Darbotin 25Mcg Injectionpfs 1'S

Introduction About DARBOTIN 25MCG INJECTIONPFS

DARBOTIN 25MCG INJECTIONPFS contains Darbepoetin alfa which belongs to the group
of medicines called Erythropoiesis-stimulating agents. It is used to manage
symptomatic anemia associated with chronic renal failure (CRF) in adults and
children. In kidney failure, the kidney does not produce enough erythropoietin
(a natural hormone) which can often cause anemia.

Before DARBOTIN 25MCG INJECTIONPFS management, your doctor may want you to take
blood tests to measure how your anaemia is responding and may adjust your dose
to maintain long-term control of your condition. Your blood pressure will also
be checked regularly, especially at the beginning of your management.

DARBOTIN 25MCG INJECTIONPFS is not recommended for use in patients having high
blood pressure which is not being controlled. Before receiving DARBOTIN 25MCG
INJECTIONPFS, inform your doctor if you have or ever had high blood pressure
which is being controlled with medicines, sickle cell anemia, fits, liver
disease, lack of response to medicines used to manage anemia, latex allergy or
hepatitis C.

DARBOTIN 25MCG INJECTIONPFS should be used with caution in pregnant women.
Patients must not breastfeed while receiving DARBOTIN 25MCG INJECTIONPFS. No
data is available regarding DARBOTIN 25MCG INJECTIONPFS use in children (less
than 1 month old) with CKD receiving and not receiving dialysis. The safety and
efficacy of DARBOTIN 25MCG INJECTIONPFS in children with cancer have not been
established so, consult your child’s doctor for advice.

The most common side effects of receiving DARBOTIN 25MCG INJECTIONPFS are high
blood pressure, allergic reactions, pain around the area injected and rash or
redness of the skin. Call your doctor if any of the symptoms worsen.

Uses Of DARBOTIN 25MCG INJECTIONPFS

Manages symptomatic anemia

• associated with chronic renal failure (CRF) in adults and children
• with non-myeloid malignancies receiving chemotherapy in adult cancer patients

How DARBOTIN 25MCG INJECTIONPFS Works

DARBOTIN 25MCG INJECTIONPFS increases red blood cell counts by stimulating the
bone marrow (soft tissue inside the bones where blood is made) to make more red
blood cells.

How to use DARBOTIN 25MCG INJECTIONPFS

DARBOTIN 25MCG INJECTIONPFS will be given to you only by a doctor or a nurse
either under your skin (subcutaneous) or into a vein (intravenous). Your doctor
will decide on a proper dose and duration depending on your age, body weight and
disease condition. Do not stop receiving DARBOTIN 25MCG INJECTIONPFS unless your
doctor advises you to stop.

Side Effects Of DARBOTIN 25MCG INJECTIONPFS

Common

• high blood pressure
• allergic reactions
• stroke
• pain around the area of injection
• rash or redness of the skin
• blood clots
• fluid retention (swelling)

Uncommon

• convulsions (fits and seizures)
• bruising and bleeding at the site of injection
• blood clots in a dialysis access

Rare

Stop receiving DARBOTIN 25MCG INJECTIONPFS and contact your doctor immediately
if you experience any of the following side effects:

• serious skin rashes like Stevens-Johnson syndrome and toxic epidermal necrolysis (reddish macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and fever or flu-like symptoms)
• severe headache, drowsiness, confusion, eyesight problem, nausea, vomiting or fits (could imply very high blood pressure)
• lack of energy and tiredness (pure red cell aplasia (PRCA)), which means that the body has stopped or reduced the production of red blood cells which causes severe anemia

How To Manage Side Effects

Skin rash:

Avoid hot showers as they can further irritate your skin. Do not scratch the
affected area. Use protective clothing when going outdoors. Regularly moisturize
your skin. If the symptom persists, contact your doctor.

Drowsiness:

Try a few lifestyle changes to improve your energy levels when you feel drowsy
such as taking and maintaining a consistent sleep schedule. Exercise regularly
(such as a daily walk or running) and eat a nutritious diet with plenty of whole
grains, legumes, fruits and vegetables. If the symptom persists, contact your
doctor.

Headache:

Drink plenty of water and get adequate rest. Try to be relaxed and stress-free.
Call your doctor before taking any medicine for headaches. If the headache
persists, consult your doctor.

Nausea:

Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to
simple meals. Avoid eating oily or spicy foods. If the symptom persists, contact
your doctor.

Vomiting:

Get adequate rest. Drink lots of fluids, especially water. Have small sips if
you feel sick. Eat when you feel like it – no need to eat or avoid any specific
foods. If the symptom persists, contact your doctor.

Warning & Precautions

!### Pregnancy

DARBOTIN 25MCG INJECTIONPFS should be used with caution in pregnant women. If
you are pregnant, think you may be pregnant or are planning for a baby, consult
your doctor before receiving it.

