LUTATHERA (Injection) : Drug Approval History

LUTATHERA 

(Active ingredient: Lutetium 177 Dotate)

Lutathera Approval History

• Licensed by FDA: Yes (Licensed first on 26 January 2018)
• Name of Brand:     Lutathera
• Generic name:       Lutetium Lu 177 dotate
• Form of dosage:     Injection
• Company:              Advanced Accelerator Application S.A.
• Treatment for:       Neuroendocrine Gastroenteropancreatic Tumors. 

• LUTATHRA:

(lutetium Lu 177 dotatate) is an analog of Lu-177-labeled somatostatin for the treatment of somatostatin receptor-positive neuroendocrine tumors. 

• Drug Use For?

LUTATHERA is a drug used for the diagnosis of patients who have a particular form of tumor termed a gastroenteropancreatic neuroendocrine tumor (GEP-NET). NETs are unusual cancers that exist in many hormone-producing cells of the body.

LUTATHERA is designed to treat neuroendocrine tumors of the mouth, esophagus, liver, and intestines that have somatostatin receptors. 

• How To Use?

LUTATHERA is delivered directly into the bloodstream by a health care practitioner. This is referred to as intravenous or intravenous infusion. Receiving an injection of LUTATHERA takes about 30 minutes.

LUTATHERA is delivered once every eight weeks with 4 doses in total. 

• Benefits of this drug?

LUTATHERA increased the amount of time the tumors did not develop after (progression free survival) therapy. 

• Side Effetcs: 

The following severe adverse reactions are mentioned elsewhere in the labelling.

• Myelosuppressions
• Myelodysplastic Syndrome and Leukemia
• Toxicity of the kidney
• Hepatotoxicity
• Neuroendocrin Hormone Depression