Azzure Injection 1'S

Introduction About AZZURE INJECTION

AZZURE INJECTION contains Azacitidine which belongs to the group of medicines
called Anticancer agents. It is used in adults in the management of all
sub-types of myelodysplastic syndromes (MDS, a group of cancers associated with
blood and bone marrow), and certain types of blood cancer known as chronic
myelomonocytic leukaemia (CMML) and acute myeloid leukaemia (AML).

CMML is a type of blood cancer where the bone marrow releases an excess amount
of monocytes (a type of blood cell) into the blood stream, whereas in AML, the
bone marrow releases an excess amount of immature white blood cells. Both are
characterized by recurrent infections, fever, tiredness, and increased bleeding
or bruising.

AZZURE INJECTION is typically used in adults who cannot undergo stem cell
transplantation. Before receiving AZZURE INJECTION, inform your doctor if you
have any lung, liver, kidney, or heart problems.

AZZURE INJECTION is not recommended for use by pregnant or breastfeeding women.
Both men and women of childbearing potential must use a suitable contrace
to avoid pregnancy while undergoing therapy with this medicine. Men may seek
advice on sperm preservation, if necessary, prior to therapy with this medicine.

The most common side effects of receiving AZZURE INJECTION are increased
bleeding, increased infections, tiredness, nausea, vomiting, diarrhea,
constipation, loss of appetite, stomach pain, weakness, pain and redness at the
site of injection, sore nose and throat, cold sores, headache, dizziness,
trouble sleeping, weight loss, ulcers of the mouth or tongue, and hair loss.
Consult your doctor if any of these side effects trouble you.

Uses Of AZZURE INJECTION

It is used by adults to manage:

• all sub-types of myelodysplastic syndromes (MDS; a group of cancers associated with blood and bone marrow)
• Chronic myelomonocytic leukaemia (CMML; blood cancer of monocytes)
• acute myeloid leukaemia (AML; blood cancer of the WBC)

How AZZURE INJECTION Works

AZZURE INJECTION is an anticancer medication. It works by blocking the actions
of certain enzymes (DNA/RNA methyltransferase) within the cancer cells that are
required for the cells to grow and multiply. It also reduces the production of
new genetic material (RNA and DNA) within the cells. As a result, it manages
abnormal cell division within the body, slows down the growth of cancer cells,
and helps the bone marrow produce normal blood cells.

How to use AZZURE INJECTION

AZZURE INJECTION will be given to you only by a doctor or a nurse beneath the
skin (subcutaneously) of your thighs, arms, or abdomen.

Your doctor will decide the correct dose and duration of therapy for you
depending on your age, body weight, and disease condition.

Side Effects Of AZZURE INJECTION

Common

• low RBC count, causing anemia, tiredness, and pale skin
• increased infections, lung infections (pneumonia), fever, and chills
• increased bleeding tendency due to low blood platelet counts
• nausea, vomiting
• diarrhea, constipation, loss of appetite, and stomach pain
• tiredness, weakness
• injection site reactions (such as pain, redness, swelling, or lump formation)
• Joint pain, muscle pain, and skin rashes with redness and itching
• sore nose and throat, cold sores, sinusitis
• headache, dizziness
• trouble sleeping (insomnia)
• Nosebleeds, bleeding gums
• weight loss
• urinary tract infections
• ulcers of the mouth or tongue
• high or low blood pressure
• anxiety, confusion
• hair loss, dehydration
• oral fungal infection
• sleepiness
• fluid around the lungs or heart

Uncommon

• painful skin ulceration

Rare

• dry cough
• painless swelling in the fingertips

Consult your doctor immediately if you experience any of the following side
effects after receiving AZZURE INJECTION:

• signs of liver problems (such as yellowing of the skin and whites of the eye, drowsiness, shakiness, bloating, and easy bruising)
• signs of kidney problems (such as low urine output, swollen feet and legs, back pain, rapid heart rate, dizziness, nausea, vomiting, tiredness, reduced appetite, confusion, and restlessness)
• signs of increased infections, such as fever
• lung infections causing fever, chest pain, and shortness of breath
• bleeding within the head or bleeding within the stomach, causing bloody stools, bloody urine, or bleeding under the skin, causing red pin points to appear on the skin
• signs of allergic reactions (such as skin rash, itching, swelling of the face, lips, mouth, or throat, which can lead to difficulty breathing or swallowing, or fainting)
• blood infections (sepsis)

How To Manage Side Effects

!### Constipation

Try to eat more high-fibre foods such as fresh fruit, vegetables, and cereals,
and drink plenty of water. Try doing exercise regularly (going for a daily walk
or run). If this does not help, inform your doctor about receiving alternate
managements for constipation.

!### Injection Site Reactions

Place an ice pack on the injected site. Do not move the affected area
frequently. If the symptom worsens, consult your doctor.

!### Mouth Ulcers

Avoid eating spicy foods. Drink plenty of water. Apply a pain-relieving gel to
the affected areas of the mouth if required. Consult your doctor if the symptom
does not improve.

Warning & Precautions

!### Pregnancy

ContraindicatedAZZURE INJECTION is not recommended for use in pregnant women as it may harm the
growing baby. Therefore, inform your doctor before receiving it. Women of
childbearing potential must use a suitable contrace
while undergoing therapy with AZZURE INJECTION and until 6 months after stopping
the therapy. If you accidentally became pregnant while receiving AZZURE
INJECTION, inform your doctor immediately.

