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Epofer 4000IU Injection 1'S
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INTRODUCTION
EPOFER 4000IU INJECTION contains Epoetin Alfa which belongs to the group of medicines called Erythropoiesis-stimulating agents. It is used to treat anemia caused due to chronic kidney disease (CKD), chemotherapy, anti-viral therapy (Ex. zidovudine), blood donation or due to any bone marrow disorders/cancers (such as myelodysplastic syndromes).
It can also be used to prevent or manage anemia in patients who are planning to undergo any major bone surgery (such as hip or knee replacement operations). It may also reduce the potential need for blood transfusion in cancer patients and in patients undergoing bone surgery or chemotherapy.
EPOFER 4000IU INJECTION is suitable for use both in adults and in children. During treatment with EPOFER 4000IU INJECTION your doctor will constantly monitor your blood pressure and iron levels in blood and will adjust the dose accordingly to avoid the risk of unwanted side effects.
Before receiving EPOFER 4000IU INJECTION inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have high blood pressure, diabetes, obesity, breast cancer, head and neck cancer, fits, previous history of blood clots or if you are undergoing dialysis or any surgery as a precaution.
EPOFER 4000IU INJECTION is not recommended for use in patients with recent heart attack or stroke. It is also not suitable for use in patients having severe uncontrollable high blood pressure and pure red aplastic anemia (a condition in which the bone marrow cannot produce RBC).
Inform your doctor before receiving EPOFER 4000IU INJECTION if you are pregnant or breastfeeding as a precaution. The most common side effects of receiving EPOFER 4000IU INJECTION are diarrhea, nausea, vomiting, fever, stuffy nose and sore throat. Contact your doctor if any of these side effect worsens.
USES OF EPOFER 4000IU INJECTION
It is used in adults and in children to treat:
- anemia (low RBC in blood) caused due to chronic kidney disease, chemotherapy, anti-viral therapy (Ex. zidovudine), blood donation or any bone marrow disorders/cancers (such as myelodysplastic syndromes)
- prevent or manage anemia in patients undergoing any major bone surgery (such as hip or knee replacement operations)
- reduce the need for blood transfusion in cancer patients and in patients undergoing bone surgery or chemotherapy
HOW EPOFER 4000IU INJECTION WORKS
EPOFER 4000IU INJECTION is an Erythropoiesis-stimulating agent. Following administration, it stimulates the bone marrow to produce red blood cells. It contains a medicine called Epoetin Alfa which acts similar to the endogenous human protein called erythropoietin (a substance that stimulates bone marrow to produce red blood cells).
Therefore, it replaces the lost red blood cells (RBC) in the body of anaemic patients and in patients who are at risk of developing anemia due to chemotherapy, anti-viral therapy or bone marrow disorders.
DIRECTIONS FOR USE
EPOFER 4000IU INJECTION will be given to you only by a doctor or a nurse into the vein (intravenously) or under the skin (subcutaneously). It can also be self-administered by the patient if instructed by the doctor. Carefully follow the instructions given by your doctor in case of self-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 EPOFER 4000IU INJECTION
COMMON
- diarrhoea, nausea, vomiting
- fever, chills, flu-like symptoms
- stuffy nose, sore throat, cough
- signs of high blood pressure (such as severe headaches, confusion and fits)
- signs of blood clots in the body (such as chest pain, breathlessness, pain and tenderness of legs)
- joint pain, muscle pain, arm pain or leg pain
- feeling weak, tired or dizzy
- swollen legs, ankles or feet
- high blood sugar levels
UNCOMMON
- abnormal heart rate due to high blood potassium levels
- fits
RARE
Consult your doctor immediately if you experience any of the following side effects after receiving EPOFER 4000IU INJECTION:
- severe skin reactions (such as skin rash, blistering and peeling of the skin and soft tissues, skin rash on the face, legs, genitals, trunk, reddish target-like spots or circular patches often with central blisters on the trunk, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms)
- signs of allergic reactions (such as skin rash, itching, swelling of the eyes, face, lips, tongue or throat leading to difficulty in breathing or swallowing)
- fits (seizures)
- uncontrollably severe increase in blood pressure
HOW TO MANAGE SIDE EFFECTS
Injection site reactions:
Place an ice pack on the affected area. Do not frequently move the injection site. Consult your doctor if the symptom did not improve.
Feeling dizzy:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
Nausea and Vomiting:
Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your symptom worsens.
