Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Advanced Accelerator Applications, 20 rue Diesel, 01630 Saint Genis Pouilly, France
Lutathera 370 MBq/mL solution for infusion.
| Pharmaceutical Form |
|---|
|
Solution for infusion. Clear, colourless to slightly yellow solution. |
One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration.
The total amount of radioactivity per single dose vial is 7,400 MBq at the date and time of infusion. Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution is adjusted between 20.5 mL and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion.
Lutetium (177Lu) has a half-life of 6.647 days. Lutetium (177Lu) decays by β-emission to stable Hafnium (177Hf) with the most abundant β- (79.3%) having a maximum energy of 0.497 MeV. The average beta energy is approximately 0.13 MeV. Low gamma energy is also emitted, for instance at 113 keV (6.2%) and 208 keV (11%).
Excipient with known effect: Each mL of solution contains 0.14 mmol (3.2 mg) of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lutetium ¹⁷⁷Lu oxodotreotide |
Lutetium (177Lu) oxodotreotide has a high affinity for subtype 2 somatostatin receptors (sst2). It binds to malignant cells which overexpress sst2 receptors. Lutetium-177 (177Lu) is a βemitting radionuclide with a maximum penetration range in tissue of 2.2 mm (mean penetration range of 0.67 mm), which is sufficient to kill targeted tumour cells with a limited effect on neighbouring normal cells. |
| List of Excipients |
|---|
|
Acetic acid |
Clear colourless Type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal.
Each vial contains a volume varying from 20.5 to 25.0 mL of solution corresponding to an activity of 7,400 MBq at date and time of infusion.
The vial is enclosed within a lead container for protective shielding.
Advanced Accelerator Applications, 20 rue Diesel, 01630 Saint Genis Pouilly, France
EU/1/17/1226/001
Date of first authorisation: 26 September 2017
| Drug | Countries | |
|---|---|---|
| LUTATHERA | Austria, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, United States |
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