DRAXIMAGE DTPA by is a Prescription medication manufactured, distributed, or labeled by Jubilant DraxImage Inc., dba Jubilant Radiopharma, Jubilant HollisterStier General Partnership. Drug facts, warnings, and ingredients follow.
DRAXIMAGE® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection. Technetium Tc 99m pentetate is a radioactive diagnostic agent indicated for:
Kit for the preparation of Technetium Tc 99m pentetate injection: 10 mL multiple dose vials containing up to 9250 MBq / mL (250 mCi / mL) at time of preparation (reconstitution) (3).
Hypersensitivity to the active ingredient or any component of this product (4).
Most common adverse reactions reported with Technetium Tc 99m pentetate injection include allergic reactions, rash, itching (6).
To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2018
Tc 99m labeled DRAXIMAGE® DTPA injection is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure to the patient and healthcare worker. During preparation and handling, use water proof gloves and effective shielding, including syringe shields [see Warnings and Precautions (5.3)].
Indication | Route of Administration | Dose | Image Acquisition |
Brain Imaging | Intravenous Injection | 370 to 740 MBq (10 to 20 mCi) | Immediate dynamic imaging. Obtain at least one blood-pool image in same position as flow. Delayed images can be obtained 1 hour later. |
Renal Visualization and Perfusion Assessment | Intravenous Injection | 370 to 740 MBq (10 to 20 mCi) | Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection. |
Renal Visualization with Estimation of Glomerular Filtration Rate | Intravenous Injection | 111 to 185 MBq (3 to 5 mCi) | Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection. |
Estimation of Glomerular Filtration Rate (with no renal imaging) | Intravenous Injection | 7.4 to 18.5 MBq (0.2 to 0.5 mCi) | Blood sampling only is performed. |
Indication | Route of Administration | Dose | Image Acquisition |
Renal Visualization and Perfusion Assessment | Intravenous Injection | 3.7 to 7.4 MBq/kg (0.1 to 0.2 mCi/kg) Minimum 37 MBq (1 mCi) Maximum 185 MBq (5 mCi) | Immediate dynamic imaging. Static imaging 1 to 30 minutes after injection. |
Estimation of Glomerular Filtration Rate (with no renal imaging) | Intravenous Injection | 7.4 to 18.5 MBq (0.2 to 0.5 mCi) | Blood sampling only is performed. |
* For lung imaging performed after perfusion imaging, target count rate should be approximately three times that of perfusion count rate. | |||
Indication | Route of Administration | Dose | Image Acquisition |
Lung Ventilation Adults | Aerosol Inhalation | 925 to 1850 MBq (25 to 50 mCi) in the nebulizer to achieve a lung dose of approximately 18.5 to 37 MBq (0.5 to 1.0 mCi) | For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved after 3 to 5 minutes of inhalation or at an imaging count rate of 50,000 to 100,000 per minute*. |
Lung Ventilation Pediatric Patients | Aerosol Inhalation | 925 MBq (25 mCi) in the nebulizer to achieve a lung dose of approximately 18.5 MBq (0.5 mCi) | For lung imaging performed prior to perfusion imaging, the target administered dose to the lungs is achieved at an imaging count rate of approximately 10,000 to 50,000 per minute*. |
Step 5:
System A – Determination of reduced
hydrolyzed technetium:
System B – Determination of free pertechnetate:
The estimated radiation absorbed dose to various organs from an intravenous injection of Tc 99m pentetate in patients with normal and abnormal renal function is shown respectively in Table 4 and Table 5.
