SubcutaneousIncrease bone mass in men with osteoporosis, Osteoporosis in postmenopausal womenAdult: 60 mg every 6 mth. Co-administer oral Ca 1,000 mg and vit D ≥400 IU daily.
SubcutaneousGiant cell tumour of bone, Hypercalcaemia of malignancyAdult: 120 mg every 4 wk, w/ additional 120 mg doses on days 8 and 15 of the initial 4-wk cycle. Co-administer oral Ca ≥500 mg and vit D ≥400 IU daily.
SubcutaneousBone metastases associated with solid tumoursAdult: 120 mg every 4 wk. Co-administer oral Ca ≥500 mg and vit D ≥400 IU daily.
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Hypocalcaemia. Pregnancy.
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Patient w/ impaired immune system, disturbances of mineral metabolism. Severe renal impairment (CrCl <30 mL/min) including dialysis patients. Lactation.
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Significant: Back pain, musculoskeletal pain, hypercholesterolaemia, hypercalcaemia, cystitis, dermatitis, rash, eczema, hypersensitivity (including anaphylaxis). Rarely, osteonecrosis of the jaw, atypical femoral fractures.
Nervous: Fatigue/asthenia, headache, peripheral oedema, sciatica, insomnia.
CV: HTN, angina pectoris, AF.
GI: Nausea, diarrhoea, decreased appetite, vomiting, constipation, flatulence, tooth extraction, GERD.
Resp: Dyspnoea, cough, nasopharyngitis, upper resp tract infection.
Genitourinary: Urinary retention, UTI.
Endocrine: Hypophosphataemia.
Haematologic: Anaemia.
Musculoskeletal: Arthralgia, weakness, myalgia, ostealgia.
Ophthalmologic: Cataract.
Otic: Vertigo.
Dermatologic: Hyperhidrosis.
Immunologic: Influenza.
Potentially Fatal: Severe hypocalcaemia, pancreatitis, serious infections.
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Ensure adequate Ca and vit D intake. Maintain good oral hygiene.
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Monitor serum creatinine, Ca and 25(OH)D, phosphorous, and Mg prior to and during therapy. Re-evaluate BMD every 2 yr, annual measurement of ht/wt. Assess sign/symptoms of hypo-/hypercalcaemia, chronic back pain, infections, or dermatologic reactions. Prior to therapy, perform dental exam and preventive dentistry in patients at risk of osteonecrosis.
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May enhance the adverse effect of belimumab. Increased risk for serious infections and adverse effect w/ immunosuppressants.
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Description:
Mechanism of Action: Denosumab, a monoclonal antibody, binds to receptor activator of nuclear factor kappa-B ligand (RANKL) preventing activation from its receptor, RANK, thus inhibits osteoclast formation, function, and survival thereby reducing bone resorption.
Pharmacokinetics:
Absorption: Bioavailability: 62%. Time to peak plasma concentration: 10 days.
Metabolism: Metabolised via Ig clearance pathways, resulting in degradation to small peptides and amino acids.
Excretion: Via the reticuloendothelial system. Elimination half-life: Approx 25-28 days.
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Store between 2-8°C. Do not freeze. Protect from direct light and heat.
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M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
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Anon. Denosumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/04/2017. Buckingham R (ed). Denosumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com . Accessed 07/04/2017. Joint Formulary Committee. Denosumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/04/2017. McEvoy GK, Snow EK, Miller J et al (eds). Denosumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 07/04/2017. Prolia Injection (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/04/2017. Xgeva Injection (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/04/2017.
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