Epithra 10mg Injection

Brand Name Epithra 10mg Injection
Salt Composition Epirubicin (10mg)
Strength 10mg
Product Form Injection
Pack 1 Injection in 1 Vial
Category Anti Cancer
Country of Origin India
Manufacturer Glenmark Pharmaceuticals Ltd
Manufacturer/Marketer AddressGlenmark Pharmaceuticals Limited, B/2, Mahalaxmi Chambers, 22, Bhulabhai Desai Road, Mumbai – 400 026.
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    Medical Description of Epithra 10mg Injection

    Epithra contains an active substance called Epirubicin hydrochloride. It is an antineoplastic and anthracycline agent. It is a cytotoxic medication recommended in adults and used in the treatment of primary breast cancer. It is used as an orphan drug in the treatment of soft tissue sarcoma, colorectal cancers, non-small cell lung cancer, small cell lung cancer, papillary transitional bladder carcinoma, and prostate cancer.


    Epithra 10mg Injection Uses

    It is used in the treatment of breast cancer. Epirubicin is used in adults only.


    Epithra 10mg Injection Benefits

    Epirubicin is used in the treatment of breast cancer which is hormone dependant. Epithra is used in adults only.

    Breast Cancer:

    Breast cancer is a type of cancer that develops from breast tissue. The most common presenting signs and symptoms of breast cancer is a lump in the breast, a change in breast shape, dimpling of the skin, fluid coming from the nipple, an inverted nipple, red or scaly patch of skin. it is more commonly found in women when compared to men.


    Epithra 10mg Injection Indication

    Epirubicin is used to treat breast cancer as an adjuvant. It is used as an orphan drug in the case of soft tissue sarcoma, colorectal cancers, non-small cell lung cancer, small cell lung cancer, papillary transitional bladder carcinoma, and prostate cancer.


    Mechanism of action of Epithra 10mg Injection

    Epithra contains its active substance called Epirubicin hydrochloride. It is an anthracycline cytotoxic medication, inhibits DNA and RNA replication by acting on DNA topoisomerase 2 that intercalates DNA base pairs. Thus, causes the formation of an impaired DNA sequence containing abnormal cells where apoptosis occurs and results in cell death. Thus, Epithra treats breast cancer and other cancers.


    How Epithra 10mg Injection works

    Epithra contains its active substance called Epirubicin hydrochloride. It is an anthracycline cytotoxic medication, inhibits DNA and RNA replication by acting on DNA topoisomerase 2 that intercalates DNA base pairs. Thus, causes the formation of an impaired DNA sequence containing abnormal cells where apoptosis occurs and results in cell death. Thus, Epithra treats breast cancer and other cancers.


    Epithra 10mg Injection Contraindication

    • if you are allergic to Epithra or its ingredients
    • if you have a liver disorder
    • if you have a blood disorder
    • if you have a heart disorder
    • if you are pregnant
    • if you are breastfeeding


    Epithra 10mg Injection Side Effects

    Common side effects that occur 1:10 patients: Alopecia, Nausea and vomiting, Leukopenia or neutropenia, Amenorrhea, Anemia, Mucositis, Thrombocytopenia, Lethargy, Hot flashes, Diarrhea, Conjunctivitis

    Uncommon side effects that occur 1:100 patients: Rash, Fever, Skin changes, Anorexia

    Rare side effects that occur 1:1,000 patients: Acute lymphoid leukemia, Acute myelogenous leukemia, Atrioventricular block, Esophagitis, Hyperpigmentation, Myelodysplastic syndrome, Myocardial toxicity, Severe myelosuppression, Risk of secondary AML, Sepsis, pneumonia, Anaphylaxis, Dehydration, hyperuricemia, Shock, haemorrhage, embolism arterial, thrombophlebitis, phlebitis, Pulmonary embolism, Erosions, ulcerations, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa, Erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin, urticaria, Red coloration of urine, Fever, chills, Chemical cystitis


    FAQs for Epithra 10mg Injection

    • Is Epithra safe during pregnancy?

    No, taking Epithra during pregnancy is not recommended thus inform your physician if you are pregnant or plan to get pregnant

    • Can Epithra be taken while breastfeeding?

    No, in general, it is suggested that drugs and their metabolites can pass via breastfeeding thus it is suspected that Epithra can also pass via breastfeeding.

    • Can you smoke or use tobacco while using Epithra?

    No, smoking and tobacco use causes interaction with Epithra thus should be avoided.

    • Is Epirubicin injection a vesicant?

    Yes, it is a vesicant that can cause blisters in tissue if the medicine leaks out from the vein

    • How effective is Epirubicin injection?

    It is very effective against various cancer includes breast, ovary, stomach, lung, bowel or rectum, malignant lymphomas, multiple myeloma. The epirubicin inhibit the growth of cancer cell in your body

    • Is Epirubicin injection safe?

    Yes, the injection is safe to use if the dose and duration are prescribed by your doctor.


    Precautions and general warning of Epithra 10mg Injection

    Alcohol

    It is unsafe to consume alcohol. It may cause side effects. Kindly consult with your doctor

    Driving or operating machinery

    Driving or operating heavy machinery may cause side effects thus caution is required. Kindly consult with your doctor.

