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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.<br>
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Rozel 60mg injection | Rozel 60mg tablet | denosumab Apple pharmaceuticals
Rozel 60mg injection | Rozel 60mg tablet • 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.
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
MECHANISM • Denosumab linked to RANKL, a protein which is specific for the formation, function and survival of osteoclasts, the cells necessary for bone resorption. • Denosumabprohibits 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.
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.
DRUG INTERACTION • No formal drug-drug interaction with denosumabduring trials. • When interacting with some anticancer drug, orthopedic drugs, vaccines will lead to risk of adverse effects can be increased • Rozel is contraindicated in patients having Hypocalcemia, Pregnancy, Hypersensitivity
LACTATION • Rozel60mg is excreted into human milk is not known. Since possible for severe side effects occurs in nursing infants fromRozel 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 • Rozelprotect from direct light and heat.
SIDE EFFECTS Common side effects : • Fatigue, Muscle weakness, Phosphorus level reduced in blood, Nausea Less common side effects : • Dyspnea, Hypocalcemia, Cough, Arthralgia, Limb pain, Eczema, Headache
Contact Us • phone No :9987711567 • Email :info@myapplepharma.com website • https://myapplepharma.com/rozel-60mg.php