UNITINIB 400mg Capsule 10's

Introduction About UNITINIB 400MG CAPSULE

UNITINIB 400MG CAPSULE contains Imatinib which belongs to the group of medicines
called Tyrosine Kinase Inhibitors. It is used in adults, children and
adolescents to manage chronic myeloid leukaemia (CML) (a form of leukaemia in
which certain abnormal white cells (named myeloid cells) start growing out of
control) and philadelphia chromosome positive acute lymphoblastic leukaemia
(Ph-positive ALL) (a form of leukaemia in which certain abnormal white cells
(named lymphoblasts) start growing out of control).

Also, it is used in adults only to manage myelodysplastic/myeloproliferative
diseases (MDS/MPD) (a group of blood diseases in which some blood cells start
growing out of control), hyper eosinophilic syndrome (HES) and/or chronic
eosinophilic leukaemia (CEL) (a blood diseases in which some blood cells (named
eosinophils) start growing out of control), gastrointestinal stromal tumours
(GIST) (cancer of the stomach and bowels) and dermatofibrosarcoma protuberans
(DFSP) (cancer of the tissue beneath the skin in which some cells start growing
out of control).

Before taking UNITINIB 400MG CAPSULE, inform your doctor if you have or ever had
kidney, liver or heart problems, hepatitis B infection and thrombotic
microangiopathy (symptoms include bruising, bleeding, fever, fatigue and
confusion).

UNITINIB 400MG CAPSULE is generally not recommended for use in pregnant women
unless advised by the doctor and it is not recommended for use in breastfeeding
women. UNITINIB 400MG CAPSULE should be used with caution in children,
adolescents and elderly patients (aged 65 years and above).

The most common side effects of taking UNITINIB 400MG CAPSULE are nausea,
vomiting, diarrhea, headache, weight gain, loss of appetite, disturbed sense of
taste, blurred vision and weakness. Consult your physician if any of the side
effects worsen.

Uses Of UNITINIB 400MG CAPSULE

Manage adults, children and adolescents for:

• chronic myeloid leukaemia (CML)
• philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL)

Manage adults for:

• myelodysplastic/myeloproliferative diseases (MDS/MPD)
• hyper-eosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL)
• gastrointestinal stromal tumors (GIST)
• dermatofibrosarcoma protuberans (DFSP)

How UNITINIB 400MG CAPSULE Works

UNITINIB 400MG CAPSULE is a protein-tyrosine kinase inhibitor. Tyrosine kinases
are proteins which act as chemical messengers that are used by the cancer cells
to signal each other for their growth, therefore this medicine works by blocking
the enzyme which stops the cancer cells from growing.

How to use UNITINIB 400MG CAPSULE

Take UNITINIB 400MG CAPSULE as advised by your physician. Swallow the UNITINIB
400MG CAPSULE with a glass of water. Do not crush or chew the medicine. Your
doctor will decide the correct dose and duration for you depending upon your
age, body weight and disease condition.

Side Effects Of UNITINIB 400MG CAPSULE

Common

• headache or feeling tired
• nausea, vomiting, diarrhea or indigestion
• rash
• muscle cramps, joint, muscle or bone pain
• swelling such as round ankles or puffy eyes
• weight gain
• loss of appetite, weight loss or disturbed sense of taste
• feeling dizzy or weak
• insomnia
• conjunctivitis watery eyes, or blurred vision
• nose bleeds
• pain or swelling in the abdomen, flatulence, heartburn or constipation
• itching
• unusual hair loss or thinning
• numbness of the hands or feet
• mouth ulcers
• dry mouth, dry skin or dry eye
• decreased or increased skin sensitivity
• hot flushes, chills or night sweats

Rare

Stop taking UNITINIB 400MG CAPSULE and contact your doctor immediately if you
experience any of the following side effects:

• rapid weight gain, severe fluid retention
• infection symptoms such as fever, severe chills, sore throat or mouth ulcers, low white blood cells
• unexpected bleeding or bruising
• sign of heart problems like chest pain or irregular heart rhythm
• sign of lung problems like cough, difficulty in breathing or painful breathing
• signs of low blood pressure like feeling light-headed, dizzy or fainting
• sign of liver problems like nausea, loss of appetite, dark-colored urine, yellow skin or eyes
• sign of skin problems like rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, a pustular eru
• sign of gastrointestinal disorders like severe abdominal pain, blood in vomit, stools or urine, black stools
• signs of kidney problems like severely decreased urine output and feeling thirsty
• signs of bowel problems like nausea with diarrhea and vomiting, abdominal pain or fever
• signs of nervous system problems like severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness, bleeding or swelling in skull/brain
• signs of low levels of red blood cells like pale skin, feeling tired and breathlessness and having dark urine
• signs of raynaud’s syndrome like numb or cold toes and fingers
• signs of muscle problems like muscle spasms with a fever, red-brown urine, pain or weakness in your muscles
• eye pain or deterioration in vision, bleeding in the eyes
• pain in hips or difficulty walking
• difficulty in hearing
• signs of problems with ovaries or womb like pelvic pain with unexpected vaginal bleeding
• thrombotic microangiopathy (blood clots in small blood vessels)

How To Manage Side Effects

Nausea or vomiting:

Try to take UNITINIB 400MG CAPSULE with or just after a meal or a snack. Stick
to simple meals. Avoid eating oil rich, fried or spicy foods. Consult your
doctor if the symptom does not improve.

