GA-68-DOTATOC- edotreotide gallium ga-68 injection, solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
EDOTREOTIDE GALLIUM GA-68 (UNII: Y68179SY2L) (EDOTREOTIDE GALLIUM GA-68 - UNII:Y68179SY2L)
Available from:
UIHC – P E T Imaging Center
Administration route:
INTRAVENOUS
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. None Risk Summary There are no available data on the use of Ga 68 DOTATOC Injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Ga 68 DOTATOC. However, all radiopharmaceuticals, including Ga 68 DOTATOC Injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Ga 68 DOTATOC Injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from Ga 68 DOTATOC Injection and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnanc
Product summary:
Ga 68 DOTATOC Injection is supplied in a multiple-dose, capped 30 mL glass vial containing 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC at calibration time in approximately 14 mL of solution (NDC 24417-681-30). Store Ga 68 DOTATOC Injection upright in a lead shielded container at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Receipt, transfer, handling, possession or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate. Store and dispose of Ga 68 DOTATOC Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.
Authorization status:
New Drug Application
Authorization number:
24417-681-30

GA-68-DOTATOC- edotreotide gallium ga-68 injection, solution

UIHC – P E T Imaging Center

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Ga 68 DOTATOC INJECTION safely and

effectively. See full prescribing information for Ga 68 DOTATOC INJECTION.

Ga 68 DOTATOC Injection, for intravenous use

Initial U.S. Approval: 2019

INDICATIONS AND USAGE

Ga 68 DOTATOC Injection is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for

localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. (1)

DOSAGE AND ADMINISTRATION

Recommended dose for adults is 148 MBq (4 mCi) as a bolus intravenous injection (2.2)

Recommended dose for pediatric patients is 1.59 MBq/kg (0.043 mCi/kg) with a range of 11.1 MBq (0.3 mCi) to 111

MBq (3 mCi), as a bolus intravenous injection (2.2)

Initiate imaging 55 to 90 minutes after drug administration (2.4)

See full prescribing information for additional preparation, administration, imaging and radiation dosimetry information

DOSAGE FORMS AND STRENGTHS

Injection: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC Injection in a multiple-dose glass

vial (3)

CONTRAINDICATIONS

None (4)

WARNINGS AND PRECAUTIONS

Radiation Risk: Ensure safe handling and preparation procedures to protect patients and health care workers from

unintentional radiation exposure Advise patients to hydrate before and after administration and to void frequently after

administration (2.1, 2.3, 5.1)

Risk for Image Misinterpretation: Uptake of Ga 68 DOTATOC injection can be seen in a variety of tumor types that

contain somatostatin receptors, and in other pathologic conditions, and as a normal physiologic variant (e.g. uncinate

process of the pancreas) (5.2)

ADVERSE REACTIONS

Reported adverse reactions include: Nausea, pruritis, and flushing.

To report SUSPECTED ADVERSE REACTIONS, contact the UIHC – P E T Imaging Center at 1-319-356-1092 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch (6)

DRUG INTERACTIONS

Somatostatin Analogs: Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 DOTATOC

Injection and may affect imaging –Discontinue short-acting somatostatin analogs 24 hours before imaging with Ga 68

DOTATOC and image just prior to dosing with long-acting somatostatin analogs (2.3, 7)

USE IN SPECIFIC POPULATIONS

Lactation: Breast milk should be pumped and discarded for 8 hours after administration (8.2)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Radiation Safety – Drug Handling

2.2 Recommended Dosage and Administration Instructions

2.3 Use with Somatostatin Analogs and Patient Hydration

2.4 Image Acquisition

2.5 Image Interpretation

2.6 Radiation Dosimetry

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Radiation Risk

5.2 Risk for Image Misinterpretation

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

11.1 Chemical Characteristics

11.2 Physical Characteristics

11.3 External Radiation

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Ga 68 DOTATOC Injection is indicated for use with positron emission tomography (PET) for the

localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric

patients.

