Lutetium lu 177 vipivotide tetraxetan (Intravenous)

Lutetium Lu 177 vipivotide tetraxetan injection is used to treat prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. This is prostate cancer that does not respond to treatments that lower testosterone and has spread to other parts of the body. It is for patients who have already received other cancer treatments, such as androgen receptor pathway inhibition or taxane-based chemotherapy.

Lutetium Lu 177 vipivotide tetraxetan is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to locate and treat certain diseases or to study how the body's organs work.

This medicine should be given only by or under the direct supervision of a doctor who has specialized training in nuclear medicine.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working correctly. You may need blood and urine tests to check for any 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 may be pregnant while using this medicine, tell your doctor immediately.

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

Lutetium lu 177 vipivotide tetraxetan will reduce the number of certain types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these issues, avoid being near people who are sick or have infections. Wash your hands frequently. Stay away from rough sports or any situation where you could get 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. Contact your doctor right away if you experience 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). Discuss with your doctor before using this medicine if you plan to have children.

In deciding to use a medicine, you and your doctor will need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, please think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to understand how age affects the effects of lutetium Lu 177 vipivotide tetraxetan injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any problems specific to elderly patients that would limit the usefulness of lutetium Lu 177 vipivotide tetraxetan injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines might be used together even if an interaction could happen. In such cases, your doctor may need to adjust the dose, or other precautions may be required. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco while taking certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may impact the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Blood disease (e.g., anemia, leukopenia, neutropenia, thrombocytopenia) or
• Severe kidney disease—Use with caution. This may worsen these conditions.

• Mild to moderate kidney disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

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.

In the U.S.

• Pluvicto

Available Dosage Forms:

• Solution

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.