Description
Gallium Ga 68 PSMA-11 injection is used with a PET scan (positron emission tomography) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer. It is given in patients with suspected metastasis (cancer that has spread to the other parts of the body) who are candidates for initial treatment, in patients with suspected recurrence (cancer that keeps coming back) based on an increased serum prostate-specific antigen (PSA) level, for selection of patients with metastatic (cancer that has spread) prostate cancer, for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed treatment is used, and for selection of patients who are indicated for PSMA-directed treatment.
Gallium Ga 68 PSMA-11 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 diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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 Gozellix®, Illuccix®, and Locametz® in the pediatric population. Safety and efficacy have not been established.
Use of gallium Ga 68 PSMA-11 injection in children is not indicated.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gallium Ga 68 PSMA-11 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. 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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:
- Asthma—Use with caution. May make this condition worse.
Proper Use
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 just before you have a PET scan.
Drink enough water to be hydrated before the PET scan.
You will need to urinate right away and as often as possible for at least 1 hour after the PET scan.
Precautions
It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.
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.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
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:
Incidence not known
- Chest tightness
- cough
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- trouble breathing
- unusual tiredness or weakness
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:
Rare
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- constipation
- diarrhea
- dry mouth
- nausea
- vomiting
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-20506366
