| name | Denosumab |
| classification | RANK Ligand inhibitor |
| pharmacokinetics | | absorption | Administered subcutaneously, with variable bioavailability. Peak serum concentration achieved within 2-3 days after administration. | | distribution | Distributed throughout the body, including bone. High concentrations are found in bone. | | metabolism | Minimal metabolism; primarily eliminated unchanged via the kidneys. | | elimination | Elimination half-life is approximately 16-20 days. Renal impairment can significantly affect clearance. |
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| dosage | | adults | 60mg subcutaneously every 6 months. Dosage adjustments may be required in patients with renal impairment. |
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| indications | | 1 | Treatment of osteoporosis in postmenopausal women at high risk for fracture | | 2 | Treatment of bone loss in patients with multiple myeloma | | 3 | Treatment of bone metastases in patients with solid tumours | | 4 | Treatment of Paget's Disease of bone | | 5 | Prevention of skeletal-related events in patients with bone metastases |
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| safety in pregnancy | | category | Pregnancy Category C. Not recommended during pregnancy. Animal studies have shown adverse effects, but adequate and well-controlled studies in humans are not available. Risks and benefits must be weighed carefully. | | additional info | If pregnancy is suspected or occurs during treatment, discontinuation of denosumab may be necessary. |
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| safety in breastfeeding | | category | Limited data available. Denosumab is present in breast milk. Benefits and risks must be weighed carefully. Discontinuation of breastfeeding or denosumab may be necessary. | | additional info | Consider alternative therapies where possible. |
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| side effects | | 1 | Hypocalcemia (low calcium levels) | | 2 | Osteonecrosis of the jaw (ONJ) | | 3 | Fractures | | 4 | Skin reactions at injection site | | 5 | Back pain | | 6 | Headache | | 7 | Muscle spasms | | 8 | Increased risk of infections | | 9 | Serious allergic reactions |
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| alternatives | |
| contraindications | | 1 | Hypersensitivity to Denosumab or its excipients | | 2 | Severe hypocalcemia | | 3 | Active or untreated infections in the jaw bone |
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| interactions | | 1 | Concurrent use of corticosteroids may increase the risk of osteonecrosis of the jaw. Calcium and Vitamin D supplements may be needed to prevent hypocalcemia. Check for other potential drug interactions with the patient's existing medications. |
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| warnings and precautions | | 1 | Monitor calcium and phosphate levels regularly, particularly in patients with renal impairment. | | 2 | Monitor for signs and symptoms of osteonecrosis of the jaw (ONJ), especially in patients with risk factors. | | 3 | Patients with a history of jaw conditions and/or dental procedures should be evaluated before starting treatment. | | 4 | Consider baseline bone mineral density and fracture risk before therapy initiation and throughout treatment. | | 5 | Inform the patient about the potential for atypical femur fractures. |
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| patient considerations | | patient specific considerations | A 25-year-old male with a weight of 70 kg is generally not a primary candidate for denosumab unless there is a specific, very high-risk indication like malignancy with bone metastases. | | discussion | Discussion with a physician is essential to evaluate the suitability of denosumab for the patient's specific needs and possible alternative therapies, including their risk profile. |
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