RENOCRIT 2000iu Prefilled Syringe(Pfs) 0.5ml

Introduction About RENOCRIT 2000IU PREFILLED SYRINGE(PFS)

RENOCRIT 2000IU PREFILLED SYRINGE(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.

RENOCRIT 2000IU PREFILLED SYRINGE(PFS) is suitable for use both in adults and in
children. During management with RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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.

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

Uses Of RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) Works

RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS)

RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS).

!### Alcohol

Consult your doctorAvoid consum
SYRINGE(PFS).

!### Kidney

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

!### Liver

Use with CautionRENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) if
you are allergic to Epoetin Alfa.

Heart Disease

Consult your doctorRENOCRIT 2000IU PREFILLED SYRINGE(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 doctorRENOCRIT 2000IU PREFILLED SYRINGE(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 CautionRENOCRIT 2000IU PREFILLED SYRINGE(PFS) should be used with caution in elderly
patients. Therefore, consult your doctor before receiving it.

Others

RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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:

RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) out of reach of children
• Store RENOCRIT 2000IU PREFILLED SYRINGE(PFS) in a refrigerator (2-8°C)
• Do not freeze

FAQs About RENOCRIT 2000IU PREFILLED SYRINGE(PFS)

Q: What is the use of RENOCRIT 2000IU PREFILLED SYRINGE(PFS)?

A: RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) works?

A: RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) is administered?

A: RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS)?

A: Before receiving RENOCRIT 2000IU PREFILLED SYRINGE(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. RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) safe?

A: RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS)?

A: The most common side effects of receiving RENOCRIT 2000IU PREFILLED
SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) once my symptoms subside?

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

Q: Can I use RENOCRIT 2000IU PREFILLED SYRINGE(PFS) during pregnancy?

A: It is not known whether the use of RENOCRIT 2000IU PREFILLED SYRINGE(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 RENOCRIT 2000IU PREFILLED SYRINGE(PFS) be used in children?

A: RENOCRIT 2000IU PREFILLED SYRINGE(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