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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
8-Hydroxyquinoline is a that is FDA approved for the {{{indicationType}}} of *Indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes.
Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes.
Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process.
Indium In 111 oxyquinoline labeled leukocyte imaging is not the preferred technique for the initial evaluation of patients with a high clinical probability of an abscess in a known location. Ultrasound or computed tomography may provide a better anatomical delineation of the infectious process and information may be obtained more quickly than with labeled leukocytes. If localization by these techniques is successful, labeled leukocytes should not be used as a confirmatory procedure. If localization or diagnosis by these methods fails or is ambiguous, indium In 111 oxyquinoline labeled leukocyte imaging may be appropriate.
Dosing Information
The recommended adult (70 kg) dose of indium In 111 oxyquinoline labeled autologous leukocytes is 7.4 to 18.5 MBq, 200-500 µCi. Indium In 111 oxyquinoline solution is intended for the radiolabeling of autologous leukocytes. The indium In 111 oxyquinoline labeled autologous leukocytes are administered intravenously.
Imaging is recommended at approximately 24 hours post injection. Typically, anterior and posterior views of the chest, abdomen and pelvis should be obtained with other views as required.
Aseptic procedures and a shielded syringe should be employed in the withdrawal of indium In 111 oxyquinoline from the vial. Similar procedures should be employed during the labeling procedure and the administration of the labeled leukocytes to the patient. The user should wear waterproof gloves during the entire procedure. The patient's dose should be measured by a suitable radioactivity calibration system immediately before administration. At this time, the leukocyte preparation should be checked for gross clumping and red blood cell contamination.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
There is limited information regarding Off-Label Guideline-Supported Use of 8-Hydroxyquinoline in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of 8-Hydroxyquinoline in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of 8-Hydroxyquinoline in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of 8-Hydroxyquinoline in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of 8-Hydroxyquinoline in pediatric patients.
Contraindications
None known.
Warnings
Title
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
The content of the vial of indium In 111 oxyquinoline solution is intended only for use in the preparation of indium In 111 oxyquinoline labeled autologous leukocytes, and is not to be administered directly. Autologous leukocyte labeling is not recommended in leukopenic patients because of the small number of available leukocytes.
Due to radiation exposure, indium In 111 oxyquinoline labeled leukocytes could cause fetal harm when administered to pregnant women. If this radiopharmaceutical is used during pregnancy, the patient should be informed of the potential hazard to the fetus.
Indium In 111 oxyquinoline labeled autologous leukocytes should be used only when the benefit to be obtained exceeds the risks involved in children under eighteen years of age owing to the high radiation burden and the potential for delayed manifestation of long-term adverse effects.
Precautions
Clumping of cells may produce focal accumulations of radioactivity in lungs which do not wash out in 24 hours and thus may lead to false positive results. This phenomenon can be detected by imaging the chest immediately after injection.
The normally high uptake of indium In 111 oxyquinoline labeled leukocytes by spleen and liver may mask inflammatory lesions in these organs. Labeled leukocytes have been observed to accumulate in the colon and accessory spleens of patients with or without disease.
Chemotaxis of granulocytes deteriorates during storage and loss of chemotaxis may cause false negative scans. The spontaneous release of indium In 111 has been reported to range from about 3% at one hour to 24% at 24 hours [ten Berge, R.J.M., Natarajan, A.T., Hardeman, M.R., et al, Labeling with indium In 111 has detrimental effects on human lymphocytes, Journal of Nuclear Medicine, 24, 615-620 (1983)]. The maximum amount of time recommended between drawing the blood and reinjection should not exceed 5 hours. It is recommended that the labeled cells be used within one hour of preparation, if possible and in no case more than three hours after preparation.
Plasma and red cell contamination impairs labeling efficiency of leukocytes. Hemolyzed blood in labeled leukocytes may produce heart pool activity and should be avoided.
Cell aggregates of various degrees have been reported. Cell labeling techniques and standing of cell preparation may be contributing factors.
Nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. Procedures should be implemented to avoid administration errors and viral contamination of personnel during blood product labeling. A system of checks similar to the ones used for administering blood transfusions should be routine.
General
Strict aseptic techniques should be used to maintain sterility throughout the procedures for using this product.
Do not use after the expiration time and date (5 days after calibration time) stated on the label.
The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times.
Indium In 111 oxyquinoline, like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management.
Radiopharmaceuticals should be used only by 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 radio-nuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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 [ten Berge, R.J.M., Natarajan, A.T., Hardeman, M.R., et al, Labeling with indium In 111 has detrimental effects on human lymphocytes, Journal of Nuclear Medicine, 24, 615-620 (1983)] 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 [Goodwin, David A., Cell labeling with oxine chelates of radioactive metal ions: Techniques and clinical implications, Journal of Nuclear Medicine, 19, 557-559 (1978)].
Studies have not been performed to evaluate whether indium In 111 oxyquinoline affects fertility in male or female laboratory animals or humans.
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 a 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.
Nursing Mothers
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.
Pediatric Use
Safety and effectiveness in pediatric patients below age 18 have not been established (SeeWARNINGS).
Geriatric Use
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.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of 8-Hydroxyquinoline in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of 8-Hydroxyquinoline in the drug label.
