Posology : מינונים

4.2    Posology and method of administration

Mifamurtide treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of osteosarcoma.

Posology

The recommended dose of mifamurtide for all patients is 2 mg/m2 body surface area. It should be administered as adjuvant therapy following resection: twice weekly at least 3 days apart for 12 weeks, followed by once-weekly treatments for an additional 24 weeks for a total of 48 infusions in 36 weeks.

Special populations

Adults > 30 years
None of the patients treated in the osteosarcoma studies were 65 years or older and in the phase III randomised study, only patients up to the age of 30 years were included. Therefore, there are not sufficient data to recommend the use of MEPACT in patients > 30 years of age.

Renal or hepatic impairment
There are no clinically meaningful effects of mild to moderate renal (creatinine clearance (CrCL)≥ 30 mL/min) or hepatic impairment (Child-Pugh class A or B) on the pharmacokinetics of mifamurtide; therefore, dose adjustments are not necessary for these patients. However, as the variability in pharmacokinetics of mifamurtide is greater in subjects with moderate hepatic impairment (see section 
5.2), and safety data in patients with moderate hepatic impairment is limited, caution when administering mifamurtide to patients with moderate hepatic impairment is recommended.
As no pharmacokinetic data of mifamurtide is available in patients with severe renal or hepatic impairment, caution when administering mifamurtide to these patients is recommended. Continued monitoring of the kidney and liver function is recommended if mifamurtide is used beyond completion of chemotherapy until all therapy is completed.

Paediatric population < 2 years
The safety and efficacy of mifamurtide in children aged 0 to 2 years have not been established. No data are available.

Method of administration

MEPACT is administered by intravenous infusion over a period of 1 hour.
MEPACT must not be administered as a bolus injection.

For further instructions on reconstitution, filtering using the filter provided and dilution of the medicinal product before administration, see section 6.6.