Recommended Topic Related To:

Neotect

"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.

Dotarem is a gadolinium-based"...

NeoTect

Neotect Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Neotect Kit for the Preparation of Technetium Tc 99m Depreotide Injection is a diagnostic radiopharmaceutical that identifies somatostatin receptor-bearing pulmonary masses in patients presenting with pulmonary lesions on computed tomography and/or chest x-ray who have known malignancy or who are highly suspect for malignancy. Common side effects include headache, dizziness, nausea, and flushing.

For imaging, NeoTect is administered as a peripheral intravenous injection at a single dose of 15 to 20 mCi containing approximately 47g of Technetium Tc 99m radiolabeled Depreotide peptide. Neotect Kit may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, NeoTect should be administered only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Neotect Kit for the Preparation of Technetium Tc 99m Depreotide Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Neotect FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse events were evaluated in clinical studies of 647 adults who received 15.0 to 20.0 mCi Technetium Tc 99m labeled to approximately 47µg of depreotide. Of these adults, 58% were men and 42% women. The mean age was 59.0 years (18-86 years).

Deaths did not occur during the clinical study period. After Technetium Tc 99m Depreotide Injection, serious adverse events were not reported.

At least one adverse event occurred in 29/647 (4.5 %) patients after Technetium Tc 99m Depreotide Injection. Headache was the most commonly reported adverse event (1% of patients). Table 8 lists adverse events reported in 0.5% or more of patients who received Technetium Tc 99m Depreotide Injection.

TABLE 8. ADVERSE EVENTS REPORTED IN ≥ 0.5% OF PATIENTS FOLLOWING NeoTect® (technetium tc 99m depreotide injection) INJECTION IN CLINICAL TRIALS

Number of Patients Exposed 647
Number of Patients with At Least One Adverse Event 29 (4.5%)
Nervous System 13 (2%)
  Headache 7 (1.0%)
  Dizziness 5 (0.8%)
Gastrointestinal System 7 (1.0%)
  Nausea 4 (0.6%)
Vascular (extracardiac) Disorder 3 (0.5%)
  Flushing 3 (0.5%)

Other adverse events which occurred in < 0.5% of patients following administration of NeoTect® (technetium tc 99m depreotide injection) included: arthrosis, back pain, chest pain, diarrhea, fatigue, gait abnormality, glossitis, hemoptysis, hypoaesthesia, infection, leg cramps, lymphocytosis, malaise, pharyngitis, somnolence, taste perversion.

Read the entire FDA prescribing information for Neotect (Technetium Tc 99m Depreotide Injection) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.