2 DOSAGE AND ADMINISTRATION

2.1 Radiation Safety – Drug Handling

Handle Ga 68 DOTATOC Injection with appropriate safety measures to minimize radiation exposure

[see Warnings and Precautions (5.1)]. Use waterproof gloves, effective radiation shielding and

appropriate safety measures when preparing and handling Ga 68 DOTATOC Injection.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by

specific training and experience in the safe use and handling of radionuclides, and whose experience

and training have been approved by the appropriate governmental agency authorized to license the use

of radionuclides.

2.2 Recommended Dosage and Administration Instructions

Sections or subsections omitted from the full prescribing information are not listed.

Recommended Dosage

In adults, the recommended amount of radioactivity to be administered for PET imaging is 4 mCi (148

MBq) with a range of 3 mCi to 5 mCi (111 MBq to 185 MBq) administered as an intravenous injection

with an injection rate of approximately 10 seconds per mL.

In pediatric patients, the recommended amount of radioactivity to be administered for PET imaging is

0.043 mCi/kg of body weight (1.59 MBq/kg) with a range of 0.3 mCi (11.1 MBq) to 3 mCi (111 MBq) as

an intravenous injection with an injection rate of approximately 10 seconds per mL.

Administration

Use Ga 68 DOTATOC Injection within 3 hours of calibration time.

Use aseptic technique and radiation shielding when withdrawing and administering Ga 68

DOTATOC Injection.

Inspect Ga 68 DOTATOC Injection visually for particulate matter and discoloration before

administration. Do not use the drug if the solution contains particulate matter or is discolored.

Calculate the necessary volume to administer based on measured activity, volume, calibration time,

and date.

Measure the patient dose immediately prior to administration in a dose calibrator.

After injection of Ga 68 DOTATOC Injection, administer an intravenous flush of sodium chloride

injection, 0.9% to ensure full delivery of the dose.

Dispose of any unused drug in a safe manner in compliance with applicable regulations.

2.3 Use with Somatostatin Analogs and Patient Hydration

Somatostatin Analogs

Somatostatin analogs bind to the same somatostatin receptors as Ga 68 DOTATOC

Discontinue short-acting somatostatin analogs 24 hours before imaging with Ga 68 DOTATOC

Injection.

Image patients with Ga 68 DOTATOC Injection just prior to dosing with long-acting analogs of

somatostatin [see Drug Interactions (7)].

Patient Hydration

Instruct patients to drink water to ensure adequate hydration prior to administration of Ga 68 DOTATOC

Injection and to continue to drink and void frequently during the first hours following administration to

reduce radiation exposure [see Warnings and Precautions (5.1)].

2.4 Image Acquisition

For Ga 68 DOTATOC PET imaging, a whole-body acquisition from the skull vertex to mid-thigh is

recommended. Image acquisition can begin at 60 minutes (range 55 to 90 minutes) after the intravenous

administration of the Ga 68 DOTATOC Injection. Adapt Ga 68 DOTATOC Injection uptake time and

scan duration according to the equipment used, and the patient and tumor characteristics, to obtain the

optimal image quality.

2.5 Image Interpretation

Ga 68 DOTATOC binds to somatostatin receptors. Based upon the intensity of the signals, PET images

obtained using Ga 68 DOTATOC Injection indicate the presence and density of somatostatin receptors

in tissues, .Uptake can also be seen in a variety of non-NET tumors that contain somatostatin receptors

or as a normal physiologic variant [see Warnings and Precautions (5.2)]. NET tumors that do not bear

somatostatin receptors will not be visualized.

2.6 Radiation Dosimetry

Estimated radiation absorbed doses per injected activity for organs and tissues of adult patients

following an intravenous bolus of Ga 68 DOTATOC Injection are shown in Table 1. Estimated

radiation effective doses per injected activity for adult and pediatric patients following an intravenous

bolus administration of Ga 68 DOTATOC Injection are shown in Table 2.

