Active Substance: Denosumab.
Overview
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This medicine contains an important and useful components, as it consists of
Denosumabis available in the market in concentration
Denosumab
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
Postmenopausal Osteoporosis
Clinically significant hypersensitivity to denosumab or to any of the components. Hypocalcemia.
>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%)
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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.
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.
Information not available