Brand Name

Netspot

Generic Name
68GA-Dotatate
View Brand Information
FDA approval date: June 01, 2016
Form: Kit

What is Netspot (68GA-Dotatate)?

For people living with certain rare cancers, getting an accurate diagnosis can be one of the most challenging steps in their journey. Neuroendocrine tumors (NETs), which can develop in the pancreas, gastrointestinal tract, or lungs, often grow slowly and may not cause clear symptoms at first. Detecting and understanding these tumors requires precise imaging and that’s where Netspot (68Ga-Dotatate) plays a critical role. 

Netspot is a radiopharmaceutical imaging agent used in positron emission tomography (PET) scans to locate and evaluate somatostatin receptor–positive neuroendocrine tumors in adults and children. It belongs to a class of diagnostic agents known as somatostatin analogs, which bind to specific receptors on neuroendocrine tumor cells. Introduced as a specialized diagnostic tool, Netspot helps physicians visualize the extent and activity of NETs more clearly than traditional imaging methods, guiding more accurate diagnosis and treatment planning. 

Approved by the U.S. Food and Drug Administration (FDA) in 2016, Netspot marked a major advancement in nuclear medicine by offering improved precision in detecting these complex tumors. 

What does Netspot do? 

Netspot is not a cancer treatment. Instead, it is a diagnostic imaging agent that helps doctors detect and monitor neuroendocrine tumors (NETs). These tumors often express a protein called the somatostatin receptor, which is found in higher concentrations on the surface of NET cells. 

When used during a PET scan, Netspot helps physicians see where these receptors and therefore, the tumors are located in the body. This can include tumors in the pancreas, intestines, or lungs, and areas where cancer may have spread. 

By providing high-resolution, whole-body images, Netspot allows healthcare teams to: 

  • Identify the location, size, and number of NET lesions 
     
  • Assess whether the cancer has metastasized (spread to other organs) 
     
  • Determine eligibility for targeted treatments, such as peptide receptor radionuclide therapy (PRRT) 

Clinical studies have shown that Netspot PET imaging is significantly more accurate than older imaging techniques like octreotide scans, leading to better-informed treatment decisions and improved patient outcomes (NIH, 2023). 

How does Netspot work? 

Netspot works through a combination of molecular targeting and advanced imaging technology. The active ingredient, 68Ga-Dotatate, is a radioactive tracer made by attaching the radioactive isotope gallium-68 to a somatostatin analog called Dotatate. 

When injected into the body, 68Ga-Dotatate travels through the bloodstream and attaches to somatostatin receptors found on neuroendocrine tumor cells. Once bound, it emits tiny signals of positron radiation, which are detected by the PET scanner. The scanner then converts these signals into detailed, three-dimensional body images, highlighting areas where NETs are active. 

In simpler terms, Netspot “lights up” the tumor cells that have somatostatin receptors, allowing doctors to see the precise location and spread of the disease. This level of clarity is crucial for choosing the most appropriate therapy whether surgery, targeted therapy, or radiotherapy. 

Clinically, this mechanism matters because accurate tumor mapping helps avoid unnecessary procedures and ensures that treatment is directed at the most affected areas. 

Netspot side effects 

Netspot is generally very well tolerated, and side effects are uncommon. Because the drug is used only for diagnostic purposes and is quickly cleared from the body, the amount of radiation exposure is low. 

Common side effects may include: 

  • Mild nausea 
     
  • Headache or dizziness 
     
  • Injection site pain or redness 
     
  • Flushing or warmth sensation 

Less common or serious side effects may include: 

  • Allergic reactions (such as rash, itching, or swelling) 
     
  • Low blood pressure or fainting during injection 
     
  • Temporary changes in heart rate 

Allergic or hypersensitivity reactions are rare but can occur, particularly in people who have had reactions to similar contrast agents. The injection is administered by trained medical professionals in a controlled environment, allowing for immediate management of any adverse response. 

Netspot’s radiation dose is carefully controlled and safe for diagnosis. Pregnant or breastfeeding women should inform their doctors due to potential risks to the baby. 

Netspot dosage 

Netspot is administered as a single IV injection just before a PET scan, prepared by nuclear medicine professionals. Patients wait 30-90 minutes for the tracer to circulate, then undergo a 30-minute PET scan requiring stillness. 

Netspot dosage is standardized, not based on body weight or age. Patients should drink fluids and urinate frequently post-scan to eliminate the tracer. Immediate side effects are rare. Long-term or repeated use is typically not needed unless follow-up imaging is required. 

Does Netspot have a generic version? 