Absorbed Dose Per Unit Activity Administered (μGy/MBq) | ||||||
Organ | Adult | 15 Years | 10 Years | 5 Years | 1 Year | |
Adrenals | 1.4 | 1.8 | 2.7 | 4.0 | 7.2 | |
Bone surfaces | 2.4 | 2.9 | 4.3 | 6.1 | 10 | |
Brain | 0.86 | 1.1 | 1.7 | 2.8 | 4.9 | |
Breast | 0.72 | 0.92 | 1.3 | 2.2 | 4.1 | |
Gallbladder wall | 1.5 | 2.1 | 3.8 | 5.0 | 6.1 | |
Gastrointestinal tract | ||||||
Esophagus | 1.0 | 1.3 | 1.9 | 3.0 | 5.4 | |
Stomach wall | 1.3 | 1.7 | 2.8 | 4.0 | 6.8 | |
Small intestine wall | 2.5 | 3.1 | 4.9 | 7.0 | 10 | |
Colon wall | 3.1 | 3.9 | 6.0 | 8.1 | 11 | |
Upper large intestine wall | 2.1 | 2.8 | 4.3 | 6.5 | 9.2 | |
Lower large intestine wall | 4.3 | 5.4 | 8.2 | 10 | 13 | |
Heart wall | 1.2 | 1.5 | 2.2 | 3.3 | 5.9 | |
Kidneys | 4.4 | 5.3 | 7.5 | 11 | 18 | |
Liver | 1.2 | 1.6 | 2.5 | 3.8 | 6.4 | |
Lungs | 1.0 | 1.3 | 2.0 | 3.0 | 5.5 | |
Muscles | 1.6 | 2.0 | 3.0 | 4.3 | 6.8 | |
Ovaries | 4.2 | 5.3 | 7.7 | 10 | 13 | |
Pancreas | 1.4 | 1.8 | 2.8 | 4.3 | 7.4 | |
Red marrow | 1.5 | 1.8 | 2.7 | 3.7 | 5.7 | |
Skin | 0.87 | 1.0 | 1.7 | 2.6 | 4.4 | |
Spleen | 1.3 | 1.6 | 2.6 | 3.9 | 6.8 | |
Testes | 2.9 | 4.0 | 6.8 | 9.4 | 13 | |
Thymus | 1.0 | 1.3 | 1.9 | 3.0 | 5.4 | |
Thyroid | 1.0 | 1.3 | 2.1 | 3.3 | 6.0 | |
Urinary bladder wall | 62 | 78 | 110 | 150 | 170 | |
Uterus | 7.9 | 9.6 | 15 | 18 | 22 | |
Remaining organs | 1.7 | 2.1 | 3.0 | 4.2 | 6.6 | |
Effective dose per unit activity (μSv/MBq) | 4.9 | 6.3 | 9.4 | 12 | 16 |
Absorbed Dose Per Unit Activity Administered (μGy/MBq) | ||||||
Organ | Adult | 15 Years | 10 Years | 5 Years | 1 Year | |
Adrenals | 4.1 | 5.1 | 7.6 | 11 | 21 | |
Bone surfaces | 6.0 | 7.1 | 11 | 15 | 28 | |
Brain | 2.8 | 3.5 | 5.7 | 9.1 | 16 | |
Breast | 2.3 | 3.0 | 4.2 | 6.8 | 13 | |
Gallbladder wall | 4.2 | 5.7 | 9.2 | 13 | 16 | |
Gastrointestinal tract | ||||||
Esophagus | 3.3 | 4.2 | 6.2 | 9.6 | 17 | |
Stomach wall | 3.8 | 5.0 | 7.9 | 11 | 19 | |
Small intestine wall | 4.5 | 5.6 | 8.5 | 13 | 22 | |
Colon wall | 4.5 | 5.8 | 8.7 | 13 | 22 | |
Upper large intestine wall | 4.3 | 5.6 | 8.1 | 13 | 21 | |
Lower large intestine wall | 4.9 | 6.1 | 9.5 | 13 | 23 | |
Heart wall | 3.7 | 4.7 | 7.0 | 10 | 18 | |
Kidneys | 7.7 | 9.2 | 13 | 19 | 32 | |
Liver | 3.7 | 4.6 | 7.1 | 11 | 19 | |
Lungs | 3.3 | 4.2 | 6.2 | 9.5 | 17 | |
Muscles | 3.2 | 4.0 | 6.1 | 9.1 | 17 | |
Ovaries | 5.0 | 6.2 | 9.2 | 14 | 23 | |
Pancreas | 4.3 | 5.3 | 8.0 | 12 | 21 | |
Red marrow | 3.4 | 4.2 | 6.4 | 9.3 | 16 | |
Skin | 2.2 | 2.6 | 4.2 | 6.7 | 12 | |
Spleen | 3.8 | 4.7 | 7.3 | 11 | 19 | |
Testes | 3.5 | 4.5 | 6.9 | 10 | 18 | |
Thymus | 3.3 | 4.2 | 6.2 | 9.6 | 17 | |
Thyroid | 3.4 | 4.2 | 6.7 | 11 | 19 | |
Urinary bladder wall | 21 | 27 | 39 | 50 | 66 | |
Uterus | 6.1 | 7.4 | 11 | 16 | 25 | |
Remaining organs | 3.3 | 4.1 | 6.3 | 9.7 | 17 | |
Effective dose per unit activity (μSv/MBq) | 4.6 | 5.8 | 8.7 | 13 | 21 |
The estimated radiation absorbed dose to various organs from the inhalation of Tc 99m Pentetate Injection is shown in Table 6.
