Jeanatope

ADVERSE REACTIONS Although the immunological properties of serum albumin are believed to be virtually unaltered by the iodinated process, there is a theoretical possibility that allergic reactions may occur in patients receiving additional doses a number of weeks after an initial dose.

CONTRAINDICATIONS At present there are no known contraindications to the use of this preparation.

DESCRIPTION Jeanatope 1-125 (Iodinated 1-125 Albumin Injection) is a sterile, nonpyrogenic, aqueous solution for intravenous use. Each milliliter provides approximately 10 mg protein (normal human serum albumin), 1.6 mg sodium phosphate, 16 mg sodium biphosphate, not more than 0.4 mg guanidine hydrochloride, sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. The stabilizer aceryltryptophanate and sodium caprylate have a concentration of less than 0.0089M. The pH has been adjusted to 7.2-7.8 with sodium hydroxide or hydrochloric acid. Jeanotope I-125 was prepared from the blood that was non-reactive when tested for hepatitis B surface antigen (HBsAg) and HIV antibody.

DOSAGE AND ADMINISTRATION Radioiodinated serum albumin is administered intravenously. When a procedure such as a blood volume determination is to be repeated, the total dosage administered in any one week should not exceed 7.4 megabecquerels (200 microcuries). To minimise the uptake of radioactive iodine by the thyroid, prior administration of Lugol's Solution (Strong Iodine Solution USP) may be used. Ten drops of Lugol's Solution three times a daily, beginning at least 24 hours before administration of Iodinated Serum Albumin I-125 and continuing for one or two weeks thereafter, is a suitable dose. Complete assay data for each vial are provided on the container. Note: The expiration date given on the container pertains to the biologic properties of the material and not to the radioactivity label, it is important to make certain that the radioactivity in the dose at the time of administration is sufficient for the intended use.

INDICATIONS AND USAGE Jeanotope I-125 is indicated for use in the determination of total blood and plasma volume.

WARNINGS Radiopharmaceuticals should not be administered to patients who are pregnant or to nursing mothers unless the expected benefit to be gained outweighs the potential hazards. Since I-125 is excreted in human milk during lactation, formula-feedings should be substituted for breast-feedings. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses. A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported with the use of this product in cisternography. This material is not approved for use in cisternography.

CLINICAL PHARMACOLOGY Following intravenous injection, radioiodinated serum albumin is uniformly distributed throughout the intravascular pool within 10 minutes; extravascular distribution takes place more slowly. Labeled albumin also can be detected in the lymph and in certain body tissues within 10 minutes after injection, but maximum distribution of radioactivity throughout the extravascular space does not occur until two to four days after administration. The time at which extravascular activity is maximal has been designated as the "equilibrium time." When this point has been reached, the radioactivity remaining in the intravascular and extravascular spaces decreases slowly and exponentially in parallel fashion. The administered radioactivity is eliminated almost entirely in the urine, only about 2 percent of the total dose ultimately appearing in the feces. The biologic half-life of labeled albumin is dependent upon a number of factors, and published studies have varied considerably in their reporting of this figure. It has ranged, in the literature, from below 10 days to over 20 days. One important factor affecting the biologic half-life is the initial rate of excretion, and this depends in part on the quality of the labeled albumin. With Jeanatope 1-125 the biologic half-life in normal individuals has been reported to be approximately 14 days.

20200630

3

Jeanatope Iodinated I-125 Albumin HUMAN SERUM ALBUMIN I-125 HUMAN SERUM ALBUMIN I-125 ALBUMIN HUMAN BENZYL ALCOHOL

BLA017836

Jeanatope

Iodinated I-125 Albumin

50914-7732

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

Packaging image description

R x Only

HOW SUPPLIED Jeanotope (Iodinated I-125 Albumin Injection USP) is available in multiple dose vials containing the following amounts of activity on the date of calibration: 3.7 megabequerels /10.0 ml (100 microcuries/10.0 ml), 18.5 megabequerels/0.5 ml (500 microcuries/0.5 ml) and 37.0 megabequerels/1.0 ml (1.0 millicuries/1.0 ml). Complete assay data for each vial is provided on the container. The maximum concentration of Iodinated I-125 Injection does not exceed one millicurie per milliliter at time of calibration.

PRECAUTIONS In the use of any radioactive material, care should be taken to insure minimum radiation exposure to the patient and occupational workers consistent with proper patient management.