As of 2025, there is no FDA-approved generic version of Netspot (68Ga-Dotatate). It is currently available only under the brand name Netspot, manufactured by Advanced Accelerator Applications USA, Inc., a subsidiary of Novartis. However, international versions may exist in other markets. 

While other approved imaging agents like Locametz (68Ga-PSMA-11) for prostate cancer and 68Ga-DOTATOC (for somatostatin receptors) exist, they serve different diagnostic purposes and aren’t Netspot substitutes. A generic Netspot will need to prove identical purity, effectiveness, and safety. Currently, Netspot is used in specialized centers for neuroendocrine tumor PET scans. 

Conclusion 

Netspot (68Ga-Dotatate) represents a breakthrough in neuroendocrine tumor detection and management. By combining targeted molecular imaging with PET technology, it allows doctors to see tumors with remarkable clarity, improving diagnostic accuracy and guiding more effective treatment strategies. 

Netspot is crucial for understanding and monitoring neuroendocrine tumors, from diagnosis to ongoing care. It boasts a strong safety record, minimal side effects, and precise imaging. This diagnostic tool empowers both patients and clinicians by providing detailed information for confident, personalized decisions, ultimately leading to better outcomes. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Netspot (68Ga-Dotatate) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Gallium Ga 68 Dotatate (intravenous route): Description and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Gallium Ga 68 Dotatate injection: Uses and safety information. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2023). Advances in molecular imaging of neuroendocrine tumors using Ga-68-labeled tracers. Retrieved from https://www.nih.gov 

