Farmorubicin 100 Injection
Epirubicin Hydrochloride
100mg
Pharmaco
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Available as:
Indications
Farmorubicin 100 Injection is used for:
Acute leukaemias; Lymphoma; Multiple myeloma, Breast cancer, Bladder carcinoma
Adult Dose
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
Child Dose
Safety & efficacy not established
Renal Dose
Renal Impairment
SCr >5 mg/dL [>442 micromoles/L]: Decrease dose by 50%; test cardiac ejection fraction via MUGA before starting treatment
Administration
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
Contra Indications
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.
Precautions
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-Lactation
Interactions
Paclitaxel and other anthracyclines. Cimetidine, heparin. Antineoplastic drugs, cardiotoxic drugs, radiation, hepatoactive drugs.
Adverse Effects
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
Mechanism of Action
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.
Note
Farmorubicin 100 100mg Injection manufactured by Pharmaco. Its generic name is Epirubicin Hydrochloride. Farmorubicin 100 is availble in Nepal.
Farmaco Nepal drug index information on Farmorubicin 100 Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.