TADRO 50 Injection 25ml

Introduction About TADRO 50 INJECTION

TADRO 50 INJECTION contains Doxorubicin which belongs to the group of medicines
called Anti-cancer agents. It is used to manage certain types of cancers. It is
used either alone or along with other anti-cancer medicines.

Cancer is a disease in which some of the cells of the body grow uncontrollably
and spread to other parts of the body.

Before receiving TADRO 50 INJECTION, inform your doctor if you have or ever had
heart disease, either before or during radiotherapy, had or having live or
live-attenuated vaccinations, are currently taking or have recently taken
Trastuzumab (used in the management of certain cancers).

There are no adequate and well-controlled studies in pregnant women. Consult
your doctor during breast-feeding before starting management with this medicine
as it may pass through the breast milk and possibly harm your child. Consult
your doctor for advice before receiving the medicine.

The most common side effects of TADRO 50 INJECTION are infection, lack of
appetite, inflammation in the mouth, diarrhea, nausea, vomiting, reddening,
swelling, pain, numbness and tingling in the palms and feet may also occur
whilst being managed with this medicine.

Hair loss is very common and may be quite severe, beard growth may stop in men,
fever, feeling weak, chills, abnormal ECG (electrical trace of the heart)
results, raised levels of liver enzymes (as detected by a blood test) can
determine if the medicine is having an abnormal effect on your liver, weight
increased in patients with early breast cancer.

Uses Of TADRO 50 INJECTION

• Used to manage certain types of cancer

How TADRO 50 INJECTION Works

TADRO 50 INJECTION works by suppressing the activity of an enzyme (topoisomerase
II) involved in the DNA multiplication of the cancer cells. On the other hand,
this also forms harmful chemicals (free radicals) which cause damage to the DNA.
This slowdown the growth of cancer cells and eventually works against them.

How to use TADRO 50 INJECTION

TADRO 50 INJECTION will be administered intravenously (IV) into the vein by your
doctor or nurse. Your doctor will administer the correct dose and duration for
you depending upon your age, body weight and disease condition.

Side Effects Of TADRO 50 INJECTION

Common

• infection
• lack of appetite
• inflammation in the mouth
• diarrhea
• nausea, vomiting
• hair loss
• beard growth may stop (in men)
• redness, swelling and blistering on the palms of the hands and soles of the feet (palmar-plantar erythrodysesthesia syndrome)
• chills
• weakness
• abnormal ECG
• raised levels of liver enzymes
• weight increased in patients with early breast cancer
• blood poisoning
• heart problems
• conjunctivitis (red watery eyes)
• lacrimation, excess tear production
• shortness of breath and swelling of the ankles
• increased heart rate
• inflammation of the throat and gullet
• stomach pain
• skin rashes, redness, hives
• nails and skin may appear darker than usual
• injection site reactions such as redness and swelling
• neutropenia
• thrombocytopenia
• malaise/asthenia
• infertility (in women)
• absence or decrease in sperm count (in men)

Uncommon

• embolism (blockage in the bloodstream)

Rare

Stop receiving TADRO 50 INJECTION and contact your doctor immediately if you
experience any of the following side effects:

• dizzy, feverish, short of breath with a tight chest or throat or having an itchy rash
• anemia (low red blood cell count)
• decrease in white blood cell counts which in turn causes an increase in infections and a raised temperature (fever)
• platelets can be affected which could make a bruise or bleed more easily
• decreased activity in bone marrow
• reddening of urine
• dehydration
• inflammation of veins
• irritation or bleeding in the intestines
• inflammation of the lining of the stomach
• heartburn
• soreness or ulcers in the mouth

Warning & Precautions

!### Pregnancy

There are no adequate and well-controlled studies in pregnant women. Consult
your doctor before receiving TADRO 50 INJECTION.

!### Breastfeeding

TADRO 50 INJECTION is generally not recommended for use in breastfeeding women
as it may pass through breast milk. Consult your doctor before receiving it.

!### Driving and Using Machines

There are no special precautions and can drive and operate machinery as long as
you feel fully recovered after management with TADRO 50 INJECTION.

!### Alcohol

Avoid consum
doctor for advice.

!### Liver

TADRO 50 INJECTION is not recommended for use in patients having a hepatic
impairment. Consult your doctor before receiving it.

!### Allergy

Do not receive TADRO 50 INJECTION if you are allergic (hypersensitivity) to
Doxorubicin or other similar medicines called anthracyclines or anthracenediones
or any of the other ingredients of this medicine.

!### Heart Disease

TADRO 50 INJECTION is not recommended in patients with a current or previous
history of cardiac impairment (severe myocardial insufficiency, recent
myocardial infarction, severe arrhythmia) Consult your doctor before receiving
it.

Others

TADRO 50 INJECTION is not recommended for use if you have:

• low blood cell counts

Before receiving TADRO 50 INJECTION, inform your doctor if you have:

• any other medical conditions

Use in pediatrics:

TADRO 50 INJECTION should be used with caution in children. Your doctor will
administer the right dose depends on your child’s age, body weight and disease
condition. Consult your doctor before receiving the medicine.

Use in geriatrics:

TADRO 50 INJECTION should be used with caution in elderly patients (aged 65
years and above). Consult your doctor before receiving the medicine.

Interactions

A. Drug-Drug interactions:

Before receiving TADRO 50 INJECTION, inform your doctor if you are taking any of
the following medicine:

• verapamil (used to manage high blood pressure)
• phenobarbital (used to control seizures)
• phenytoin (used to manage certain seizures)
• St. John’s Wort (used to manage depression and mood stabilizer)
• cyclosporine
• calcium channel blockers (medicines for the heart)
• sorafenib (used to manage inoperable liver cancer and advanced kidney cancer)
• paclitaxel
• progesterone
• dexrazoxane
• cytarabine
• cyclophosphamide
• streptozocin (used to manage cancer of the pancreas)
• saquinavir (used to manage HIV)
• trastuzumab (used to manage certain cancers)

Overdosage:

TADRO 50 INJECTION will be administered to you only by a doctor or a nurse in a
hospital and it is so unlikely to receive an overdose. However, consult your
doctor or nurse if you experience any unusual problems.

Synopsis

Drug	:	Doxorubicin
Pharmacological Category	:	Anthracyclin derivatives
Therapeutic Indication	:	Cancer
Dosage Forms	:	Injection

More Information

• Keep TADRO 50 INJECTION out of reach of children
• Store at 2-8°C

FAQs About TADRO 50 INJECTION

Is TADRO 50 INJECTION can be used in pregnant women?

There are no adequate and well-controlled studies in pregnant women. Consult
your doctor before receiving TADRO 50 INJECTION.

What for TADRO 50 INJECTION is used?

TADRO 50 INJECTION is used to manage cancer particularly useful in the
management of cancers of the breast and lung. In addition, it can be given to
manage cancers of the blood-forming tissues such as malignant lymphomas and
leukemia.

Is there any food restriction while receiving TADRO 50 INJECTION?

No, there is no food restriction while receiving TADRO 50 INJECTION. Consult
your doctor before undergoing management.

When do I need to seek medical help?

Contact your doctor or nurse immediately if you notice any of the following side
effects feeling dizzy, feverish, short of breath with a tight chest or throat or
have an itchy rash. This type of allergic reaction can be very serious. Your
doctor will test your blood cell count during management. Doxorubicin may also
cause decreased activity in your bone marrow.

What is the effect of TADRO 50 INJECTION on the heart?

TADRO 50 INJECTION should be used with caution in patients with a current or
previous history of cardiac impairment (severe myocardial insufficiency, recent
myocardial infarction, severe arrhythmia) Consult your doctor before receiving
TADRO 50 INJECTION.

What precautions should take before receiving TADRO 50 INJECTION?

Before receiving TADRO 50 INJECTION, inform your doctor if you have heart
problems, have had radiation management or currently receiving radiation
therapy, are over the age of 50, have liver problems, plan to receive any
vaccines, have any other medical conditions. Consult your doctor before
receiving the medicine.