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Mayo Clinic Drugs

Rx Act Nasal Original

Rx Act Nasal Original

2.1       Radiation Safety - Drug Handling

Choline C 11 Injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration. Use waterproof gloves and effective shielding when handling Choline C 11 Injection. Radiopharmaceuticals, including Choline C 11 Injection, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

2.2       Recommended Dose and Administration Instructions

The recommended dose is 370 – 740 MBq (10 – 20 mCi) administered as a bolus intravenous injection. The radioactivity dose (370 – 740 MBq, 10 – 20 mCi) is chosen based on patient body dimensions and the characteristics of the image acquisition system
Inspect Choline C 11 Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Aseptically withdraw Choline C 11 Injection from its container and administer the drug as a bolus through a peripheral venous catheter. Dispose of any unused drug in a safe manner, in compliance with applicable regulations.
2.3       Patient Preparation

Prior to administration of Choline C 11 Injection:
Fasting for at least six hours is recommended to minimize the potential for dietary choline interference with radioactivity uptake in tissue. Ensure that the patient is well hydrated and encourage voiding when imaging is completed.
2.4       Radiation Dosimetry

The estimated radiation absorbed doses for adults from intravenous injection of Choline C 11 Injection are shown in Table 1. These estimates are calculated from data in Tolvanen 1and using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software from Vanderbilt University.2
Table 1: Estimated Radiation Absorbed Dose Per Unit Activity for Adults, Choline C 11 Injection Organ/Tissue Mean Absorbed Dose Per Unit Administered Activity (μGy/MBq)b Adrenals 3.59 Bone – Osteogenic Cells 4.81 Bone – Red Marrow 1.90 Brain 1.16 Breast 1.39 Gallbladder Wall 4.54 GIa – Lower Large Intestine Wall 1.81 GIa – Small Intestine 2.35 GIa – Stomach Wall 6.00 GIa – Upper Large Intestine Wall 6.41 Heart wall 3.43 Kidneys 20.62 Liver 20.11 Lungs 4.59 Muscle 2.54 Ovaries 2.02 Pancreas 29.19 Skin 1.22 Spleen 9.16 Testes 1.36 Thymus 1.69 Thyroid 1.49 Urinary Bladder Wall 3.41 Uterus 1.96 Total body 2.97 Effective Dose (μSv/MBq)c 4.35
a Gastrointestinalb Assumed radiation weighting factor, wr, (formerly defined as quality factor, Q) of 1 for conversion of absorbed dose (Gray or rad) to dose equivalent (Sieverts or rem) for C 11. To obtain radiation absorbed dose in rad/mCi from the above table, multiply the dose in μGy/MBq by 0.0037, (e.g., 3.59 μGy/MBq × 0.0037 = 0.0133 rad/mCi).c Radiation tissue weighting factors, wT, used in the calculation of effective dose are from 1990 Recommendations of the International Commission on Radiological Protection, ICRP Publication 60 (1991). To obtain radiation absorbed dose in rem/mCi from above table, multiply the dose in μGy/MBq by 0.0037, (e.g., 4.35 μGy/MBq × 0.0037 = 0.0161 rem/mCi).

The effective dose resulting from a 740 MBq (20 mCi) dosage of Choline C 11 Injection is 3.22 mSv in an adult, (740 × 4.35 = 3219 μSv = 3.2 mSv). The use of a CT scan to calculate attenuation correction for reconstruction of 11C-choline images (as done in PET/CT imaging) will add radiation exposure. Based upon current scanning techniques, an effective dose of 5.8 mSv would be added from CT scanning. The actual radiation dose is operator, scanner, and patient dependent. The total radiation exposure from 11C-choline administration and subsequent scan on a PET/CT scanner is estimated to be 9.0 mSv (3.2 mSv + 5.8 mSv).

2.5       Imaging Guidelines
Initiate image acquisition immediately after administration of Choline C 11 Injection.  Imaging is typically performed from the base of the pelvis to the base of the skull. Acquire static emission images 0 – 15 minutes from the time of injection. Localized uptake of 11C-choline in a site suspicious for prostate cancer recurrence (a positive image) is determined by comparison of the anatomical relationship of concentrated radioactivity to the neighboring tissue background, exclusive of the radioactivity physiologically accumulated within the pancreas, liver, spleen, kidney and colon.
Up And Up Allergy Relie...

