Pharmaceutical Imaging Agents

Nuclear Imaging Agents

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IMPORTANT SAFETY INFORMATION FOR DATSCAN 

CONTRAINDICATIONS  

DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: Hypersensitivity reactions, generally consisting of skin erythema and pruritus, have been reported following DaTscan administration

Thyroid Accumulation: The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least one hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia  

ADVERSE REACTIONS

In clinical trials, headache, nausea, vertigo, dry mouth, or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection-site pain have been reported 

DRUG INTERACTIONS

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

USE IN SPECIFIC POPULATIONS

Pregnancy: Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of a thyroid blocking agent is recommended before the use of DaTscan in a pregnant woman. All radiopharmaceuticals have potential to cause fetal harm. There are no available data on DaTscan use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant woman of the potential risks of fetal exposure to radiation with the administration of DaTscan     

Lactation:  Iodine 123 (I 123), the radionuclide in DaTscan, is present in human milk. There is no information on the effects on breastfed infants or on milk. Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for at least 6 days after DaTscan administration to minimize radiation exposure to a breastfeeding infant

Pediatric Use: The safety and efficacy of DaTscan have not been established in pediatric patients

Geriatric Use: There were no differences in responses between elderly patients and younger patients that would require a dose adjustment

Renal and Hepatic Impairment: The effect of renal or hepatic impairment on DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.

OVERDOSAGE

It is unknown whether or not ioflupane is dialyzable. The major risks of overdosage relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient 

PROCEDURE — Radiation Safety

DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients  

Prior to DaTscan administration, please read the full Prescribing Information for additional Important Safety Information.

Product Indications and Important Safety Information About AdreView

PRODUCT INDICATIONS

AdreView  is a radiopharmaceutical indicated for: (1) Use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests and (2) Scintigraphic imaging assessment of sympathetic innervation of the myocardium to assist in the evaluation of adult patients with NYHA Class II or Class III heart failure and left ventricular ejection fraction ≤35% to help identify patients with lower one- and two-year mortality risks, as indicated by a heart-to-mediastinum (H/M) ratio of radioactivity uptake ≥1.6. Limitations: In patients with congestive heart failure (CHF), utility has not been established for selecting therapy, monitoring response to therapy, or identifying a patient with a high risk of death.

CONTRAINDICATIONS 

AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate.