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All about: Phosphocol P 32

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Generic Name: Chromic Phosphate P-32
Dosage Form: Suspension

Rx Only.

Therapeutic – For Interstitial or Intracavitary Use Only

Phosphocol P 32 Description

Phosphocol® P 32 is supplied as a sterile, nonpyrogenic aqueous suspension in a 30% dextrose solution with 2% benzyl alcohol added as preservative. Each milliliter contains 1 mg sodium acetate. Sodium hydroxide or hydrochloric acid may be present for pH adjustment.

ACTIONS

Local irradiation by beta emission.

INDICATIONS

Phosphocol P 32 is employed by intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease, and may be injected interstitially for the treatment of cancer.

Contraindications

Chromic phosphate P 32 therapy should not be used in the presence of ulcerative tumors.

Administration should not be made in exposed cavities or where there is evidence of loculation unless the extent of loculation is determined.

Warnings

Not for intravascular use.

This radiopharmaceutical should not be administered to patients who are pregnant or during lactation unless the therapeutic benefits outweigh the potential hazards.

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

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.

Careful intracavitary instillation is required to avoid placing the dose of chromic phosphate P 32 into intrapleural or intraperitoneal loculations, bowel lumen or into the body wall. Intestinal fibrosis or necrosis and chronic fibrosis of the body wall have been reported to result from unrecognized misplacement of the therapeutic agent.

The presence of large tumor masses indicates the need for other forms of treatment. However, when other forms of treatment fail to control the effusion, chromic phosphate P 32 may be useful. In bloody effusion, treatment may be less effective.

Pediatric Use

Safety and effectiveness in pediatric patients has not been established.

Adverse Reactions

Untoward effects may be associated with use of chromic phosphate P 32. These include transitory radiation sickness, bone marrow depression, pleuritis, peritonitis, nausea and abdominal cramping. Radiation damage may occur if accidentally injected interstitially or into a loculation.

Phosphocol P 32 Dosage and Administration

The suggested dose range employed in the average patient (70 kg) is:

 
Intraperitoneal instillation: 370 to 740 megabecquerels (10 to 20 millicuries)
 
Intrapleural instillation: 222 to 444 megabecquerels (6 to 12 millicuries)

Doses for interstitial use should be based on estimated gram weight of tumor, about 3.7 to 18.5 MBq/gm (0.1 to 0.5 mCi/gm).

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

PHYSICAL CHARACTERISTICS

Phosphorus P 32 decays by beta emission with a physical half-life of 14.3 days1. The mean energy of the beta particle is 695 keV.

Table 1. Principal Radiation Emission Data
Radiation Mean Percent/ Disintegration Mean Energy (keV)
Beta-1 100.0 694.9

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 percentages that remain 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
Days Fraction
Remaining
Days Fraction
Remaining
Days Fraction
Remaining

*Calibration Day

-15
-10
-5
-2
-1
0*
1
2.07
1.62
1.28
1.10
1.05
1.00
0.953
2
5
10
15
20
25
30
0.908
0.785
0.616
0.483
0.379
0.297
0.233
35
40
45
50
55
60
65
0.183
0.144
0.113
0.089
0.070
0.055
0.043
1
Kocher, David C., "Radioactive Decay Data Tables," DOE/TIC 11026, page 70 (1981).

RADIATION DOSIMETRY

The effective half-life of phosphorus P 32 is considered to be equal to its physical half-life, with a residence time of 495 hours.

The radiation dose from a uniformly distributed concentration of 37 kilobecquerels (1 microcurie) per gram within a 16-gram prostate is estimated to be equivalent to about 7.3 grays (730 rads). Table 3 shows the estimated radiation doses to the prostate and the pleural or peritoneal surfaces of an average patient (70 kg) from a dose of 740 megabecquerels (20 millicuries) of phosphorus P 32.

In comparison to the distribution in the prostate, the distribution of phosphorus P 32 on the pleural and peritoneal surfaces is non-uniform, with great extremes in local doses. To obtain an estimate of the average dose, the surface area of the pleural and peritoneal cavities can be assumed to amount to 4,000 and 5,000 cm2, respectively. The estimated2 radiation doses to an average patient (70 kg) with 90% retention of a dose of 740 megabecquerels (20 millicuries) of phosphorus P 32 distributed uniformly over these areas are shown in Table 3. The decreases of the averaged radiation doses at various tissue depths away from the surfaces of the pleural and peritoneal cavities are also tabulated.

Table 3. Estimated Radiation Doses
Surface/Organ Pleural Peritoneal Prostate
% Retention
Area/wt
90
4000 cm2
90
5000 cm2
100
16 gm
Depth in tissue (cm) Dose rate*
rads/hr    (mGy/hr)
Tissue Dose / 740 MBq (20mCi)
rads    grays Rads    grays Rads    grays

*For surface deposition of 37 kBq(1 μCi)/ cm2

0.004
0.008
0.012
0.016
0.020
0.10  
0.20  
10.2    102    
8.58    85.8
7.61    76.1
6.91    69.1
6.36    63.6
2.41    24.1
0.94    9.4 
23000    230
19000    190
17000    170
15000    150
14000    140
  5400     54
  2100     21
18000    180
15000    150
14000    140
12000    120
11000    110
  4300     43
  1700     17
910000    9100
2
Estimated radiation doses shown in Table 3 are based on compilations by Cross, William G., Table of Beta Dose Distribution, Report AECL 2793 Chalk River, Ontario, November 1967.

How is Phosphocol P 32 Supplied

Catalog Number 470

Phosphocol P 32 - Chromic Phosphate P 32 Suspension (NDC No. 0019-N470-P0) is available in 10 milliliter vials containing 555 megabecquerels (15 millicuries) with a concentration of 185 megabecquerels (5 millicuries) per milliter. The radiopharmaceutical is manufactured with a specific activity of 122 megabecquerels (3.3 millicuries) per milligram Chromic Phosphate at the time of standardization.

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.

STORAGE AND HANDLING

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

Mallinckrodt Inc.
St. Louis, MO 63134

MALLINCKRODT
A470I0


Phosphocol P 32 (Chromic Phosphate, P-32)
PRODUCT INFO
Product Code 0019-N470 Dosage Form INJECTION, SUSPENSION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Chromic Phosphate, P-32 (Chromic Phosphate, P-32) Active 15 MILLICURIE  In 10 MILLILITER
anhydrous dextrose Inactive  
benzyl alcohol Inactive  
sodium acetate Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0019-N470-PO 10 MILLILITER In 1 VIAL None

Revised: 05/2006

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