!### Breastfeeding

Contraindicated
AZZURE INJECTION is not recommended for use in breastfeeding women. Therefore,
inform your doctor before receiving it.

!### Driving and Using Machines

Use with CautionAZZURE INJECTION may cause tiredness. Therefore, do not drive or operate any
machines if your ability is affected by AZZURE INJECTION.

!### Kidney

Use with CautionAZZURE INJECTION should be used with caution in patients with kidney diseases.
Therefore, inform your doctor before receiving it.

!### Liver

Consult your doctorAZZURE INJECTION is not recommended for use in patients with advanced liver
cancer. It should be used with caution in patients with other liver diseases.
Therefore, inform your doctor before receiving it.

!### Allergy

ContraindicatedTalk to your doctor before receiving AZZURE INJECTION if you are allergic to
Azacitidine.

!### Lungs

Use with CautionAZZURE INJECTION should be used with caution in patients with a previous history
of lung diseases. Therefore, inform your doctor before receiving it.

!### Heart Disease

Use with CautionAZZURE INJECTION should be used with caution in patients with a previous history
of heart attack or any other heart conditions. Therefore, inform your doctor
before receiving it.

!### Use In Pediatrics

ContraindicatedAZZURE INJECTION is not recommended for use in children and adolescents (aged
below 18 years) due to lack of safety data. Therefore, consult your doctor for
advice.

!### Use In Geriatrics

Use with CautionAZZURE INJECTION should be used with caution in elderly patients (aged 65 years
or above). Therefore, consult your doctor before receiving it.

Others

Inform your doctor, before receiving AZZURE INJECTION, if you:

• have low RBC, WBC or platelet count in blood

Interactions

A. Drug- Drug interactions:

Before receiving AZZURE INJECTION, inform your doctor about all the prescri
medicines, non-prescri
supplements taken by you as a precaution.

Overdosage:

If you or anyone else accidentally took more AZZURE INJECTION, consult your
doctor immediately or visit the nearby hospital right away.

Synopsis

Drug	:	Azacitidine
Pharmacological Category	:	Cytidine Analogs
Therapeutic Indication	:	Blood cancer, Myelodysplastic syndromes
Dosage Forms	:	Injection, Tablet

More Information

• Keep AZZURE INJECTION out of reach of children
• Before opening: Store AZZURE INJECTION at room temperature
• After opening: Store AZZURE INJECTION in refrigerator between 2-8°C

FAQs About AZZURE INJECTION

Q: What is the use of AZZURE INJECTION?

A:AZZURE INJECTION is used in adults in the management of all sub-types of
myelodysplastic syndromes (MDS; a group of cancers associated with blood and
bone marrow), and certain types of blood cancer known as chronic myelomonocytic
leukaemia (CMML) and acute myeloid leukaemia (AML).

Q: How does AZZURE INJECTION work?

A: AZZURE INJECTION is an anticancer medication. It works by blocking the
actions of certain enzymes (DNA/RNA methyltransferase) within the cancer cells
that are required for the cells to grow and multiply. It also reduces the
production of new genetic material (RNA and DNA) within the cells. As a result,
it manages abnormal cell division within the body, slows down the growth of
cancer cells, and helps the bone marrow produce normal blood cells.

Q: Can I take AZZURE INJECTION during breastfeeding?

A: No. AZZURE INJECTIONis not recommended for use in breast-feeding women.
Therefore, inform your doctor before receiving it.

Q: Can AZZURE INJECTION increase the risk of infection?

A: AZZURE INJECTION may cause a drop in the number of white blood cells in the
body and may weaken your immune system. As a result, you may be at a greater
risk of getting infected while receiving AZZURE INJECTION. To avoid this, your
doctor will regularly monitor your blood counts as a precaution. However, inform
your doctor if you experience any signs of infection, such as a fever.

Q: Can the use of AZZURE INJECTION make me feel tired?

A: Yes. AZZURE INJECTION may make you feel tired easily. This is because it
reduces the levels of red blood cells in your blood and may make you anaemic.
Consult your doctor if you experience tiredness after receiving AZZURE
INJECTION. Tiredness can also occur if you have any pre-existing disease
conditions, such as liver or kidney impairment, while receiving this medicine.

Q: Can I drive a car after receiving AZZURE INJECTION?

A: AZZURE INJECTION may make you feel tired or weak. Therefore, do not drive or
operate any heavy tools or machines if your abilities are affected by AZZURE
INJECTION.

Q: How is AZZURE INJECTION administered?

A: AZZURE INJECTION will be given to you only by a doctor or a nurse beneath the
skin (subcutaneously) of the thighs, arms, or abdomen.

Q: How do you control nausea caused by AZZURE INJECTION?

A: Generally, anticancer medicines are associated with uncontrollable nausea and
vomiting. To avoid this, your doctor would prescribe a suitable medicine to
control them, along with AZZURE INJECTION. If not, consult your doctor for a
suitable anti-emetic medicine. Do not self-manage nausea.

Useful Diagnostic Tests

• Bone marrow smear microscopy examination
• Complete Blood Count
• Peripheral Smear Examination