Table 1: Estimated Radiation Absorbed Dose per Injected Activity in

Selected Organs with Ga 68 DOTATOC

Site

Absorbed Dose (mGy/MBq)

Urinary bladder wall

0.119 ± 0.058

Spleen

0.108 ± 0.065

Kidney

0.082 ± 0.020

Adrenal gland

0.077 ± 0.028

Liver

0.041 ± 0.014

Red marrow

0.016 ± 0.003

Gallbladder wall

0.015 ± 0.001

Total body

0.014 ± 0.002

Lungs

0.007 ± 0.001

Effective dose (mSv/MBq)

0.021 ± 0.003

The effective radiation dose resulting from the administration of 148 MBq (4 mCi) to an adult weighing

75 kg, is about 3.11 mSv. For an administered activity of 148 MBq (4 mCi) the typical radiation dose to

the critical organs, which are the urinary bladder wall, the spleen and the kidneys/adrenals, are about 18

mSv, 16 mSv and 12 mSv, respectively. Because the spleen has one of the highest physiological

uptakes, higher uptake and radiation dose to other organs or pathologic tissues may occur in patients

with splenectomy.

Table 2: Estimated Radiation Effective Dose per Injected Activity after a

Ga-68 DOTATOC Injection

Age

Model Weight (kg)

Effective Dose per Injection Activity

(mSv/MBq)

Adult

73.7

0.019

15 years

56.8

0.026

10 years

33.2

0.041

5 years

19.8

0.066

1 year

0.13

Newborn

0.36

3 DOSAGE FORMS AND STRENGTHS

Injection: Gallium Ga 68 DOTATOC Injection is a clear, colorless solution in a 30 mL multiple-dose

vial containing 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC Injection

at calibration date and time.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Radiation Risk

Ga 68 DOTATOC Injection contributes to a patient's overall long-term cumulative radiation exposure.

Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe

handling and preparation procedures to protect patients and health care workers from unintentional

radiation exposure. Advise patients to hydrate before and after administration and to void frequently

after administration [see Dosage and Administration (2.1, 2.3)].

5.2 Risk for Image Misinterpretation

The uptake of Ga 68 DOTATOC Injection reflects the level of somatostatin receptor density in NETs,

however, uptake can also be seen in a variety of other tumors that also express somatostatin receptors.

Increased uptake might also be seen in other non-cancerous pathologic conditions that express

somatostatin receptors including thyroid disease or in subacute inflammation, or might occur as a normal

physiologic variant (e.g. uncinate process of the pancreas) [see Dosage and Administration (2.5)].

A negative scan after the administration of Ga 68 DOTATOC Injection in patients who do not have a

history of NET disease does not rule out disease [see Clinical Studies (14)].

6 ADVERSE REACTIONS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in practice.

The safety of Ga-68 DOTATOC injection was evaluated in 334 patients in clinical trials of patients

receiving a single dose of Ga-68 DOTATOC injection for imaging known or suspected NET.

The following adverse reactions occurred at a rate of < 2%:

Gastrointestinal Disorders: nausea

The following adverse reactions occurred at a rate of a < 1%

Skin and Subcutaneous Tissue Disorders: pruritus

Vascular Disorders: flushing

7 DRUG INTERACTIONS

Non-radioactive somatostatin analogs bind to the same somatostatin receptors as Ga 68 DOTATOC

Injection. Image patients with Ga 68 DOTATOC Injection just prior to dosing with long-acting analogs

of somatostatin. Short-acting analogs of somatostatin can be used up to 24 hours before imaging with

Ga 68 DOTATOC Injection [see Dosage and Administration (2.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available data on the use of Ga 68 DOTATOC Injection in pregnant women to identify a

risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction

studies have not been conducted with Ga 68 DOTATOC. However, all radiopharmaceuticals, including

Ga 68 DOTATOC Injection have the potential to cause fetal harm depending on the fetal stage of

development and the magnitude of the radiation dose. If considering Ga 68 DOTATOC Injection

administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes

based on the radiation dose from Ga 68 DOTATOC Injection and the gestational timing of exposure.

