U.S. FDA APPROVED  DRUGS DURING 2020

Sr.No-  47

ADVERSE REACTIONS

 The most commonly reported adverse reactions include nausea, diarrhea, and dizziness. (6)

CONTRAINDICATIONS-                                                                                                        None 

WARNINGS AND PRECAUTIONS-

 • Risk for misdiagnosis: Ga 68 PSMA-11 uptake can be seen in a variety of tumor types and in non-malignant processes. Image interpretation errors can occur with Ga 68 PSMA-11 PET. 

• Radiation risk: Ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

 HOW SUPPLIED/STORAGE AND HANDLING

1 How Supplied Ga 68 PSMA-11 Injection (NDC 76394-2642-3) is a clear, colorless solution, supplied in a capped glass vial containing 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL) of Ga 68 PSMA-11 at end of synthesis, in approximately 12 mL.

The contents of each vial are sterile, pyrogen-free and preservativefree. The expiration date and time are provided on the container label. Use Ga 68 PSMA-11 Injection within 3 hours of end of synthesis time.

2 Storage and Handling-

Storage Store Ga 68 PSMA-11 Injection upright in a lead shielded container at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F).

Store Ga 68 PSMA-11 Injection within the original container in radiation shielding.

Handling Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States, or Licensing States as appropriate.

PATIENT COUNSELING INFORMATION-

 Adequate Hydration Instruct patients to drink a sufficient amount of water to ensure adequate hydration before their PET study and urge them to drink and urinate as often as possible during the first hours following the administration of Ga 68 PSMA-11 Injection, in order to reduce radiation exposure

Manufactured and Distributed by: University of California, Los Angeles UCLA Biomedical Cyclotron Facility 780 Westwood Plaza Los Angeles, CA 90095 (310) 794-7638

 CLINICAL PHARMACOLOGY

1. Mechanism of Action-                                                                                                        Ga 68 PSMA-11 binds to prostate-specific membrane antigen (PSMA). It binds to cells that express PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. Gallium-68 (Ga 68) is a ß+ emitting radionuclide that allows positron emission tomography (PET).

2. Pharmacodynamics-                                                                                                         The relationship between Ga 68 PSMA-11 plasma concentrations and successful imaging was not explored in clinical trials.

3. Pharmacokinetics-                                                                                                          Distribution-                                                                                                                     Intravenously injected Ga 68 PSMA-11 is cleared from the blood and is accumulated preferentially in the liver (15%), kidneys (7%), spleen (2%), and salivary glands (0.5%).

Ga 68 PSMA-11 uptake is also seen in the adrenals and prostate. There is no uptake in the cerebral cortex or in the heart, and usually lung uptake is low.

Elimination-                                                                                                                              A total of 14% of the injected dose is excreted in urine in the first 2 hours post-injection.

USE IN SPECIFIC POPULATIONS-

1. Pregnancy Risk Summary-                                                                                                   Ga 68 PSMA-11 Injection is not indicated for use in females. There are no available data with Ga 68 PSMA-11 Injection 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 Ga 68 PSMA-11 Injection, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Animal reproduction studies have not been conducted with Ga 68 PSMA-11 Injection.

2. Lactation Risk Summary-                                                                                                   Ga 68 PSMA-11 Injection is not indicated for use in females. There are no data on the presence of Ga 68 PSMA-11 in human milk, the effect on the breastfed infant, or the effect on milk production.

3.Pediatric use-                                                                                                                            Ga 68 PSMA-11 Injection is not indicated for use in the pediatric population. There are no studies of Ga 68 PSMA-11 Injection in pediatric patients.

4. Geriatric Use-                                                                                                                     The efficacy of Ga 68 PSMA-11 PET in geriatric patients with prostate cancer is based on data from two prospective studies. Most patients in these trials were 65 years of age or older (72%).

The efficacy and safety profiles of Ga 68 PSMA-11 Injection appear similar in adult and geriatric patients with prostate cancer, although the number of adult patients in the trials was not large enough to allow definitive comparison.

 OVERDOSAGE-                                                                                                                            In the event of an overdose of Ga 68 PSMA-11 Injection, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding.

A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.