Absorbed Dose Per Unit Activity Administered (μGy/MBq) | ||||||
Organ | Adult | 15 Years | 10 Years | 5 Years | 1 Year | |
Adrenals | 2.1 | 2.9 | 4.4 | 6.7 | 12 | |
Bone surfaces | 1.9 | 2.4 | 3.5 | 5.3 | 9.8 | |
Breast | 1.9 | 1.9 | 3.3 | 4.8 | 7.8 | |
Gastrointestinal tract | ||||||
Stomach wall | 1.7 | 2.2 | 3.5 | 5.1 | 8.9 | |
Small intestine wall | 2.1 | 2.6 | 4.1 | 6.3 | 11 | |
Upper large intestine wall | 1.9 | 2.4 | 3.8 | 6.1 | 10 | |
Lower large intestine wall | 3.2 | 4.2 | 6.3 | 8.8 | 15 | |
Kidneys | 4.1 | 5.1 | 7.2 | 11 | 19 | |
Liver | 1.9 | 2.5 | 3.7 | 5.5 | 9.7 | |
Lungs | 17 | 26 | 36 | 54 | 100 | |
Ovaries | 3.3 | 4.1 | 6.1 | 8.9 | 15 | |
Pancreas | 2.1 | 2.6 | 4.0 | 6.1 | 11 | |
Red marrow | 2.7 | 3.4 | 4.7 | 6.2 | 9.6 | |
Spleen | 1.9 | 2.4 | 3.6 | 5.6 | 9.9 | |
Testes | 2.1 | 3.1 | 5.2 | 7.9 | 15 | |
Thyroid | 0.99 | 1.7 | 2.7 | 4.4 | 7.8 | |
Urinary bladder wall | 47 | 58 | 84 | 120 | 230 | |
Uterus | 5.9 | 7.2 | 11 | 16 | 27 | |
Other tissue | 1.8 | 2.2 | 3.2 | 4.9 | 8.6 | |
Effective dose per unit activity (μSv/MBq) | 5.9 | 8.0 | 11 | 17 | 31 |
Kit for the preparation of Technetium Tc 99m pentetate injection: multiple-dose 10 mL glass vial contains a non-radioactive (white) lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen.
Following reconstitution with the Technetium Tc 99m eluate, the radioactive solution produced is a clear solution not exceeding 9250 MBq/mL (250 mCi/mL) of Tc 99m.
Hypersensitivity to the active ingredient or to any component of the product [see Warnings and Precautions (5.1)].
Hypersensitivity reactions, including anaphylaxis, have been reported during post-approval diagnostic use of Technetium Tc 99m pentetate injection. Monitor all patients for hypersensitivity reactions and have access to cardiopulmonary resuscitation equipment and personnel.
In patients with obstructive pulmonary disease there may be deposition of particles in the proximal airways influencing image quality and interfering with diagnostic interpretation, therefore to ensure diagnostic quality, careful use of the nebulizer to assure optimal particle delivery is essential. If interfering particle deposition occurs, consider additional diagnostic options.
Technetium Tc 99m 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. Use the lowest dose of Technetium Tc 99m pentetate necessary for imaging. Encourage patients to drink fluids and void as frequently as possible after intravenous administration [see Dosage and Administration (2.1, 2.3)].
Radiation risks associated with the use of Technetium Tc 99m pentetate are greater in pediatric patients than in adults due to greater radiosensitivity and longer life expectancy.
As with other inhaled medications, inhalation of Technetium Tc 99m pentetate solution may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity, such as patients with asthma or other lung or allergic disorders. Monitor all patients for bronchoconstriction.
