Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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.
5 WARNINGS AND PRECAUTIONS 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).
Like all medications, Netspot can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: