QUADRAMET Solution for injection Ref.[10957] Active ingredients: Samarium ¹⁵³Sm lexidronam

Quadramet should only be administered by physicians experienced in the use of radiopharmaceuticals and after full oncological evaluation of the patient by qualified physicians.

Posology

The recommended dose of Quadramet is 37 MBq per kg body weight.

Paediatric population

Quadramet is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.

Method of administration

Quadramet is to be administered by slow intravenous route through an established intravenous line over a period of one minute. Quadramet should not be diluted before use.

Patients who respond to Quadramet generally experience the onset of pain relief within 1 week after treatment. Relief of pain may persist for 4 weeks up to 4 months. Patients who experience a reduction in pain may be encouraged to decrease their use of opioid analgesics.

Repeat administration of Quadramet should be based on an individual patient’s response to prior treatment and on clinical symptoms. A minimum interval of 8 weeks should be respected, subject to recovery of adequate bone marrow function.

The data on the safety of repeated dosing are limited and based on compassionate use of the product.

For instructions on preparation of the medicinal product before administration, see section 12.

The product should only be administered by qualified personnel in authorised settings. The possibility of pharmacological overdose is therefore remote.

The risks to be expected are associated with the inadvertent administration of excess radioactivity. Radiation dose to the body can be limited by promoting a diuresis and frequent voiding of urine.

1 day from the activity reference time stated on the label.

Use within 6 hours of thawing. After thawing, do not freeze again.

Quadramet is delivered frozen in dry ice.

Store in a freezer at -10°C to -20°C in the original package.

Storage procedures should be in accordance with local regulations for radioactive substances.

15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.

Each vial contains 1.5 ml (2 GBq at calibration) to 3.1 ml (4 GBq at calibration) of solution for injection.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.