Technetium (99mTc) exametazime

Technetium (99mTc) exametazime
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sree Teja Yelamanchili, MBBS [2]

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Overview

Technetium (99mTc) exametazime is a diagnostic radiopharmaceutical agent that is FDA approved for the diagnosis of infectious disease of abdomen, inflammatory bowel disease, radioisotope brain imaging. Common adverse reactions include hypertension.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• 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.

Dosage

Tc99m 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 Tc99m 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 Tc99m 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Diagnosis of:

• Alzheimer's disease
• Electrocerebral silence
• Epilepsy

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Technetium (99mTc) exametazime in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-labeled indications and dosage of Technetium (99mTc) exametazime in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Technetium (99mTc) exametazime in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Technetium (99mTc) exametazime in pediatric patients.

Contraindications

None known.

Warnings

• As with any injected product, acute hypersensitivity or allergic reactions are possible.
• Limited reports have been received of hypersensitivity reactions following administration of Tc99m labeled leukocytes prepared using Tc99m 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 Tc99m 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 Tc99m 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 Tc99m 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Technetium (99mTc) exametazime Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Technetium (99mTc) exametazime Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Technetium (99mTc) exametazime Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Technetium (99mTc) exametazime in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Technetium (99mTc) exametazime in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Technetium (99mTc) exametazime during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Technetium (99mTc) exametazime in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Technetium (99mTc) exametazime in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Technetium (99mTc) exametazime in geriatric settings.

Gender

There is no FDA guidance on the use of Technetium (99mTc) exametazime with respect to specific gender populations.

Race

There is no FDA guidance on the use of Technetium (99mTc) exametazime with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Technetium (99mTc) exametazime in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Technetium (99mTc) exametazime in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Technetium (99mTc) exametazime in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Technetium (99mTc) exametazime in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Technetium (99mTc) exametazime Administration in the drug label.

Monitoring

There is limited information regarding Technetium (99mTc) exametazime Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Technetium (99mTc) exametazime and IV administrations.

Overdosage

There is limited information regarding Technetium (99mTc) exametazime overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Technetium (99mTc) exametazime Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Technetium (99mTc) exametazime Mechanism of Action in the drug label.

Structure

There is limited information regarding Technetium (99mTc) exametazime Structure in the drug label.

Pharmacodynamics

There is limited information regarding Technetium (99mTc) exametazime Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Technetium (99mTc) exametazime Pharmacokinetics in the drug label.

Nonclinical Toxicology

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).

Clinical Studies

There is limited information regarding Technetium (99mTc) exametazime Clinical Studies in the drug label.

How Supplied

There is limited information regarding Technetium (99mTc) exametazime How Supplied in the drug label.

Storage

There is limited information regarding Technetium (99mTc) exametazime Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Technetium (99mTc) exametazime Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Technetium (99mTc) exametazime interaction has not been established.

Brand Names

There is limited information regarding Technetium (99mTc) exametazime Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Technetium (99mTc) exametazime Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.