SubcutaneousOsteoporosis in postmenopausal womenAdult: As treatment for patients who are at high risk of fracture or in whom other available therapies have failed or cannot be used: 210 mg once a month for 12 months; each monthly dose is given as 2 consecutive 105 mg SC inj administered at different sites (into the abdomen, thigh or upper arm). After completion of romosozumab therapy, transition to antiresorptive therapy (e.g. bisphosphonate or denosumab) is recommended to maintain bone 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.
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Hypersensitivity. Uncorrected hypocalcaemia and history of MI or stroke.
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Patient with CV disease risk factors (e.g. established CV disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking); known risk factors for osteonecrosis of the jaw (e.g. tooth extraction or other invasive dental procedures, cancer, radiotherapy, chemotherapy, poor oral hygiene, anaemia, coagulopathy, infection, preexisting dental or periodontal disease). Patient must be adequately supplemented with calcium and vitamin D prior to and during treatment. Severe renal impairment (eGFR: 15-29 mL/min/1.73 m2) or those undergoing dialysis. Not indicated for use in women of reproductive potential or in women who are pregnant or breastfeeding.
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Significant: MI, stroke, hypocalcaemia, hypersensitivity reactions (e.g. angioedema, erythema multiforme, urticaria, rash, dermatitis), osteonecrosis of the jaw, atypical femur fractures.
Eye disorders: Cataract.
General disorders and administration site conditions: Inj site reactions, asthenia, peripheral oedema.
Musculoskeletal and connective tissue disorders: Arthralgia, neck pain, muscle spasms.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, sinusitis, cough.
Potentially Fatal: Increased risk of CV death.
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Maintain good oral hygiene. Ensure adequate intake of calcium and vitamin D; take supplements if dietary intake is insufficient.
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Correct hypocalcaemia and perform routine oral examination before starting treatment. Monitor serum calcium and evaluate BMD. Assess for signs and symptoms of hypersensitivity, hypocalcaemia (e.g. tingling, seizures, muscle cramps), CV events, jaw pain or swelling, and new or unusual hip, thigh, or groin pain.
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Description:
Overview: Romosozumab is a humanised anti-sclerostin monoclonal antibody and a bone anabolic agent.
Mechanism of Action: Romosozumab binds to and inhibits sclerostin, a negative regulator of bone formation, thereby promoting bone formation through activation of bone-lining cells, enhanced bone matrix production by osteoblasts, and recruitment of osteoprogenitor cells. In addition, romosozumab decreases bone resorption by modulating the expression of osteoclast mediators.
Pharmacodynamics: Romosozumab has a dual action of increasing bone formation and decreasing bone resorption, which leads to a rapid increase in trabecular and cortical bone mass, and improvements in structure and strength. In postmenopausal women with osteoporosis, an increase in the bone formation marker procollagen type 1 N-terminal propeptide (P1NP) and a decrease in the bone resorption marker type 1 collagen C-telopeptide (CTX) have been observed, with marker levels returning toward baseline after discontinuation of therapy.
Onset: Peak increase in P1NP and peak decrease in CTX: 2 weeks after treatment initiation. Increased histomorphometric indices of bone formation: 2 months after treatment initiation.
Duration: CTX reduction lasts throughout the 12 months of treatment; P1NP returns to baseline by 9 months and declines at 12 months; anabolic effect wanes after 12 months of therapy. After treatment discontinuation, CTX increased above baseline levels within 3 months; CTX, P1NP, and BMD returned to baseline within approx 12 months.
Pharmacokinetics:
Absorption: Bioavailability: 81%. Time to peak plasma concentration: 5 days (range: 2-7 days).
Metabolism: Expected to be degraded via catabolic pathways into small peptides and amino acids like endogenous IgG.
Excretion: Elimination half-life: 12.8 days after 3 doses over 12 weeks (i.e. 1 dose every 4 weeks).
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Store between 2-8°C. Do not freeze. Protect from light. If removed from the refrigerator, store at controlled room temperature (up to 25°C) in the original carton and must be used within 30 days; discard if unused after 30 days. Do not store in extreme heat or cold. Do not shake.
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M05BX06 - romosozumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
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Brayfield A, Cadart C (eds). Romosozumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/01/2026. Evenity 105 mg Solution for Injection in Pre-filled Pen (UCB Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 07/01/2026. Evenity Injection, Solution (Amgen Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/01/2026. Evenity Solution for Injection in Pre-filled Syringe 105 mg/1.17 mL (Amgen Biopharmaceuticals Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 07/01/2026. Joint Formulary Committee. Romosozumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/01/2026. Romosozumab-aqqg. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/01/2026. Romosozumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 07/01/2026.
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