NDC 65174-288 Draximage Dtpa

Kit For The Preparation Of Technetium Tc 99m Pentetate

NDC Product Code 65174-288

NDC CODE: 65174-288

Proprietary Name: Draximage Dtpa What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Kit For The Preparation Of Technetium Tc 99m Pentetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Score: 1

NDC Code Structure

NDC 65174-288-05

Package Description: 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT

NDC 65174-288-30

Package Description: 30 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 KIT

NDC Product Information

Draximage Dtpa with NDC 65174-288 is a a human prescription drug product labeled by Jubilant Draximage Inc., Dba Jubilant Radiopharma. The generic name of Draximage Dtpa is kit for the preparation of technetium tc 99m pentetate. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous; respiratory (inhalation) form.

Labeler Name: Jubilant Draximage Inc., Dba Jubilant Radiopharma

Dosage Form: Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Draximage Dtpa Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PENTETIC ACID 20 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • AMINOBENZOIC ACID (UNII: TL2TJE8QTX)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • STANNOUS CHLORIDE (UNII: 1BQV3749L5)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Lead Chelating Activity - [MoA] (Mechanism of Action)
  • Lead Chelator - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Jubilant Draximage Inc., Dba Jubilant Radiopharma
Labeler Code: 65174
FDA Application Number: NDA018511 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-29-1989 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Draximage Dtpa Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

DRAXIMAGE® DTPA, after radiolabeling with Technetium Tc 99m, is indicated for

1.1 Brain Imaging

Brain
imaging in adults by intravenous administration.

1.2 Renal Scintigraphy

Renal visualization, assessment of renal perfusion, and estimation
of glomerular filtration rate in adult and pediatric patients by intravenous
administration.

1.3 Lung Ventilation Imaging

Lung ventilation imaging and evaluation
of pulmonary embolism when paired with perfusion imaging in adult
and pediatric patients when administered by nebulizer for inhalation.

2.1 Radiation Safety – Drug Handling

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)].

  • The recommended dose ranges for intravenous
  • Or inhalation administration of DRAXIMAGE® DTPA, after reconstitution, are presented in Table 1 through Table 3.Do not administer more than one dose.Table 1 Tc 99m Labeled DRAXIMAGE® DTPA Injection – Intravenous Administration, AdultsIndicationRoute of AdministrationDoseImage AcquisitionBrain ImagingIntravenous Injection370 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 AssessmentIntravenous Injection370 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 RateIntravenous Injection111 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 Injection7.4 to 18.5 MBq(0.2 to 0.5 mCi)Blood sampling only is performed.Table 2 Tc 99m Labeled DRAXIMAGE® DTPA Injection – Intravenous Administration, Pediatric PatientsIndicationRoute of AdministrationDoseImage AcquisitionRenal Visualization and Perfusion AssessmentIntravenous Injection3.7 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 Injection7.4 to 18.5 MBq (0.2 to 0.5 mCi)Blood sampling only is performed.Table 3 Tc 99m Labeled DRAXIMAGE® DTPA – Aerosol Inhalation Administration* For lung
  • Imaging performed after perfusion imaging, target count rate should
  • Be approximately three times that of perfusion count rate.IndicationRoute of AdministrationDoseImage AcquisitionLung Ventilation AdultsAerosol Inhalation925 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 VentilationPediatric PatientsAerosol Inhalation925 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*.

2.3 Administration Instructions

  • Use aseptic technique for all drug preparation and handling.Visually inspect the Tc 99m labeled DRAXIMAGE® DTPA injection after reconstitution for particulate
  • Matter prior to administration. Do not use or administer if there
  • Is evidence of foreign matter or the solution is not clear.Measure the patient dose by a radioactivity calibration
  • System immediately prior to administration.Intravenous
  • UseInstruct the patient to increase fluid intake and to void
  • Frequently for the next 4 to 6 hours after Tc 99m labeled DRAXIMAGE® DTPA administration by injection to minimize the
  • Radiation dose to the bladder.Inhalation
  • UseUse the selected nebulizer in accordance
  • With the manufacturer’s instructions.Instruct the patient to rinse their mouth
  • And expectorate after Tc 99m labeled DRAXIMAGE® DTPA administration by inhalation to minimize the radiation dose
  • To the mouth and esophagus.

2.4 Instructions For Drug Preparation

  • The prepared solution can either be administered
  • Via intravenous injection or aerosolized by nebulizer for inhalation
  • Use.Before reconstitution, inspect the integrity
  • Of the vial.Add 2 to 10 mL [maximum amount 18.5 gigabecquerels
  • (500 mCi)] of sodium pertechnetate Tc 99m injection USP to the reaction
  • Vial. The volume of pertechnetate added should be balanced by the
  • Removal of the same volume of air. Cover the vial shield and invert
  • To mix the contents.Assay the preparation in a calibrator,
  • Record the radio assay information on the label with radiation warning
  • Symbol, and affix it to the reaction vial.After reconstitution, store the solution at 25°C (77°F)
  • In a lead shield and discard after 12 hours; excursions permitted
  • Between 15 and 30°C (59 and 86°F).Allow the preparation to stand for 15 minutes before determining
  • The radiochemical purity of Tc 99m labeled DRAXIMAGE® DTPA injection.After reconstitution, do not vent the vial.