!### Breastfeeding

DARBOTIN 25MCG INJECTIONPFS is not recommended for use in breastfeeding women
because it is not known if it is excreted in breast milk. Consult your doctor
before receiving it.

!### Driving and Using Machines

DARBOTIN 25MCG INJECTIONPFS should not affect the ability to drive or use
machines.

!### Kidney

In patients with chronic kidney failure, your doctor will adjust the correct
dose and duration of DARBOTIN 25MCG INJECTIONPFS management depending on your
age, body weight and disease condition. Consult your doctor before receiving
DARBOTIN 25MCG INJECTIONPFS.

!### Liver

DARBOTIN 25MCG INJECTIONPFS should be used with caution in patients with liver
disease and hepatitis C. Consult your doctor before receiving DARBOTIN 25MCG
INJECTIONPFS.

!### Allergy

Before receiving DARBOTIN 25MCG INJECTIONPFS inform your doctor if you are
allergic to Darbepoetin alfa or any of the other ingredients of this medicine or
latex (Ex. needle cap on the pre-filled syringe).

!### Heart Disease

DARBOTIN 25MCG INJECTIONPFS is not recommended for use in patients with high
blood pressure which is not being controlled with other medicines. DARBOTIN
25MCG INJECTIONPFS should be used with caution in patients with high blood
pressure which is being controlled. Consult your doctor before receiving
DARBOTIN 25MCG INJECTIONPFS.

Others

Before receiving DARBOTIN 25MCG INJECTIONPFS, inform your doctor if you have:

• sickle cell anemia
• epile
• convulsions
• lack of response to certain medicines used to manage anemia

Use in pediatrics:

No data is available regarding DARBOTIN 25MCG INJECTIONPFS use in children (less
than 1-month-old) with CKD receiving and not receiving dialysis. The safety and
efficacy of DARBOTIN 25MCG INJECTIONPFS in children with cancer have not been
established so, consult your child’s doctor for advice.

Use in geriatrics:

No differences in safety or efficacy have been observed between older and
younger patients. Consult your doctor before receiving DARBOTIN 25MCG
INJECTIONPFS.

Interactions

A. Drug-Drug interactions:

Before receiving DARBOTIN 25MCG INJECTIONPFS, inform your doctor if you are
taking any of the following medicines:

• cyclosporin and tacrolimus (used to suppress the immune system)

Overdosage:

DARBOTIN 25MCG INJECTIONPFS will be administered to you only by a doctor or a
nurse in a hospital, so it is unlikely to receive an overdose. However, consult
your doctor or nurse if you experience any unusual symptoms like high blood
pressure.

Synopsis

Drug	:	Darbepoetin alfa
Pharmacological Category	:	Erythropoiesis-stimulating agent
Therapeutic Indication	:	Symptomatic anemia associated with chronic renal failure (CRF) and chemotherapy
Dosage Forms	:	Injection, Prefilled syringe

More Information

• Keep DARBOTIN 25MCG INJECTIONPFS out of reach from children
• Store DARBOTIN 25MCG INJECTIONPFS in a refrigerator (2-8°C). Do not freeze

FAQs About DARBOTIN 25MCG INJECTIONPFS

Can DARBOTIN 25MCG INJECTIONPFS affect blood pressure?

Yes. DARBOTIN 25MCG INJECTIONPFS can affect blood pressure. Blood pressure
should be monitored initially and those who have high blood pressure should take
appropriate measures to control blood pressure. Consult your doctor for advice.

How long does it take for DARBOTIN 25MCG INJECTIONPFS to start working?

You will be able to notice an increase in the count of red blood cells
(haemoglobin levels) within 2-6 weeks of starting DARBOTIN 25MCG INJECTIONPFS.
If you have any other concerns, consult your doctor.

Can there be reasons for not responding to DARBOTIN 25MCG INJECTIONPFS?

You may not respond to DARBOTIN 25MCG INJECTIONPFS if you have pure red cell
aplasia, deficiencies of iron, folic acid or vitamin B12. It is important to
correct these deficiencies. Consult your doctor for advice.

Can DARBOTIN 25MCG INJECTIONPFS be used in healthy individuals?

Misuse of DARBOTIN 25MCG INJECTIONPFS by healthy people can cause very serious
problems with the heart or blood vessels. Consult your doctor if you or any
other healthy person is about to use it.

What if I forget to receive a dose of DARBOTIN 25MCG INJECTIONPFS?

Please stick to the prescribed schedule agreed upon with your doctor for o
efficacy of DARBOTIN 25MCG INJECTIONPFS management. Notify your doctor whenever
you miss receiving any dose. Do not take the medicine two times to make up for
the missed dose.

Useful Diagnostic Tests

• Complete Blood Count (CBC)