LUTATHERA Solution for infusion Ref.[10985] Active ingredients: Lutetium ¹⁷⁷Lu oxodotreotide

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Advanced Accelerator Applications, 20 rue Diesel, 01630 Saint Genis Pouilly, France

Product name and form

Lutathera 370 MBq/mL solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless to slightly yellow solution.

Qualitative and quantitative composition

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
Sodium acetate
Gentisic acid
Ascorbic acid
Pentetic acid
Sodium chloride
Sodium hydroxide
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Advanced Accelerator Applications, 20 rue Diesel, 01630 Saint Genis Pouilly, France

Marketing authorization dates and numbers

EU/1/17/1226/001

Date of first authorisation: 26 September 2017

Drugs

Drug Countries
LUTATHERA Austria, Estonia, Spain, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Poland, United States

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