Romosozumab


Generic Medicine Info
Indications and Dosage
Subcutaneous
Osteoporosis in postmenopausal women
Adult: For women at high risk of fracture or who have failed or are intolerant to other osteoporosis therapies: 210 mg (to be given as 2 consecutive 105 mg inj at different sites) once monthly for 12 months. Initiation of antiresorptive therapy (e.g. bisphosphonate or denosumab) after a course of romosozumab therapy is recommended to maintain bone mineral density gains. Missed dose: Administer as soon as it can be rescheduled then subsequent doses must be scheduled every month from the date of the last dose.
Contraindications
Hypersensitivity, uncorrected hypocalcaemia, history of MI or stroke (within the preceding year).
Special Precautions
Patient with other CV risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus, established CV disease, smoking); known risk factors for osteonecrosis of the jaw (ONJ) or medication-related osteonecrosis of the jaw (e.g. tooth extraction or other invasive dental procedures, cancer, radiotherapy, poor oral hygiene, anaemia, coagulopathy, infection, pre-existing dental or periodontal disease, concomitant drug use). Patient requiring invasive dental procedures. Not indicated for use in women of reproductive potential or in women who are pregnant or breastfeeding. Severe renal impairment (eGFR 15-29 mL/min/1.73 m2) or receiving dialysis. Patient must be adequately supplemented with Ca and vitamin D prior to and during treatment.
Adverse Reactions
Significant: MI, stroke, transient hypocalcaemia, hypersensitivity reactions (e.g. angioedema, erythema multiforme, urticaria, dermatitis, rash). Rarely, ONJ, atypical low-energy or low trauma fracture of the femoral shaft.
Eye disorders: Cataract.
General disorders and administration site conditions: Inj site reactions, peripheral oedema.
Musculoskeletal and connective tissue disorders: Arthralgia, muscle spasms, neck pain.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, sinusitis, cough.
Potentially Fatal: Increased risk of CV death.
Patient Counseling Information
Maintain good oral hygiene.
Monitoring Parameters
Correct hypocalcaemia and perform routine oral examination before starting treatment. Monitor serum Ca level, BMD; signs and symptoms of hypersensitivity, CV events, hypocalcaemia.
Action
Description: Romosozumab, a humanised monoclonal antibody (IgG2), binds to and inhibits sclerostin, a regulatory factor in bone metabolism which inhibits the canonical Wnt signalling pathway that regulates bone growth. This results in increased bone formation and decreased bone resorption leading to immediate increase in trabecular and cortical bone mass and improvement in bone structure and strength.
Pharmacokinetics:
Absorption: Bioavailability: 81%. Time to peak plasma concentration: 5 days (range: 2-7 days).
Metabolism: Expected to be reduced via catabolic pathways (in a similar manner to endogenous IgG) into smaller peptides and amino acids.
Excretion: Elimination half-life: 12.8 days (after 3 doses over 12-week period or 1 dose every 4 weeks).
Storage
Store between 2-8°C. Do not freeze. Protect from light. Once removed from the refrigerator, store at up to 25°C in the original package for up to 30 days.
ATC Classification
M05BX06 - romosozumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
References
Anon. Romosozumab-aqqg. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 21/07/2021.

Anon. Romosozumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/07/2021.

Buckingham R (ed). Romosozumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/07/2021.

Evenity 105 mg Solution for Injection in Pre-Filled Pen (Amgen Biopharmaceuticals Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/07/2021.

Evenity 105 mg Solution for Injection in Pre-Filled Pen (UCB Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/07/2021.

Evenity Injection Solution (Amgen Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/07/2021.

Evenity Solution for Injection in Pre-Filled Syringe 105 mg/1.17 mL (Amgen Hong Kong Limited). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 21/07/2021.

Joint Formulary Committee. Romosozumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/07/2021.

Disclaimer: This information is independently developed by MIMS based on Romosozumab 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 © 2021 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in