Epocept 4000IU Injection 1's

Introduction About EPOCEPT 4000IU INJECTION

EPOCEPT 4000IU INJECTION contains Epoetin Alfa which belongs to the group of
medicines called Erythropoiesis-stimulating agents. It is used to manage 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 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.

EPOCEPT 4000IU INJECTION is suitable for use both in adults and in children.
During management with EPOCEPT 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 EPOCEPT 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.

EPOCEPT 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 EPOCEPT 4000IU INJECTION if you are pregnant
or breastfeeding as a precaution. The most common side effects of receiving
EPOCEPT 4000IU INJECTION are diarrhea, nausea, vomiting, fever, stuffy nose and
sore throat. Contact your doctor if any of these side effect worsens.

Uses Of EPOCEPT 4000IU INJECTION

It is used in adults and in children to manage or reduce the chances of:

• 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),
• anemia in patients undergoing any major bone surgery (such as hip or knee replacement operations)
• need for blood transfusion in cancer patients and in patients undergoing bone surgery or chemotherapy

How EPOCEPT 4000IU INJECTION Works

EPOCEPT 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.

How to use EPOCEPT 4000IU INJECTION

EPOCEPT 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 EPOCEPT 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

Consult your doctor immediately if you experience any of the following side
effects after receiving EPOCEPT 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

!### Dizziness Or Drowsiness

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.

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.

!### 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.

!### Nausea And Vomiting

Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor
if your symptom worsens.

Warning & Precautions

!### Pregnancy

Monitoring requiredIt is not known whether the use of EPOCEPT 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

Monitoring requiredIt is not known whether EPOCEPT 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

Use with CautionDo not drive or handle any heavy tools or machines if your ability is affected
by EPOCEPT 4000IU INJECTION.

!### Alcohol

Consult your doctorAvoid consum

!### Kidney

Use with CautionEPOCEPT 4000IU INJECTION should be used with caution in patients undergoing
dialysis. Therefore, consult your doctor before receiving it.

!### Liver

Use with CautionEPOCEPT 4000IU INJECTION should be used with caution in patients suffering from
liver diseases. Therefore, consult your doctor before receiving it.

!### Allergy

ContraindicatedTalk to your doctor before receiving EPOCEPT 4000IU INJECTION if you are
allergic to Epoetin Alfa.

!### Heart Disease

Consult your doctorEPOCEPT 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.

!### Use In Pediatrics

Consult your doctorEPOCEPT 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

Use with CautionEPOCEPT 4000IU INJECTION should be used with caution in elderly patients.
Therefore, consult your doctor before receiving it.

Others

EPOCEPT 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 EPOCEPT 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

Interactions

A. Drug-Drug interactions:

Before receiving EPOCEPT 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 managing iron deficiency anaemia)
• other blood stimulants (medicines used to stimulate blood cell production) Ex. darbepoetin alfa
• interferons (medicines used to manage cancer) Ex. interferon alfa 2A
• ribavirin (a medicine used to manage hepatitis C infection)

Overdosage:

EPOCEPT 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

Storage

• Keep EPOCEPT 4000IU INJECTION out of reach of children
• Store EPOCEPT 4000IU INJECTION in a refrigerator (2-8°C)
• Do not freeze

FAQs About EPOCEPT 4000IU INJECTION

Q: What is the use of EPOCEPT 4000IU INJECTION?

A: EPOCEPT 4000IU INJECTION is used to manage 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 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.

Q: How EPOCEPT 4000IU INJECTION works?

A: EPOCEPT 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.

Q: How EPOCEPT 4000IU INJECTION is administered?

A: EPOCEPT 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.

Q: What precautions must be followed while receiving EPOCEPT 4000IU INJECTION?

A: Before receiving EPOCEPT 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. EPOCEPT 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
EPOCEPT 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.

Q: Is EPOCEPT 4000IU INJECTION safe?

A: EPOCEPT 4000IU INJECTION is considered safe at the doses administered by the
physician. However, consult your doctor if you experience any unusual side
effects.

Q: What are the common side effects of receiving EPOCEPT 4000IU INJECTION?

A: The most common side effects of receiving EPOCEPT 4000IU INJECTION are
diarrhea, nausea, vomiting, fever, stuffy nose and sore throat. Contact your
doctor if any of these side effect worsens.

Q: Can I stop receiving EPOCEPT 4000IU INJECTION once my symptoms subside?

A: Do not stop receiving EPOCEPT 4000IU INJECTION without consulting your
doctor. You need to receive EPOCEPT 4000IU INJECTION for the duration
recommended by your doctor to achieve better results.

Q: Can I use EPOCEPT 4000IU INJECTION during pregnancy?

A: It is not known whether the use of EPOCEPT 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.

Q: Can EPOCEPT 4000IU INJECTION be used in children?

A: EPOCEPT 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.

Useful Diagnostic Tests

• Complete blood count (CBC)
• kidney function tests (KFT)
• Complete Blood Count (CBC)/ Hemogram
• Advance Hormones