Up And Up Allergy Relief

Fludeoxyglucose F 18 Injection USP emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)].

2.1 Recommended Dose for Adults

Within the oncology, cardiology and neurology settings, the recommended dose for adults is 5 – 10 mCi (185 – 370 MBq) as an intravenous injection.

2.2 Recommended Dose for Pediatric Patients

Within the neurology setting, the recommended dose for pediatric patients is 2.6 mCi, as an intravenous injection. The optimal dose adjustment on the basis of body size or weight has not been determined [see Use in Special Populations (8.4)].

2.3 Patient Preparation
To minimize the radiation absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to drink water or other fluids (as tolerated) in the 4 hours before their PET study. Encourage the patient to void as soon as the imaging study is completed and as often as possible thereafter for at least one hour. Screen patients for clinically significant blood glucose abnormalities by obtaining a history and/or laboratory tests [see Warnings and Precautions (5.2)]. Prior to Fludeoxyglucose F 18 PET imaging in the oncology and neurology settings, instruct patient to fast for 4 – 6 hours prior to the drug’s injection. In the cardiology setting, administration of glucose-containing food or liquids (e.g.,50 – 75 grams) prior to Fludeoxyglucose F 18 Injection USP facilitates localization of cardiac ischemia.
2.4 Radiation Dosimetry

The estimated human absorbed radiation doses (rem/mCi) to a newborn (3.4 kg), 1-year old (9.8 kg), 5-year old (19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection USP are shown in Table 1. These estimates were calculated based on human2 data and using the data published by the International Commission on Radiological Protection4 for Fludeoxyglucose 18F. The dosimetry data show that there are slight variations in absorbed radiation dose for various organs in each of the age groups. These dissimilarities in absorbed radiation dose are due to developmental age variations (e.g., organ size, location, and overall metabolic rate for each age group). The identified critical organs (in descending order) across all age groups evaluated are the urinary bladder, heart, pancreas, spleen, and lungs.
Table 1. Estimated Absorbed Radiation Doses (rem/mCi) After Intravenous Administration of Fludeoxyglucose F 18 Injection USPa Organ Newborn(3.4 kg) 1-year old(9.8 kg) 5-year old(19 kg) 10-year old(32 kg) 15-year old(57 kg) Adult(70 kg) Bladder wallb 4.3 1.7 0.93 0.60 0.40 0.32 Heart wall 2.4 1.2 0.70 0.44 0.29 0.22 Pancreas 2.2 0.68 0.33 0.25 0.13 0.096 Spleen 2.2 0.84 0.46 0.29 0.19 0.14 Lungs 0.96 0.38 0.20 0.13 0.092 0.064 Kidneys 0.81 0.34 0.19 0.13 0.089 0.074 Ovaries 0.80 0.8 0.19 0.11 0.058 0.053 Uterus 0.79 0.35 0.19 0.12 0.076 0.062 LLI wall * 0.69 0.28 0.15 0.097 0.060 0.051 Liver 0.69 0.31 0.17 0.11 0.076 0.058 Gallbladder wall 0.69 0.26 0.14 0.093 0.059 0.049 Small intestine 0.68 0.29 0.15 0.096 0.060 0.047 ULI wall ** 0.67 0.27 0.15 0.090 0.057 0.046 Stomach wall 0.65 0.27 0.14 0.089 0.057 0.047 Adrenals 0.65 0.28 0.15 0.095 0.061 0.048 Testes 0.64 0.27 0.14 0.085 0.052 0.041 Red marrow 0.62 0.26 0.14 0.089 0.057 0.047 Thymus 0.61 0.26 0.14 0.086 0.056 0.044 Thyroid 0.61 0.26 0.13 0.080 0.049 0.039 Muscle 0.58 0.25 0.13 0.078 0.049 0.039 Bone surface 0.57 0.24 0.12 0.079 0.052 0.041 Breast 0.54 0.22 0.11 0.068 0.043 0.034 Skin 0.49 0.20 0.10 0.060 0.037 0.030 Brain 0.29 0.13 0.09 0.078 0.072 0.070 Other tissues 0.59 0.25 0.13 0.083 0.052 0.042
a MIRDOSE 2 software was used to calculate the radiation absorbed dose. Assumptions on the biodistribution based on data from Gallagher et al.1 and Jones et al.2 b The dynamic bladder model with a uniform voiding frequency of 1.5 hours was used.*LLI = lower large intestine; **ULI = upper large intestine