The following adverse reactions have been identified post-approval. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their exact frequency or establish a causal relationship to Technetium Tc 99m pentetate exposure.
Adverse reactions are presented in decreasing order of reported frequency:
Limited available data with Technetium Tc 99m pentetate use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. Technetium Tc 99m pentetate is transferred across the placenta (see Data). No animal reproductive studies have been conducted with Technetium Tc 99m pentetate. All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technetium Tc 99m pentetate administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Technetium Tc 99m pentetate and the gestational timing of exposure.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S., general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
Human Data
Limited published literature describes Technetium Tc
99m pentetate crossing the placental barrier. No adverse fetal effects
or radiation-related risks have been identified for diagnostic procedures
involving less than 50 mGy, which represents less than 10 mGy fetal
doses.
Risk Summary
There are limited data available in scientific literature on the
presence of Technetium Tc 99m pentetate in human milk. There are
no data available on the effects of Technetium Tc 99m pentetate on
the breastfed infant or the effects on milk production. Based on
the United States Nuclear Regulatory Commission guidelines for breast
feeding interruption after exposure to radiopharmaceuticals, breastfeeding
interruption is not recommended for Technetium 99m pentetate at levels
less than 1000 MBq (30 mCi). The developmental and health benefits
of breastfeeding should be considered along with the mother’s clinical
need for Technetium Tc 99m pentetate, any potential adverse effects
on the breastfed child from Technetium Tc 99m pentetate or from the
underlying maternal condition.
Technetium Tc 99m pentetate is indicated for lung ventilation and evaluation of pulmonary embolism when paired with perfusion imaging and for renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in pediatric patients ages birth to less than 17 years of age. Pediatric use is supported by evidence from controlled studies in adults and dosing and safety are based on clinical experience.
The radiation risk of Technetium Tc 99m pentetate is greater in pediatric patients than adults [See Warnings and Precautions, (5.3)].
No formal studies of Technetium Tc 99m pentetate in the elderly were performed 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.
DRAXIMAGE® DTPA is a kit for the preparation of Technetium Tc 99m pentetate injection, a radioactive diagnostic agent, for intravenous or inhalation use. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, non-radioactive lyophilized powder of 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg maximum tin expressed as stannous chloride dihydrate. The lyophilized product is sealed under an atmosphere of nitrogen. No bacteriostatic preservative is present. Its chemical name is:
Technetate (1-)99mTc,[N,N-bis[2-[bis(carboxymethyl)amino]ethyl]-glycinato(5-)]-, sodium. The structure of the technetium labeled form is:
The pH is adjusted with HCl and/or NaOH prior to lyophilization so that the pH range of the reconstituted radiopharmaceutical is 6.5 to 7.5.
Technetium Tc 99m decays by isomeric transition with a physical half-life of 6 hours. The principal photon that is useful for detection and imaging studies is listed in Table 7.
Radiation | Mean % per Disintegration | Mean Energy (keV) |
Gamma-2 | 88.5 | 140.5 |
The air-kerma-rate (exposure-rate) constant for Technetium Tc 99m is 5.23 m2·pGy·(MBq)−1·s−1 [0.795 cm2·R·(mCi)−1·h−1]. A range of values for the relative radiation attenuation by the various thicknesses of lead is shown in Table 8. For example, the use of a 3 mm thickness of lead will attenuate the radiation emitted by a factor of about 1,000.
Shield Thickness (Pb) cm | Coefficient of Attenuation |
0.25 | 0.5 |
1 | 10-1 |
2 | 10-2 |
3 | 10-3 |
4 | 10-4 |
To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 9.
*Calibration Time | |||
Hours | Fraction Remaining | Hours | Fraction Remaining |
0* | 1.000 | 5 | 0.562 |
1 | 0.891 | 6 | 0.501 |
2 | 0.794 | 8 | 0.398 |
3 | 0.708 | 10 | 0.316 |
4 | 0.631 | 12 | 0.251 |
Intravenous Administration
Following intravenous
administration for brain and renal imaging, Technetium Tc 99m pentetate
is distributed in the vascular compartment. It is cleared by the
kidneys, which results in the ability to image the kidney.
Aerosolized Inhalation Administration
Following inhalation of the aerosol, Technetium Tc 99m pentetate
deposits on the epithelium of ventilated alveoli.
