ESENTRA 60mg Prefilled Syringe(Pfs) 1's

Introduction About ESENTRA 60MG PREFILLED SYRINGE(PFS)

ESENTRA 60MG PREFILLED SYRINGE(PFS) contains Denosumab which belongs to the
group of medicines called Monoclonal antibodies. It is used in adults to manage
advanced cancer and to manage serious complications caused by bone metastasis
(Ex. fractures, pressure on the spinal cord, radiation therapy, or surgery). It
is also used to manage giant cell tumours of the bone, which cannot be managed
by surgery, especially in adults whose bones have stopped growing. Symptoms
include a visible mass and bone joints being affected (fracture, fluid buildup,
limited movement, swelling, and pain in the joints).

Denosumab binds to RANKL, a protein that is essential for the formation,
function, and survival of osteoclasts (the cells responsible for bone
resor
decreasing bone resor
this management, your doctor might ask you to make certain lifestyle changes,
such as maintaining good oral hygiene and quitting smoking. Your doctor may ask
you to undergo a dental examination before you start the management. ESENTRA
60MG PREFILLED SYRINGE(PFS) is not recommended for use in patients with
hypocalcemia (low calcium levels in the blood) and unhealed wounds from oral
surgery. Before receiving ESENTRA 60MG PREFILLED SYRINGE(PFS), inform your
doctor if you have any problems with your mouth or teeth (poor dental health,
gum disease, etc.).

ESENTRA 60MG PREFILLED SYRINGE(PFS) is not recommended among women who are
pregnant. Consult your doctor for advice before receiving ESENTRA 60MG PREFILLED
SYRINGE(PFS) if you are breast-feeding. ESENTRA 60MG PREFILLED SYRINGE(PFS) is
not recommended for children and adolescents under 18 years of age, except for
adolescents with giant cell tumours of the bone whose bones have stopped
growing. The most common side effects of receiving ESENTRA 60MG PREFILLED
SYRINGE(PFS) are pain in the bones, joints, and muscles, shortness of breath,
diarrhea, hypophosphatemia (low phosphate level), and excessive sweating.

Uses Of ESENTRA 60MG PREFILLED SYRINGE(PFS)

It is used to manage:

• Giant cell tumour of bone in adults whose bones have stopped growing
• Complications caused by bone metastasis in advanced cancer (fracture, pressure on the spinal cord)

How ESENTRA 60MG PREFILLED SYRINGE(PFS) Works

ESENTRA 60MG PREFILLED SYRINGE(PFS) works to slow down bone destruction caused
by cancer spreading to the bone (bone metastasis) or by giant cell tumour of
bone.

How to use ESENTRA 60MG PREFILLED SYRINGE(PFS)

ESENTRA 60MG PREFILLED SYRINGE(PFS) will usually be administered to you
subcutaneously (under the skin) by a doctor or nurse. You should also take
calcium and vitamin D supplements while being managed with ESENTRA 60MG
PREFILLED SYRINGE(PFS). Your doctor will decide the correct dose and duration
for you depending on your age, body weight, and disease condition.

Side Effects Of ESENTRA 60MG PREFILLED SYRINGE(PFS)

Common

• Bone, joint, and muscle pain
• Shortness of breath, excessive sweating
• Diarrhea
• Low phosphate levels in the blood (hypophosphatemia)
• Development of another form of cancer in patients with advanced cancer

Uncommon

• High calcium levels in the blood (hypercalcemia) after management stops in patients with giant cell tumours of the bone
• New or unusual pain in the hip, groin, or thigh (possible fracture of the thigh bone)
• Rash on the skin or sores in the mouth (lichenoid drug eru

Rare

• Severe allergic reactions (wheezing or difficulty breathing, swelling of the face, lips, tongue, throat, or other parts of the body, rash, itching, or hives on the skin)

Stop receiving ESENTRA 60MG PREFILLED SYRINGE(PFS) and contact your doctor
immediately if you experience any of the following side effects:

• Osteonecrosis (persistent pain, swelling, non-healing sores, discharge in the mouth and/or jaw, numbness of the jaw, loosening of a tooth)
• Signs of low calcium levels in the blood (spasms, twitches, cramps in muscles, numbness or tingling of fingers, toes, or around the mouth; seizures, confusion, or loss of consciousness). It can also lead to a change in heart rhythm

How To Manage Side Effects

!### Diarrhea

Drink lots of fluids, such as water or fruit juice, to keep yourself hydrated.
Do not consume any medicine on your own without consulting your doctor.

