Cardiolite - Tetrakis(2-methoxyisobutylisocyanide)copper(i) Tetrafluoroborate injection, Powder, Lyophilized, For Solution

CARDIOLITE® is a myocardial perfusion agent indicated for:

• detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects)
• evaluating myocardial function and developing information for use in patient management decisions

• For Myocardial Imaging: The suggested dose range for I.V. administration of CARDIOLITE® in a single dose to be employed in the average patient (70 Kg) is 370 - 1110 MBq (10 - 30 mCi).
• For Breast Imaging: The recommended dose range for I.V. administration of MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi).

CARDIOLITE^®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is supplied as a lyophilized mixture in a 5 mL vial.

• In one study of 46 subjects who received CARDIOLITE® administration, the radioactivity in both children and adolescents exhibited blood PK profiles similar to those previously reported in adults.
• Lactation: Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary, however, a lactating woman should be advised to consider restricting close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure. (
  8.2 Lactation

  Risk Summary

  Limited data in the scientific literature on the presence of Technetium Tc99m Sestamibi in human milk, demonstrate that between 0.01% and 0.03% of maternal injected activity of technetium Tc99m Sestamibi was excreted in human milk. Technetium Tc99m Sestamibi accumulates in the lactating breast

  [see Clinical Considerations]

  . There are limited data in the scientific literature on effects of Technetium Tc99m Sestamibi on the breastfed infant or on milk production The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Technetium Tc99m Sestamibi and any potential adverse effects on the breastfed infant from Technetium Tc99m Sestamibi or from the underlying maternal condition.

  Clinical Considerations

  Interruption of breastfeeding after exposure to Technetium Tc99m Sestamibi is not necessary because Technetium Tc99m Sestamibi excretion in breast milk is low. However, a lactating woman may restrict close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration in order to minimize radiation exposure.
  )

• Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.
• CARDIOLITE® has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during CARDIOLITE® imaging.
• Caution should be exercised and emergency equipment should be available when administering CARDIOLITE®.
• Before administering CARDIOLITE® patients should be asked about the possibility of allergic reactions to either drug.
• The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.