Adverse events were evaluated in clinical studies of 647 adults who received 15.0 to 20.0 mCi Technetium Tc 99m labeled to approximately 50 µg 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.

Other adverse events which occurred in < 0.5% of patients following administration of NeoTect^® included:arthrosis, back pain, chest pain, diarrhea, fatigue, gait abnormality, glossitis, hemoptysis, hypoaesthesia, infection, leg cramps, lymphocytosis, malaise, pharyngitis, somnolence, taste perversion.

Drug interactions were not noted in clinical studies in which Technetium Tc 99m Depreotide Injection was administered to patients receiving concomitant medication.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been conducted to evaluate carcinogenic potential or effects on fertility.

The results of the following genotoxicity studies with decayed Technetium Tc 99m Depreotide Injection or with depreotide were negative: Salmonella/Escherichia coli reverse mutation assay, in vitro mouse lymphoma assay with and without metabolic activation, and in vivo mouse micronucleus assay.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with decayed Technetium Tc 99m Depreotide Injection.It is not known whether Technetium Tc 99m Depreotide Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.Technetium Tc 99m Depreotide Injection should be given to a pregnant woman only if clearly needed. Studies in pregnant women have not been conducted.

Nursing Mothers

Studies have not been conducted with depreotide to determine its excretion in human milk.

Technetium Tc 99m Pertechnetate is excreted in human milk. It is not known whether Technetium Tc 99m Depreotide Injection is excreted in human milk. Caution should be exercised when Technetium Tc 99m Depreotide Injection is administered to a nursing woman. Wherever possible, infant formula should be substituted for breast milk until the technetium has been eliminated.

Pediatric Use

Safety and effectiveness of Depreotide in pediatric patients below the age of 16 years have not been established.

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