Gallium Ga-68 PSMA-11 5 mCi/mL
GALLIUM GA-68 GOZETOTIDE · INJECTION, SOLUTION · UCSF Radiopharmaceutical Facility
Gallium Ga-68 PSMA-11 is a injection, solution containing gallium ga-68 gozetotide at 5 mCi/mL, taken intravenous. Manufactured by UCSF Radiopharmaceutical Facility.
Key Facts
- Brand Name
- Gallium Ga-68 PSMA-11
- Generic Name
- GALLIUM GA-68 GOZETOTIDE
- NDC Code (Product)
24275-0525- Manufacturer
- UCSF Radiopharmaceutical Facility
- Strength
- 5 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA212643
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 12/14/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Gallium Ga 68 gozeotide injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gallium Ga 68 gozetotide injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy. with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use appropriate aseptic technique and radiation safety handling measures to maintain sterility during all operations involved in the manipulation and administration of Gallium Ga 68 gozetotide injection. ( 2.1 ) The recommended adult dose is 111 MBq to 259 MBq (3 mCi to 7 mCi) as a bolus intravenous injection. ( 2.2 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. ( 2.2 ) Initiate imaging 50 to 100 minutes after administration. The patient should void immediately prior to initiation of imaging. Scan should begin caudally and proceed cranially. ( 2.4 ) See full prescribing information for additional preparation, administration, imaging, and radiation dosimetry information. ( 2 ) 2.1 Radiation Safety – Drug Handling Handle Gallium Ga 68 gozetotide injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Gallium Ga 68 gozetotide injection. Radiopharmaceuticals should be used by or under the control of physicians who …
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ionetix at 1-517-252-4069 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Gallium Ga 68 gozetotide injection was evaluated in 960 patients, each receiving one dose of Gallium Ga 68 gozetotide injection. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%
Frequently Asked Questions
What is Gallium Ga-68 PSMA-11 used for?
Gallium Ga-68 PSMA-11 contains GALLIUM GA-68 GOZETOTIDE. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Gallium Ga-68 PSMA-11 a controlled substance?
Gallium Ga-68 PSMA-11 is not classified as a controlled substance by the DEA.
What is the generic name for Gallium Ga-68 PSMA-11?
The generic name for Gallium Ga-68 PSMA-11 is GALLIUM GA-68 GOZETOTIDE. There are no other listed brand versions of GALLIUM GA-68 GOZETOTIDE.
What is the NDC code for Gallium Ga-68 PSMA-11 5 mCi/mL?
The NDC (National Drug Code) for Gallium Ga-68 PSMA-11 5 mCi/mL is 24275-0525, listed by UCSF Radiopharmaceutical Facility.
Other Gallium Ga-68 PSMA-11 Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)