The estimated background risk of major birth defects and miscarriage for the indicated population is

unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In

the U.S general population, the estimated background risks of major birth defects and miscarriage in

clinically recognized pregnancies are 2-4% and 15-20%, respectively.

8.2 Lactation

Risk Summary

There is no information on the presence of Ga 68 DOTATOC in human milk, the effect on the breastfed

infant, or the effect on milk production. The developmental and health benefits of breastfeeding should

be considered along with the mother's clinical need for Ga 68 DOTATOC Injection and any potential

adverse effects on the breastfed child from Ga 68 DOTATOC Injection or from the underlying maternal

condition.

Clinical Considerations

To decrease exposure to the breastfed infant, advise a lactating woman to interrupt breastfeeding and

pump and discard breast milk for 8 hours after Ga 68 DOTATOC Injection administration.

8.4 Pediatric Use

The safety and efficacy of Ga 68 DOTATOC Injection have been established in pediatric patients with

neuroendocrine tumors. Efficacy is based on data from 14 patients in Study A and B demonstrating the

ability of Ga 68 DOTATOC to image NETs [see Clinical Studies (14)]. The safety profile of Ga 68

DOTATOC Injection is similar in adult and pediatric patients with somatostatin receptor positive

tumors. The recommended Ga 68 DOTATOC injected dose in pediatric patients is weight based [see

Dosage and Administration (2.2)].

8.5 Geriatric Use

Clinical studies of Ga 68 DOTATOC 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.

10 OVERDOSAGE

In the event of a radiation overdose, reduce the absorbed dose to the patient by increasing the

elimination of the radionuclide from the body by reinforced hydration, frequent bladder voiding, and

diuretics, if needed. If possible, perform an estimate of the radioactive dose given to the patient.

11 DESCRIPTION

11.1 Chemical Characteristics

Ga 68 DOTATOC Injection is a radioactive diagnostic agent for intravenous administration. It contains

3.6 mcg/mL (DOTA-0-Phe1-Tyr3) octreotide, 18.5 MBq/mL to 148 MBq/mL (0.5 mCi to 4 mCi/mL) of

Ga 68 DOTATOC at calibration time, and ethanol (10% v/v) in sodium chloride (9 mg/mL) solution

(approximately 14 mL volume). Ga 68 DOTATOC Injection is a sterile, pyrogen free, clear, colorless,

buffered solution, with a pH between 4 to 8.

Ga 68 DOTATOC, also known as Gallium-68 (DOTA0-Phe1-Tyr3) octreotide, is a cyclic 8 amino

acid peptide with a covalently bound chelator (DOTA). The peptide has the amino acid sequence: H-D-

Phe-Cys-Tyr-D-Trp-Lys-Thr-Cys-Thr-OH, and contains one disulfide bond. Ga 68 DOTATOC has a

molecular weight of 1489.65 g/mol and its chemical structure is shown in Figure 1.

Figure 1: Chemical Structure of Ga 68 DOTATOC

Gallium-68 labeled 2-[4-[2-[[(2R)-1-[[(4R,7S,10S,13R,16S,19R)-10-(4-aminobutyl)-4-[[(2R,3R)-1,3-

dihydroxybutan-2-yl]carbamoyl]-7-[(1R)-1-hydroxyethyl]-16-[(4-hydroxyphenyl)methyl]-13-(1H-indol-

3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicos-19-yl]amino]-1-oxo-3-

phenylpropan-2-yl]amino]-2-oxoethyl]-7,10-bis(carboxymethyl)-1,4,7,10-tetrazacyclododec-1-yl]acetic

acid.

11.2 Physical Characteristics

Table 3 and Table 4 display the principal radiation emission data and physical decay of Ga 68.

