FARMORUBICIN RAPID DISSOLUTION 10mg/5ml Infusion

FARMORUBICIN RAPID DISSOLUTION 10mg/5ml Infusion is used for: Acute leukaemias; Lymphoma; Multiple myeloma, Breast cancer, Bladder carcinoma

Adjuvant Breast Cancer Treatment Option 1 (Day 1 dose schedule) Day 1: Epirubicin 100 mg/m² IV, AND 5-fluorouracil 500 mg/m² IV, AND cyclophosphamide 500 mg/m² IV Repeat q21Days x 6 cycles Option 2 (Divided dose schedule) First dose divided equally between days 1 & 8: Epirubicin 60 mg/m² IV, AND 5-fluorouracil 500 mg/m² IV, AND Days 1-14: Cyclophosphamide 75 mg/m² PO Repeat q28Days x 6 cycles Intravenous Lymphoma; Multiple myeloma; Solid tumours; Acute leukaemias Adult: As a single agent: 60-90 mg/m2 every 3-4 wk. May divide dose over 2-3 days if desired. May admin as an inj over 3-5 minutes or as an infusion over up to 30 minutes. Max (total cumulative dose limit): 0.9-1 g/m2. For palliative care: 12.5-25 mg/m2 once wkly. Hepatic Impairment Billirubin < 1.2 mg/dL: Dose adjustment not necessary Bilirubin 1.2-3 mg/dL or AST 2-4 x ULN: 50% of recommended starting dose Bilirubin >3 mg/dL or AST > 4 x ULN: 25% of recommended starting dose (ie, decrease starting dose by 75%) Severe hepatic impairment: Not recommended

Safety & efficacy not established

Renal Impairment SCr >5 mg/dL [>442 micromoles/L]: Decrease dose by 50%; test cardiac ejection fraction via MUGA before starting treatment

IV Administration Administer infuse into tubing of a freely flowing infusion (NS or D5W) over 3-5 min Avoid extravasation, associated with severe ulceration & soft tissue necrosis; flush with 5-10 mL of IV solution before & after drug administration

Cardiac impairment, severe or recent MI; previous full cumulative doses of anthracyclines. Hypersensitivity; severe hepatic dysfunction. Not for intravesical use where invasive tumours have penetrated the bladder wall; urinary infections, bladder inflammation or catheterisation problems. Pregnancy, lactation.

Previous extensive radiotherapy, bone infiltration by tumour, severe renal and hepatic dysfunction. May cause tumor lysis syndrome or radiation recall. Elderly women >70 yr. CV disease, hypertensive cardiomyopathy; monitor hematological and cardiac function regularly. Extravasation during IV admin may result in severe local tissue necrosis. Do not give via IM/SC routes as extravasation can lead to severe local necrosis. Lactation: not known if excreted in breast milk; do not nurse

Pregnancy Verify pregnancy status in female patients of reproductive potential prior to initiating Based on findings from animal studies and mechanism of action, drug can cause fetal harm when administered to a pregnant woman; avoid use during the 1st trimester Available human data do not establish presence or absence of major birth defects and miscarriage related to use during the 2nd and 3rd trimesters; there are reports of fetal and/or neonatal cardiotoxicity following in utero exposure to epirubicin There have been rare reports of fetal and/or neonatal transient ventricular hypokinesia, transient elevation of cardiac enzymes, and a case of fetal demise from suspected anthracycline-induced cardiotoxicity following in utero exposure to epirubicin in 2nd and/or 3rd trimesters Cardiotoxicity is a known risk of anthracycline treatment in adults; monitor fetus and/or neonate for cardiotoxicity and perform testing consistent with community standards of care Advise pregnant women and females of reproductive potential of potential risk to a fetus Contraception Can cause fetal harm in females when administered to a pregnant woman; advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after last dose Based on its mechanism of action and genotoxicity studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after last dose Advise male patients with pregnant partners to use condoms during treatment and for at least 7 days after last dose Infertility Based on clinical findings and animal studies, therapy may impair female fertility and result in amenorrhea; premature menopause can occur; recovery of menses and ovulation is related to age at treatment Based on clinical findings and animal studies in males, therapy may cause oligospermia, azoospermia, and permanent loss of fertility; sperm counts have been reported to return to normal levels in some men; may occur several years after end of therapy Lactation There are no data on presence of drug in human milk, effects on breastfed child, or on milk production; drug is present in rat milk; when a drug is present in animal milk it is likely the drug will be present in human milk Because of potential for serious adverse reactions in breastfed child, advise lactating women not to breastfeed during treatment and for at least 7 days after last dose

Paclitaxel and other anthracyclines. Cimetidine, heparin. Antineoplastic drugs, cardiotoxic drugs, radiation, hepatoactive drugs.

Side effects of Epirubicin Hydrochloride : >10% Alopecia (96%), Nausea and vomiting (92%), Leukopenia or neutropenia (80%), Amenorrhea (72%), Anemia (72%), Mucositis (59%), Thrombocytopenia (49%), Lethargy (46%), Hot flashes (39%), Diarrhea (25%), Conjunctivitis (15%) 1-10% Rash (9%), Fever (5%), Skin changes (5%), Anorexia (3%) <1% Acute lymphoid leukemia, Acute myelogenous leukemia, Atrioventricular block, Esophagitis, Hyperpigmentation, Myelodysplastic syndrome Frequency Not Defined Myocardial toxicity (including CHF), Severe myelosuppression, Risk of secondary AML

Epirubicin, an anthracycline with cytotoxic properties. It inhibits DNA and RNA synthesis by steric obstruction after intercalating between DNA base pairs that triggers DNA cleavage by by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.

FARMORUBICIN RAPID DISSOLUTION 10mg/5ml 2mg/ml Infusion manufactured by PHARMACIA & UPJOHN S.p.A.. Its generic name is Epirubicin Hydrochloride. FARMORUBICIN RAPID DISSOLUTION 10mg/5ml is availble in United Arab Emirates. Farmaco UAE drug index information on FARMORUBICIN RAPID DISSOLUTION 10mg/5ml Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.