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Biorubin 50mg Injection 1'S
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INTRODUCTION
BIORUBIN 50MG INJECTION contains Epirubicin which belongs to the group of medicines called Anticancer agents. It is used to treat various types of cancer such as breast cancer, ovarian cancer, gastric cancer (stomach cancer), small cell lung cancer, head and neck cancer, liver cancer, blood cancer (leukemia), lymph cancer (lymphoma), pancreatic cancer and colorectal cancer (cancers of colon or rectam).
It can also be used to treat cancers of soft tissues such as soft tissues sarcoma (cancer of the soft tissues that connects muscles, fats, blood vessels, nerves, tendons etc.) and helps in the prevention of bladder cancer following surgeries (such as transurethral resection).
Before receiving BIORUBIN 50MG INJECTION inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have any severe infections, low blood count or any bladder problems (such as problems in passing urine, burning sensation while passing urine etc.) as a precaution.
BIORUBIN 50MG INJECTION is not recommended for use in pregnant or breastfeeding women. Both men and women of childbearing potential must use a suitable contraceptive to avoid pregnancy while undergoing therapy with this medicine. Men may seek advice on sperm preservation, if necessary, prior to the therapy with this medicine.
The most common side effects of receiving BIORUBIN 50MG INJECTION are hair loss, red urine, increased infection, hot flashes, mouth ulcers, inflammation of oesophagus, nausea, vomiting (within first 24 hours), loss of appetite, bladder infection, burning sensation while passing urine and pain, redness and swelling at the site of injection. Consult your doctor if any of these side effects trouble you.
USES OF BIORUBIN 50MG INJECTION
It is used to treat:
- breast cancer
- ovarian cancer
- gastric cancer (stomach cancer)
- small cell lung cancer
- head and neck cancer
- liver cancer (hepatic carcinoma)
- blood cancer (leukemia)
- lymph cancer (lymphoma)
- pancreatic cancer
- colorectal cancer (such as Sigmoid-rectal carcinoma)
- soft tissue sarcoma (cancer of the soft tissues that connects muscles, fats, blood vessels, nerves, tendons etc.)
- and prevent bladder cancer following surgery (such as transurethral resection)
HOW BIORUBIN 50MG INJECTION WORKS
BIORUBIN 50MG INJECTION is an anticancer medication. It works by blocking the synthesis of genetic material (DNA and RNA) and certain essential proteins and enzymes which are required for the cells to grow and multiply. As a result, it prevents abnormal cell division within the body, slows down the growth of cancer cells and eventually kills them.
DIRECTIONS FOR USE
BIORUBIN 50MG INJECTION will be given to you only by a doctor or a nurse into the vein (as an intravenous infusion) or into the bladder (intravesical administration).
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF BIORUBIN 50MG INJECTION
COMMON
- hair loss (including facial hair)
- red urine
- increased infection
- hot flashes
- mouth ulcers, inflammation of oesophagus
- nausea, vomiting (within first 24 hours)
- diarrhoea, dehydration, loss of appetite
- bladder infection or inflammation, sometimes bleeding
- burning sensation while passing urine, urge to pass urine
- injection site reactions (such as pain, redness or burning sensation)
- hyperpigmentation of the skin and mouth
- eye inflammation
UNCOMMON
- swelling at the injection site
- inflammation of the injected vein
RARE
- dizziness
- abnormal heart rate
- skin rash with little bumps on the skin and severe itching
- lack of menstrual periods
- low sperm production
- weakness, fever, chills
Contact your doctor immediately if you experience any of the following side effects after receiving BIORUBIN 50MG INJECTION:
- bone marrow suppression causing low RBC, WBC and platelets leading to increased infections, severe general weakness and increased bleeding tendency
- signs of allergic reactions (such as skin rash, itching, swelling of the face, lips, mouth, or throat which can lead to difficulty in breathing or swallowing, fainting)
- heart problems, shortness of breath, fluid accumulation in the body, liver enlargement, fluid accumulation in the stomach and or lungs, abnormal heart rhythm
- sepsis (blood poisoning)
- shock (dangerous drop in blood pressure with cold skin, rapid shallow breathing, dizziness, weakness, fainting and a rapid weak pulse)
- blood clot formation in the body
- severe cellulitis causing red, swollen skin that feels hot and tender/painful that can spread rapidly to other parts of the body
- severe burning sensation at the site of injection
HOW TO MANAGE SIDE EFFECTS
Injection Site Reactions
Place an ice pack on the injected site. Do not move the affected area frequently. If the symptom worsens, consult your doctor.