Gallium-68 (Ga 68) decays with a half-life of 68 minutes to stable Zn 68:

89% through positron emission with a mean energy of 836 keV followed by emission of two 511

keV annihilation photons (178%),

10% through orbital electron capture (with associated X-ray or Auger emissions), and

3% through 13 gamma transitions from 5 excited levels of the daughter Zn 68 nucleus. The most

probable prompt gamma emission is a 1088 keV gamma with a 3.2% per decay probability.

Table 3: Principal Radiation Emission Data

(>1%)

Radiation/Emis s ion

%

Dis integration

Mean

Energy

(MeV)

beta+

0.8360

beta+

1.1%

0.3526

gamma

178%

0.5110

gamma

1.0770

X-ray

2.8%

0.0086

X-ray

1.4%

0.0086

Table 4: Physical Decay Chart for Gallium Ga-

68

Minutes

Fraction Remaining

1.000

0.858

0.736

0.541

0.398

0.293

0.158

0.025

11.3 External Radiation

Gamma constant: 1.8 × 10

mSv/hr per MBq at 1 meter [0.67 mrem/hr per mCi at 1 meter] Table 5

displays the radiation attenuation by lead shielding of Ga 68.

Table 5: Radiation Attenuation of 511 keV

Photons by Lead (Pb) Shielding

Shield Thickness

(Pb) mm

Coefficient of

Attenuation

0.25

0.01

0.001

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ga 68 DOTATOC binds to somatostatin receptors, with highest affinity (K = 2.5± 0.5 nanomolar) for

subtype 2 receptors (sstr2). Ga 68 DOTATOC binds to cells that express somatostatin receptors

including malignant neuroendocrine cells, which overexpress sstr2 receptors. Gallium 68 is a β+

emitting radionuclide with associated 511 keV annihilation photons that allow positron emission

tomography (PET) imaging.

12.2 Pharmacodynamics

The relationship between Ga 68 DOTATOC plasma concentrations and successful imaging was not

explored in clinical trials.

12.3 Pharmacokinetics

Distribution

Ga 68 DOTATOC distributes to all sstr2-expressing organs such as pituitary, thyroid, spleen, adrenals,

kidney, pancreas, prostate, liver, and salivary glands. Uptake in the lung and lymph nodes are lower as

compared to other sstr-2 expressing organs.

Elimination

Radiotracer elimination is exclusively via urine. Approximately 16% of the injected dose is excreted in

urine in the first two to four hours post-injection.

14 CLINICAL STUDIES

The safety and efficacy of Ga-68 DOTATOC Injection were established in two single-center, open-

label studies (Study A and Study B) in which 282 patients with known or suspected SSTR-positive

NETs received a single dose of Ga-68 DOTATOC. A total of 238 of the 282 patients (84%) had a

history of neoplasm at the time of Ga-68 DOTATOC imaging. Among the 282 patients, 59% were

female and 95% white; the mean age was 54 years (range from 4 to 82 years).

The Ga-68 DOTATOC images were rated by two independent readers blinded to clinical information

as either positive or negative for NET within each patient. The imaging results were compared to a

composite reference consisting of histopathology and imaging (MR, CT, or In-111 pentetreotide

imaging) acquired within 1 year of the Ga-68 DOTATOC imaging, as well as chromogranin A and

pancreastatin levels. The proportion of patients positive for NET per composite reference who were

identified as positive by the Ga-68 DOTATOC image was used to quantify positive percent agreement.

The proportion of patients without NET per composite reference who were identified as negative by

the Ga-68 DOTATOC image was used to quantify negative percent agreement.

