Indium DTPA In 111 (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Pentetate lndium Disodium In 111 affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111. Also, it is not known whether Pentetate Indium Disodium In 111 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentetate Indium Disodium In 111 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. Because many drugs are excreted in human milk, formula feedings should be substituted for breast feedings when Pentetate Indium Disodium In 111 is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

Clinical studies of Indium DTPA In 111 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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.

The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions to Indium DTPA In 111

Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111.

One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported. There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.

DOSAGE AND ADMINISTRATION

Extreme care must be exercised to assure aseptic conditions in intrathecal injections.

The maximum recommended intrathecal dose in the average patient (70 kg) is 18.5 MBq, 500 µ Ci. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

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

RADIATION DOSIMETRY

The estimated absorbed radiation doses * to selected organs of an average (70 kg) patient from intrathecal administration of a maximum dose of 18.5 MBq, 500 µ Ci of Pentetate Indium Disodium In 111 are shown in Table 4.

Table 4. Absorbed Radiation Dose *
Organ mGy/18.5 MBq rads/500 µ Ci
*
Method of Calculation: “S” Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11, 1975.
Total Body 0.41 0.041
Kidneys 2.2 0.22
Spinal Cord
Surface 50.0 5.0
Average 15.0 1.5
Brain
Surface 41.0 4.1
Average 4.0 0.4
Bladder
2-hour void 2.1 0.21
4.8-hour void 5.0 0.5
Testes
2-hour void 0.4 0.04
4.8-hour void 0.5 0.05
Ovaries
2-hour void 0.6 0.06
4.8-hour void 0.6 0.06

HOW SUPPLIED

Pentetate Indium Disodium In 111 (no-carrier-added) is supplied in single-dose glass vials, each containing 1.5 mL of solution with a concentration of 37 MBq, 1 mCi per mL and a total activity of 55.5 MBq, 1.5 mCi per vial at calibration time. Vials are packaged in individual lead shields with plastic outer containers.

NDC 17156-251-08

Storage

Store vial in its lead shield at a temperature of 5°-30°C (41°-86°F). Do not freeze.

Disposal

The residual materials may be discarded in ordinary trash provided the vials and syringes read no greater than background with an appropriate low-range survey meter. All identifying labels should be destroyed before discarding.

This radiopharmaceutical is licensed by Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 III. Adm. Code 330.260(a) and Part 335, Subpart E, 335.4010, or under equivalent licenses of an Agreement State or a Licensing State.

Product Number: 2051

GE Healthcare
Medi-Physics, Inc.
3350 North Ridge Avenue
Arlington Heights, IL 60004

GE and the GE Monogram are trademarks of General Electric Company.

43-2051G

Revised February 2020

PRINCIPAL DISPLAY PANEL — 1.5 mL Vial Label

GE Healthcare

Indium DTPA In 111
Pentetate Indium Disodium In 111

Sterile, Nonpyrogenic, Aqueous
Solution for Intrathecal Injection

DISCARD AFTER SINGLE USE.

DO NOT USE IF CONTENTS ARE TURBID.

VOLUME: 1.5 mL

SPECIFIC
CONCENTRATION:
37 MBq/mL
(1 mCi/mL)

TOTAL
ACTIVITY:
55.5 MBq
(1.5 mCi)

CALIB.
DATE:

TIME: 1200

LOT
NO.:
2051 –

Principal Display Panel -- 1.5 mL Vial Label
(click image for full-size original)
INDIUM DTPA IN 111
indium in-111 pentetate disodium solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17156-251
Route of Administration INTRATHECAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Indium In-111 Pentetate Disodium (Indium Cation In-111) Indium Cation In-111 1 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
Pentetic Acid
Sodium Bicarbonate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17156-251-08 1.5 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017707 02/18/1982
Labeler — Medi-Physics, Inc. dba GE Healthcare (095263729)
Establishment
Name Address ID/FEI Operations
Medi-Physics, Inc. dba GE Healthcare 095263729 MANUFACTURE (17156-251), ANALYSIS (17156-251), API MANUFACTURE (17156-251)

Revised: 01/2024 Medi-Physics, Inc. dba GE Healthcare

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