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Brand Information

NETSPOT (68Ga-DOTATATE)
1INDICATIONS AND USAGE
NETSPOT, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
2DOSAGE FORMS AND STRENGTHS
NETSPOT is supplied as a multiple-dose kit, containing two vials for preparation of gallium Ga 68 dotatate injection:
  • Vial 1 (reaction vial with lyophilized powder): 40 mcg of dotatate, 5 mcg of 1,10-phenanthroline, 6 mcg gentisic acid and 20 mg D-mannitol for injection as a white lyophilized powder in a 10 mL glass vial with light-blue flip-off cap
  • Vial 2 (buffer vial): clear, and colorless reaction buffer solution (60 mg formic acid, 56.5 mg sodium hydroxide in approximately 1 mL volume) in a 10 mL olefin polymer vial with a yellow flip-off cap
Gallium-68 is obtained from one of the following generators:
  • Eckert & Ziegler GalliaPharm (
  • IRE ELiT Galli Eo (
After radiolabeling with gallium-68 and pH adjustment with Reaction Buffer, Vial 1 contains a sterile solution of gallium Ga 68 dotatate at a strength of up to 218 MBq/mL (5.89 mCi/mL).
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Hypersensitivity reactions
4.1Clinical Trials Experience
The safety of gallium Ga 68 dotatate was evaluated in three single center studies
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of NETSPOT or other somatostatin receptor imaging agents. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.
Gastrointestinal Disorders: Nausea and vomiting
General Disorders and Administration Site Conditions: Injection site pain and burning sensation
Immune System Disorders: Hypersensitivity reactions, predominantly rash, pruritus, less frequently angioedema or features of anaphylaxis.
5OVERDOSAGE
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.
6DESCRIPTION
NETSPOT is supplied as a sterile, multiple-dose kit for preparation of gallium Ga 68 dotatate injection for intravenous use.
Dotatate, also known as DOTA-0-Tyr3-Octreotate, is a cyclic 8 amino acid peptide with a covalently bound chelator (dota). The peptide has the amino acid sequence: H-D-Phe-Cys-Tyr-D-Trp-Lys-Thr-Cys-Thr-OH, and contains one disulfide bond. Dotatate has a molecular weight of 1435.6 Daltons and its chemical structure is shown in Figure 3.
Figure 3. Chemical Structure of Dotatate
Figure 3.	Chemical Structure of dotatate
[(4,7,10-Tricarboxymethyl-1,4,7,10-tetrazacyclododec-1-yl)acetyl]-(D)-Phenylalanyl-(L)Cysteinyl-(L)-Tyrosyl-(D)-Tryptophanyl-(L)-Lysyl-(L)-Threoninyl-(L)-Cysteinyl-(L)-Threonine-cyclic(2-7)disulfide
NETSPOT is a kit with the following components:
  • Vial 1 (reaction vial with lyophilized powder) contains: 40 mcg dotatate, 5 mcg 1,10-phenanthroline; 6 mcg gentisic acid; 20 mg mannitol.
  • Vial 2 (buffer vial) contains: 60 mg formic acid; 56.5 mg sodium hydroxide and water for injection.
After radiolabeling,
7CLINICAL STUDIES
The efficacy of NETSPOT was established in three open label single center studies (Study A-C).
In Study A, 97 adult patients (mean age 54; 41 men and 56 women) with known or suspected neuroendocrine tumors (NETs) were evaluated with gallium Ga 68 dotatate PET. The gallium Ga 68 dotatate images were read by two independent readers blinded to clinical information. The reads were compared to CT and/or MR images and to indium In 111 pentetreotide images obtained with Single Photon Emission Computed Tomography (SPECT) within previous 3 years. Among 78 patients in whom CT and/or MR images and indium In 111 pentetreotide images were available, gallium Ga 68 dotatate PET was in agreement with the CT and/or MR images in 74 patients. Out of 50 patients with NETs localized by CT and/or MR imaging, gallium Ga 68 dotatate was positive in 48 patients, including 13 patients in whom indium In 111 pentetreotide was negative. Gallium Ga 68 dotatate was negative in 26 out of 28 patients in whom CT and/or MR imaging was negative.
Study B was a published study which involved 104 patients (mean age 58; 52 men and 52 women) with suspected NETs due to clinical symptoms, elevated levels of tumor markers, or indeterminate tumors suggestive of NET. Diagnostic performance of gallium Ga 68 dotatate PET in localizing tumor sites was retrospectively assessed using a reference standard: histopathology (n = 49) or clinical follow up of up to 5-month duration (n = 55). Images were interpreted by consensus between two on-site readers who were not blinded to clinical information. NET sites were localized by reference standard in 36 patients (all by histopathology). Out of these, gallium Ga 68 dotatate was positive, correctly identifying an NET site, in 29 patients and was falsely negative in seven. In 68 patients with no NET identified by a reference standard, the images were negative in 61 and falsely positive in seven patients.
Study C was a published study which involved 63 patients (mean age 58; 34 men and 29 women) evaluated for NET recurrence using a reference standard as described for Study B. Gallium Ga 68 dotatate images were interpreted independently by two central readers blinded to clinical information. Reader 1 correctly localized NETs in 23 out of 29 reference standard-positive patients and reader 2 correctly localized NETs in 22 such patients. In 34 patients with no NET identified by a reference standard, reader 1 was correct in 29 patients and reader 2 in 32.
8PATIENT COUNSELING INFORMATION
Adequate Hydration
Advise 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 gallium Ga 68 dotatate injection, in order to reduce radiation exposure
Lactation
Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 12 hours after gallium Ga 68 dotatate injection administration in order to minimize radiation exposure to a breastfed infant
Close Contact
Advise patients to avoid close contact with infants and pregnant women during the first 12 hours after administration of gallium Ga 68 dotatate.
Distributed by:
T2023-68
9PRINCIPAL DISPLAY PANEL
NDC 69488-001-40
Rx Only
NETSPOT
(kit for the preparation of
40 mcg dotatate
For Intravenous Use Only
PRINCIPAL DISPLAY PANEL
									NDC 69488-001-40
									Rx Only
									NETSPOT®
									(kit for the preparation of Gallium Ga 68 dotatate injection)
									40 mcg dotatate
									For Intravenous Use Only
10PRINCIPAL DISPLAY PANEL
NETSPOT
(kit for the preparation of
40 mcg dotatate per vial
Vial 1 (Reaction vial with
NDC 69488-001-04
Rx Only
Multiple-dose vial
For Intravenous Use Only
VIAL 1 – 3 LAYER label
VIAL 1 – 3 LAYER label
VIAL 1 – 3 LAYER label
11PRINCIPAL DISPLAY PANEL
NETSPOT
For adjusting pH of Gallium Ga 68 dotatate injection
For pH adjustment of radiolabeled Netspot only
1 mL in 10 mL Vial
Vial 2 (Buffer)
NDC 69488-001-01
Rx Only
Each vial of buffer is
VIAL 2 – 3 LAYER label
VIAL 2 – 3 LAYER label
VIAL 2 – 3 LAYER label
12PRINCIPAL DISPLAY PANEL
NETSPOT
(Gallium Ga 68 dotatate injection)
APPLY TO SYRINGE
See Prescribing Information before use.
Rx Only
PRINCIPAL DISPLAY PANEL
									NETSPOT®
									(Gallium Ga 68 dotatate injection)
									APPLY TO SYRINGE
									See Prescribing Information before use.
									Rx Only
13PRINCIPAL DISPLAY PANEL
Ga 68 dotatate injection
Diagnostic
Rx Only
FOR INTRAVENOUS USE
See Prescribing Information for dosage and
Activity Label