Mouth Ulcers
Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel on the affected areas of the mouth if required. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
Consult your doctorThere is no proper information regarding the use of BIORUBIN 50MG INJECTION in pregnant women. Animal studies have indicated harm to the growing offspring. Therefore, BIORUBIN 50MG INJECTION is not recommended for use in pregnant women unless considered necessary by the physician. Women of childbearing potential must use a suitable contraceptive method to avoid pregnancy during the treatment and for at least 6.5 months after the last dose.
BREASTFEEDING
ContraindicatedBIORUBIN 50MG INJECTION is not recommended for use in women who are breastfeeding. Therefore, consult your doctor before receiving it.
DRIVING AND USING MACHINES
Use with CautionBIORUBIN 50MG INJECTION does not affect your ability to drive or handle any heavy tools or machines.
KIDNEY
Consult your doctorBIORUBIN 50MG INJECTION is not recommended to use in patients with severe kidney problems. It should be used with caution in patients with other mild kidney problems. Therefore, consult your doctor before receiving it.
LIVER
Consult your doctorBIORUBIN 50MG INJECTION is not recommended to use in patients with severe liver problems. It should be used with caution in patients with other mild liver problems. Therefore, consult your doctor before receiving it.
ALLERGY
ContraindicatedTalk to your doctor before receiving BIORUBIN 50MG INJECTION if you are allergic to Epirubicin.
HEART DISEASE
Consult your doctorBIORUBIN 50MG INJECTION is not recommended for use in patients with severe heart problems. It should be used with caution in patients with other mild heart problems. Therefore, consult your doctor before receiving it.
USE IN PEDIATRICS
Consult your doctorThe safety and efficacy of BIORUBIN 50MG INJECTION have not been established in children and adolescents (aged below 18 years). Therefore, consult your doctor before receiving it.
USE IN GERIATRICS
Use with CautionBIORUBIN 50MG INJECTION should be used with caution in elderly patients (aged 65 years or above). Therefore, consult your doctor before receiving it.
OTHERS
BIORUBIN 50MG INJECTION is not recommended for use if you:
- have previously received high doses of similar anticancer medicines
- suffer from severely reduced number of blood cells
- have an acute severe infection
- have bladder cancer that has been spread until the bladder wall
- have urinary tract infection
- have pain or inflammation of the bladder
- have problems in emptying your bladder
- pass bloody urine
- have a contracted bladder
Inform your doctor, before receiving BIORUBIN 50MG INJECTION, if you:
- recently received any vaccine or plan to receive any vaccines
- recently had radiation therapy
INTERACTIONS
A. Drug-Drug interactions:
Inform your physician, before receiving BIORUBIN 50MG INJECTION, if you are taking any of the following medicines such as:
- other anticancer medicines (such as doxorubicin, daunorubicin, mitomycin-C, dacarbazine, dactinomycin, 5-fluorouracil, cyclophosphaminde, cisplatin, paclitaxel and docetaxel
- cimetidine (a medicine used to treat stomach ulcer)
- calcium channel blockers (used to treat high blood pressure or other heart conditions) such as amlodipine, nifedipine, diltiazem, verapamil, dexverapamil
- trastuzumab (a medicine used to treat certain cancers like breast cancer)
- rifampicin (a medicine used to treat tuberculosis)
- barbiturates (medicines used to induce sleep and to reduce anxiety) such as phenobarbital
- interferon alpha-2b (immune therapy used in some cancers and lymphomas)
- quinine (a medicine used to treat malaria and leg cramps)
- dexrazoxane (a medicine sometimes used with doxorubicin to reduce the risk of heart problems)
- medicines used for bacterial infections (such as sulfonamides, chloramphenicol)
- phenytoin (a medicine used for fits)
- aminophenazone (a pain killer)
- medicines used to treat HIV infection (such as ritonavir, nelfinavir, saquinavir, indinavir)
- live vaccines
- ciclosporin (a medicine that suppresses the immune system)
Overdosage:
BIORUBIN 50MG INJECTION will be administered to you only by a doctor or a nurse in a hospital, and so it is unlikely to receive an overdose. However, consult your doctor if you experience any unusual symptoms.
