Rozel 60mg


Rozel 60mg injection is a monoclonal antibody.
Rozel 60mg injection which attack and damage only certain cells in the body and help to protect healthy cells from demolish. Rozel 60mg injection is a trade name of denosumab.
This drug is classified as a “bone-modifying agent”, it works as a RANK ligand (RANKL) inhibitor.

Used For

Rozel 60mg injection is indicated for the treatment of osteoporosis occur in and women (menopause stage) (end of menopause/ change of life), whose risk of fractures increased or who failed to other medication of osteoporosis.
Rozel 60mg is indicated to treat breast cancer in women whose taking certain treatment which make severe their risk of fractures and bone loss in men with prostate cancer.
In adults and some adolescents with giant cell tumor of bone which cannot cured with surgery / surgery is not possible is treated with Rozel 60mg injection.

Mechanism Of Action

Denosumab is plan to aim RANKL (RANK ligand), a protein which work as the primary signal to help bone removal/resorption. In many bone loss conditions, RANKL overcome the body's natural defense against bone eradication. Denosumab inhibits RANKL from activating its receptor, RANK, which is on the surface of osteoclasts and their messengers. Prohibition of the RANKL/RANK interplay prevents osteoclast formation, function, and survival, Hence reducing bone resorption and raising bone mass and vitality in both cortical and trabecular bone.
Peak plasma concentration: 6.75mcg/mL
Tmax : 10days
Without aggregation in Rozel pharmacokinetics with duration was noticed upon multiple dosing of 60 mg SC administered once every 6 months.
Pharmacokinetics of Rozel will not affected by the binding antibodies formation.
Half-life is 25.4 days.

Dosage and administration

Dosage and administration for adult :
Osteoporosis :
60mg SC (subcutaneously) once every 6 months
Injection of drug should be done in upper arm, upper thigh or abdomen
Giant Cell Tumor of bone:
120mg SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment
Injection of drug should be done in upper arm, upper thigh or abdomen
Osteolytic Bone Metastases of Solid Tumors
120mg subcutaneously every 4 weeks
Injection of drug should be done in upper arm, upper thigh or abdomen
Hypercalcemia :
Dose of 120mg Rozel tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment
Injection of drug should be done in upper arm, upper thigh or abdomen
Dosage and administration in pediatric
13 years and older and 45kg or more
Giant Cell Tumor of bone
Dose of 120mg Rozel tablet given SC, every 4 weeks with additional 120mg doses on days 8 and 15 of the 1st month treatment
No experienced with Rozel overdose. If occurs seek to emergency department and call poison control


• Prior to start treatment with denosumab, consult with your doctor about any other regimens you are using (including over-the-counter drugs, vitamins, or herbal remedies). Not to take aspirin or products containing aspirin unless your doctor permits this.
• Rozel injection may improve the negative effects of immuno-suppressants. Especially the risk for severe infections may be raised. Inform your doctor of any immuno-suppressive drugs you early consume.
• Not to receive any type of vaccination without your doctor's consultation while admonishing denosumab.
• if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category C (use in pregnancy only if benefit to mother outweighs risk to fetus). Consult with doctor before the treatment.
• Avoid breast feeding during Denosumab treatment.

Drug Interaction

No formal drug-drug interaction with denosumab during trials.
When interacting with some anticancer drug, orthopedic drugs, vaccines will lead to risk of adverse effects can be increased


The drug in pregnant women is contraindicated for use because it may cause serious risk to the fetus. The Rozel belongs to category C which has no sufficient data in pregnant women to convey any drug analog risk for adverse development outcomes.

Side Effects

Common side effects for the patient taking Rozel 60mg as follows :
• Fatigue
• Muscle weakness
• Phosphorus level reduced in blood
• Nausea
Less common side effects for patients taking Rozel:
• Dyspnae
• Hypocalcemia
• Cough
• Arthralgia
• Limb pain
• Eczema
• Headache.

Missed Dose

Take the dose immediately before next dose duration
Next dose time reaches then left off the missed dose and continue regular schedule.
Avoid taking double dose at same time.
Please consult the doctor for further information.


Rozel 60mg is excreted into human milk is not known. Since possible for severe side effects occurs in nursing infants from Rozel 60mg injection, a decision should be considered that to discontinue nursing or discontinue the drug by giving preference of the importance of the drug to the mother.


Stored at 20C to 80C in the original container.
Avoid freeze.
Before to administration keep at room temperature.
Rozel protect from direct light and heat.


Rozel is contraindicated in
Hypersensitivity .

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