LUPROCAN 22.5 Injection 1's

Introduction About LUPROCAN 22.5 INJECTION

LUPROCAN 22.5 INJECTION contains Leuprolide which belongs to the group of
medicines called Gonadotropin Releasing Hormone (GnRH) Agonist. It is used for
palliative management (relieving symptoms and minimising the associated
suffering) of advanced prostatic cancer. Advanced prostatic cancer is a cancer
(abnormal cell multiplication and differentiation) that originates in the
prostate gland and spreads to the other parts of the body. It is characterized
by the symptoms such as painful urination, decreased urine pressure, blood in
the semen, bone pain, leg swelling, and weakness.

Do not receive LUPROCAN 22.5 INJECTION if you are allergic to Leuprolide, GnRH,
GnRH agonist analogs. Before receiving the medicine, inform your doctor if you
have liver impairment, kidney impairment, congenital long QT syndrome,
congestive heart failure, frequent electrolyte abnormalities, metastatic
vertebral lesions, urinary tract obstruction, or diabetes. Before receiving this
medicine, inform your doctor if you have a history of seizures, epilepsy,
cerebrovascular disorders, or central nervous system anomalies/tumours. LUPROCAN
22.5 INJECTION is not recommended for use in pregnant women, breastfeeding
women, and children.

It should be used with caution in elderly patients (aged above 65 years).
Consult your doctor before receiving. The most common side effects associated
with the use of LUPROCAN 22.5 INJECTION are general pain, reactions at the site
of injection, hot flashes/sweating, gastrointestinal disorders, joint disorders,
shrinking of testes, urinary disorders, infections in upper respiratory tract,
and fatigue. Consult your doctor if any of these side effects worsens.

Uses Of LUPROCAN 22.5 INJECTION

• Used for palliative management (relieving symptoms and minimize the associated suffering) of advanced prostatic cancer

How LUPROCAN 22.5 INJECTION Works

LUPROCAN 22.5 INJECTION contains Leuprolide which works by blocking the
secretion of gonadotropin releasing hormone (GnRH) following an initial
stimulation, resulting in suppression of ovarian and testicular steroidogenesis
(process of synthesis of steroid hormones), thereby relieving the symptoms
associated with increased testosterone levels in advanced prostatic cancer.

How to use LUPROCAN 22.5 INJECTION

LUPROCAN 22.5 INJECTION will be administered to you only by a doctor or a nurse
intramuscularly (into the muscle) or subcutaneously (under the skin). Your
doctor will administer the correct dose and duration for you depending upon your
age, body weight and disease condition.

Side Effects Of LUPROCAN 22.5 INJECTION

Common

• hot flashes, sweating
• general pain in the body
• pain at the site of injection
• gastrointestinal disorders
• respiratory disorders
• urinary disorders
• shrinking of testicles
• extreme weakness
• headache
• joint disorders
• dizziness
• neuromuscular disorders
• skin reactions
• flu-syndrome
• dehydration
• muscle pain
• sensation of pins and needles
• lethargy
• constipation
• sinus headache
• influenza-like illness including influenza, nasopharyngitis, nasal congestion, upper respiratory tract infection, rhinorrhea, and viral upper respiratory tract infection
• cough
• hemorrhagic cystitis
• high blood pressure
• rash
• urinary tract infection
• cystitis (an inflammatory condition of bladder)
• decreased haemoglobin
• increased frequency of urination in night
• peripheral/pitting oedema (swelling in legs and feet due to water retention)
• itching
• hair loss
• pain in testicles
• clamminess
• breast enlargement in males
• reduced libido

Stop receiving LUPROCAN 22.5 INJECTION and contact your doctor if you experience
any of the following side effects:

• COPD (chronic obstructive pulmonary disease)
• coronary artery disease (heart disease) is characterized by angina (chest pain)
• cerebrovascular accident/transient ischemic attack (life-threatening events related to impaired heart function)
• pneumonia (a life-threatening lung disease)
• second primary neoplasm (cancer) including basal cell carcinoma, lung neoplasm, bladder transitional cell carcinoma, malignant melanoma, squamous cell carcinoma, non-Hodgkin’s lymphoma

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.

!### Dizziness Or Drowsiness

Lie down until the dizziness passes and get up slowly. Do not bend down
suddenly. Get a lot of rest. Walk slowly and carefully. Take plenty of fluids.
Avoid drinking coffee, alcohol, or smoking. Consult your doctor if the condition
persists for long or gets worsens.

Headache

Take rest and plenty of water. Avoid taking alcohol and skipping meals. Do not
strain your eyes by watching the screen for a long time. Consult your doctor if
the condition persists for long or gets worsens.

Warning & Precautions

Pregnancy

ContraindicatedLUPROCAN 22.5 INJECTION is not recommended for use during pregnancy. Consult
your doctor before receiving the medicine.