SYNOPSIS
| Drug | : | Epirubicin |
| Pharmacological Category | : | Anticancer Antibiotics |
| Therapeutic Indication | : | Different forms of cancer |
| Dosage Forms | : | Injection, Infusion |
MORE INFORMATION
- Keep BIORUBIN 50MG INJECTION out of reach of children
- Store BIORUBIN 50MG INJECTION in a refrigerator between 2-8°C
FAQs ABOUT BIORUBIN 50MG INJECTION
Q: What is the use of BIORUBIN 50MG INJECTION?
A: BIORUBIN 50MG INJECTION is used to treat various types of cancer such as breast cancer, ovarian cancer, gastric cancer (stomach cancer), small cell lung cancer, head and neck cancer, liver cancer, blood cancer (leukemia), lymph cancer (lymphoma), pancreatic cancer and colorectal cancer (cancers of colon or rectam). It can also be used to treat cancers of soft tissues such as soft tissues sarcoma (cancer of the soft tissues that connects muscles, fats, blood vessels, nerves, tendons etc.) and helps in the prevention of bladder cancer following surgeries (such as transurethral resection).
Q: Will men treated with BIORUBIN 50MG INJECTION be able to father a child?
A: No. BIORUBIN 50MG INJECTION may affect sperm production and quality in men. Therefore, men undergoing therapy with BIORUBIN 50MG INJECTION should seek advice on sperm preservation due to the possibility of irreversible infertility caused by therapy. Also, it is important to use an effective contraception or protection methods to avoid pregnancy in your partners during the treatment and for at least 3.5 months after the last dose.
Q: How BIORUBIN 50MG INJECTION works?
A: BIORUBIN 50MG INJECTION is an anticancer medication. It works by blocking the synthesis of genetic material (DNA and RNA) and certain essential proteins and enzymes which are required for the cells to grow and multiply. As a result, it prevents abnormal cell division within the body, slows down the growth of cancer cells and eventually kills them.
Q: How BIORUBIN 50MG INJECTION is administered?
A: BIORUBIN 50MG INJECTION will be given to you only by a doctor or a nurse into the vein (as an intravenous infusion) or into the bladder (intravesical administration).
Q: What are the most common side effects of receiving BIORUBIN 50MG INJECTION?
A: The most common side effects of receiving BIORUBIN 50MG INJECTION are hair loss, red urine, increased infection, hot flashes, mouth ulcers, inflammation of oesophagus, nausea, vomiting (within first 24 hours), loss of appetite, bladder infection, burning sensation while passing urine and pain, redness and swelling at the site of injection. Consult your doctor if any of these side effects trouble you.
Q: Will the use of BIORUBIN 50MG INJECTION cause infertility?
A: Yes. BIORUBIN 50MG INJECTION has the potential to cause infertility in both men and in women. In men, it may reduce sperm production and quality. In women, it may cause early menopause or amenorrhoea (lack of menstrual periods). Therefore, consult your doctor for advice.
Q: Can BIORUBIN 50MG INJECTION cure cancer?
A: The cure rate of cancer depends upon the severity of the disease. However, BIORUBIN 50MG INJECTION acts by preventing the abnormal growth and multiplication of cancer cells in the body, which may help in curing cancer completely.
Q: Can the use of BIORUBIN 50MG INJECTION cause hair loss?
