SubcutaneousOsteoporosis in postmenopausal womenAdult: 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.
|
Hypersensitivity, uncorrected hypocalcaemia, history of MI or stroke (within the preceding year).
|
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.
|
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.
|
Maintain good oral hygiene.
|
Correct hypocalcaemia and perform routine oral examination before starting treatment. Monitor serum Ca level, BMD; signs and symptoms of hypersensitivity, CV events, hypocalcaemia.
|
Description: Mechanism of Action: 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).
|
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.
|
|
M05BX06 - romosozumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
|
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.
|