UJVIRA 100mg Infusion 1's

Introduction About UJVIRA 100MG INFUSION

UJVIRA 100MG INFUSION contains Ado-Trastuzumab Emtansine which belongs to the
group of medicines called Antibody-Drug Conjugates. It is used to manage
metastatic breast cancer (cancer that has been spread to other body parts from
breasts). It can also be used to manage relapsing breast cancer in patients when
complete manage is not achievable.

UJVIRA 100MG INFUSION will be administered to you only by an oncologist or by a
trained professional into your vein. It is suitable for use in patients with
high levels of human epidermal growth factor 2 (HER2) or hormone receptor
positive metastatic breast cancer (cancer this is more sensitive for hormonal
changes).

Before receiving UJVIRA 100MG INFUSION inform your doctor if you have any liver
problems. UJVIRA 100MG INFUSION is not recommended for use in pregnant or
breastfeeding women. Both men and women receiving UJVIRA 100MG INFUSION must use
a suitable contrace
UJVIRA 100MG INFUSION.

The most common side effects of receiving this medicine are mouth ulcers, skin
rashes, nausea, stomach upset, lack of sleep, tingling and numbness of hands and
feet, muscle pain, joint pain, hair loss and urinary tract infections. Consult
your doctor if any of these side effect worsens.

Uses Of UJVIRA 100MG INFUSION

• Manage metastatic breast cancer

How UJVIRA 100MG INFUSION Works

UJVIRA 100MG INFUSION contains a medicine called Ado-trastuzumab emtansine
(T-DM1). It is a conjugate of antibody (trastuzumab) and a drug (Emtansine).
Trastuzumab works by blocking the actions of certain cellular proteins (HER2)
that triggers cancer cell formation. It also blocks various downstream cell
signalling pathways that triggers cancer growth within the body.

Emtansine (known as DM-1) is an anticancer agent. It destroys the cancer cells
and manages their multiplication within the body. As a result, this medicine
reduces cancer formation and manages its further growth within the body.

How to use UJVIRA 100MG INFUSION

UJVIRA 100MG INFUSION will be given to you only by a doctor or a nurse into the
vein (intravenously).

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 UJVIRA 100MG INFUSION

Common

• low RBC, WBC counts in blood
• nausea, vomiting, diarrhea, stomach pain, constipation, indigestion
• dry mouth, changes in taste
• fever, cough, mouth ulcers, sore throat
• hair loss
• urinary tract infection
• headache, dizziness, tiredness, weakness
• low blood potassium levels
• bleeding gums, high blood pressure
• problems in falling asleep
• eye inflammation, dry eyes or watery eyes, blurred vision
• shortness of breath
• muscle pain, joint pain
• swelling of the hands or ankles
• hand and foot reaction
• nail disorder

Rare

Contact your doctor immediately if you experience any of the following side
effects:

• Infusion site reactions (such as pain, inflammation, swelling, leakage)
• Liver inflammation
• Signs of nerve damage (such as tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet)
• Unexpected bleeding or bruising
• Signs of heart problems (such as fever, flushing, shivering, fits, fever, trouble breathing, low blood pressure or a rapid heartbeat, cough shortness of breath at rest or when sleeping flat, chest pain and swollen ankles or arms, a sensation of rapid or irregular heartbeats)
• Signs of lung inflammation (such as shortness of breath, coughing or coughing spells with a dry cough)
• Yellowing of the skin and whites of the eye
• Signs of an allergic reaction (such as skin rash, itching, swelling of the face, lips, tongue and throat with difficulty in breathing)

How To Manage Side Effects

!### Constipation

Try to eat more high-fibre foods such as fresh fruit, vegetables, 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 for receiving alternate
managements for constipation.

!### Diarrhea

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid
taking any medicine on your own to manage diarrhoea and consult your doctor if
the symptom gets worse.

!### 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. 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. Consult your doctor if your headache worsens.

!### Mouth Ulcers

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

!### Nausea And Vomiting

Stick to simple meals. Avoid eating oil rich or spicy foods. If your nausea
worsens, consult your doctor for advice.

!### Skin rash Or Itching

Avoid hot showers because hot water can irritate your skin further. Do not
scratch the affected area. Use protective clothing when going outdoors.
Regularly moisturize your skin. Consult your doctor if your skin rash worsens.

Warning & Precautions

!### Pregnancy

ContraindicatedUJVIRA 100MG INFUSION is not recommended for use in pregnant women. Therefore,
consult your doctor before receiving it. Women of childbearing potential must
use a suitable contrace
UJVIRA 100MG INFUSION and until 7 months after stopping the therapy. If you
accidentally became pregnant while receiving UJVIRA 100MG INFUSION, inform your
doctor immediately.

!### Breastfeeding

ContraindicatedUJVIRA 100MG INFUSION may pass through breast milk. Therefore, it is not
recommended for use in breastfeeding women. However, consult your doctor before
receiving it.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if your ability is affected by UJVIRA 100MG
INFUSION.

!### Alcohol

Consult your doctorAvoid consum
make you feel drowsier.

!### Liver

Use with CautionUJVIRA 100MG INFUSION should be used with caution in patients with a history of
liver problems. Therefore, consult your doctor before receiving it.

!### Allergy

ContraindicatedTalk to your doctor before receiving UJVIRA 100MG INFUSION if you are allergic
to Ado-Trastuzumab Emtansine or trastuzumab.

!### Use In Pediatrics

ContraindicatedUJVIRA 100MG INFUSION is not recommended for use in children and adolescents
(aged below 18 years). Therefore, consult your doctor for advice before
receiving it.

!### Use In Geriatrics

Use with CautionUJVIRA 100MG INFUSION should be used with caution in elderly patients (aged 65
years or above). Therefore, consult your doctor before receiving it.

Interactions

A. Drug - Drug interactions:

Before receiving UJVIRA 100MG INFUSION, inform your doctor if you are taking any
of the following medicines such as:

• medicines used for blood thinning (such as warfarin, aspirin)
• medicines used to manage fungal infections (such as ketoconazole, itraconazole or voriconazole)
• medicines used for bacterial infections (such as clarithromycin or telithromycin)
• medicines used for HIV infection (such as atazanavir, indinavir, nelfinavir, ritonavir or saquinavir)
• nefazodone (a medicine used for depression)

Overdosage:

UJVIRA 100MG INFUSION 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 if you experience any unusual symptoms

Synopsis

Drug	:	Ado-Trastuzumab Emtansine
Pharmacological Category	:	Antibody-Drug Conjugate
Therapeutic Indication	:	Breast cancer
Dosage Forms	:	Injection, Infusion

More Information

• Keep UJVIRA 100MG INFUSION out of reach of children
• Store UJVIRA 100MG INFUSION in a refrigerator between (2-8°C)

FAQs About UJVIRA 100MG INFUSION

Q: What UJVIRA 100MG INFUSION is used for?

A: UJVIRA 100MG INFUSION is used to manage metastatic breast cancer.

Q: How UJVIRA 100MG INFUSION works on my body?

A: UJVIRA 100MG INFUSION contains a medicine called Ado-trastuzumab emtansine
(T-DM1). It is a conjugate of antibody (trastuzumab) and a drug (Emtansine).
Trastuzumab works by blocking the actions of certain cellular proteins (HER2)
that triggers cancer cell formation. Emtansine (known as DM-1) destroys the
cancer cells and manages their multiplication within the body. As a result, this
medicine reduces cancer formation and manages its further growth within the
body.

Q: Can UJVIRA 100MG INFUSION manage cancer?

A: The manage rate of cancer depends upon the severity of the disease. However,
UJVIRA 100MG INFUSION acts by managing the abnormal growth and multiplication of
cancer cells in the body, which may help in managing cancer completely.

Q: Can the use of UJVIRA 100MG INFUSION cause hair loss?

A: Hair loss is one of the common side effects of receiving UJVIRA 100MG
INFUSION. If it bothers you, consult your doctor for advice.

Q: Can the use of UJVIRA 100MG INFUSION cause mouth ulcers?

A: Mouth ulcers are one of the common side effects of receiving UJVIRA 100MG
INFUSION. Avoid eating spicy foods. Drink plenty of water. Apply a
pain-relieving gel on the affected areas of the mouth if required. Consult your
doctor if the symptom did not improve.

Q: Can UJVIRA 100MG INFUSION be used in children?

A: UJVIRA 100MG INFUSION is not recommended for use in children and adolescents
(aged below 18 years). Therefore, consult your doctor for advice before
receiving it.

Q: What happens if I stop receiving UJVIRA 100MG INFUSION?

A: No. Do not stop receiving UJVIRA 100MG INFUSION without consulting your
doctor as it may make your symptoms reappear. Therefore, take UJVIRA 100MG
INFUSION as advised by your doctor for the stipulated duration.

Q: Can UJVIRA 100MG INFUSION be used during pregnancy?

A: UJVIRA 100MG INFUSION is not recommended for use in pregnant women. If you
accidentally became pregnant while receiving UJVIRA 100MG INFUSION, inform your
doctor immediately.

Q: Can the use of UJVIRA 100MG INFUSION make me feel tired?

A: Yes. UJVIRA 100MG INFUSION 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 UJVIRA 100MG
INFUSION. Tiredness can also occur if you have any pre-existing disease
conditions such as liver or kidney impairment while taking this medicine.

Q: Can I drive a car after receivingUJVIRA 100MG INFUSION?

A: UJVIRA 100MG INFUSION may make you feel tired or dizzy. Therefore, do not
drive or operate any heavy tools or machines if your ability is affected by
UJVIRA 100MG INFUSION.

Q: How UJVIRA 100MG INFUSION is administered?

A: UJVIRA 100MG INFUSION will be given to you only by a doctor or a nurse into a
vein (intravenously).

Q: How to control nausea caused due to UJVIRA 100MG INFUSION?

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 UJVIRA 100MG INFUSION. If not, consult your doctor for a
suitable anti-emetic medicine. Do not self-manage nausea.

Q: What are the side effects of receiving UJVIRA 100MG INFUSION?

A: The most common side effects of receiving this medicine are mouth ulcers,
skin rashes, nausea, stomach upset, lack of sleep, tingling and numbness of
hands and feet, muscle pain, joint pain, hair loss and urinary tract infections.
Consult your doctor if any of these side effect worsens.

Useful Diagnostic Tests

• Complete Blood Count
• Peripheral Smear Examination
• Rheumatoid Factor - Agglutination
• Rheumatoid Factor - Turbidometry
• Rheumatoid Factor IgG Antibody