Brain Imaging
Technetium Tc 99m pentetate with intravenous administration
tends to accumulate in intra-cranial lesions with excessive neovascularity
or an altered blood brain barrier. Technetium Tc 99m pentetate accumulation
in the brain is prevented by an intact blood brain barrier. It does
not accumulate in the choroid plexus.
Renal Scintigraphy
The first few minutes after intravenous administration,
Technetium Tc 99m pentetate is present in the vascular compartment
within the renal system.
Lung Ventilation
Imaging
In patients with normal lungs, the
deposition of Technetium Tc 99m pentetate is homogeneous throughout
the lungs. In patients with airway disease, the deposition patterns
become inhomogeneous with irregular deposition of Technetium Tc 99m
pentetate in the airways and alveolar regions of the lung.
After an intravenous administration, the pharmacokinetics of Technetium Tc 99m pentetate were studied by monitoring radioactivity in serial venous blood samples for 7 hours post-administration. The mean plasma clearance rate was 6.8 (L/h) and the mean plasma elimination half-life (t½) was 2.1 hours. The mean volume of distribution at steady state conditions calculated with clearance and mean residence time was 17 L. This relatively low volume of distribution after intravenous administration suggests that Technetium Tc 99m pentetate distributes to the extracellular fluid only. The rate of elimination of Technetium Tc 99m pentetate from the systemic circulation appears to be constant over an approximately 20-fold intravenous dose range.
Absorption
Following inhalation Technetium Tc 99m pentetate was
absorbed (Tmax <2 hours after inhalation)
and distributed across the lung epithelium (bioavailability approximately
70%) and into the systemic circulation.
Following intravenous administration, Technetium Tc 99m pentetate is distributed throughout the extracellular fluid space and is cleared from the body by the kidney.
The steady-state volume of distribution (Vss) was 17 L following an intravenous administration. Technetium Tc 99m pentetate distribution appears to be limited to the extravascular compartment.
A variable percentage of the Technetium Tc 99m pentetate binds to the serum proteins; this ranges from 3.7% following a single injection to approximately 10% if the material is continuously infused. Although the chelate gives useful information on the glomerular filtration rate, the variable percent which is protein bound leads to a measured renal clearance rate which is lower than that determined by inulin clearance.
Elimination
Metabolism
Technetium Tc
99m pentetate is not metabolized.
Excretion
After either intravenous administration or inhalation,
excretion is by glomerular filtration. The mean fraction of intravenously
administered Technetium Tc 99m pentetate excreted in urine over 24
hours was 102%.
DRAXIMAGE® DTPA is supplied as multiple dose kits consisting of 10 mL reaction vials containing a white, lyophilized powder with 20 mg of pentetic acid, 5 mg of p-aminobenzoic acid, 3.73 mg of calcium chloride dihydrate, and not less than 0.25 mg stannous chloride dihydrate and not more than 0.385 mg tin expressed as stannous chloride dihydrate.
The radionuclide is not part of the kit. Before reconstitution and radiolabeling with sodium pertechnetate Tc 99m injection USP, the contents of the kit are not radioactive.
The kits are supplied in the following formats:
Store the unreconstituted reaction vials at 25°C (77°F); excursions permitted between 15 and 30°C (59 and 86°F).
This radiopharmaceutical is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
Administration Instructions
Intravenous Use
Advise patients
to hydrate after administration of Tc 99m labeled DRAXIMAGE® DTPA injection and to void frequently to minimize
radiation dose [see Dosage and Administration (2.3)].
Inhalation
Use
To minimize the potential of mouth and esophageal
activity of Tc 99m labeled DRAXIMAGE® DTPA,
advise the patient to rinse their mouth with water and spit it out
prior to imaging [see Dosage and Administration (2.3)].
Pregnancy
Advise pregnant women of the risk
of fetal exposure to radiation if they undergo a radionuclide procedure [see Use in Specific Populations (8.1)].
DRAXIMAGE DTPA
kit for the preparation of technetium tc 99m pentetate injection, powder, lyophilized, for solution |
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Labeler - Jubilant DraxImage Inc. (243604761) |
Registrant - Jubilant DraxImage Inc. (243604761) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Jubilant HollisterStier General Partnership | 246762764 | MANUFACTURE(65174-288) |