!### Breastfeeding

ContraindicatedLUPROCAN 22.5 INJECTION is not recommended for use in breastfeeding women as it
can pass through milk. Consult your doctor before receiving the medicine.

!### Driving and Using Machines

Use with CautionDo not receive LUPROCAN 22.5 INJECTION if you are allergic to Leuprolide, GnRH,
GnRH agonist analogs, or to any of the other ingredients of this medicine.

!### Kidney

Use with CautionLUPROCAN 22.5 INJECTION should be used with caution in patients with renal
impairment. Consult your doctor before receiving the medicine.

!### Liver

Use with CautionLUPROCAN 22.5 INJECTION should be used with caution in patients with hepatic
impairment. Consult your doctor before receiving the medicine.

!### Heart Disease

Monitoring requiredLUPROCAN 22.5 INJECTION should be used with caution in patients with congenital
long QT syndrome and congestive heart failure only if clearly necessary. Consult
your doctor before receiving.

!### Use In Pediatrics

ContraindicatedLUPROCAN 22.5 INJECTION is not recommended for use in children. Consult your
doctor before receiving.

!### Use In Geriatrics

Use with CautionLUPROCAN 22.5 INJECTION should be used with caution in elderly patients (above
65 years). Consult your doctor before receiving the medicine.

Others

Before receiving LUPROCAN 22.5 INJECTION, inform your doctor if you:

• have frequent electrolyte abnormalities
• have metastatic vertebral lesions
• have urinary tract obstruction
• have diabetes
• have a history of epilepsy
• have a history of cerebrovascular disorders
• have a history of central nervous system anomalies or tumours

Interactions

A. Drug-Drug Interactions:

Before receiving LUPROCAN 22.5 INJECTION, inform your doctor, if you are taking
any of the following medicine:

• medicines that prolong the QT interval (Ex. haloperidol, amiodarone, erythromycin)

Overdosage:

LUPROCAN 22.5 INJECTION will be given to you only by a doctor or nurse in a
hospital, and so it is unlikely to receive an overdose. If you or anyone else
accidentally receives too much of this medicine, consult your doctor immediately
or visit the nearby hospital. Symptoms of overdose are shortness of breath,
decreased activity, and increased scratching.

Synopsis

Drug	:	Leuprolide
Pharmacological Category	:	Gonadotropin Releasing Hormone (GnRH) Agonist
Therapeutic Indication	:	Palliative management for advanced prostatic cancer
Dosage Forms	:	Injection, Injection depot

More Information

Storage

• Keep LUPROCAN 22.5 INJECTION out of reach of children
• Store between 2-8°C

FAQs About LUPROCAN 22.5 INJECTION

Q: What LUPROCAN 22.5 INJECTION is used for?

A: LUPROCAN 22.5 INJECTION for palliative management (relieving symptoms and
minimize the associated suffering) of advanced prostatic cancer. Consult your
doctor before receiving.

Q: What side effects are seen with LUPROCAN 22.5 INJECTION?

A: The most common side effects associated with the use of LUPROCAN 22.5
INJECTION are general pain, reactions at the site of injection, hot
flashes/sweating, gastrointestinal disorders, joint disorders, shrinking of
testes, urinary disorders, infections in the upper respiratory tract, and
fatigue. Consult your doctor if any of these symptoms worsens.

Q: Who should avoid receiving LUPROCAN 22.5 INJECTION?

A: Do not receive LUPROCAN 22.5 INJECTION if you are allergic to leuprolide,
GnRH, GnRH agonist analogs. It is not recommended for use in pregnant women,
breastfeeding women, and children. Consult your doctor before receiving.

Q: Is LUPROCAN 22.5 INJECTION safe to use in children?

A: LUPROCAN 22.5 INJECTION is not recommended for use in children because the
safety and effectiveness of this medicine have not been established in this
population. Consult your doctor before receiving.

Q: Is LUPROCAN 22.5 INJECTION safe to use in pregnant and breastfeeding women?

A: LUPROCAN 22.5 INJECTION is not recommended for use during pregnancy as it may
increase the risk for pregnancy loss. It is also not recommended for use in
breastfeeding women as it can pass through milk. Consult your doctor before
receiving.

Q: What happens if you take more LUPROCAN 22.5 INJECTION than your required dose?

A: LUPROCAN 22.5 INJECTION will be given to you only by a doctor or nurse in a
hospital, and so it is unlikely to receive an overdose. If you or anyone else
accidentally receives too much of this medicine, consult your doctor immediately
or visit the nearby hospital. Symptoms of overdose are shortness of breath,
decreased activity, and increased scratching.

Q: Is LUPROCAN 22.5 INJECTION safe to use in heart patients?

A: LUPROCAN 22.5 INJECTION should be used with caution in patients with
congenital long QT syndrome and congestive heart failure only if clearly
necessary. Consult your doctor before receiving.