2.5 Radiation Safety – Drug Handling
Use waterproof gloves, effective radiation shielding, and appropriate safety measures when handling Fludeoxyglucose F 18 Injection USP to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel and other persons. 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. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [see Description (11.2)]. The dose of Fludeoxyglucose F 18 used in a given patient should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.
2.6 Drug Preparation and Administration
Calculate the necessary volume to administer based on calibration time and dose. Aseptically withdraw Fludeoxyglucose F 18 Injection USP from its container. Inspect Fludeoxyglucose F 18 Injection USP visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Use Fludeoxyglucose F 18 Injection USP within 12 hours from the EOS.
2.7 Imaging Guidelines
Initiate imaging within 40 minutes following Fludeoxyglucose F 18 Injection USP administration. Acquire static emission images 30 – 100 minutes from the time of injection.
Choline C 11

Choline C 11

2.1 Radiation Safety - Drug Handling

Choline C 11 Injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration. Use waterproof gloves and effective shielding when handling Choline C 11 Injection. Radiopharmaceuticals, including Choline C 11 Injection, should only be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radioactive materials, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

2.2 Recommended Dose and Administration Instructions

The recommended dose is 370 to 740 MBq (10 to 20 mCi) administered as a bolus intravenous injection. The radioactivity dose (370 to 740 MBq, 10 to 20 mCi) is chosen based on patient body dimensions and the characteristics of the image acquisition system
Inspect Choline C 11 Injection visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored. Aseptically withdraw Choline C 11 Injection from its container and administer the drug as a bolus through a peripheral venous catheter. Dispose of any unused drug in a safe manner, in compliance with applicable regulations.
2.3 Patient Preparation

Prior to administration of Choline C 11 Injection:
Fasting for at least six hours is recommended to minimize the potential for dietary choline interference with radioactivity uptake in tissue. Ensure that the patient is well hydrated and encourage voiding when imaging is completed.
2.4 Radiation Dosimetry

The estimated radiation absorbed doses for adults from intravenous injection of Choline C 11 Injection are shown in Table 1. These estimates are calculated from data in Tolvanen 1 and using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software from Vanderbilt University.2
Table 1: Estimated Radiation Absorbed Dose Per Unit Activity for Adults, Choline C 11 Injection a Gastrointestinalb Assumed radiation weighting factor, wr, (formerly defined as quality factor, Q) of 1 for conversion of absorbed dose (Gray or rad) to dose equivalent (Sieverts or rem) for C 11. To obtain radiation absorbed dose in rad/mCi from the above table, multiply the dose in μGy/MBq by 0.0037, (e.g.,3.59 μGy/MBq x 0.0037 = 0.0133 rad/mCi).c Radiation tissue weighting factors, wT, used in the calculation of effective dose are from 1990 Recommendations of the International Commission on Radiological Protection, ICRP Publication 60 (1991). To obtain radiation absorbed dose in rem/mCi from above table, multiply the dose in μGy/MBq by 0.0037, (e.g., 4.35 μGy/MBq x 0.0037 = 0.0161 rem/mCi). Organ/Tissue Mean Absorbed Dose Per Unit Administered Activity (μGy/MBq)b Adrenals 3.59 Bone - Osteogenic Cells 4.81 Bone - Red Marrow 1.90 Brain 1.16 Breast 1.39 Gallbladder Wall 4.54 GIa - Lower Large Intestine Wall 1.81 GIa - Small Intestine 2.35 GIa - Stomach Wall 6.00 GIa - Upper Large Intestine Wall 6.41 Heart wall 3.43 Kidneys 20.62 Liver 20.11 Lungs 4.59 Muscle 2.54 Ovaries 2.02 Pancreas 29.19 Skin 1.22 Spleen 9.16 Testes 1.36 Thymus 1.69 Thyroid 1.49 Urinary Bladder Wall 3.41 Uterus 1.96 Total body 2.97 Effective Dose (μSv/MBq)c 4.35
The effective dose resulting from a 740 MBq (20 mCi) dosage of Choline C 11 Injection is 3.22 mSv in an adult, (740 x 4.35 = 3219 μSv = 3.2 mSv). The use of a CT scan to calculate attenuation correction for reconstruction of 11C-choline images (as done in PET/CT imaging) will add radiation exposure. Based upon current scanning techniques, an effective dose of 5.8 mSv would be added from CT scanning. The actual radiation dose is operator, scanner, and patient dependent. The total radiation exposure from 11C-choline administration and subsequent scan on a PET/CT scanner is estimated to be 9.0 mSv (3.2 mSv + 5.8 mSv).

