Indium ¹¹¹In oxyquinoline

Pregnancy Category C.

Animal reproduction studies have not been conducted with indium In-111 oxyquinoline labeled leukocytes. It is also not known whether indium In-111 oxyquinoline labeled leukocytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

However, indium nitrate, a closely related compound, was teratogenic and embryopathic in hamsters. Indium In-111 oxyquinoline labeled leukocytes should be given to pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, in women of childbearing capability should be performed during the first few (approximately ten) days following the onset of menses.

It is reported that indium 111 is secreted in human milk following administration of indium In-111 labeled leukocytes. Therefore, formula feedings should be substituted for breast feedings.

Although earlier studies suggested that oxyquinoline (oxine) might have carcinogenic potential, recent studies have found no evidence of carcinogenicity in either rats or mice given oxyquinoline in feed at concentrations of 1,500 or 3,000 ppm for 103 weeks.

It has been reported that human lymphocytes labeled with recommended concentrations of indium In-111 oxyquinoline showed chromosome aberrations consisting of gaps, breaks and exchanges that appear to be radiation induced. At 555 kBq/10⁷, 15 µCi/10⁷ lymphocytes 93% of the cells were reported to be abnormal. The oncogenic potential of such lymphocytes has not been studied. It has been reported that the radiation dose to 10⁸ leukocytes is 9 × 10⁴ mGy (0.9 × 10⁴ rads) from 18.5 MBq, 500 µCi.

Studies have not been performed to evaluate whether indium In-111 oxyquinoline affects fertility in male or female laboratory animals or humans.

Sensitivity reactions (urticaria) have been reported. The presence of fever may mask pyrogenic reactions from indium In-111 oxyquinoline labeled leukocytes. The possibility of delayed adverse reactions has not been studied.