Erypro Safe 2000IU Injection(Pfs) 1ml

Introduction About ERYPRO SAFE 2000IU INJECTION(PFS)

ERYPRO SAFE 2000IU INJECTION(PFS) 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.

ERYPRO SAFE 2000IU INJECTION(PFS) is suitable for use both in adults and in
children. During management with ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) 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.

ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) if you are
pregnant or breastfeeding as a precaution. The most common side effects of
receiving ERYPRO SAFE 2000IU INJECTION(PFS) are diarrhea, nausea, vomiting,
fever, stuffy nose and sore throat. Contact your doctor if any of these side
effect worsens.

Uses Of ERYPRO SAFE 2000IU INJECTION(PFS)

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 ERYPRO SAFE 2000IU INJECTION(PFS) Works

ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS)

ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS)

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 ERYPRO SAFE 2000IU INJECTION(PFS):

• 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 ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS).

!### Alcohol

Consult your doctorAvoid consum

!### Kidney

Use with CautionERYPRO SAFE 2000IU INJECTION(PFS) should be used with caution in patients
undergoing dialysis. Therefore, consult your doctor before receiving it.

!### Liver

Use with CautionERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) if you
are allergic to Epoetin Alfa.

!### Heart Disease

Consult your doctorERYPRO SAFE 2000IU INJECTION(PFS) 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 doctorERYPRO SAFE 2000IU INJECTION(PFS) 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 CautionERYPRO SAFE 2000IU INJECTION(PFS) should be used with caution in elderly
patients. Therefore, consult your doctor before receiving it.

Others

ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS), 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:

ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) out of reach of children
• Store ERYPRO SAFE 2000IU INJECTION(PFS) in a refrigerator (2-8°C)
• Do not freeze

FAQs About ERYPRO SAFE 2000IU INJECTION(PFS)

Q: What is the use of ERYPRO SAFE 2000IU INJECTION(PFS)?

A: ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) works?

A: ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) is administered?

A: ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS)?

A: Before receiving ERYPRO SAFE 2000IU INJECTION(PFS) 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. ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) safe?

A: ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS)?

A: The most common side effects of receiving ERYPRO SAFE 2000IU INJECTION(PFS)
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 ERYPRO SAFE 2000IU INJECTION(PFS) once my symptoms subside?

A: Do not stop receiving ERYPRO SAFE 2000IU INJECTION(PFS) without consulting
your doctor. You need to receive ERYPRO SAFE 2000IU INJECTION(PFS) for the
duration recommended by your doctor to achieve better results.

Q: Can I use ERYPRO SAFE 2000IU INJECTION(PFS) during pregnancy?

A: It is not known whether the use of ERYPRO SAFE 2000IU INJECTION(PFS) 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 ERYPRO SAFE 2000IU INJECTION(PFS) be used in children?

A: ERYPRO SAFE 2000IU INJECTION(PFS) 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