Curium Announces FDA Approval of Generic Version of

ST. LOUIS, April 05, 2022 (GLOBE NEWSWIRE) — Curium today announced that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022 by the United States Food and Drug Administration (FDA) . Ioflupane I 123 Injection is a single photon emission computed tomography (SPECT) brain imaging agent used to aid in the evaluation of adult patients with suspected Parkinsonian syndrome. Curium began accepting customer orders for fulfillment from Monday, April 11.

“The number of patients diagnosed with parkinsonian syndrome is unfortunately increasing. Approximately 1% of the population over the age of 65 is affected and this population is increasing. The addition of Curium’s generic Ioflupane I 123 Injection to the market will provide suitable patients with the option of being scanned Monday through Thursday early in the morning,” said Michael Patterson, North American CEO of Curium. “Offering hospitals and imaging centers the ability to scan patients on a day or at a time not currently available provides flexibility when planning this important study.”

“Injectable ioflupane I 123 is an important tool that many neurologists and movement disorder specialists use to diagnose adult patients with suspected Parkinsonian syndrome,” said Ed Porter, North American Vice President of Medicine and compliance. “Over the past two years, Curium has introduced several new products, both branded and generic, that help physicians diagnose patients. We are excited to add Ioflupane I 123 Injection to this growing list of medications to help patients move forward in life.

DaTscan™ is a registered trademark of GE Healthcare Limited.

About Ioflupane I 123 Injection
INDICATIONS AND USE
Ioflupane I 123 Injection is a radiopharmaceutical indicated for visualization of the striatal dopamine transporter using single photon emission computed tomography (SPECT) brain imaging to aid in the evaluation of adult patients with suspected Parkinsonian syndrome ( SP). In these patients, Ioflupane I 123 Injection can be used to help differentiate essential tremor from tremor due to MS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy). Ioflupane I 123 Injection is an adjunct to other diagnostic assessments.

Ioflupane I 123 Injection has not been designed to distinguish between PD, MSA and PSP. The effectiveness of Ioflupane I 123 Injection as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.

IMPORTANT RISK INFORMATION
Contraindications

  • Ioflupane I 123 Injection is contraindicated in patients with known hypersensitivity to the active substance, to any of the excipients or to iodine.

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions: Hypersensitivity reactions, usually consisting of skin erythema and pruritus, have been reported following administration of Ioflupane I 123 Injection.
  • Thyroid buildup: Ioflupane I 123 injection may contain up to 6% free iodide (iodine 123 or I-123). To decrease the accumulation of I-123 in the thyroid, block the thyroid gland at least one hour before the administration of Ioflupane I 123 Injection; failure to do so may increase the long-term risk of thyroid neoplasia

NEGATIVE REACTIONS

  • In clinical trials, mild to moderate headache, nausea, dizziness, dry mouth, or dizziness have been reported. In post-marketing experience, hypersensitivity reactions and pain at the injection site have been reported.

DRUG INTERACTIONS

  • Drugs that bind to the dopamine transporter with high affinity may interfere with the Ioflupane I 123 Injection image. The impact of dopamine agonists and antagonists on Ioflupane I 123 Injection imaging results has not been established.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Radioactive iodine products cross the placenta and can permanently alter the thyroid function of the fetus. Administration of a thyroid blocking agent is recommended prior to the use of Ioflupane I 123 Injection in pregnant women. All radiopharmaceuticals have the potential to cause fetal harm. There are no data available from the use of Ioflupane I 123 Injection in pregnant women to assess a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Inform pregnant women of the potential risks of radiation exposure to the fetus with the administration of Ioflupane I 123 Injection
  • Lactation: Iodine 123 (I 123), the radionuclide contained in Ioflupane I 123 injection, is present in breast milk. There is no information on the effects on breast-fed infants or milk. Advise a nursing woman to discontinue breastfeeding and to pump and discard breast milk for at least 6 days after administration of Ioflupane I 123 Injection to minimize radiation exposure to a nursing infant
  • Pediatric Use: The safety and effectiveness of Ioflupane I 123 Injection have not been established in pediatric patients.
  • Geriatric Use: There were no differences in responses between elderly and younger patients that would require dose adjustment
  • Renal and hepatic impairment: The effect of renal or hepatic impairment on Ioflupane I 123 Injection imaging has not been established. The kidney excretes Ioflupane I 123 Injection; patients with severe renal impairment may have increased radiation exposure and impaired Ioflupane I 123 injection images

OVERDOSAGE

  • It is not known whether ioflupane is dialysable or not. The main risks of overdose are related to increased exposure to radiation and the long-term risk of neoplasia. In the event of a radioactivity overdose, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient.

PROCEDURE – Radiation Security

  • Ioflupane I 123 Injection emits radiation and should be handled with safety precautions to minimize radiation exposure of clinical staff and patients

Please see full prescribing information by clicking here or by visiting: https://www.curiumpharma.com/Ioflupane-PI.pdf

About Curium

Curium is the largest nuclear medicine company in the world. We develop, manufacture and distribute world-class radiopharmaceuticals to help patients around the world. Our proven heritage combined with a pioneering approach are the hallmarks of delivering innovation, excellence and unparalleled service.

With manufacturing facilities in Europe and the United States, Curium provides therapeutic SPECT, PET and radiopharmaceutical solutions for life-threatening diseases to more than 14 million patients each year. The name “Curium” pays homage to the legacy of the pioneering researchers in the field of radioactive materials, Marie and Pierre Curie, who gave their name to the radioactive element curium, and underlines our interest in nuclear medicine. To learn more, visit curiumpharma.com.

For more information on this press release, please contact Sandy Borgschulte [email protected] or 314.954.6637.

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