CERETEC- technetium tc-99m exametazime and cobaltous chloride kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Technetium Tc-99m Exametazime (UNII: 3B744AG22N) (Technetium Tc-99m Exametazime - UNII:3B744AG22N)

Available from:

Medi-Physics, Inc. dba GE Healthcare

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ceretec, when reconstituted with technetium Tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. Ceretec, when reconstituted with technetium Tc 99m exametazime (with or without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for cerebral scintigraphy as an adjunct in the detection of altered regional cerebral perfusion in stroke. None Risk Summary Limited available data with technetium Tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks for major birth defects and miscarriage. Technetium Tc 99m exametazime is transferred across the placenta [see Data]. Animal reproduction studies with technetium Tc 99m exametazime have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering technetium Tc 99m exametazime administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m exametazime and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data Limited published literature describes Tc 99m exametazime crossing the placental barrier and visualization of radioactivity in the fetal liver. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mGy, which represents less than 10 mGy fetal doses. Risk Summary There are limited data available in the scientific literature on the presence of technetium Tc 99m exametazime in human milk. There are no data available regarding the effects of technetium Tc 99m exametazime on the breastfed infant or on milk production. Exposure of technetium Tc 99m exametazime to a breast fed infant can be minimized by temporary discontinuation of breastfeeding [see Clinical Considerations ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ceretec and any potential adverse effects on the breastfed child from Ceretec or from the underlying maternal condition. Clinical Considerations To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration of technetium Tc 99m exametazime injection or technetium Tc 99m exametazime-labeled leukocytes for 12 to 24 hours, where the duration corresponds to the typical range of administered activity, 259 MBq to 925 MBq (7 mCi to 25 mCi). Ceretec is indicated for use in pediatric patients from 2 to 17 years of age for leukocyte labelled scintigraphy and brain scintigraphy. The use of Ceretec for leukocyte labelled scintigraphy and brain scintigraphy is supported by extrapolation from clinical effectiveness in adults. The safety and dosing recommendations are based on clinical experience. Safety and effectiveness in pediatric patients less than 2 years of age have not been established. 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 radiation exposure may be greater in patients with impaired renal function. A reduction in administered Tc 99m can be considered provided an adequate number of leukocytes are administered.

Product summary:

Each Ceretec Kit (NDC 17156-025-05) contains: Sodium Pertechnetate Tc 99m is not part of the Ceretec kit. Before reconstitution and radiolabeling with Tc 99m, the contents of the kit are not radioactive. Store Ceretec kits at controlled room temperature 15°C to 25°C (59°F to 77°F). This reagent kit is approved for use by persons licensed by the U.S. Nuclear Regulatory Commission or the relevant Agreement State. Store and dispose of technetium Tc 99m exametazime in compliance with the regulations of the government agency authorized to license the use of this radionuclide.

Authorization status:

New Drug Application

Summary of Product characteristics

CERETEC- TECHNETIUM TC-99M EXAMETAZIME AND COBALTOUS CHLORIDE
MEDI-PHYSICS, INC. DBA GE HEALTHCARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CERETEC SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CERETEC.
CERETEC (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M EXAMETAZIME
INJECTION) FOR
INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
Ceretec is a radioactive diagnostic agent, indicated in adults and
pediatric patients age 2 to 17 for:
Leukocyte Labeled Scintigraphy – As an adjunct in the localization
of intraabdominal infection and
inflammatory bowel disease. (1.1)
Cerebral Scintigraphy – As an adjunct in the detection of altered
regional cerebral perfusion in stroke.
(1.2)
DOSAGE AND ADMINISTRATION
Do not use cobalt stabilizer solution for leukocyte labeled
scintigraphy. (2.1)
Use appropriate radiation safety measures and aseptic technique during
preparation and handling.
(2.1)
Leukocyte Labeled Scintigraphy - The recommended adult dose is 185 MBq
to 370 MBq (5 mCi to 10
mCi) of Tc 99m exametazime labeled leukocytes by intravenous
injection. Administer as soon as
possible after labeling, preferably within 20 minutes but no later
than 1 hour. (2.2)
Cerebral Scintigraphy - The recommended adult dose is 555 MBq to 1110
MBq (15 mCi to 30 mCi) by
intravenous injection. (2.2)
See full prescribing information for preparation and administration,
interpretation of chromatograms
and radiation dosimetry. (2)
DOSAGE FORMS AND STRENGTHS
Each Ceretec kit consists of 5 units. (3) Each unit contains:
One vial of Ceretec: A lyophilized mixture of 0.5 mg exametazime and
4.5 mg sodium chloride.
One vial of cobalt stabilizer solution: 200 mcg cobalt chloride
6-hydrate stabilizer solution in 2 mL of
Water for Injection.
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Have cardiopulmonary resuscitation
equipment and personnel available and
monitor all patients for hypersensitivity reactions (5.1