in men. However, you should not assume that your female partner cannot become pregnant during your treatment.

• you should minimize exposing other people to radiation after you receive a dose of lutetium Lu 177 vipivotide tetraxetan by limiting close contact with other people. Stay at least 3 feet away from household contacts for 2 days and from children and pregnant women for 7 days. You should also sleep in a separate bedroom apart from household contacts for 3 days, apart from children for 7 days, and apart from pregnant women for 15 days. You should also avoid sexual activity for 7 days after receiving a dose of lutetium Lu 177 vipivotide tetraxetan injection.

What SPECIAL DIETARY instructions should I follow?

Make sure you drink plenty of water or other fluids while you are receiving lutetium Lu 177 vipivotide tetraxetan injection.

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Lutetium Lu 177 vipivotide tetraxetan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth or throat
• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• decreased appetite
• decreased weight
• change in the ability to taste
• headache
• dry eye

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• unusual tiredness or weakness, pale skin, dizziness, shortness of breath
• unusual bleeding or bruising
• fever, chills, sore throat, or other signs of infection
• mouth sores
• increased or decreased urination
• swelling of the arms, hands, feet, ankles, or lower legs

Lutetium Lu 177 vipivotide tetraxetan therapy may increase your risk of cancer due to exposure to radiation. Talk to your doctor about the risks of receiving this medication.

Lutetium Lu 177 vipivotide tetraxetan may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to lutetium Lu 177 vipivotide tetraxetan.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving lutetium Lu 177 vipivotide tetraxetan injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2022.