Warning & Precautions

!### Pregnancy

ContraindicatedESENTRA 60MG PREFILLED SYRINGE(PFS) is not recommended for use if you are
pregnant. If you become pregnant during management or in less than 5 months
after stopping management, then consult your doctor before receiving it.

!### Breastfeeding

Consult your doctorIt is not known about the excretion of ESENTRA 60MG PREFILLED SYRINGE(PFS) in
the breast milk. Your doctor will help you decide whether to stop breast-feeding
or to stop receiving the management, considering the benefits to the mother and
the baby.

!### Driving and Using Machines

Use with CautionESENTRA 60MG PREFILLED SYRINGE(PFS) has negligible influence on the ability to
drive and use machines.

!### Kidney

Use with CautionESENTRA 60MG PREFILLED SYRINGE(PFS) should be used with caution in patients with
severe kidney problems, kidney failure, or who have needed dialysis in the past.
Consult your doctor before receiving it.

!### Allergy

ContraindicatedBefore receiving ESENTRA 60MG PREFILLED SYRINGE(PFS), inform your doctor if you
are allergic to denosumab.

!### Use In Pediatrics

ContraindicatedESENTRA 60MG PREFILLED SYRINGE(PFS) is not recommended for children and
adolescents under 18 years of age, except for adolescents with giant cell
tumours of the bone whose bones have stopped growing. Consult your doctor before
receiving it.

Others

ESENTRA 60MG PREFILLED SYRINGE(PFS) is not recommended for use if you:

• Have unmanageed low levels of calcium in the blood
• Have unhealed wounds from oral surgery

Before receiving ESENTRA 60MG PREFILLED SYRINGE(PFS), inform your doctor if you:

• Have any problems with your mouth or teeth (poor dental health, gum disease, or tooth extraction)
• Have not had a dental check-up recently
• Have a habit of smoking (increases dental problems)

Interactions

A. Drug-Drug interactions:

Before receiving ESENTRA 60MG PREFILLED SYRINGE(PFS), inform your doctor if you
are taking any of the following medicines:

• Another medicine containing denosumab
• Bisphosphonate (other medicines used to manage bone loss)

Overdosage:

ESENTRA 60MG PREFILLED SYRINGE(PFS) 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 or nurse if you experience any unusual symptoms.

Synopsis

Drug	:	Denosumab
Pharmacological Category	:	RANK ligand inhibitor
Therapeutic Indication	:	Giant cell bone tumour and advanced cancer by bone metastasis
Dosage Forms	:	Injection, prefilled syringes

More Information

Storage

• Keep ESENTRA 60MG PREFILLED SYRINGE(PFS) out of reach of children
• Store in a refrigerator at 2-8°C

FAQs About ESENTRA 60MG PREFILLED SYRINGE(PFS)

Q: Can ESENTRA 60MG PREFILLED SYRINGE(PFS) cause weight gain?

A: ESENTRA 60MG PREFILLED SYRINGE(PFS) has not been associated with weight gain
in clinical studies. It can cause peripheral edema (fluid retention) or
swelling, which may lead to weight gain in some people.

Q: Is calcium needed along with ESENTRA 60MG PREFILLED SYRINGE(PFS)?

A: Yes. You should also take calcium and vitamin D supplements while being
managed with ESENTRA 60MG PREFILLED SYRINGE(PFS). Your doctor will discuss the
right dosage with you.

Q: Can I undergo dental procedures while receiving ESENTRA 60MG PREFILLED
SYRINGE(PFS)?

A: If you are under dental management or will undergo dental surgery (Ex. tooth
extractions), inform your doctor about it and tell your dentist that you are
being managed with ESENTRA 60MG PREFILLED SYRINGE(PFS). If you wear dentures,
you should make sure they fit properly. Contact your physician and dentist
immediately if you experience any problems with your mouth or teeth (loose
teeth, pain or swelling, or non-healing of sores or discharge).

Q: What happens after I stop receiving ESENTRA 60MG PREFILLED SYRINGE(PFS)?

A: Some patients with giant cell tumours of the bone have developed high calcium
levels in the blood weeks to months after stopping management. Your doctor will
monitor you for signs and symptoms of high levels of calcium after you stop
receiving ESENTRA 60MG PREFILLED SYRINGE(PFS).

Useful Diagnostic Tests

• Calcium
• Bone Strength Package
• Bone Profile-Advanced
• Bone Strength