2.5 Imaging Guidelines
Initiate image acquisition immediately after administration of Choline C 11 Injection. Imaging is typically performed from the base of the pelvis to the base of the skull. Acquire static emission images 0 to 15 minutes from the time of injection. Localized uptake of 11C-choline in a site suspicious for prostate cancer recurrence (a positive image) is determined by comparison of the anatomical relationship of concentrated radioactivity to the neighboring tissue background, exclusive of the radioactivity physiologically accumulated within the pancreas, liver, spleen, kidney and colon.
Sodium Fluoride F 18

Sodium Fluoride F 18

2.1 Radiation Safety - Drug Handling
Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection USP. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experienced 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. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection USP. The dose of Sodium Fluoride F 18 Injection USP should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed. The final dose for the patient should be calculated using proper decay factors from the time of End of Synthesis (EOS), and measured by a suitable radioactivity calibration system before administration [see Description (11.2)].
2.2 Radiation Safety - Patient Preparation
To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection USP. Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection USP and as frequently thereafter as possible for the next 8 hours.
2.3 Drug Preparation and Administration
Calculate the necessary volume to administer based on calibration time and dose. Inspect Sodium Fluoride F 18 Injection USP visually for particulate matter and discoloration before administration, whenever solution and container permits. Do not administer Sodium Fluoride F 18 Injection USP containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Aseptically withdraw Sodium Fluoride F 18 Injection USP from its container.
2.4 Recommended Dose for Adults

Administer 300-450 MBq (8-12 mCi) as an intravenous injection.

2.5 Recommended Dose for Pediatric Patients

In reported clinical experience in approximately 100 children, weight-based doses (2.1 MBq/kg) ranging from 19 MBq-148 MBq (0.5 mCi‑4 mCi) were used.

2.6 Radiation Dosimetry

The age/weight-based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection USP are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection USP [2]. The bone, bone marrow and urinary bladder are considered target and critical organs.
Table 1: Estimated Absorbed Radiation Does after Intravenous administration of Sodium Fluoride F 18 Injection Organ Estimated Radiation Dose mGy/MBq Adult70 kg [1] 15 year56.8 kg [2] 10 year33.2 kg [2] 5 year19.8 kg [2] 1 year9.7 kg [2] Adrenals 0.0062 0.012 0.018 0.028 0.052 Brain 0.0056 N/A N/A N/A N/A Bone surfaces 0.060 0.050 0.079 0.13 0.30 Breast 0.00028 0.0061 0.0097 0.015 0.030 GI Gallbladder wall 0.0044 N/A N/A N/A N/A Stomach wall 0.0038 0.008 0.013 0.019 0.036 Small intestine 0.0066 0.012 0.018 0.028 0.052 Upper large intestine wall 0.0058 0.010 0.016 0.026 0.046 Lower large intestine wall 0.0012 0.016 0.025 0.037 0.063 Heart wall 0.0039 N/A N/A N/A N/A Kidneys 0.019 0.025 0.036 0.053 0.097 Liver 0.0040 0.0084 0.013 0.021 0.039 Lungs 0.0041 0.0084 0.013 0.020 0.039 Muscle 0.0060 N/A N/A N/A N/A Ovaries 0.011 0.016 0.023 0.036 0.063 Pancreas 0.0048 0.0096 0.015 0.023 0.044 Red marrow 0.028 0.053 0.0.88 0.18 0.38 Skin 0.0040 N/A N/A N/A N/A Spleen 0.0042 0.0088 0.014 0.021 0.041 Testes 0.0078 0.013 0.021 0.033 0.062 Thymus 0.0035 N/A N/A N/A N/A Thyroid 0.0044 0.0084 0.013 0.020 0.036 Urinary bladder wall 0.25 0.27 0.4 0.61 1.1 Uterus 0.019 0.023 0.037 0.057 0.099 Other tissue NA 0.010 0.015 0.024 0.044 Effective Dose Equivalent (mSv/MBq) 0.027 0.034 0.052 0.086 0.17
[1] Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.