Diarrhoea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated.
Avoid taking any medicine on your own for managing diarrhea. Consult your doctor
if the symptom does not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a
pain-relieving balm on the forehead if required. Do not consume too much of
alcohol. Consult your doctor if the symptom does not improve.

Dry mouth:

Sip water regularly and other sugar free liquids. Do not use mouthwashes that
contain alcohol because they can make your mouth dry, use mouthwash that is used
only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco
products. Consult your doctor if the symptom does not improve.

Tiredness:

Drink plenty of fluid and eat balanced diet and frequent meals. Do regular
minimal exercise and follow regular sleep schedule. Consult your doctor if the
symptom does not improve.

Warning & Precautions

!### Pregnancy

UNITINIB 400MG CAPSULE is generally not recommended for use in pregnant women
unless considered clearly necessary. Women who might become pregnant are advised
to use effective contrace
ending the> management. Consult your doctor before taking UNITINIB 400MG
CAPSULE.

!### Breastfeeding

UNITINIB 400MG CAPSULE is not recommended for use during breastfeeding and for
15 days after ending the management as it may harm the baby. Consult your doctor
before taking UNITINIB 400MG CAPSULE.

!### Driving and Using Machines

Do not drive or operate any machines if you experience dizziness, drowsiness or
blurred vision after taking UNITINIB 400MG CAPSULE.

!### Kidney

UNITINIB 400MG CAPSULE should be used with caution in patients with kidney
problem. Consult your doctor before taking UNITINIB 400MG CAPSULE.

!### Liver

UNITINIB 400MG CAPSULE should be used with caution in patients with liver
problems and hepatitis B infection. Consult your doctor before taking UNITINIB
400MG CAPSULE.

!### Allergy

Do not take UNITINIB 400MG CAPSULE if you are allergic to imatinib or any other
ingredients of this medicine.

!### Heart Disease

UNITINIB 400MG CAPSULE should be used with caution in patients with heart
problem. Consult your doctor before taking UNITINIB 400MG CAPSULE.

Others

Before taking UNITINIB 400MG CAPSULE, inform your doctor if you have:

• thrombotic microangiopathy symptoms such as bruising, bleeding, fever, fatigue and confusion

Use in pediatrics:

UNITINIB 400MG CAPSULE should be used with caution in children and adolescents.
Consult your child’s doctor for advice.

Use in geriatrics:

UNITINIB 400MG CAPSULE should be used with caution in elderly patients (aged 65
years and above). Consult your doctor before taking UNITINIB 400MG CAPSULE.

Interactions

A. Drug-Drug interactions:

Before taking UNITINIB 400MG CAPSULE, inform your doctor if you are taking any
of the following medicines:

• medicines used to manage fever and pain (Ex. paracetamol)
• st. john’s wort (used to manage depression)
• medicines used to manage blood clots (Ex. clopidogrel)
• medicine used to manage thyroid (levothyroxine)

Overdosage:

If you or anyone else accidentally take too much of UNITINIB 400MG CAPSULE,
consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Imatinib
Pharmacological Category	:	Tyrosine kinase inhibitor
Therapeutic Indication	:	Chronic myeloid leukaemia, Philadelphia chromosome positive acute lymphoblastic leukaemia, myelodysplastic/myeloproliferative diseases hyper eosinophilic syndrome or chronic eosinophilic leukaemia, Gastrointestinal stromal tumors, dermatofibrosarcoma protuberans
Dosage Forms	:	Tablet, Capsule

More Information

• Keep UNITINIB 400MG CAPSULE out of reach of children
• Store UNITINIB 400MG CAPSULE at room temperature

FAQs About UNITINIB 400MG CAPSULE

What happens if I stop taking UNITINIB 400MG CAPSULE on my own?

Do not stop taking UNITINIB 400MG CAPSULE unless your doctor tells you to stop
even if the condition improves. If you are not able to take the UNITINIB 400MG
CAPSULE as your doctor prescribed or feel you do not need it anymore, contact
your doctor immediately.

It is safe to drive after taking UNITINIB 400MG CAPSULE?

In some patients UNITINIB 400MG CAPSULE may cause dizziness, drowsiness or
blurred vision. So, it is better to avoid driving or operating any machine after
taking UNITINIB 400MG CAPSULE. Consult your doctor for advice before taking it.

Can I take UNITINIB 400MG CAPSULE during pregnancy?

UNITINIB 400MG CAPSULE is generally not recommended for use in pregnant women
unless advised by the doctor. Women who might become pregnant are advised to use
effective contrace
the management. Consult your doctor before taking this medicine.

How does UNITINIB 400MG CAPSULE work?

UNITINIB 400MG CAPSULE is a protein-tyrosine kinase inhibitor. Tyrosine kinases
are proteins which act as chemical messengers that are used by the cancer cells
to signal each other for their growth, therefore this medicine works by blocking
the enzyme which stops the cancer cells from growing.

CanUNITINIB 400MG CAPSULE be used in patients with liver problems?

UNITINIB 400MG CAPSULE should be used with caution in patients with liver
problems and hepatitis B infection. Your doctor may monitor your liver function
during and after management with this medicine to manage the risk of any unusual
effects. Consult your doctor before taking it.

Useful Diagnostic Tests

• Bcr-Abl Gene Translocation
• Bcr-Abl Gene Translocation
• Complete Blood Count
• Peripheral Smear Examination