Technetium Tc 99m Exametazime

Technetium Tc 99m Exametazime is a radioactive diagnostic agent indicated for:

• Leukocyte Labeled Scintigraphy – as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease
• Regional cerebral Flow Scintigraphy (Ceretec)– as an adjunct in the detection of altered regional cerebral perfusion in stroke
• Technetium Tc 99m Exametazime is available under the following different brand names: Ceretec, Drax Exametazime.

Common side effects of Technetium Tc 99m Exametazime include:

• a temporary rise in blood pressure
• rash with redness
• facial swelling
• fever

Serious side effects of Technetium Tc 99m Exametazime include:

• not available

Rare side effects of Technetium Tc 99m Exametazime include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Multi-dose vial kit (Ceretec)

• 5 multidose powder vials each containing 0.5 mg exametazime
• 5 vials of methylene blue injection USP 1%
• 5 vials of 0.003 M Monobasic Sodium

Single-dose vial kit (Drax Exametazime)

• 5 single-dose vials, each vial containing a lyophilized mixture of 0.5 mg exametazime

Regional cerebral flow scintigraphy (Ceretec)

Adult dosage

• Dosing
  • Recommended dose: 370-740 MBq (10-20 mCi) IV
  • Dynamic imaging: Administer less than 10 minutes before the examination
  • Planar/tomographic imagining: Administer 15 minutes to 6 hours before examination

Leukocyte-labeled scintigraphy

Adult dosage

• Dosing
  • Recommend dosage range for technetium Tc 99m Exametazime labeled leukocytes: 259-925 IV MBq [7-25 millicuries (mCi)] IV
  • Administer at least 30 minutes before serial pelvic and abdominal imaging
  • Complete procedures within 4 hours postinjection

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

• If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.
• Technetium Tc 99m Exametazime has severe interactions with no other drugs
• Technetium Tc 99m Exametazime has serious interactions with no other drugs
• Technetium Tc 99m Exametazime has moderate interactions with no other drugs
• Technetium Tc 99m Exametazime has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Technetium Tc 99m Exametazime?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Technetium Tc 99m Exametazime?”

Cautions

• Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m Exametazime have been reported; monitor for hypersensitivity reactions and always have cardiopulmonary resuscitation equipment and personnel available
• Image interpretation may be affected by the presence of other pathophysiological processes within and outside of the abdominal cavity (eg, tumor, infarction, trauma, and other inflammatory conditions)
• Technetium Tc 99m contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is associated with an increased risk of cancer; ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure; encourage patients to drink fluids and void as frequently as possible after administration

Pregnancy and Lactation

• Limited available data with technetium Tc 99m Exametazime use in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage
• Animal reproduction studies with technetium Tc 99m Exametazime have not been conducted
• Inform patients who are pregnant or may become pregnant about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m Exametazime and the gestational timing of exposure
• Limited data describes technetium 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
• Lactation
  • Unknown if distributed in human breast milk
  • To decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after administration of Technetium Tc 99m Exametazime-labeled leukocytes for 12 to 24 hours, where the duration corresponds to the typical range of administered activity, 259-925 MBq (7-25 mCi)
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition