Kit For The Preparation Of Gallium Ga 68 Gozetotide
Generic Name: kit for the preparation of gallium ga 68 gozetotide
Brand Names:
Locametz
11 DESCRIPTION 11.1 Chemical Characteristics LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection) is a sterile, radioactive diagnostic agent for intravenous administration after radiolabeling. Each vial contains 25 micrograms of gozetotide, 1 mg gentisic acid, 78 mg of sodium acetate trihydrate, and 40 mg sodium chloride. Gozetotide is also known as PSMA-11.
Overview
11 DESCRIPTION 11.1 Chemical Characteristics LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection) is a sterile, radioactive diagnostic agent for intravenous administration after radiolabeling. Each vial contains 25 micrograms of gozetotide, 1 mg gentisic acid, 78 mg of sodium acetate trihydrate, and 40 mg sodium chloride. Gozetotide is also known as PSMA-11.
Uses
1 INDICATIONS AND USAGE LOCAMETZ, after radiolabeling with gallium-68, 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. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.
Dosage
2 DOSAGE AND ADMINISTRATION Use appropriate radiation safety measures and aseptic precautions while handling and administering gallium Ga 68 gozetotide injection. ( 2.1 ) The recommended amount of radioactivity is 111 MBq to 259 MBq (3 mCi to 7 mCi). Administered as slow intravenous injection. ( 2.2 ) Advise patients to be well hydrated prior to the administration and to void immediately prior to and frequently after image acquisition. ( 2.3 ) A diuretic expected to act within the uptake time period may be administered at the time of radiotracer injection. ( 2.6 ) Acquire PET whole body images 50 minutes to 100 minutes after administration. ( 2.7 ) See the full prescribing information for detailed instructions on preparation, administration, imaging, and radiation dosimetry.
Side Effects
6 ADVERSE REACTIONS The adverse reactions (incidence ≥ 0.5%) are fatigue, nausea, constipation, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 LOCAMETZ has been established based on three prospective studies of gallium Ga 68 gozetotide in patients with prostate cancer (i.e., Studies 1, 2, and 3). Adverse reactions from these studies are reported below.
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 LOCAMETZ PET has not been established.
Warnings
5 WARNINGS AND PRECAUTIONS Risk for Misinterpretation: Gallium Ga 68 gozetotide uptake may occur in other tumor types and in non-malignant processes. Interpretation of LOCAMETZ PET imaging with histopathology and/or other diagnostic procedures is recommended. ( 5.1 ) Radiation Risk: Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. ( 5.2 ) 5.1 Risk for Misinterpretation Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and positive imaging does not confirm the presence of prostate cancer. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary LOCAMETZ is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including LOCAMETZ, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LOCAMETZ is supplied as a kit for the preparation of gallium Ga 68 gozetotide injection in a carton of 1 vial (NDC# 0078-1224-61). Each multiple-dose vial contains 25 micrograms of gozetotide as white lyophilized powder packaged in a 10 mL type I Plus glass vial closed with a rubber stopper and sealed with a flip-off cap.
Frequently Asked Questions
What is Kit For The Preparation Of Gallium Ga 68 Gozetotide used for?▼
1 INDICATIONS AND USAGE LOCAMETZ, after radiolabeling with gallium-68, 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. for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.
What are the side effects of Kit For The Preparation Of Gallium Ga 68 Gozetotide?▼
6 ADVERSE REACTIONS The adverse reactions (incidence ≥ 0.5%) are fatigue, nausea, constipation, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 LOCAMETZ has been established based on three prospective studies of gallium Ga 68 gozetotide in patients with prostate cancer (i.e., Studies 1, 2, and 3). Adverse reactions from these studies are reported below.
Can I take Kit For The Preparation Of Gallium Ga 68 Gozetotide during pregnancy?▼
8.1 Pregnancy Risk Summary LOCAMETZ is not indicated for use in females. There are no available data with gallium Ga 68 gozetotide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. All radiopharmaceuticals, including LOCAMETZ, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. Animal reproduction studies have not been conducted with gallium Ga 68 gozetotide.
What are the important warnings for Kit For The Preparation Of Gallium Ga 68 Gozetotide?▼
5 WARNINGS AND PRECAUTIONS Risk for Misinterpretation: Gallium Ga 68 gozetotide uptake may occur in other tumor types and in non-malignant processes. Interpretation of LOCAMETZ PET imaging with histopathology and/or other diagnostic procedures is recommended. ( 5.1 ) Radiation Risk: Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. ( 5.2 ) 5.1 Risk for Misinterpretation Image interpretation errors can occur with LOCAMETZ PET. Negative imaging does not rule out the presence of prostate cancer and positive imaging does not confirm the presence of prostate cancer. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.