2.5 Determination Of Radiochemical Purity

  • Obtain the following:Two ITLC-SG (1 x 10 cm)0.9% Sodium Chloride Injection USP (for
  • Determination of reduced hydrolyzed technetium)Acetone (for determination of free pertechnetate)Two glass test tubes (18 mm x 150 mm)
  • With stoppersStep
  • 1:System A: Add 1 mL of 0.9% Sodium Chloride Injection USP in an 18
  • Mm x 150 mm test tube. Place the stopper and allow the atmosphere
  • In the tube to equilibrate for 1 minute.System B: Repeat with Acetone in a separate test tube.Step
  • 2:Mark each chromatographic strip with
  • A pencil mark 1.5 cm (see Figure 1 and Figure 2) from one end
  • Of the strip (mark as origin).Place one drop (approximately 0.01 -
  • 0.02 mL) of the Technetium Tc 99m pentetate injection at the origin.For System A (saline), do not allow the
  • Strip to dry.For System B (acetone), dry the strip
  • Using a gentle stream of nitrogen gas.Step
  • 3:Place each strip with the origin end
  • Towards the bottom of the previously equilibrated test tube to develop
  • (the origin must be above the surface of the solvent).Place stopper in the test tube and keep
  • Upright.Step
  • 4:When the solvent front has reached the
  • Top of the strip, remove the strip with forceps and allow it to dry.Step 5:System A – Determination of reduced
  • Hydrolyzed technetium:In System A (saline), reduced hydrolyzed
  • Technetium (99mTcO2) stays at the origin (Rf 0 to 0.1), while
  • The bound technetium and free pertechnetate (99mTcO4–) migrates
  • To the solvent front (Rf 0.85 to 1.0).Cut the dried strip 3 cm from the origin.The short piece is marked as Part I and the long piece is marked as Part II.Count the pieces in a counter and determine
  • The percentage of reduced hydrolyzed technetium according to the following
  • Formula:Figure 1 System A DiagramSystem B – Determination of free
  • Pertechnetate:In System B (acetone), the bound technetium
  • And reduced hydrolyzed technetium (99mTcO2) stay at the origin (Rf 0 to
  • 0.1), while free pertechnetate (99mTcO4–) migrates to the solvent
  • Front (Rf 0.85 to 1.0).Cut the dried strip 2 cm from the solvent
  • Front end.The short piece is marked Part
  • III and the long piece is marked Part IV.Count the pieces in a counter and determine
  • The percentage of free pertechnetate according to the following formula:Figure 2 System B DiagramStep
  • 6:Determine the radiochemical purity according
  • To the following formula: Use Technetium Tc 99m pentetate injection
  • Only if the radiochemical purity is 90% or greater.

2.6 Radiation Dosimetry

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.Table 4 Estimated Radiation Absorbed Dose for Technetium
Tc 99m Pentetate Injection in Patients With Normal Renal Function
Following Intravenous InjectionAbsorbed Dose Per Unit Activity Administered (μGy/MBq)OrganAdult15 Years10 Years5 Years1 YearAdrenals1.41.82.74.07.2Bone
surfaces2.42.94.36.110Brain0.861.11.72.84.9Breast0.720.921.32.24.1Gallbladder
wall1.52.13.85.06.1Gastrointestinal
tractEsophagus1.01.31.93.05.4Stomach wall1.31.72.84.06.8Small intestine wall2.53.14.97.010Colon wall3.13.96.08.111Upper large intestine wall2.12.84.36.59.2Lower large intestine wall4.35.48.21013Heart
wall1.21.52.23.35.9Kidneys4.45.37.51118Liver1.21.62.53.86.4Lungs1.01.32.03.05.5Muscles1.62.03.04.36.8Ovaries4.25.37.71013Pancreas1.41.82.84.37.4Red
marrow1.51.82.73.75.7Skin0.871.01.72.64.4Spleen1.31.62.63.96.8Testes2.94.06.89.413Thymus1.01.31.93.05.4Thyroid1.01.32.13.36.0Urinary
bladder wall6278110150170Uterus7.99.6151822Remaining
organs1.72.13.04.26.6Effective dose per unit activity(μSv/MBq)4.96.39.41216Table 5 Estimated Radiation Absorbed Dose for Technetium
Tc 99m Pentetate Injection in Patients With Abnormal Renal Function
Following Intravenous InjectionAbsorbed Dose Per Unit Activity Administered (μGy/MBq)OrganAdult15 Years10 Years5 Years1 YearAdrenals4.15.17.61121Bone
surfaces6.07.1111528Brain2.83.55.79.116Breast2.33.04.26.813Gallbladder
wall4.25.79.21316Gastrointestinal
tractEsophagus3.34.26.29.617Stomach wall3.85.07.91119Small intestine wall4.55.68.51322Colon wall4.55.88.71322Upper large intestine wall4.35.68.11321Lower large intestine wall4.96.19.51323Heart
wall3.74.77.01018Kidneys7.79.2131932Liver3.74.67.11119Lungs3.34.26.29.517Muscles3.24.06.19.117Ovaries5.06.29.21423Pancreas4.35.38.01221Red
marrow3.44.26.49.316Skin2.22.64.26.712Spleen3.84.77.31119Testes3.54.56.91018Thymus3.34.26.29.617Thyroid3.44.26.71119Urinary
bladder wall2127395066Uterus6.17.4111625Remaining
organs3.34.16.39.717Effective dose per unit activity(μSv/MBq)4.65.88.71321The estimated radiation
absorbed dose to various organs from the inhalation of Tc 99m Pentetate
Injection is shown in Table 6.Table 6 Estimated Radiation Absorbed Dose for Technetium
Tc 99m Pentetate Injection Administered by InhalationAbsorbed Dose Per Unit Activity Administered (μGy/MBq)OrganAdult15 Years10 Years5 Years1 YearAdrenals2.12.94.46.712Bone
surfaces1.92.43.55.39.8Breast1.91.93.34.87.8Gastrointestinal
tractStomach wall1.72.23.55.18.9Small intestine wall2.12.64.16.311Upper large intestine wall1.92.43.86.110Lower large intestine wall3.24.26.38.815Kidneys4.15.17.21119Liver1.92.53.75.59.7Lungs17263654100Ovaries3.34.16.18.915Pancreas2.12.64.06.111Red
marrow2.73.44.76.29.6Spleen1.92.43.65.69.9Testes2.13.15.27.915Thyroid0.991.72.74.47.8Urinary
bladder wall475884120230Uterus5.97.2111627Other
tissue1.82.23.24.98.6Effective dose per unit activity(μSv/MBq)5.98.0111731

