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 adverse reactions are described elsewhere in the labeling;
Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] .
The following adverse reactions associated with the use of technetium Tc 99m exametazime have been identified in clinical trials or post-marketing reports.
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 drug exposure.
Cardiovascular: transient blood pressure increase Skin and subcutaneous tissue disorders: rash, generalized erythema, urticaria, angioedema, pruritus.
General disorders and administration site conditions: facial edema, fever, asthenic conditions (e.g., malaise, fatigue).
Nervous system disorders: headache, dizziness, paraesthesia.
Vascular disorders: flushing.
Gastrointestinal disorders: nausea, vomiting.
Most common adverse reactions include transient increase in blood pressure, rash, generalized erythema, facial edema and fever.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m exametazime have been reported.
Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m exametazime have been reported.
Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.
5.2 Risk for Image Interpretation Error The interpretation of images can be affected by the presence of other pathophysiological processes within and outside of the abdominal cavity such as: tumor, infarction, trauma, and other inflammatory conditions.
Like all medications, Drax Exametazime 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: