Pronunciation:

loo-TEE-shee-um loo 177 vye-PIV-oh-tide te-TRAX-e-tan

Brand Names:

• Pluvicto

Dosage Forms:

• Solution

Uses of This Medicine:

Lutetium Lu 177 vipivotide tetraxetan injection is used to treat prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (prostate cancer that is resistant to medical or surgical treatments that lower testosterone and has spread to other parts of the body) in patients who have received other cancer treatments (eg, androgen receptor pathway inhibition, taxane-based chemotherapy).

Lutetium Lu 177 vipivotide tetraxetan is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents, which may be used to find and treat certain diseases or to study the function of the body's organs.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lutetium Lu 177 vipivotide tetraxetan injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lutetium Lu 177 vipivotide tetraxetan injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disease (eg, anemia, leukopenia, neutropenia, thrombocytopenia) or
• Kidney disease, severe—Use with caution. May make these conditions worse.

• Kidney disease, mild to moderate—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 minutes.

Drink extra fluids so you will pass more urine during treatment with this medicine. This may help prevent kidney problems.

You will need to urinate right away and as often as possible before and after you receive this medicine. This will help remove this radioactive medicine from your body.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 14 weeks after the last dose. If you think your partner has become pregnant while using this medicine, tell your doctor right away.

While receiving this medicine, you will be exposed to radiation and increase risk of cancer. If you have any questions about this, talk to your doctor.

Lutetium Lu 177 vipivotide tetraxetan will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious kidney problems. Check with your doctor right away if you have agitation, blood in the urine, coma, confusion, decreased urine output, depression, dizziness, headache, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

bloody or cloudy urine

difficult, burning, or painful urination

lower back or side pain

pale skin

pinpoint red spots on the skin

rapid weight gain

tingling of the hands or feet

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

Less common

Anxiety

chest pain or tightness

chills

confusion

coughing up blood

difficulty in breathing or swallowing

dizziness

fainting

fast heartbeat

fever

headache

increased menstrual flow or vaginal bleeding

lightheadedness

nosebleeds

paralysis

prolonged bleeding from cuts

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

Rare

Blurred vision

dark-colored urine

irregular heartbeat

light-colored stools

nausea and vomiting

stomach pain, continuing

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Change in taste

constipation

decreased appetite

diarrhea

dry mouth

loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.