Rozel 60mg belongs to novel, fully human IgG2 monoclonal antibody especially to receptor activator of nuclear factor kappa-B ligand (RANKL), restrain bone resorption markers in patients with a difference of metastatic tumors and is being examined in multiple clinical trials for the inhibition and treatment of bone metastases. Chemically, it exists of 2 heavy and 2 light chains. Each light chain contains of 215 amino acids. Each heavy chain contains of 448 amino acids with 4 intramolecular disulfides.
PRESCRIBED FOR
Treatment for patients having postmenopausal women with osteoporosis at high risk for fracture.
Treatment for patients with increase bone mass in men at more risk for fracture getting androgen deprivation therapy for non-metastatic prostate cancer.
Treatment for patients having to increase bone mass in women at more risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Treatment for patients with increase bone mass in men at more risk for fracture getting androgen deprivation therapy for non-metastatic prostate cancer.
Treatment for patients having to increase bone mass in women at more risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
DOSAGE
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 :
120mg subcutaneously every 4 weeks
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
OVERDOSE:
Rozel overdose has no overdose. If occurs seek to emergency department and call poison control
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 :
120mg subcutaneously every 4 weeks
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
OVERDOSE:
Rozel overdose has no overdose. If occurs seek to emergency department and call poison control
MECHANISM
Denosumab linked to RANKL, a protein which is specific for the formation, function and survival of osteoclasts, the cells necessary for bone resorption. Denosumab prohibits osteoclast formation, function and survival hence, reducing bone resorption and raising bone mass and strength of the bone.
ADME
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.
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.
PRECAUTION
• Before to start treatment with Rozel, discuss with the doctor about any other regimens you are using (including over-the-counter drugs, vitamins, or herbal remedies). Avoid having aspirin or products containing aspirin unless your doctor permits this.
• Rozel injection may improve the negative effects of immuno-suppressants. Especially the risk for serious infections may be increased. 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.
• Use in pregnancy only if benefit to mother outweighs risk to fetus. Consult with doctor before the treatment
• During Rozel treatment do not breastfeed your infants.
• Rozel injection may improve the negative effects of immuno-suppressants. Especially the risk for serious infections may be increased. 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.
• Use in pregnancy only if benefit to mother outweighs risk to fetus. Consult with doctor before the treatment
• During Rozel treatment do not breastfeed your infants.
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
When interacting with some anticancer drug, orthopedic drugs, vaccines will lead to risk of adverse effects can be increased
CONTRAINDICATION
Rozel is contraindicated in patients having Hypocalcemia, Pregnancy, Hypersensitivity
LACTATION
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.
STORAGE
Store at 2℃ to 8℃ in the original container, avoid freeze
Before to administration keep at room temperature
Rozel protect from direct light and heat.
Before to administration keep at room temperature
Rozel protect from direct light and heat.
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