SODIUM PHOSPHATE P-32 - sodium phosphate p-32 solution 
Mallinckrodt Inc.

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Rx Only.

DESCRIPTION

Sterile, non-pyrogenic Sodium Phosphate P 32 is available for therapeutic application as an intravenous solution dosage form with a concentration of 24.8 megabecquerels (0.67 millicurie) per milliliter. The intravenous solution contains 1.6 milligrams per milliliter of sodium acetate as a buffer, 0.9% sodium chloride for isotonicity and may contain sodium hydroxide or hydrochloric acid for pH adjustment. The pH of the solution is between 5.0 and 6.0.

PHYSICAL CHARACTERISTICS

Phosphorus P 32 decays by beta emission with a physical half-life of 14.3 days.1 The mean energy of the phosphorus P 32 beta particle is 694.9 keV.

Table 1. Principal Radiation Emission Data

Radiation	Mean Percent Per Disintegration	Mean Energy (keV)
Beta-1	100.0	694.9

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1

Kocher, David C., “Radioactive Decay Data Tables,” DOE/TIC 11026, page 70 (1981).

EXTERNAL RADIATION

The range of the phosphorus P 32 beta particle, which has a maximum energy of 1.71 MeV, is 2.8 mm of aluminum.

To correct for physical decay of this radionuclide, the fractions remaining at selected time intervals before and after the day of calibration are shown in Table 2.

Table 2. Physical Decay Chart; Phosphorus P 32, Half-Life 14.3 days

*Calibration Day
Days	Fraction Remaining		Days	Fraction Remaining
0*	1.000		30	0.233
1	0.953		35	0.183
2	0.908		40	0.144
5	0.785		45	0.113
10	0.616		50	0.089
15	0.483		55	0.070
20	0.379		60	0.055
25	0.297

CLINICAL PHARMACOLOGY

Phosphorus is necessary to metabolic and proliferative activity of cells. Radioactive phosphorus concentrates to a very high degree in rapidly proliferating tissue.

INDICATIONS AND USAGE

The principal use of Sodium Phosphate P 32 is for the treatment of polycythemia vera, and it is effective for the treatment of chronic myelocytic leukemia and chronic lymphocytic leukemia. Sodium Phosphate P 32 is also used in palliative treatment of selected patients with multiple areas of skeletal metastases.

CONTRAINDICATIONS

Sodium Phosphate P 32 should not be used as a part of sequential treatment with a chemotherapeutic agent.

In polycythemia vera, Sodium Phosphate P 32 should not be administered when the leukocyte count is below 5,000/cu mm, or a platelet count is below 150,000/cu mm.

In chronic myelocytic leukemia, Sodium Phosphate P 32 should not be administered when the leukocyte count is below 20,000/cu mm.

For treatment of bone metastases it is usually not administered when the leukocyte count is below 5,000/cu mm, and platelet count is below 100,000/cu mm.

WARNINGS

This radiopharmaceutical should administered for intracavitary use.

Overdose of Sodium Phosphate P 32 may produce serious effects on the hemopoietic system. The blood and bone marrow should be carefully monitored at regular intervals.

Sodium Phosphate P 32 ordinarily does not localize in retinoblastomas.

PRECAUTIONS.

General

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

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 potential, mutagenic potential, or whether Sodium Phosphate P 32 affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Phosphate P 32. It is also not known whether Sodium Phosphate P 32 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium Phosphate P 32 should be given 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

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken when a patient is being given Sodium Phosphate P 32.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

None known.

DOSAGE AND ADMINISTRATION

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Oral administration of high-specific-activity Sodium Phosphate P 32 in the fasting state may equal intravenous administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Waterproof gloves should be used during the entire handling and administration procedure.

Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the drug.

For polycythemia vera, intravenous dosages from 37 to 296 megabecquerels (1 to 8 millicuries) are given depending upon the stage of disease and size of the patient. Repeat doses must be adjusted to individual needs.

For chronic leukemia, the individual dose is 222 to 555 megabecquerels (6 to 15 millicuries), usually administered with concomitant hormone manipulation.

RADIATION DOSIMETRY

The estimated absorbed radiation doses2 to an average patient (70 kg) following intravenous administration of 555 megabequerels (15 millicuries) of Sodium Phosphate P 32 are shown in Table 3.

Table 3. Absorbed Radiation Doses

	Absorbed radiation doses for 555 megabecquerels (15 millicuries)
Tissue	grays	rads
Skeleton	9.45	945
Liver	0.93	93
Spleen	1.10	110
Brain	0.45	45
Testes	0.15	15
Ovaries	0.12	12
Total Body	1.50	150

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2

Method of Calculation: “S”, Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet #11 (1975).

HOW SUPPLIED

Catalog Number 461

Sodium Phosphate P 32 is supplied as a sterile, non-pyrogenic solution in single dose vials containing 185 megabequerels (5 millicuries) of phosphorus P 32. Each milliliter contains 24.8 megabecquerels (0.67 millicuries) sodium phosphate P 32 at the time of calibration, 1.6 milligrams sodium acetate and 9 milligrams sodium chloride. The solution may contain sodium hydroxide or hydrochloric acid for pH adjustment.

STORAGE AND HANDLING

Store at controlled room temperature 20-25°C (68-77°F).

Storage and disposal of Sodium Phosphate P 32 Solution should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Section 35.300, and to persons who hold an equivalent license issued by an Agreement State.

Revised 11/2000
Mallinckrodt Inc.
St. Louis, MO 63134

A461I0

PRINCIPAL DISPLAY PANEL - A461VO

Sodium Phosphate P32 Solution

THERAPEUTIC
Sterile, Non-Pyrogenic Solution
For Intravenous or Oral Administration
Not for Intracavitary Use.
Store at controlled room temperature 20-25°C (68-77°F).
CAUTION
RADIOACTIVE MATERIAL
Each milliliter contains 24.8 MBq (0.67 mCi)
Sodium Phosphate P32 and 1.6 mg of sodium
acetate as a buffer. Made isotonic with 0.9%
sodium chloride. Sodium hydroxide or hydro-
chloric acid may be present for pH adjustment.
The pH is between 5.0 and 6.0.
Rx Only.
In Canada:
Mallinckrodt Canada Inc.
Pointe-Claire, Qc
Est. Lic. No. 100107-A

Mallinckrodt Inc.
St. Louis, MO 63134 USA

MALLINCKRODT

A461VO
R11/2000

SODIUM PHOSPHATE P-32  sodium phosphate p-32   solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0019-N461 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE P-32 (PHOSPHORUS P-32) SODIUM PHOSPHATE P-32 0.67 mCi  in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM ACETATE   SODIUM CHLORIDE   SODIUM HYDROXIDE   HYDROCHLORIC ACID

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0019-N461-F0 1 VIAL In 1 CAN contains a VIAL 1 7.5 mL In 1 VIAL This package is contained within the CAN (0019-N461-F0)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA011777	04/04/2001	09/16/2007

Labeler - Mallinckrodt Inc. (047021092)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Inc.		557570652	manufacture, analysis

Revised: 01/2011Mallinckrodt Inc.