Study A (NCT: 01619865) included 220 subjects with known or suspected SSTR positive tumors

referred for diagnosis or evaluation of disease extension before or after treatment. A total of 178 of the

220 patients (81%) had a history of neoplasm at the time of Ga-68 DOTATOC imaging. In 177 of the

220 patients, sufficient data to establish NET status per composite reference was available for efficacy

evaluation. Table 6 shows the performance of Ga-68 DOTATOC in the detection of NETs for Study

Table 6: Study A. Performance of Ga-68 DOTATOC in the detection of NET by reader

N = 177

NET status as identified

by reader

Reference

Pos itive

Negative

N: number of patients, CI: confidence interval,

Reader 1

Positive

Negative

Agreement (%) (95% CI)

91 (85, 95)

89 (75, 96)

Reader 2

Positive

Negative

Agreement (%) (95% CI)

90 (84, 95)

86 (73, 95)

Study B (NCT: 01869725) included 62 patients with histologically positive NET or other SSTR

positive tumor referred for evaluation of disease before or after treatment. In 59 of the 62 patients,

sufficient data to establish NET status per composite reference was available for efficacy evaluation.

The estimated positive and negative percent agreements were 92% and 75% for reader 1 and 90% and

75% for reader 2, respectively.

16 HOW SUPPLIED/STORAGE AND HANDLING

Ga 68 DOTATOC Injection is supplied in a multiple-dose, capped 30 mL glass vial containing 18.5

MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of Ga 68 DOTATOC at calibration time in

approximately 14 mL of solution (NDC 24417-681-30).

Store Ga 68 DOTATOC Injection upright in a lead shielded container at 25°C (77°F); excursions

permitted to 15°C to 30°C (59°F to 86°F).

Receipt, transfer, handling, possession or use of this product is subject to the radioactive material

regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States

or Licensing States as appropriate. Store and dispose of Ga 68 DOTATOC Injection in accordance with

the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State.

Percent reader agreement with reference;

Exact method

17 PATIENT COUNSELING INFORMATION

Radiation Risk

Advise patients to drink water to ensure adequate hydration prior to their PET study and recommend they

drink and urinate as often as possible during the first hours following the administration of Ga 68

DOTATOC Injection, in order to reduce radiation exposure [see Dosage and Administration (2.3) and

Warnings and Precautions (5.1)].

Lactation

Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 8 hours after

Ga 68 DOTATOC Injection administration in order to minimize radiation exposure to a breastfed infant

[see Use in Specific Populations (8.2)].

Manufactured and Distributed by:

UIHC – P E T Imaging Center

0911Z JPP

200 Hawkins Drive

Iowa City, IA 52242

PRINCIPAL DISPLAY PANEL - 14 mL Vial Label

DOTATOC Ga 68 INJECTION

BATCH#

Diagnostic - For intravenous Use Only

Contains: 18.5 MBq/mL to 148 MBq/mL (0.5 mCi/mL to 4 mCi/mL) of no-carrier

added Ga-68 DOTATOC @ end of synthesis; 9 mg/mL of sodium chloride

Rx ONLY

Sterile, non-pyrogenic

Multiple-dose Vial

NDC# 24417-681-30

Manufactured by:

UIHC-PET Imaging Center

200 Hawkins Drive

Iowa City, IA 52242

TOTAL ACTIVITY: mCi

TOTAL VOLUME: mL

RADIOACTIVE CONCENTRATION: mCi/mL @ EOS TIME

EOS TIME:

EXPIRATION TIME:

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F–86°F);

Store upright in a lead shielded container. Expires 3 hours from end of synthesis.

See full prescribing information for dosage and administration information.

Do not use if cloudy or if contains particulate matter.

CAUTION: RADIOACTIVE MATERIAL

GA-68-DOTATOC

edotreotide gallium ga-68 injection, solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:24417-6 8 1

Route of Administration

INTRAVENOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

EDO TREO TIDE GALLIUM GA-6 8 (UNII: Y6 8 179 SY2L) (EDOTREOTIDE GALLIUM GA-6 8

- UNII:Y6 8 179 SY2L)

EDOTREOTIDE GALLIUM

GA-6 8

4 mCi

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

so dium chlo ride (UNII: 451W47IQ8 X)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:24417-6 8 1-

14 mL in 1 VIAL, MULTI-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

0 9 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA210 8 28

0 9 /0 1/20 19

UIHC – P E T Imaging Center

Labeler -

UIHC – P E T Imaging Center (063513265)

Revised: 9/2019

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