Description
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) or who may delay receiving other cancer treatments (eg, 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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Cholera Vaccine
- Ebola Zaire Vaccine, Live
- Influenza Virus Vaccine, Live
- Rotavirus Vaccine, Live
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—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
A doctor or other trained health professional will give you this medicine. This medicine is given through an IV catheter placed into one of your veins. It must be given slowly, so the IV 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
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
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
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- difficult, burning, or painful urination
- lower back or side pain
- pale skin
- rapid weight gain
- tingling of the hands or feet
- trouble breathing
- unusual tiredness or weakness
- unusual weight gain or loss
Less common
- Anxiety
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- 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
- pinpoint red spots on the skin
- prolonged bleeding from cuts
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- unusual bleeding or bruising
Rare
- Blurred vision
- dark-colored urine
- irregular heartbeat
- light-colored stools
- nausea and vomiting
- stomach pain, continuing
- yellow eyes or skin
Incidence not known
- Agitation
- coma
- decreased urine output
- depression
- irritability
- lethargy
- muscle twitching
- seizures
- stupor
- swelling of the face, ankles, or hands
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
- Back pain
- change in taste
- constipation
- decreased appetite
- diarrhea
- difficulty in moving
- dry mouth
- joint pain
- loss of taste
- muscle pain or stiffness
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.
DRG-20531832
