Doxorubicin(Myocet) 50mg powder, dispersion and solvent for concentrate for dispersion for infusion(四)
re were nine cases of accidental extravasation of Myocet, none of which were associated with severe skin damage, ulceration or necrosis.
Infusion associated reactions
When infused rapidly acute reactions associated with liposomal infusions have been reported. Reported symptoms have included flushing, dyspnoea, fever, facial swelling, headache, back pain, chills, tightness in the chest and throat, and/or hypotension. These acute phenomena may be avoided by using a 1-hour infusion time.
Other
For precautions regarding the use of Myocet with other medicinal products, see section 4.5.
As for other anthracyclines and doxorubicin products, radiation recall may occur in previously irradiated fields.
Efficacy and safety of Myocet in the adjuvant treatment of breast cancer have not been determined. The importance of apparent differences in tissue distribution between Myocet and conventional doxorubicin has not been elucidated with respect to long-term antitumour efficacy.
4.5 Interaction with other medicinal products and other forms of interaction
Specific medicinal product compatibility studies have not been performed with Myocet. Myocet is likely to interact with substances that are known to interact with conventional doxorubicin. Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporin, verapamil, paclitaxel or other agents that inhibit P-glycoprotein (P-Gp). Interactions with doxorubicin have also been reported for streptozocin, phenobarbital, phenytoin and warfarin. Studies of the effect of Myocet on other substances are also lacking. However, doxorubicin may potentiate the toxicity of other antineoplastic agents. Concomitant treatment with other substances reported to be cardiotoxic or with cardiologically active substances (e.g. calcium antagonists) may increase the risk for cardiotoxicity. Concomitant therapy with other liposomal or lipid-complexed substances or intravenous fat emulsions could change the pharmacokinetic profile of Myocet.
4.6 Fertility, pregnancy and lactation
Women of childbearing potential
Women of childbearing potential should use an effective contraceptive during treatment with Myocet and up to 6 months following discontinuation of therapy.
Pregnancy
Due to the known cytotoxic, mutagenic and embryotoxic properties of doxorubicin, Myocet should not be used during pregnancy unless clearly necessary.
Breast-feeding
Women receiving Myocet should not breastfeed.
4.7 Effects on ability to drive and use machines
Myocet has been reported to cause dizziness. Patients who suffer from this should avoid driving and operating machinery.
4.8 Undesirable effects
During clinical trials, the most frequently reported adverse reactions were nausea/vomiting (73%), leucopoenia (70%), alopecia (66%), neutropenia (46%), asthenia/fatigue (46%), stomatitis/mucositis (42%), thrombocytopenia (31%) and anaemia (30%).
The following adverse reactions have been reported with Myocet during clinical studies and post marketing experience. Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, not known (cannot be estimated from the available data).
All grades
Grades ≥ 3
Infections and infestations
Neutropenic |