[2] Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals, Ann ICRP, Volume 18, pages 15 and 74, 1987.

2.7 Imaging Guidelines
Imaging of Sodium Fluoride F 18 Injection USP can begin 1-2 hours after administration; optimally at 1-hour post-administration. Encourage the patient to void immediately prior to imaging the fluoride F 18 radioactivity in the lumbar spine or bony pelvis.
Medroxyprogesterone Ace...

Medroxyprogesterone Acetate

2.1 Rest Imaging Study
Aseptically withdraw Ammonia N 13 Injection USP from its container and administer 0.368-0.736 GBq (10-20 mCi) as a bolus through a catheter inserted into a large peripheral vein. Start imaging 3 minutes after the injection and acquire images for a total of 10-20 minutes.
2.2 Stress Imaging Study
If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N 13 injection USP to allow sufficient isotope decay. Administer a pharmacologic stress-inducing drug in accordance with its labeling. Aseptically withdraw Ammonia N 13 Injection USP from its container and administer 0.368-0.736 GBq (10-20 mCi) of Ammonia N 13 Injection USP as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug. Start imaging 3 minutes after the Ammonia N 13 Injection USP and acquire images for a total of 10-20 minutes.
2.3 Patient Preparation

To increase renal clearance of radioactivity and to minimize radiation dose to the bladder, ensure that the patient is well hydrated before the procedure and encourage voiding as soon as a study is completed and as often as possible thereafter for at least one hour.

2.4 Radiation Dosimetry

The converted radiation absorbed doses in rem/mCi are shown in Table 1. These estimates are calculated from the Task Group of Committee 2 of the International Commission on Radiation Protection.1
*Upper large intestine, ** Lower large intestine Table 1: N 13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups. Organ Age (years) Adult 15 10 5 1 Adrenals 0.0085 0.0096 0.016 0.025 0.048 Bladder wall 0.030 0.037 0.056 0.089 0.17 Bone surfaces 0.0059 0.0070 0.011 0.019 0.037 Brain 0.016 0.016 0.017 0.019 0.027 Breast 0.0067 0.0067 0.010 0.017 0.033 Stomach wall 0.0063 0.0078 0.012 0.019 0.037 Small intestine 0.0067 0.0081 0.013 0.021 0.041 *ULI 0.0067 0.0078 0.013 0.021 0.037 **LLI 0.0070 0.0078 0.013 0.020 0.037 Heart 0.0078 0.0096 0.015 0.023 0.041 Kidneys 0.017 0.021 0.031 0.048 0.089 Liver 0.015 0.018 0.029 0.044 0.085 Lungs 0.0093 0.011 0.018 0.029 0.056 Ovaries 0.0063 0.0085 0.014 0.021 0.041 Pancreas 0.0070 0.0085 0.014 0.021 0.041 Red marrow 0.0063 0.0078 0.012 0.020 0.037 Spleen 0.0093 0.011 0.019 0.030 0.056 Testes 0.0067 0.0070 0.011 0.018 0.035 Thyroid 0.0063 0.0081 0.013 0.021 0.041 Uterus 0.0070 0.0089 0.014 0.023 0.041 Other tissues 0.0059 0.0070 0.011 0.018 0.035
2.5 Drug Handling
Inspect Ammonia N 13 Injection USP visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer Ammonia N 13 Injection USP containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Wear sterile gloves and effective shielding when handling Ammonia N 13 Injection USP. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Ammonia N 13 Injection USP. The contents of each vial are sterile and non-pyrogenic. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. 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. Before administration of Ammonia N 13 Injection USP, assay the dose in a properly calibrated dose calibrator.

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