    Pregnancy

    It is unsafe to use during pregnancy it may cause embryo-fetal toxicity. Kindly consult with your doctor.

    Breast Feeding

    It is unsafe to use during breastfeeding. It may cause toxicity to the child. Kindly consult with your doctor.

    Kidney Problem

    It is safe to use for the patient with mild to moderate kidney problems.No dose adjustment required for severe kidney disease patients. Kindly consult with your doctor.

    Liver Disease

    Dose adjustment is required for the patient with liver disease. Kindly consult with your doctor. 


    How to Take Epithra 10mg Injection

    Epithra is used only in the presence of a physician as an IV only.

    Do not shake the Epithra containing vial while diluting or infusing

    Epithra is compatible with NS or D5W

    The recommended dosage is administered as a slow infusion at the direct line over 3-5mins

    Flush with 5-10ml of fluid before and after administration of Epithra 

    Avoid small veins, swollen veins, edematous limbs on the injection site

    Apply a cold pack on the excavation site 15 to 20mins 4 times/d for 2 days

    After therapy has been initiated, do not take more or less of this drug than prescribed or stop taking it without your physicians’ approval. Skipping or changing your dose without approval may cause adverse effects making the condition more difficult to treat, or worsen side effects.


    Use of Epithra 10mg Injection in Adult

    If you are pregnant or breastfeeding inform your physician as they are not advisable.

    The recommended dosage of Epithra in breast cancer is 100mg /m2 IV with 5- fluorouracil 500mg/m2 IV and cyclophosphamide 500mg/m2 IV repeat every 21days for 6 cycles.

    Dosage modification is required in the case of hemotoxicity, bone marrow dysfunction, renal impairment and hepatic impairment


    Use of Epithra 10mg Injection in children

    It is not recommended in children


    Use of Epithra 10mg Injection in Elderly Patients

    Epithra has only been used in few patients 65 years or older. Dosage and usage are similar to adults. Discuss with your physician before usage.


    Other general warnings

    • Allergic reactions - It can be mild hypersensitivity and angioedema to severe like Stevens-Johnson Syndrome and toxic epidermal necrolysis.
    • Cardiotoxic – MI/CHF/cardiomyopathy
    • Secondary leukaemia – AML/myelodysplastic syndrome
    • Myelosuppression
    • Hepatotoxic
    • Infusion reaction


    Talk to your doctor if

    • If you have any allergy
    • If you have a liver problem
    • If you have a kidney problem
    • If you have a heart problem
    • If you are pregnant or breastfeeding


    General instructions

    It is given intravenously in the presence of a physician. It must be kept at 8C temperature. Do not store after a single use.


    Drug Interaction of Epithra 10mg Injection

    Drug-Drug Interaction

    Deferiprone + Epirubicin

    Use alternative drugs because the combination of this drug either increases the toxicity of the other by pharmacodynamic synergism. 

    Belatacept + Epirubicin 

    Therapy should be administered with caution because the combination of this drug may increase the immunosuppressive effects and also increase the risk for developing infection

    Cimetidine + Epirubicin 

    Therapy should be administered with caution because the use of cimetidine increase the effect of epirubicin by decreasing its metabolism

    Sipuleucel-T + Epirubicin 

    Closely monitor the therapy because the use of epirubicin decreases the effect of sipuleucel-T by pharmacodynamic antagonism.

    Hydroxyurea + Epirubicin 

    Therapy should be administered with caution because the combination of this drug increase the risk of myelosuppression

    Drug-Food Interaction

    Epithra can be taken with any type of food if doubts arise. kindly consult with your doctor. It generally causes side effects thus it is advised not to be taken with alcohol. The use of alcohol, while you are receiving this therapy, may cause liver damage. You may experience fever, swelling, bleeding, skin rash, itching, loss of appetite, nausea, vomiting, abdominal pain, dark coloured urine if you have liver damage immediately consult with your doctor. Do not smoke while taking this medicine. Do not use tobacco while taking Epithra.

    Drug-Disease Interaction

    Myelosuppression

    Before initiating the treatment with epirubicin, you should be very clear that the patient should be free from acute toxicities like neutropenia, thrombocytopenia, stomatitis and infection because the use of epirubicin may increase the risk of developing myelosuppression

    Liver diseases:

    Therapy should be administered with caution because the drug gets eliminated through the hepatobiliary system. Before initiating the treatment evaluate the patient's bilirubin and AST level. If it is safe to prescribe in low doses.

    Heart diseases:

    The  use of this drug is contraindicated in patients who are having heart disease includes myocardial infarction, arrhythmia and it also increases the risk of developing cardiac toxicity 


    Over Dose

    In the case of overdosage kindly consult with your doctor


    Missed Dose

    In case of missed dose Kindly consult with your doctor


    Storage and Disposal

    Keep the medication out of children’s reach

    Keep the medication away from pets

    Once expired dispose immediately

    Store at 8ºC


    Fast Tag

    Epithra is an antineoplastic drug

    It is an anthracycline derivative

    It is used to control and treat breast cancer as an adjuvant

    Do not use this medication while pregnant and lactation period.

    Don’t use this medication with liver disease or renal diseases or cardiac disorders.