Denosumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : SC Osteoporosis in postmenopausal women; Increase bone mass in men w/ osteoporosis 60 mg every 6 mth. Hypercalcaemia of malignancy; Giant cell tumour of bone 120 mg every 4 wk, w/ additional 120 mg doses on days 8 and 15 of the initial 4-wk cycle. Bone metastases associated with solid tumours 120 mg every 4 wk.
Dosage Details
Subcutaneous
Increase bone mass in men with osteoporosis, Osteoporosis in postmenopausal women
Adult: 60 mg every 6 mth. Co-administer oral Ca 1,000 mg and vit D ≥400 IU daily.

Subcutaneous
Giant cell tumour of bone, Hypercalcaemia of malignancy
Adult: 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.

Subcutaneous
Bone metastases associated with solid tumours
Adult: 120 mg every 4 wk. Co-administer oral Ca ≥500 mg and vit D ≥400 IU daily.
Contraindications
Hypocalcaemia. Pregnancy.
Special Precautions
Patient w/ impaired immune system, disturbances of mineral metabolism. Severe renal impairment (CrCl <30 mL/min) including dialysis patients. Lactation.
Adverse Reactions
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.
Patient Counseling Information
Ensure adequate Ca and vit D intake. Maintain good oral hygiene.
MonitoringParameters
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.
Drug Interactions
May enhance the adverse effect of belimumab. Increased risk for serious infections and adverse effect w/ immunosuppressants.
Action
Description: 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.
Storage
Store between 2-8°C. Do not freeze. Protect from direct light and heat.
ATC Classification
M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
References
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.

Disclaimer: This information is independently developed by MIMS based on Denosumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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