Generic Medicine Info
Indications and Dosage
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.

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.

Bone metastases associated with solid tumours
Adult: 120 mg every 4 wk. Co-administer oral Ca ≥500 mg and vit D ≥400 IU daily.
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.
Monitoring Parameters
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.
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.
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.
Store between 2-8°C. Do not freeze. Protect from direct light and heat.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Anon. Denosumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 07/04/2017.

Buckingham R (ed). Denosumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. . Accessed 07/04/2017.

Joint Formulary Committee. Denosumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. 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). Accessed 07/04/2017.

Prolia Injection (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. Accessed 07/04/2017.

Xgeva Injection (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. 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 © 2022 MIMS. All rights reserved. Powered by
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Sign up for free
Already a member? Sign in