Volumex

Iso-Tex Diagnostics, Inc.

Volumex

FULL PRESCRIBING INFORMATION

R_x Only

Volumex (Iodinated I 131 Albumin Injection) is a diagnostic radiopharmaceutical

containing iodinated I 131 albumin for intravenous use. Each mL of sterile,

nonpyrogenic, aqueous, colorless to very pale yellow solution provides approxi-

mately 10 mg protein (albumin human), 16 mg dibasic sodium phosphate, 1.6 mg

monobasic sodium phosphate, not more, than 0.4 mg guanidine hydrochloride,

sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. The

stabilizer acetyltryptophanate 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.

Volumex was prepared from blood that was nonreactive when tested for hepa-

titis B surface antigen (HB_sAg). The structure of the complex is unknown.

Iodine 131 decays by beta and gamma emissions with a physical half-life of 8.08 days.¹

Photons that are useful for detection and imaging studies are listed in Table 1.

EXTERNAL RADIATION

The specific gamma ray constant for iodine 131 is 2.2R/hour-millicurie at 1 cm.

The first half-value layer is 0.24 cm lead (Pb). A range of values for the relative

attenuation of the radiation emitted by this radionuclide that result from interpo-

sition of various thicknesses of Pb is shown in Table 2. To facilitate control of

the radiation exposure from this radionuclide, the use of a 2.55 cm thickness of Pb

will attenuate the radiation emitted by a factor of about 1,000.

Following intravenous injection, radioiodinated albumin human is uniformly dis-

tributed throughout the intravascular pool within 10 minutes; extravascular distri-

bution takes place more slowly. Iodinated I 131 albumin also can be detected in

the lymph and in certain body tissues within 10 minutes after injection, but maxi-

mum 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 extravas-

cular 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 iodinated I 131 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 iodinated I 131 albumin. With Volumex,

the biologic half-life in normal individuals has been reported to be approximately

14 days.

Volumex (Iodinated I 131 Allbumin injection) is indicated for use in determinations

of total blood and plasma volumes and in protein turnover studies

None known.

A few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported

with the use of iodinated I 131 albumin in cisternography. Iodi-

nated I 131 Albumin Injection is not approved for use in cisternography.

General

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.

   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 government

agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic po-

tential or whether iodinated I 131 albumin affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with Iodinated I 131

Albumin Injection. It is also not known whether this agent can cause fetal harm

when administered to a pregnant woman or can affect reproduction capacity.

Iodinated I 131 Albumin Injection should be administered to a pregnant woman

only if clearly needed.

   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.

Nursing Mothers

Since iodine 131 is excreted in human milk during lactation, formula feedings

should be substituted for breast feedings.

Pediatric use

Safety and effectiveness in children have not been established.

Although the immunological properties of albumin human are believed to be

virtually unaltered by the iodination process, there is a theoretical possibility that

allergic reactions may occur in patients receiving additional doses a number of

weeks after an initial dose.

Volumex (Iodinated I 131 Albumin Injection) is administered intravenously.

Parenteral drug products should be inspected visually for particulate matter and

abnormal coloration prior to administration whenever solution and container per-

mit.
    Volumex (Iodinated I 131 Albumin Injection) may be colorless to very pale

yellow. Solutions with excessive coloration should not be used.

    When a procedure such as a blood volume or a circulation time determination

is to be repeated, the total dosage administered in any one week should not

exceed 200 microcuries.

    To minimize 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 daily, beginning at least 24 hours before administra-

tion of Volumex and continuing for one or two weeks thereafter, is a suitable

dose.

   Complete assay data for each single unit dose 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 level. It is important to make

certain that the radioactivity in the dose at the time of administration is sufficient

for the intended use.

    The patient dose should be measured by a suitable radioactivity calibration

system immediately prior to administration.

   Note: A shielded syringe may be used for withdrawing and injecting the

iodinated I 131 albumin.

Total Blood and Plasma Volumes

Dosage may range from 5 to 50 microcuries.

Blood Volume Determination

A. Reference Solution

Reference solution is provided with each single unit dose of Volumex. Determine

the radioactivity concentration (net cpm/mL) of the reference solution. Care must

be taken to assure that the reference solution and the blood samples (Step B3)

are assayed using the same geometric configuration.

B. Administration of Dose

1. After withdrawing a background blood sample as described below, insert an

    intravenous (IV) line into a large vein in patient’s arm. Inject the entire

    Volumex dose (one milliliter) through the IV line for immediate delivery.

    Measure the residual radioactivity in the syringe and needle.

2. Destroy syringe after injecting. Do not attempt to resterilize. CAUTION: The

    syringe should be disposed of in accordance with the US Nuclear Regulatory

    Commission or Agreement State regulations pertaining to the disposal of ra-

    dioactive waste.