Headache:
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
WARNING & PRECAUTIONS
PREGNANCY
It is not known whether the use of EPOFER 4000IU INJECTION can harm the growing baby. Therefore, it should be used in pregnant women and in women planning to become pregnant only if considered necessary by the physician.
BREASTFEEDING
It is not known whether EPOFER 4000IU INJECTION can pass through breast milk or not. Therefore, it should be used in breastfeeding women only if considered necessary by the physician.
DRIVING AND USING MACHINES
Do not drive or handle any heavy tools or machines if your ability is affected by EPOFER 4000IU INJECTION.
ALCOHOL
Avoid consumption of alcohol before receiving EPOFER 4000IU INJECTION.
KIDNEY
EPOFER 4000IU INJECTION should be used with caution in patients undergoing dialysis. Therefore, consult your doctor before receiving it.
LIVER
EPOFER 4000IU INJECTION should be used with caution in patients suffering from liver diseases. Therefore, consult your doctor before receiving it.
ALLERGY
Talk to your doctor before receiving EPOFER 4000IU INJECTION if you are allergic to Epoetin Alfa.
HEART DISEASE
EPOFER 4000IU INJECTION is not recommended for use in patients with severe heart diseases (including recent heart attack). It should be used with caution in patients with other mild heart problems. Therefore, consult your doctor before receiving it.
OTHERS
EPOFER 4000IU INJECTION is not recommended for use if you:
- have Pure Red cell aplasia (a condition in which bone marrow cannot produce red blood cells)
- have uncontrollable high blood pressure
- have severe disorders of blood vessels in the body
- had stroke recently
- cannot have blood transfusion with your own blood
- cannot take blood thinning medicines
Before receiving EPOFER 4000IU INJECTION inform your doctor if you have:
- have diabetes
- are obese or overweight
- have a previous history of blood clots in the body
- are bed-ridden for a prolonged period
- have or ever suffered a high blood pressure
- have or ever had epilepsy (fits)
- have anemia of other causes not listed above
- have porphyria (a rare inherited blood disorder)
- have head and neck cancer, breast cancer
Use in paediatrics:
EPOFER 4000IU INJECTION should be used in children and in adolescents (aged below 18 years) only if prescribed by the physician. It is not suitable for use in young babies (aged below 1 year). Therefore, consult your doctor for advice before administration.
Use in geriatrics:
EPOFER 4000IU INJECTION should be used with caution in elderly patients. Therefore, consult your doctor before receiving it.
INTERACTIONS
A. Drug-Drug interactions:
Before receiving EPOFER 4000IU INJECTION, inform your doctor if you are taking any of the following medicines such as:
- cyclosporin (a medicine used for immunosuppression in organ transplant patients)
- iron supplements (medicines used for treating iron deficiency anaemia)
- other blood stimulants (medicines used to stimulate blood cell production) Ex. darbepoetin alfa
- interferons (medicines used to prevent cancer) Ex. interferon alfa 2A
- ribavirin (a medicine used to treat hepatitis C infection)
Overdosage:
EPOFER 4000IU 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 or nurse if you experience any unusual symptoms. Symptoms of overdose might include fits and high blood pressure.
SYNOPSIS
| Drug | : | Erythropoietin Alfa |
| Pharmacological Category | : | Erythropoiesis-stimulating agents |
| Therapeutic Indication | : | Anaemia |
| Dosage Forms | : | Injection, Pre-filled syringe |
MORE INFORMATION
- Keep EPOFER 4000IU INJECTION out of reach of children
- Store EPOFER 4000IU INJECTION in a refrigerator (2-8°C)
- Do not freeze
FAQs ABOUT EPOFER 4000IU INJECTION
What is the use of EPOFER 4000IU INJECTION?
EPOFER 4000IU INJECTION is used to treat anemia caused due to chronic kidney disease (CKD), chemotherapy, anti-viral therapy (Ex. zidovudine), blood donation or due to any bone marrow disorders/cancers (such as myelodysplastic syndromes). It can also be used to prevent or manage anemia in patients who are planning to undergo any major bone surgery (such as hip or knee replacement operations). It may also reduce the potential need for blood transfusion in cancer patients and in patients undergoing bone surgery or chemotherapy.
How EPOFER 4000IU INJECTION works?
EPOFER 4000IU INJECTION stimulates the bone marrow to produce red blood cells. Therefore, it replaces the lost red blood cells (RBC) in the body of anaemic patients and in patients who are at risk of developing anemia due to chemotherapy, anti-viral therapy or bone marrow disorders.
How EPOFER 4000IU INJECTION is administered?
