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Neotect

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NeoTect

Warnings
Precautions

WARNINGS

None.

PRECAUTIONS

General

Therapy with somatostatin analogues can produce severe hypoglycemia in patients with insulinomas. Since Depreotide binds to somatostatin receptors caution should be exercised when administering this drug to patients with insulinomas.

NeoTect® (technetium tc 99m depreotide injection) , as other small peptides, may induce hypersensitivity reactions or anaphylactic reactions. Adequate treatment provisions, including epinephrine, should be available for immediate use. In preliminary studies of 18 subjects, NeoTect® (technetium tc 99m depreotide injection) did not produce increases in IgG or IgM production 3 weeks following injection. Other immune parameters such as eosinophils, other immunoglobulins, complement, lymphokines or cytokines were not studied.

NeoTect® (technetium tc 99m depreotide injection) contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides.

Technetium Tc 99m Depreotide Injection, like other radioactive drugs, must be handled with care and appropriate safety measure should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management.

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.

Urinary excretion of radioactivity occurs primarily during the first 4 hours following injection. Studies have not been done to determine the amount of radioactivity that might be eliminated in the feces. (See CLINICAL PHARMACOLOGY Section). Special precautions should be taken with incontinent patients to minimize the risk of radioactive contamination of clothing, bed linen, and the patient's environment.

Information For Patients

To minimize radiation absorbed dose to the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection of NeoTect® (technetium tc 99m depreotide injection) . This may be achieved by having patients drink at least an 8 oz. glass of water prior to drug administration. To help protect themselves and others in their environment, patients should take the following precautions for 12 hours after injection: whenever possible a toilet should be used and should be flushed several times after each use and patients should wash their hands thoroughly after each voiding or fecal elimination. If blood, urine or feces soil the clothing, the clothing should be washed separately. Please refer to the PATIENT INFORMATION section.

Laboratory Tests

There was a low incidence (1% or less) of transient and clinically insignificant changes in alanine aminotransferase (ALT), white blood cell count and eosinophil count following administration of Technetium Tc 99m Depreotide Injection.

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.

Last reviewed on RxList: 12/1/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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