Medicine Overview of Erubin 10mg/5ml Injection
Erubin 10 is used in the treatment of various types of cancers of blood, breast, stomach, lung, ovaries and soft tissues. It also helps to prevent the recurrence of bladder cancer after surgery.
It is given as a drip or infusion vein with extreme caution by a qualified medical professional. It can be used alone, or sometimes given together with certain other medicines as part of combination chemotherapy. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. It makes contraceptive pills less effective, so it advised to both male and female to use reliable contraception during the treatment.
The most common side effects of this medicine include nausea, low blood platelets, hair loss, absence of menstrual periods, fever and rash. It is known to reduce the number of blood cells in your blood thereby, increasing the susceptibility to infections. Infections can sometimes be life threatening. Regular blood tests are required to monitor your blood cells along with kidney, liver and heart function during treatment with this medicine.
Before taking this medicine, tell your doctor if you have liver disease, or have heart problem. Your doctor should also know about all other medicines you are taking as many of these may make this medicine less effective or change the way it works. Inform your doctor if you are pregnant or breastfeeding.
- Cancer
- Low blood platelets
- Nausea
- Hair loss
- Absence of menstrual periods
- Fever
- Anemia (low number of red blood cells)
- Diarrhea
- Weight loss
- Decreased white blood cell count (neutrophils)
- Hot flashes
- Gastrointestinal inflammation
- Rash
- Low energy
- Eye disorder
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Erubin 10 is used alone or in combination with other medicines for the treatment of various types of cancers.
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It is given through a drip into a vein (intravenous infusion) by a doctor or nurse.
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It may make you feel tired or sleepy. Do not drive or do anything that requires mental focus until you know how it affects you.
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Use a reliable contraceptive method to prevent pregnancy while you are taking this medicine and for 6 months after stopping treatment.
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Your doctor may get regular blood tests done to monitor your blood cells, liver, and heart function during treatment with this medicine.
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Inform your doctor immediately if you notice any signs of infection such as fever, sore throat or rash.
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
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
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.
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
>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
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
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