Curium Announces Approval of Generic DTPA - Kit for the Preparation of Technetium Tc 99m Pentetate Injection in the U.S.

/EIN News/ -- ST. LOUIS, April 02, 2025 (GLOBE NEWSWIRE) -- Curium announced today that the U.S. Food and Drug Administration approved its generic version of the Kit for the Preparation of Technetium Tc 99m Pentetate Injection, often referred to as DTPA (diethylenetriaminepentaacetic acid). Technetium Tc 99m pentetate is a radioactive diagnostic most often used for lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients and administered by nebulizer for inhalation among other indications. Curium is now able to offer hospitals and nuclear pharmacies a suite of products used in ventilation/perfusion (V/Q) scans, streamlining product fulfillment and bolstering the supply chain to include a second supplier of this medication. Reimbursement for this medication is well established using HCPCS Code A9539. Curium will begin accepting orders immediately.

Mike Patterson, Curium’s North American Chief Executive Officer said: “Customers are looking to simplify their business. Our generic version of DTPA allows Curium to offer a more comprehensive list of products used in V/Q scans, which helps customers simplify and manage their supply chain.”

Andy Farrow, Senior Vice President, Commercial & Contracting said: “Curium now has the potential to provide a list of products to perform a V/Q scan including generic DTPA, Xenon Xe 133 Gas and Pulmotech^TM MAA. Curium is committed to becoming a ‘one stop shop’ for most customers in need of products used to perform V/Q scans. Curium continues to expand its portfolio of products and we are excited to add generic DTPA to that list.”

For a full listing of all indications of Curium’s DTPA, please see the Indications and Usage section of the Prescribing Information listed in this release.

About Kit for the Preparation of Technetium Tc 99m Pentetate Injection

INDICATIONS AND USAGE
Kit for the Preparation of Technetium Tc 99m Pentetate Injection, after radiolabeling with Technetium Tc 99m, is indicated for:

• Brain imaging in adults by intravenous administration.
• Renal visualization, assessment of renal perfusion, and estimation of glomerular filtration rate in adult and pediatric patients by intravenous administration.
• Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.
  

IMPORTANT RISK INFORMATION

CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any component of the product.

WARNINGS AND PRECAUTIONS
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.

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.

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.

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.

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.

ADVERSE REACTIONS
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.

USE IN SPECIFIC POPULATIONS
Pregnancy: 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. 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% to 4% and 15% to 20%, respectively.

Lactation: 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 breastfeeding 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.

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.

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.

To report suspected adverse reactions, contact CURIUM US LLC at 1-866-789-2211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information at https://www.curiumpharma.com/wp-content/uploads/DTPA-PI.pdf.

About Pulmotech^TM MAA (kit for the preparation of technetium Tc 99m albumin aggregated) injection

Indications and Usage

PULMOTECH MAA, after radiolabeling with technetium-99m, is indicated for:

• Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.
• Peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adults.

IMPORTANT RISK INFORMATION

CONTRAINDICATIONS
PULMOTECH MAA is contraindicated in patients with:

• Severe pulmonary hypertension.
• A history of hypersensitivity to albumin human. Reactions have included anaphylaxis.

WARNINGS AND PRECAUTIONS

Pulmonary Hypertension: Administer the lowest number of particles possible, have emergency resuscitation equipment available, and monitor patients for adverse reactions.

Hypersensitivity Reactions: Have emergency resuscitation equipment and trained personnel available prior to administration of Technetium Tc 99m Albumin Aggregated Injection. Interrupt the administration if a reaction occurs during administration. Monitor patients.

ADVERSE REACTIONS
The following adverse reactions have been reported: Death in patients with severe pulmonary hypertension, anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, blood pressure, chest pain, possible syncope, urticaria, reddening of the face, sweating, nausea, and injection site reaction.

Please see full Prescribing Information at https://www.curiumpharma.com/PulmotechMAA.

About Xenon Xe 133 Gas

Indications and Usage

Xenon Xe 133 Gas has been shown to be valuable for diagnostic inhalation studies for the evaluation of pulmonary function, for imaging the lungs and may also be applied to assessment of cerebral blood flow.

IMPORTANT RISK INFORMATION

Warnings and Precautions

• Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into the laboratory environs not specifically protected by exhaust systems.
• Xenon Xe 133 Gas adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. Loss of radioactivity due to such adherence may render the study nondiagnostic.
• Xenon Xe 133 Gas as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management.
  

Please see full Prescribing Information at https://www.curiumpharma.com/xenon-xe-133-gas.

About Curium

Curium is a world leader in nuclear medicine. We develop, manufacture, and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive materials researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. To learn more, visit www.curiumpharma.com

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