PROLIA 60MG

DESCRIPTION:

Prolia 60mg is a human monoclonal antibody for the treatment of osteoporosis,

treatment-persuaded bone loss, metastases to bone, and giant cell tumor of
bone. Prolia 60mg contraindicated in people with low blood calcium levels.
Prolia 60mg injection is prescription drug which is used under the guidance of
medical oncologist.

INDICATION:

• Indicated for treatment of osteoporosis at high risk postmenopausal women with

(end of menopause/ change of life), whose have serious problem of fractures raised or
who failed to other medication of osteoporosis.
• Indicated for treatment of Breast cancer in women whose taking certain treatment
which make severe their risk of fractures and bone loss in men with prostate cancer.
• Indicated for treatment in adults and some adolescents with giant cell tumor of bone
which cannot treat with surgery / surgery is not possible is treated with Prolia 60mg
injection.

MECHANISM OF ACTION:

Denosumab mechanism by aiming a protein called RANKL, which is required for

new osteoclasts to be made and to function. This promote to inhibit further breakdown
of bone and reduces the risk of problems caused by secondary bone cancer, such as
fractures. It can also promote to decreased pain caused by secondary bone cancer.

PRODUCT DETAILS:

Brand :Prolia
Ingredients : Denosumab
Strength : 60mg
Manufactured : Dr. Reddy’s laboratories
Package : 1 injection in a prefilled syringe
 prolia 60mg

ADME

• Peak plasma concentration: 6.75mcg/mL

• Tmax: 10days
• Without aggregation in Prolia pharmacokinetics with duration was noticed upon
multiple dosing of 60 mg SC administered once every 6 months.
• Pharmacokinetics of Prolia will not affected by the binding antibodies formation.
• Half-life is 25.4 days.

DOSAGE MANAGEMENT:

For adult :
The prescribed dose for Osteoporosis is 60mg SC (subcutaneously) once every 6
months
Administer injection in upper arm, upper thigh or abdomen
The prescribed dose for Androgen Deprivation induced bone loss is 60mg SC
q6months.
The prescribed dose is Glucocorticoid induced osteoporosis 60mg SC q6months.
The prescribed dose is Aromatase inhibitor induced bone loss 60mg SC q6months
For pediatric :
The prescribed dose is 13 years and older and 45kg or more for Giant Cell Tumor of
bone: The recommended dose is of 120mg Prolia tablet given SC, with additional
120mg doses on days 8 and 15 of the 1st month treatment every 4 weeks.
OVERDOSE:

No experienced with Prolia 60mg injection overdose. If occurs take the patient to
emergency department and call poison control

PRECAUTIONS:

• Before starting denosumab should be corrected. Hypocalcemia may worsen,

specifically in patients with renal impairment. Sufficiently supplement patients with
calcium and vitamin D.
• Prolia injection has negative effects of immuno-suppressants may improve.
Especially the harm for severe infections may be raised. Discuss with your doctor of
any immuno-suppressive drugs you early consume.
• Do not take any type of vaccination without your doctor's consultation while
administrating denosumab.
• While treatment with Prolia 60mg have Osteonecrosis of the jaw (ONJ) has been
reported with denosumab – check for symptoms.
• Planning to become pregnant before to starting this therapy, consult with doctor
before the treatment because use in pregnancy only if benefit to mother outweighs risk
to fetus).

SIDE EFFECTS:

Common side effects for the patient taking Prolia 60mg injection :
• Nausea
• Fatigue
• Muscle weakness
• Hypophosphatemia.
Less common side effects for patients taking Prolia 60mg :
• Diarrhae
• Shortness of breath
• Hypocalcemia
• Joint pain
• Hypocalcemia
• Cough
• Arthralgia
• Limb pain
• Eczema
• Headache
• Eczema
• Rash
DRUG INTERACTION

No formal drug-drug interaction with denosumab during trials.

When concomitant use with some anticancer drug, orthopedic drugs, vaccines will
lead to risk of adverse effects can be increased

CONTRAINDICATION

Prolia 60mg injection is contraindicated in

Hypocalcemia
Pregnancy
Hypersensitivity

PREGNANCY

Pregnancy category C
The Prolia 60mg which has no enough data in pregnant women to convey any drug
analog risk for adverse development outcomes the drug in pregnant women is
contraindicated for use because it may cause serious risk to the fetus.

LACTATION

Prolia 60mg injection is excreted into human milk is not known. Since possible for
severe side effects occurs in nursing infants from Prolia 60mg injection. Avoid
breastfeeding during treatment of Denosumab.

STORAGE

Store at 2°C to 8°C in the original container.

Avoid freeze.
Before to administration keep at room temperature.
Prolia protect from direct light and heat.

MISSED DOSE

If dose is missed then have the dose immediately before next dose duration. Next dose
time reaches then left off the missed dose and follows regular schedule.
Avoid taking double dose at same time.
Please consult the doctor for further information.
CONTACT US:

PHONE NO : +91-9940472902
EMAIL : millionhealthpharmaceuticals@gmail.com
WEBSITE URL: https://millionpharma.com/prolia-60mg.php