3. At 12, 18, 24, 30 and 36 minutes after injecting the dose, withdraw blood

    samples from the patient with a sterile syringe or evacuated

    sample tube containing anti-coagulant.

C. Calculation of Blood Volume

1. Take a known aliquot from each blood sample and determine radioconcentration

in net cpm/mL.

2. Plot the 12, 18, 24, 30 and 36 minute sample counts (net cpm/mL) on semilog-

    graph paper using the average count value of each sample and determine the

    radioconcentration at injection time (zero time) by drawing a straight line through

    the 12, 18, 24, 30 and 36 minute points to zero time. The x ordinate of the

    graph is the sample withdrawal time and the logarithmic y ordinate is

    radioconcentration in net cpm/mL.

3. Calculate patient’s blood volume (in mL) using the following formula:

Net cpm/mL reference solution                                  blood
Net cpm/mL patient’s blood sample         x    DF  =    volume
                                                                                 (in mL)

Sample Blood Volume Calculations

Volume of Blood sample aliquot                                           =  1.0 mL

Volume of Reference Solution aliquot                                   =  1.0 mL

Net counts at zero time                                                    =  48,100

Net counts obtained from reference solution aliquot               =  52, 430

If, for example, DF, dilution factor of the reference solution  =  4000

Using the above formula gives = 52,430   x 4000 = 4360 mL

                                                    48,100

Serial Blood Volume Determinations

Iodinated I 131 Albumin Injection is administered in sufficiently low dosage to permit

repetitions as often as required by clinical circumstances. It must be remembered

that it is always necessary to correct for background radioactivity remaining in the

blood from former determinations. Therefore, for each determination after the first

one, a background blood sample must be taken just before the iodinated I 131

albumin is injected.

Background Blood Sample

1. Withdraw background blood sample from large vein in patient’s sampling arm

    with a sterile syringe or evacuated sampling tube containing anti-coagulant.

2. Leaving needle in patient’s vein, detach syringe containing blood sample.

3. Attached syringe containing the dose of Volumex to the indwelling IV line

   and administer (see instructions under Blood Volume Determination,

   Administration of Dose).

4. Determine radioconcentration in net cpm/mL of aliquots taken from back-

   ground and postinjection blood samples, and from the reference solution.

  The radioconcentration (net cpm/mL) per aliquot of the background blood

  sample must be subtracted from the radioconcentration per aliquot of the blood

  sample obtained after the injection of iodinated I 131 albumin. The formula

  for calculating each blood volume determination after the first one thus becomes:

      Net cpm/mL reference solution blood                   x     DF     =    blood

 Net cpm/mL                           Net cpm/mL                                      volume

postinjection        minus          background                                     (in mL)

blood sample                          blood sample

Plasma Volume Determination

The procedure is essentially the same as that for blood volume determination,

except that the blood sample drawn from the patient is centrifuged, the red blood

cells are removed, and net cpm/mL of the plasma is determined. The formula for

calculation of plasma volume, therefore is:

Net cpm/mL reference solution          x DF       =           plasma

Net cpm/mL patient’s plasma sample                             volume

                                                                             (in mL)

Protein Turnover Studies

Dosages used have ranged from 10 to 150 microcuries. After injection, a period

of seven days should be allowed before determinations are made to permit the

elimination of any degraded protein in the dose.

Radiation Dosimetry

The estimated absorbed radiation doses to an average patient (70 kg) from an

intravenous injection of 50 microcuries of Iodinated I 131 Albumin Injection USP

are shown in Table 4.

For doses of 10, 25, 75, 150, 500 and 750 microcuries, the estimated absorbed

doses are 0.2, 0.5, 1.5, 3, 10 and 15 times the number of rads given, respectively.

Volumex (Iodinated I 131 Albumin Injection USP) is available in single unit dose

syringes containing 25 microcuries of activity in one milliliter per syringe on 

the date of calibration. Each single unit dose syringe is supplied with reference

solution. Complete assay data for each single unit dose syringe and reference

solution are provided on their respective containers.

       The maximum concentration of a single unit dose syringe of Volumex does not

exceed 26.3 microcuries per milliliter at time of calibration

Store in a refrigerator, 2-8°C (36-46°F)

This radiopharmaceutical is licensed by the Texas Department of Health, Bureau of Radiation Control for distribution to persons licensed 

pursuant to 41.26 (b) and Appendix 41-C, Group I and Group II, "Texas Regulations for Control of Radiation," or under equivalent licenses of the

U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State.

Manufactured for Daxor Corporation
350 Fifth Avenue, Suite 7120 · New York, NY 10118 · 212-244-0804
by Iso-Tex Diagnostics, Inc., Friendswood, Texas 77546