EPOFER 4000IU INJECTION will be given to you only by a doctor or a nurse into the vein (intravenously) or under the skin (subcutaneously). It can also be self-administered by the patients if advised by the physician. Carefully, follow the instructions given by the doctor in case of self-administration.
What precautions must be followed while receiving EPOFER 4000IU INJECTION?
Before receiving EPOFER 4000IU INJECTION inform your doctor if you have any liver, kidney or heart problems. You must also inform your doctor if you have high blood pressure, diabetes, obesity, breast cancer, head and neck cancer, fits, previous history of blood clots or if you are undergoing dialysis or any surgery as a precaution. EPOFER 4000IU INJECTION is not recommended for use in patients with recent heart attack or stroke. It is also not suitable for use in patients having severe uncontrollable high blood pressure and pure red aplastic anemia (bone marrow cannot produce RBC). Inform your doctor before receiving EPOFER 4000IU INJECTION if you are pregnant or breastfeeding as a precaution. Regularly visit your doctor and perform all blood tests and ultrasounds recommended by him/her without fail.
Is EPOFER 4000IU INJECTION safe?
EPOFER 4000IU INJECTION is considered safe at the doses administered by the physician. However, consult your doctor if you experience any unusual side effects.
What are the common side effects of receiving EPOFER 4000IU INJECTION?
The most common side effects of receiving EPOFER 4000IU INJECTION are diarrhea, nausea, vomiting, fever, stuffy nose and sore throat. Contact your doctor if any of these side effect worsens.
Can I stop receiving EPOFER 4000IU INJECTION once my symptoms subside?
Do not stop receiving EPOFER 4000IU INJECTION without consulting your doctor. You need to receive EPOFER 4000IU INJECTION for the duration recommended by your doctor to achieve better results.
Can I use EPOFER 4000IU INJECTION during pregnancy?
It is not known whether the use of EPOFER 4000IU INJECTION can harm the growing baby. Therefore, it should be used in pregnant women and in women planning to become pregnant only if considered necessary by the physician.
Can EPOFER 4000IU INJECTION be used in children?
EPOFER 4000IU INJECTION should be used in children and in adolescents (aged below 18 years) only if prescribed by the physician. It is not suitable for use in young babies (aged below 1 year). Therefore, consult your doctor for advice before administration.
REFERENCES
1. KD Tripathi. Drugs Affecting Blood and Blood Formation. Essentials of Medical Pharmacology. 7th edition. 2013. Page - 611.
2. Saumil Patel, Jayesh B. Patel. Epoetin Alfa. Statpearls. NIH. National Library of Medicine, National center for biotechnology information. May 2022. [Accessed on 15th November 2022] https://www.ncbi.nlm.nih.gov/books/NBK554547/#article-21266.s3
3. R Provenzano, L Garcia-Mayol, P Suchinda, B Von Hartitzsch, S B Woollen, R Zabaneh, J C Fink, POWER Study Group. Once-weekly epoetin alfa for treating the anemia of chronic kidney disease. NIH. National Library of Medicine, National center for biotechnology information. Pubmed.gov. June 2004. [Accessed on 15th November 2022] https://pubmed.ncbi.nlm.nih.gov/15224803/
4. Janssen Biologics B.V. Electronic Medicines Compendium (EMC). [Revised in March 2021] [ Accessed on 15th November 2022] https://www.medicines.org.uk/emc/files/pil.1193.pdf
5. Amgen Inc. U.S. Food and Drug Administration. [Revised in September 2017] [Accessed on 15th November 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103234s5363s5366lbl.pdf
6. Janssen-Cilag (New Zealand) Ltd. New Zealand Medicines and Medical Devices Safety Authority [Revised in December 2021] [Accessed on 15th November 2022] https://www.medsafe.govt.nz/profs/datasheet/e/eprexinj.pdf
7. Biocon Biologics India Limited. Erythropoietin Alfa. [Revised in December 2019] [Accessed on 15th November 2022] https://www.biocon.com/docs/domestic-market-pi/onco/ERYPRO%20SAFE%20PI.pdf
8. Janssen Products, LP. Erythropoietin Alfa. [Revised in September 2017] [Accessed on 15th November 2022] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/PROCRIT-pi.pdf
USEFUL DIAGNOSTIC TESTS
- Complete blood count
- kidney function tests
- serum ferritin
AUTHOR DETAILS
Written By Srilekha. R, B.Pharm
Last updated on 18 Nov 2022 | 11:58 AM(IST)
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