A: Hair loss is one of the common side effects of receiving BIORUBIN 50MG INJECTION. If it bothers you, consult your doctor for advice. This side effect usually disappears and new hair starts regrowing once the therapy with this medicine stops completely.
Q: Can the use of BIORUBIN 50MG INJECTION cause mouth ulcers?
A: Mouth ulcers are one of the common side effects of receiving BIORUBIN 50MG INJECTION. Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel on the affected areas of the mouth if required. Consult your doctor if the symptom did not improve.
Q: Is BIORUBIN 50MG INJECTION a chemo drug?
A: Yes. BIORUBIN 50MG INJECTION contains a medicine called Epirubicin which is a chemotherapeutic agent. It stops abnormal growth and multiplication of cancer cells in the body.
Q: What happens if I stop receiving BIORUBIN 50MG INJECTION?
A: No. Do not stop receiving BIORUBIN 50MG INJECTION without consulting your doctor as it may make your symptoms reappear. Therefore, take BIORUBIN 50MG INJECTION as advised by your doctor for the stipulated duration.
Q: Can BIORUBIN 50MG INJECTION be used during pregnancy?
A: There is no proper information regarding the use of BIORUBIN 50MG INJECTION in pregnant women. Animal studies have indicated harm to the growing offspring. Therefore, BIORUBIN 50MG INJECTION is not recommended for use in pregnant women unless considered necessary by the physician.
Q: Can the use of BIORUBIN 50MG INJECTION make me feel tired?
A: Yes. BIORUBIN 50MG INJECTION may make you feel tired easily. This is because, it reduces the levels of red blood cells in your blood and may make you anaemic. Consult your doctor if you experience tiredness after receiving BIORUBIN 50MG INJECTION. Tiredness can also occur if you have any pre-existing disease conditions such as liver or kidney impairment while taking this medicine.
Q: How to control nausea caused due to BIORUBIN 50MG INJECTION?
A: Generally, anticancer medicines are associated with uncontrollable nausea and vomiting. To avoid this, your doctor would prescribe a suitable medicine to control them along with BIORUBIN 50MG INJECTION. If not, consult your doctor for a suitable anti-emetic medicine. Do not self-treat nausea.
REFERENCES
1. KD. Tripathi. Anticancer Drugs. Essentials of Medical Pharmacology. 7th Edition. 2013. Page – 867.
2. Fang Yang, Qiao Lei, Lu Li, Jian Chang He, Jiajia Zeng, Chunxiang Luo, Sai-Ching Jim Yeung, Runxiang Yang. Delivery of epirubicin via slow infusion as a strategy to mitigate chemotherapy-induced cardiotoxicity. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. November 2017. [Accessed on 4th March 2023] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5683617/
3. Medac GmbH. Epirubicin Hydrochloride 2mg/ml solution for Injection. European Medicines Compendium. [Revised in September 2021]. [Accessed on 4th March 2023] https://www.medicines.org.uk/emc/product/6361/smpc#gref
4. Mayne Pharma Limited. Epirubicin Hydrochloride Injection. U.S. Food and Drug Administration. [Revised in July 2006]. [Accessed on 4th March 2023] https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050807lbl.pdf
5. Pfizer Ltd. Epirubicin Hydrochloride for Injection I.P. Farmorubicin. [Revised in August 2022]. [Accessed on 4th March 2023] https://labeling.pfizer.com/ShowLabeling.aspx?id=15025
6. Generics UK Limited. Epirubicin Hydrochloride 2mg/ml solution for Injection. European Medicines Compendium. [Revised in October 2015]. [Accessed on 4th March 2023] http://www.hpra.ie/img/uploaded/swedocuments/2169453.PA0405_081_001.a3bdab0d-7fe8-4e0f-a5af-f9ec9d3126af.000001Epirubicin%20PIL.151222.pdf
AUTHOR DETAILS
Written By Srilekha. R, B.Pharm
Last updated on 07 Mar 2023 | 01:47 PM(IST)
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