Neotect
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NeoTect
Neotect Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Neotect FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Adverse events were evaluated in clinical studies of 647 adults who received 15.0 to 20.0 mCi Technetium Tc 99m labeled to approximately 47µg of depreotide. Of these adults, 58% were men and 42% women. The mean age was 59.0 years (18-86 years).
Deaths did not occur during the clinical study period. After Technetium Tc 99m Depreotide Injection, serious adverse events were not reported.
At least one adverse event occurred in 29/647 (4.5 %) patients after Technetium Tc 99m Depreotide Injection. Headache was the most commonly reported adverse event (1% of patients). Table 8 lists adverse events reported in 0.5% or more of patients who received Technetium Tc 99m Depreotide Injection.
TABLE 8. ADVERSE EVENTS REPORTED IN ≥ 0.5% OF PATIENTS
FOLLOWING NeoTect® (technetium tc 99m depreotide injection) INJECTION IN CLINICAL TRIALS
| Number of Patients Exposed | 647 |
| Number of Patients with At Least One Adverse Event | 29 (4.5%) |
| Nervous System | 13 (2%) |
| Headache | 7 (1.0%) |
| Dizziness | 5 (0.8%) |
| Gastrointestinal System | 7 (1.0%) |
| Nausea | 4 (0.6%) |
| Vascular (extracardiac) Disorder | 3 (0.5%) |
| Flushing | 3 (0.5%) |
Other adverse events which occurred in < 0.5% of patients following administration of NeoTect® (technetium tc 99m depreotide injection) included: arthrosis, back pain, chest pain, diarrhea, fatigue, gait abnormality, glossitis, hemoptysis, hypoaesthesia, infection, leg cramps, lymphocytosis, malaise, pharyngitis, somnolence, taste perversion.
Read the entire FDA prescribing information for Neotect (Technetium Tc 99m Depreotide Injection) »
Additional NeoTect Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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