3 Dosage Forms And Strengths

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.

4 Contraindications

Hypersensitivity to the active
ingredient or to any component of the product [see Warnings
and Precautions (5.1)].

5.1 Hypersensitivity Reactions

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.

5.2 Image Interpretation Risks In Lung Ventilation Studies

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.

5.3 Radiation Exposure Risk

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.

5.4 Bronchospasm In Lung Ventilation Studies

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.

6 Adverse Reactions

  • 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:Immune system disorders: allergic reaction,
  • Anaphylactic reaction, angioedema.Skin and subcutaneous tissue disorders:
  • Rash, itching, hives, erythema.Respiratory, thoracic and mediastinal
  • Disorders: throat irritation, wheezing.Vascular disorders: hypotension, hypertension.Nervous system disorders: headache, fainting,
  • Dizziness.General disorders and administration
  • Site conditions: chills.Gastrointestinal disorders: nausea, vomiting.Cardiac disorders: cyanosis, tachycardia.

8.1 Pregnancy

Risk SummaryLimited 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.DataHuman DataLimited 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.

8.2 Lactation

Risk SummaryThere 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.

8.4 Pediatric Use

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)].

8.5 Geriatric Use

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.

11.1 Chemical Characteristics

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.

11.2 Physical Characteristics

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.Table 7 Principal Radiation Emission DataRadiationMean %
per DisintegrationMean Energy
(keV)Gamma-288.5140.5The 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.Table 8 Radiation Attenuation by Lead ShieldingShield
Thickness (Pb) cmCoefficient
of Attenuation0.250.5110-1210-2310-3410-4To correct for physical
decay of this radionuclide, the fractions that remain at selected
intervals after the time of calibration are shown in Table 9.Table 9 Physical Decay Chart of Technetium 99mTc, Half Life: 6 Hours*Calibration TimeHoursFraction
RemainingHoursFraction
Remaining0*1.00050.56210.89160.50120.79480.39830.708100.31640.631120.251

12.1 Mechanism Of Action

Intravenous AdministrationFollowing 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 AdministrationFollowing inhalation of the aerosol, Technetium Tc 99m pentetate
deposits on the epithelium of ventilated alveoli.

12.2 Pharmacodynamics

Brain ImagingTechnetium 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 ScintigraphyThe first few minutes after intravenous administration,
Technetium Tc 99m pentetate is present in the vascular compartment
within the renal system.Lung Ventilation
ImagingIn 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.

12.3 Pharmacokinetics

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.AbsorptionFollowing 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.DistributionFollowing 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.EliminationMetabolismTechnetium Tc
99m pentetate is not metabolized.ExcretionAfter 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%.

16.1 How Supplied

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:Carton containing 5 (five) kits NDC 65174.288.05Carton containing 30 (thirty) kits NDC
65174.288.30

16.2 Storage And Handling

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.

17 Patient Counseling Information

Administration InstructionsIntravenous UseAdvise 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
UseTo 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)].PregnancyAdvise pregnant women of the risk
of fetal exposure to radiation if they undergo a radionuclide procedure [see Use in Specific Populations (8.1)].

Other

®Registered Trademark of Jubilant DraxImage Inc.Manufactured for:Jubilant DraxImage
Inc., Kirkland,Quebec, Canada, H9H 4J4.Revised:
February 2018Art Rev.: 1.1

* Please review the disclaimer below.