DRAX EXAMETAZIME Kit, Powder for solution for injection Ref.[10222] Active ingredients: Technetium ⁹⁹ᵐTc exametazime

5.1 Hypersensitivity Reactions

Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m exametazime have been reported. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.

5.2 Risk for Image Interpretation Error

The interpretation of images can be affected by the presence of other pathophysiological processes within and outside of the abdominal cavity such as: tumor, infarction, trauma, and other inflammatory conditions.

5.3 Radiation Exposure Risk

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 [see Dosage and Administration (2.1, 2.2)].

The following adverse reactions are described elsewhere in the labeling;

• Hypersensitivity reactions [see Warnings and Precautions (5.1)].

The following adverse reactions associated with the use of technetium Tc 99m exametazime have been identified in clinical trials or post-marketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: transient blood pressure increase

Skin and subcutaneous tissue disorders: rash, generalized erythema, urticaria, angioedema, pruritus.

General disorders and administration site conditions: facial edema, fever, asthenic conditions (e.g., malaise, fatigue).

Nervous system disorders: headache, dizziness, paraesthesia.

Vascular disorders: flushing.

Gastrointestinal disorders: nausea, vomiting.

Risk Summary

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. 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 are 2-4% and 15-20%, respectively.

Data

Human Data

Limited published literature describes Tc 99m exametazime crossing the placental barrier and accumulating in the fetal liver. No adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mGy, which represents less than 10mGy 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 no data available on the effects of technetium Tc 99m exametazime on the breastfed infant or the effects on milk production. Exposure of technetium Tc 99m exametazine 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 technetium Tc 99m exametazime, any potential adverse effects on the breastfed child from technetium Tc 99m exametazime 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-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).

Safety and efficacy in pediatric patients have not been assessed.

Clinical studies of Tc 99m exametazime 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.

Technetium Tc 99m exametazime is substantially excreted by the kidneys, so excretion is decreased/delayed and therefore radiation exposure is greater in patients with impaired renal function. A reduction in administered Tc 99m can be considered provided an adequate number of labeled WBCs are administered.