netspot
Pharmaranks rates Netspot 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Netspot (Gallium Dotatate Ga-68) is a medication supplied as a kit.
Gallium Dotatate Ga-68 · by Aaa USA Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Gallium Dotatate Ga-68
- Form
- Kit
- Strength
- Gallium Dotatate GA-68 2.1-5.5mCi/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Aaa USA Inc
- FDA application
- NDA208547
What is Netspot?
From the FDA label: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 [(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, [see Dosage and Administration ( 2.3 )] , gallium Ga 68 dotatate injection also contains hydrochloric acid as an excipient derived from the generator eluate. The prepared gallium Ga 68 dotatate injection for intravenous use, is a sterile, pyrogen free, clear, colorless, buffered solution, with a pH between 3.2 and 3.8. Table 5, Table 6, and Table 7 display the principal radiation…
How to use
After radiolabeling, handle gallium Ga 68 dotatate injection with appropriate safety measures to minimize radiation exposure. ( 2.1 ) Instruct patients to drink a sufficient amount of water before administration, during the first hours following administration and to void frequently. ( 2.1 ) Recommended dose is 2 MBq/kg (0.054 mCi/kg) of body weight up to 200 MBq (5.4 mCi) administered as intravenous bolus injection. ( 2.2 ) See the Full Prescribing Information for detailed instructions on how to prepare gallium Ga 68 dotatate injection (e.g., radiolabeling). ( 2.3 ) 2.1 Radiation Safety Drug Handling After radiolabeling, handle the gallium Ga 68 dotatate injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.1 )] . Use waterproof gloves, effective radiation shielding and appropriate safety measures when preparing and handling gallium Ga 68 dotatate injection. 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, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Patient Preparation Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of gallium Ga 68 dotatate…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Nausea, vomiting, and injection site pain and burning sensation were all reported during post-approval use. ( 6 ) 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 The safety of gallium Ga 68 dotatate was evaluated in three single center studies [see Clinical Studies ( 14 )] and in a survey of the scientific literature. No serious adverse reactions were identified. 6.2 Postmarketing 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.
Warnings
Important safety information
Radiation Risk : Gallium Ga 68 dotatate 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. Restrict close contact with infants and pregnant women during the first 12 hours after administration of gallium Ga 68 dotatate. ( 5.1 ) Hypersensitivity Reactions : Most reported reactions were rash and pruritus and reversible either spontaneously or with routine symptomatic management. ( 5.2 ) Risk for Image Misinterpretation : The uptake of gallium Ga 68 dotatate can be seen in a variety of tumor types other than NETs (e.g., those derived from neural crest tissue), in sites of splenosis or other pathologic conditions, and as a normal physiologic variant (e.g., uncinate process of the pancreas). ( 5.3 ) 5.1 Radiation Risk Gallium 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 radiolabeling procedures to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration ( 2.1 )] . Avoid close contact with infants and pregnant women during the first 12 hours after administration of gallium Ga 68 dotatate injection. 5.2 Hypersensitivity Reactions Hypersensitivity reactions following administration of somatostatin receptor imaging agents predominantly consisted of cutaneous reactions, such as rash and pruritus. Reactions reversed either spontaneously or with routine symptomatic management. Less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis. 5.3 Risk for Image Misinterpretation The uptake of gallium 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 sites of splenosis or 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). PET images with gallium Ga 68 dotatate should be interpreted visually and the uptake may need to be confirmed by histopathology or other assessments [see Dosage and Administration ( 2.7 )] . A negative scan after the administration of gallium Ga 68 dotatate in patients who do not have a history of NETs, including in patients suspected of ectopic ACTH-secreting tumors, does not rule out the presence of NETs.
Who should not take Netspot
None. None. ( 4 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Somatostatin Analogs : Somatostatin analogs competitively bind to the same somatostatin receptors as gallium Ga 68 dotatate and may affect imaging – image just prior to dosing with long-acting somatostatin analogs. ( 7.1 ) Glucocorticoids : Repeated administration of high doses of glucocorticoids prior to gallium Ga 68 dotatate administration may affect imaging. ( 7.2 ) 7.1 Somatostatin analogs Non-radioactive somatostatin analogs competitively bind to the same somatostatin receptors as gallium Ga 68 dotatate. Image patients with gallium Ga 68 dotatate PET just prior to dosing with long-acting analogs of somatostatin. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with gallium Ga 68 dotatate. 7.2 Glucocorticoids Glucocorticoids can down-regulate somatostatin subtype 2 receptors (SSTR2). Repeated administration of high doses of glucocorticoids prior to gallium Ga 68 dotatate administration may result in false negative imaging.
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Frequently asked questions
- How is Netspot rated?
- pharmaranks gives Netspot a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Netspot?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Netspot. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Netspot?
- Netspot is marketed by Aaa USA Inc. You can see Aaa USA Inc's full profile, rating, and other products on pharmaranks.
- Is Netspot a brand-name or generic drug?
- Netspot is a brand-name product with the active ingredient Gallium Dotatate Ga-68.
- Is Netspot available over the counter?
- No. Netspot is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Netspot come in?
- Netspot is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Netspot FDA-registered?
- Netspot is on record with the U.S. FDA under application number NDA208547. You can verify this on its official FDA label.
- Has Netspot been recalled by the FDA?
- Yes. Netspot has 2 recorded FDA recall events in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Netspot safe?
- There's no single safe-or-not verdict. pharmaranks gives Netspot a recall-safety score of 70/100, based on its FDA recall history (2 recorded recall events) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Netspot?
- Netspot's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Nausea, vomiting, and injection site pain and burning sensation were all reported during post-approval use.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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netspot
70/100