Data from FDA - Curated by EPG Health - Last updated 20 December 2016

Indication(s)

INDICATIONS AND USAGE Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.

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Advisory information

contraindications
CONTRAINDICATIONS None known.
Special warnings and precautions

PRECAUTIONS As with any injected product, acute hypersensitivity or allergic reactions are possible.

Limited reports have been received of hypersensitivity reactions following administration of Tc99 m labeled leukocytes prepared using Tc99 m exametazime.

However, the materials used in leukocyte cell separation may cause hypersensitivity reactions.

It is essential that cells are washed free of sedimentation agents before they are reinjected into the patient.

In case of side effects following administration of radiopharmaceuticals, users should ensure the availability of appropriate medical treatment at the time of administration of any radiopharmaceutical to the patient.

A thorough knowledge of the normal distribution of intravenously administered technetium Tc99 m exametazime injection is essential in order to interpret pathologic studies accurately.

Caution should be exercised in making the final diagnosis.

Results can be affected by the presence of tumor, infarction, peritonitis, non-gastrointestinal or bony sites of inflammatory cell collections.

The contents of the Ceretec vial are not radioactive.

After the sodium pertechnetate Tc99 m is added, the product is radioactive and adequate shielding of the final preparation must be maintained.

The contents of the Ceretec vial are intended only for use in preparation of technetium Tc99 m exametazime injection and are NOT to be administered directly to the patient.

General The contents of the Ceretec vial are sterile and pyrogen free.

The vial contains no bacteriostatic preservative.

It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation of the radiopharmaceutical.

Radiopharmaceuticals should be used only by or under the control of physicians who are qualified by 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.

To minimize radiation dose to the bladder, the patient should be encouraged to void when the examination is completed and as often thereafter as possible.

Adequate hydration should be encouraged to permit frequent voiding.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long term animal studies have not been performed to evaluate carcinogenic potential or whether exametazime affects fertility in males or females.

When evaluated in the Ames test, exametazime increased the apparent rate of gene mutation in the TA100 strain of S. typhimurium.

Exametazime did not cause chromosomal aberrations in_vitro (Chinese Hamster Ovary cells) or in_vivo (rat bone marrow).

Pregnancy Category C Animal reproduction studies have not been conducted with Tc99 m exametazime.

It is also not known whether Tc99 m exametazime can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity.

Therefore, Tc99 m exametazime should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.

Nursing Mothers Technetium Tc99 m is excreted in human milk during lactation.

It is not known whether exametazime is excreted in human milk.

Therefore, formula feedings should be substituted for breast feeding for 60 hours.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Clinical studies of Ceretec™ did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse reactions
ADVERSE REACTIONS Rash with generalized erythema, facial edema and fever has been reported in less than 1% of patients. A transient increase in blood pressure was seen in 8% of patients.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION Tc99 m labeled leukocytes for adjunctive localization of intra-abdominal infection or inflammation.

The normal adult (70 kg) dose is 0.259-0.925 GBq (7-25 mCi) as Tc99 m labeled leukocytes by intravenous injection.

Optimal planar imaging is between 2-4 hours.

Cerebral Scintigraphy The recommended dose range for i.v. administration, of reconstituted sodium pertechnetate Tc99 m exametazime in the average adult (70 kg) is 370-740 MBq (10-20 mCi).

Dynamic imaging may be performed between 0 to 10 minutes following injection.

Static imaging may be performed from 15 minutes up to 6 hours after injection.

Pregnancy and lactation
Nursing Mothers Technetium Tc99m is excreted in human milk during lactation. It is not known whether exametazime is excreted in human milk. Therefore, formula feedings should be substituted for breast feeding for 60 hours.

More information

Category Value
Authorisation number NDA019829
Agency product number 3B744AG22N
Orphan designation No
Product NDC 17156-022
Date Last Revised 23-08-2013
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Medi-Physics Inc. dba GE Healthcare.