Doxorubicin(Myocet) 50mg powder, dispersion and solvent for concentrate for dispersion for infusion.
1. Name of the medicinal product
Myocet 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion.
2. Qualitative and quantitative composition
Liposome–encapsulated doxorubicin–citrate complex corresponding to 50 mg doxorubicin hydrochloride (HCl).
Excipient(s) with known effect: The reconstituted medicinal product contains approximately 108 mg sodium for a 50 mg doxorubicin HCl dose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder, dispersion and solvent for concentrate for dispersion for infusion
Myocet is supplied as a three-vial system:
Myocet doxorubicin HCl is a red lyophilised powder.
Myocet liposomes is a white to off-white, opaque and homogeneous dispersion.
Myocet buffer is a clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Myocet, in combination with cyclophosphamide, is indicated for the first line treatment of metastatic breast cancer in adult women.
4.2 Posology and method of administration
The use of Myocet should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy.
Posology
When Myocet is administered in combination with cyclophosphamide (600 mg/m2) the initial recommended dose of Myocet is 60-75 mg/m2 every three weeks.
Older people
Safety and efficacy of Myocet have been assessed in 61 patients with metastatic breast cancer, age 65 and over. Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet in this population was comparable to that observed in patients less than 65 years old.
Patients with hepaticimpairment
As metabolism and excretion of doxorubicin occurs primarily by the hepatobiliary route, eva luation of hepatobiliary function should be performed before and during therapy with Myocet.
Based on limited data in patients with liver metastases, it is recommended that the initial dose of Myocet is reduced in accordance with the following table
Liver function tests
Dose
Bilirubin < ULN and normal AST
Standard dose of 60 - 75mg/m2
Bilirubin < ULN and raised AST
Consider a 25% dose reduction
Bilirubin > ULN but < 50 μmol/l
50% dose reduction
Bilirubin > 50 μmol/l
75% dose reduction
If possible, Myocet should be avoided in patients with bilirubin > 50 μmol/l as the recommendation is based mainly on extrapolations.
For dose reductions due to other toxicity, see section 4.4.
Patients with renal impairment
Doxorubicin is metabolised largely by the liver and excreted in the bile. Therefore dose modification is not required for patients with renal function impairment.
Paediatric population
The safety and efficacy of Myocet in children aged up to 17 years has not been established. No data are available.
Method of administration
Myocet must be reconstituted and further diluted prior to administration. A final concentration of between 0.4 mg/ml to 1.2 mg/ml doxorubicin HCl, is required. Myocet is administered by intravenous infusion over a period of 1 hour.
Myocet must not be administered by the intramuscular or subcutaneous route or as a bolus injection.
For instructions on reconstitution of th