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INDICATION
NETSPOT®, kit for the preparation of gallium Ga 68 dotatate injection, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

IMPORTANT SAFETY INFORMATION

NETSPOT Product Resources

NETSPOT is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs)1,2

NETSPOT AT A GLANCE

IMPORTANT SAFETY INFORMATION2

WARNINGS AND PRECAUTIONS

Radiation Risk

  • Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides.
  • Ga 68 dotatate contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer.
  • Ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure.
  • Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Ga 68 dotatate. Drink and void frequently during the first hours following administration to reduce radiation exposure.

Risk for Image Misinterpretation

  • The uptake of Ga 68 dotatate reflects the level of somatostatin receptor density in NETs. However, uptake can also be seen in a variety of other tumor types (e.g. those derived from neural crest tissue).
  • Increased uptake might also be seen in other pathologic conditions (e.g. thyroid disease or subacute inflammation) or might occur as a normal physiologic variant (e.g. uncinate process of the pancreas).
  • Uptake may need to be confirmed by histopathology or other assessments.

ADVERSE REACTIONS

  • Clinical Trials Experience: The safety of Ga 68 dotatate was evaluated in three single center studies and in a survey of the scientific literature. No serious adverse reactions were identified.
  • Post Marketing Experience: Nausea, vomiting, and injection site pain and burning sensation were all reported during post approval use.

DRUG INTERACTIONS

  • Non-radioactive somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatate. Image patients with Ga 68 dotatate PET just prior to dosing with long-acting somatostatin analogs.
  • Short-acting somatostatin analogs can be used up to 24 hours before imaging with Ga 68 dotatate.

SPECIFIC POPULATIONS

Pregnancy

  • There are no studies with Ga 68 dotatate in pregnant women to inform any drug-associated risks; however, all radiopharmaceuticals, including Ga 68 dotatate have the potential to cause fetal harm.

Lactation

  • There is no information on the presence of Ga 68 dotatate in human milk, the effect on the breastfed infant, or the effect on milk production.
  • Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 12 hours after Ga 68 dotatate administration in order to minimize radiation exposure to a breastfed infant.

OVERDOSAGE

  • In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding. A diuretic might also be considered.
  • If possible, an estimate of the radioactive dose given to the patient should be performed.

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or www.report.novartis.com/, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information.

Manufactured by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), Italy
Distributed by: Advanced Accelerator Applications USA, Inc., NJ 07041

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References: 1. Deppen SA, Liu E, Blume JD, et al. Safety and efficacy of 68Ga-DOTATATE PET/CT for diagnosis, staging, and treatment management of neuroendocrine tumors. J Nucl Med. 2016;57(5):708-714. 2. Netspot [prescribing information]. Millburn, NJ: Advanced Accelerator Applications; 2019.