Gallium Ga 68 PSMA-11

Gallium Ga 68 PSMA-11 is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

• Gallium Ga 68 PSMA-11 is available under the following different brand names: Illuccix, gallium Ga 68 gozetotide.

Common side effects of Gallium Ga 68 PSMA-11 include:

• Nausea,
• Diarrhea, and
• Dizziness

Serious side effects of Gallium Ga 68 PSMA-11 include:

• Hives, 
• Difficulty breathing, 
• Swelling of the face, lips, tongue, or throat, andDizziness

Rare side effects of Gallium Ga 68 PSMA-11 include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection

• 18.5-185 MBq/mL (20-mL multidose vial) (generic)
• Equivalent to 0.5-5 mCi/mL at calibration time

Kit

Illuccix

• Contains the following:
  • Vial 1 containing 25 mcg gozetotide and D-mannose as a lyophilized powder.
  • Vial 2 containing acetate buffer (configuration A for use with cyclotron produced Ga 68 via GE FASTlabTM or EZAG generator, configuration B for use with IRE generator)
  • Vial 3 is a sterile vacuum reaction vial for the collection of gallium Ga 68 chloride and radiolabeling reaction.

Prostate Cancer

Adult dosage

• 111-259 MBq (3-7 mCi) IV bolus

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Gallium Ga 68 PSMA-11 has severe interactions with no other drugs.
• Gallium Ga 68 PSMA-11 has serious interactions with no other drugs.
• Gallium Ga 68 PSMA-11has moderate interactions with the following drugs:
  • abiraterone
  • apalutamide
  • bicalutamide
  • darolutamide
  • degarelix
  • enzalutamide
  • flutamide
  • goserelin
  • histrelin
  • leuprolide
  • nilutamide
  • relugolix
  • triptorelin
• Gallium Ga 68 PSMA-11 has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Gallium Ga 68 PSMA-11?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Gallium Ga 68 PSMA-11?”

Cautions

• Image interpretation errors can occur; Ga 68 PSMA-11 uptake can be seen in a variety of tumor types and nonmalignant processes.
• Ensure safe handling to protect patients and healthcare workers from unintentional radiation exposure.
• Drug interaction overview
  • Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway.
  • ADT and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in the uptake of Ga 68 PSMA-11 in prostate cancer.
  • Effect of these therapies on Ga 68 PSMA-11 PET has not been established.

Pregnancy and Lactation

• Not indicated for use in females
• No data available on use in pregnant females
• All radiopharmaceuticals, including Ga 68 PSMA-11, have the potential to cause fetal harm depending on the fetal stage of development and radiation dose.
• No animal reproduction studies have been conducted.
• Lactation
  • Not indicated for use in females
  • There are no data on drug presence in human milk, effect on breastfed infants, or effect on milk production.