ROZEL 60MG
                     ROZEL 60MG
DESCRIPTION
 Rozel 60mg  is a human monoclonal antibody for the treatment of osteoporosis, treatment-
persuaded bone loss, metastases to bone, and giant cell tumor of bone. Rozel 60mg injection is 
contraindicated in people with low blood calcium levels.
 Rozel 60mg  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 Rozel 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 :Rozel
Ingredients : Denosumab
Strength : 60mg
Manufactured : Intas Pharmaceuticals
Package : 1 injection in a prefilled syringe
Rozel 60mg
ADME
• Peak plasma concentration: 6.75mcg/mL
• Tmax: 10days
• Without aggregation in Rozel pharmacokinetics with duration was noticed upon multiple 
dosing of rozel 60 mg injection SC administered once every 6 months.
• Pharmacokinetics of  Rozel 60mg  will not affected by the binding antibodies formation.
• Half-life is 25.4 days.
DOSAGE MANAGEMENT
For adult :
The prescribed dose for Osteoporosis is  rozel 60mg injection  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 Rozel tablet given SC, with additional 120mg doses on days 8 
and 15 of the 1st month treatment every 4 weeks.
Breast Cancer
OVERDOSE
No experienced with Rozel 60mg 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.
• Rozel 60mg 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 Rozel 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  Rozel 60mg injection  :
• Nausea
• Fatigue
• Muscle weakness
• Hypophosphatemia.
Less common side effects for patients taking  Rozel 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
Rozel 60mg injection is contraindicated in
Hypocalcemia
Pregnancy
Hypersensitivity
PREGNANCY
Pregnancy category C
The  Rozel 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
Rozel 60mg injection is excreted into human milk is not known. Since possible for severe side 
effects occurs in nursing infants from Rozel 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.
Rozel 60mg injection 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 :
EMAIL ID : [email protected]
PHONE NO : +91-9940472902
WEBSITE URL : https://millionpharma.com/rozel-60mg.php