NEO RECORMON 4000IU Injection 5ml

Introduction About NEO RECORMON 4000IU INJECTION

NEO RECORMON 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.

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

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

Uses Of NEO RECORMON 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 NEO RECORMON 4000IU INJECTION Works

NEO RECORMON 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 NEO RECORMON 4000IU INJECTION

NEO RECORMON 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 NEO RECORMON 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 NEO RECORMON 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 NEO RECORMON 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 NEO RECORMON 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 NEO RECORMON 4000IU INJECTION.

!### Alcohol

Consult your doctorAvoid consum

!### Kidney

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

!### Liver

Use with CautionNEO RECORMON 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 NEO RECORMON 4000IU INJECTION if you are
allergic to Epoetin Alfa.

!### Heart Disease

Consult your doctorNEO RECORMON 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 doctorNEO RECORMON 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 CautionNEO RECORMON 4000IU INJECTION should be used with caution in elderly patients.
Therefore, consult your doctor before receiving it.

Others

NEO RECORMON 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 NEO RECORMON 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 NEO RECORMON 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:

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

FAQs About NEO RECORMON 4000IU INJECTION

Q: What is the use of NEO RECORMON 4000IU INJECTION?

A: NEO RECORMON 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 NEO RECORMON 4000IU INJECTION works?

A: NEO RECORMON 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 NEO RECORMON 4000IU INJECTION is administered?

A: NEO RECORMON 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 NEO RECORMON 4000IU INJECTION?

A: Before receiving NEO RECORMON 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. NEO RECORMON 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 NEO RECORMON 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 NEO RECORMON 4000IU INJECTION safe?

A: NEO RECORMON 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 NEO RECORMON 4000IU INJECTION?

A: The most common side effects of receiving NEO RECORMON 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 NEO RECORMON 4000IU INJECTION once my symptoms subside?

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

Q: Can I use NEO RECORMON 4000IU INJECTION during pregnancy?

A: It is not known whether the use of NEO RECORMON 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 NEO RECORMON 4000IU INJECTION be used in children?

A: NEO RECORMON 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