Denosis 120 - Injection Denosumab - 120mg/1.7ml 1 Injection(s) / Injection Incepta Pharmaceuticals Ltd. Introduction: Denosis 120 is a medicine used in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. It makes the bones strong and reduce the risk of fractures. Denosis 120 is given by a healthcare professional and should not be self-administered. You should use it regularly and at the same time each day to get maximum benefit from it. Continue using it as recommended by your doctor and complete the dose even if you feel better. To make it more effective, take adequate amount of calcium and vitamin D supplements while on treatment with this... Uses of Denosis 120: Osteoporosis Side effects of Denosis 120: Musculoskeletal (bone, muscle or joint) painPain in extremityNerve painConstipationRashUrinary tract infection How to use Denosis 120: Your doctor or nurse will guide you how to use this medicine. How Denosis 120 works: Denosis 120 is a monoclonal antibody. It binds to a protein that causes bone loss, thereby strengthening the bone and minimizing the risk of fractures. What if you forget to take Denosis 120?: If you miss a dose of Denosis 120, please consult your doctor. Indication: Osteoporosis, treatment of men and postmenopausal women with osteoporosis who are at high risk for fracture; treatment to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer; treatment to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer. Prevention of skeletal-related events (eg, pathological fracture, bone radiation, spinal cord compression or bone surgery) in adults w/ bone metastases from solid tumours. Adults & skeletally mature adolescents w/ giant cell tumor of bone that is unresectable or where surgical... Administration: Administer SC in upper arm, upper thigh, or abdomen; do NOT administer intradermally, IM, or IV Administer calcium and vitamin D as needed to treat or prevent hypocalcemia Avoid vigorous shaking of vial/syringe Adult Dose: Denosumab 60mg Subcutaneous Osteoporosis 60 mg SC every 6 months Supplement with calcium 1000 mg/day and vitamin D 400 IU/day Aromatase Inhibitor Induced Bone Loss Women with breast cancer: 60 mg SC every 6 months Androgen Deprivation Induced Bone Loss Men with prostate cancer: 60 mg SC every 6 months Denosumab 120mg Subcutaneous Skeletal-Related Events Prevention of skeletal-related events (SREs; eg, bone fractures and pain) in patients with bone metastases from solid tumors 120 mg (1.7 mL) SC every 4 weeks Giant Cell Tumor Treatment of adults and skeletally mature adolescents with giant cell tumor of bone in whom surgical... Renal Dose: Renal Impairment: Based on the available safety and efficacy data in the elderly, no dosage adjustment is required in patients with renal impairment. Patients with severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or receiving dialysis are at greater risk of developing hypocalcemia. Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis. Contraindication: Clinically significant hypersensitivity to denosumab or to any of the components. Hypocalcemia. Mode of Action: Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to receptor activator of nuclear factor kappa-B ligand (RANKL) preventing RANKL from activating its only receptor, RANK, on the surface of osteoclasts and their precursors, independent of bone surface. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival. Denosumab therefore reduces bone resorption and increases bone mass and strength in both cortical and trabecular bone. Precaution: Correct hypocalcemia prior to initiation of therapy. Patients should receive Ca & vit D supplements during treatment (unless hypercalcemia is present). Skin infections predominantly cellulitis may develop. Osteonecrosis of the jaw in patients w/ advanced cancer. Atypical femoral fracture. Severe renal impairment or undergoing dialysis. Pregnancy & lactation. Childn. Lactation: Unknown whether drug is distributed in breast milk; caution is advised Side Effect: >10% Back pain (34.7%),Extremity pain (11.7%) 1-10% Musculoskeletal pain (7.6%),Hypercholesterolemia (7.2%),Cystitis (5.9%),Upper respiratory tract infection (4.9%),New malignancies (4.8%, compared with 4.3% in placebo group),Sciatica (4.6%),Nonfatal serious infection (4%),Bone pain (3.7%),Anemia (3.3%),Upper abdominal pain (3.3%),Rash (2.5%),Flatulence (2.2%),Osteonecrosis of jaw (2.2%),Pruritus (2.2%),Hypocalcemia (1.7%) <1% Serious infection of abdomen resulting in hospitalization (0.9%),Serious infection of urinary tract resulting in hospitalization (0.7%),Serious infection resulting in death (0.2%),Pancreatitis (0.2%),Serious infection of ear resulting in hospitalization (0.1%) Pregnancy Category Note: Pregnancy Contraindicated Based on findings in animals and its mechanism of action, denosumab can cause fetal harm when administered to a pregnant woman In utero exposure in cynomolgus monkeys dosed monthly with denosumab throughout pregnancy at a dose 50-fold higher than the recommended human dose based on body weight resulted in increased fetal loss, stillbirths, and postnatal mortality, and absent lymph nodes, abnormal bone growth, and decreased neonatal growth Present at low concentrations (~2% of serum exposure) in seminal fluid of male subjects receiving therapy; following vaginal intercourse, maximum amount of denosumab delivered to a female partner would result in... Interaction: Increased risk of serious infections w/ immunosuppressive agents.Denosumab did not affect the pharmacokinetics of midazolam, a drug metabolised by cytochrome P450 3A4 (CYP3A4). Incompatibilities:Denosumab must not be mixed with other medicinal products.