In the EU and the UK, EVENITY® is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.1,2
Licenses may vary by country. Please always refer to the Prescribing Information in your country before prescribing any drug.
Adverse events should be reported. Reporting forms and information can be obtained from your local regulatory authority. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ for the UK and https://www.hpra.ie/homepage/about-us/report-an-issue for Republic of Ireland. Adverse events should also be reported to UCB. For UK and Irish healthcare professionals, adverse events should also be reported to ucbcares.uk@ucb.com or 0800 2793177 for the UK and UCB (Pharma) Ireland Ltd at ucbcares.ie@ucb.com or 1800 930075 for Republic of Ireland.
The EU SmPC can be found here.
UK Prescribing Information can be found here.
Irish Prescribing Information can be found below:
EVENITY® (romosozumab)
Active Ingredient: Romosozumab - solution for injection: 105 mg of romosozumab in 1.17 mL of solution (90 mg/mL).
Indications: Severe osteoporosis in postmenopausal women at high risk of fracture.
Dosage and Administration: Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis. Dosage: 210 mg administered as two equal subcutaneous injections of 105 mg each once monthly for 12 months. Patients to be adequately supplemented with calcium and vitamin D before and during treatment. Following completion of therapy, transition to antiresorptive therapy is recommended. Renal impairment: No dose adjustment is needed. Serum calcium to be monitored in patients with severe renal impairment or receiving dialysis. Elderly: No dose adjustment needed. Discontinuation: see SmPC for guidance.
Contraindications, Warnings, Precautions for use: Contraindications: Hypersensitivity to romosozumab or to any of the excipients listed in the SmPC; Hypocalcaemia; History of myocardial infarction or stroke.
Warnings and Precautions: Myocardial infarction and stroke: An increase in serious cases of cardiovascular events has been observed in romosozumab treated patients compared to controls. Consideration should be given to fracture risk over the next year and cardiovascular risk factors. If a patient experiences a myocardial infarction or stroke during therapy, treatment should be discontinued. Hypocalcaemia: Transient hypocalcaemia has been observed. Hypocalcaemia should be corrected prior to initiating romosozumab. Limited safety data in patients with severe renal impairment or receiving dialysis - calcium levels should be monitored in these patients. Hypersensitivity: Erythema multiforme, angioedema and urticaria have been reported. Osteonecrosis of the jaw (ONJ): Consider risk factors when evaluating risk of developing ONJ. Atypical femoral fractures: Atypical low-energy or low trauma fracture of the femoral shaft have been reported rarely. Consider interruption of romosozumab in patients presenting with an atypical femur fracture, based on an individual benefit-risk assessment.
Refer to SmPC for full information.
Interactions: No data available.
Fertility, pregnancy and lactation: Not to be used in child-bearing potential, pregnant or breastfeeding women. Risk for malformations of developing digits in the human foetus in the first trimester, a period when placental transfer of immunoglobulins is limited. No data available on human fertility.
Driving and use of machines: No or negligible influence on ability to drive and use machines.
Adverse Effects: Very Common (≥ 1/10): Nasopharyngitis, arthralgia. Common (≥ 1/100 to < 1/10): Sinusitis, hypersensitivity, rash, dermatitis, headache, neck pain, muscle spasms, injection site reactions. Uncommon (≥ 1/1,000 to < 1/100): Urticaria, hypocalcaemia, stroke, cataract, myocardial infarction. Rare (≥ 1/10,000 to < 1/1,000): angioedema, erythema multiforme. See SmPC for further details.
Pharmaceutical Precautions: Store in a refrigerator (2ºC - 8ºC) in original container, do not freeze. Keep pre-filled pen in the outer carton in order to protect from light. Do not return to refrigerator after use; EVENITY can be kept at up to 25ºC for up to 30 days in original container. Product should be discarded after this period.
Legal Category: POM
Marketing Authorisation Numbers: EU/1/19/1411/001
Marketing Authorisation Holder: UCB Pharma S.A., Allee de la Recherche 60, B-1070 Brussels, Belgium.
Further information is available from:
Republic of Ireland: UCB (Pharma) Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, City West Road, Dublin 24, Ireland. Tel: +353 1463 2371
Email: ucbcares.ie@ucb.com
Date of Revision: May 2025 (IE-RM-2400111) EVENITY is a registered trademark.
EU Prescribing Information can also be found below:
EVENITY® (romosozumab) Abbreviated Product Information
Name of the medicinal product: EVENITY® (romosozumab). Pharmaceutical form: Solution for injection containing 105 mg of romosozumab in 1.17 ml of solution (90 mg/ml) for injection in pre-filled pen or pre-filled syringe. Therapeutic indications: EVENITY® is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Posology and method of administration: Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis. The recommended dose is 210 mg romosozumab (administered as two subcutaneous injections of 105 mg each) once monthly for 12 months. To administer the 210 mg dose, 2 subcutaneous injections of romosozumab should be given into the abdomen, thigh, or upper arm. The second injection should be given immediately after the first one but at a different injection site. Administration should be performed by an individual who has been trained in injection techniques. Patients should be adequately supplemented with calcium and vitamin D before and during treatment. Following completion of romosozumab therapy, transition to antiresorptive therapy is recommended in order to extend the benefit achieved with romosozumab beyond 12 months. If the romosozumab dose is missed, it should be administered as soon as it can be feasible. Thereafter, the next romosozumab dose should not be given earlier than one month after the last dose. Based on data no dose adjustment is necessary in elderly patients or patients with renal impairment. Serum calcium should be monitored in patients with severe renal impairment or receiving dialysis. No clinical trials have been conducted to evaluate the effect of hepatic impairment. Paediatric population: romosozumab is not indicated for use in paediatric populations. The safety and efficacy of romosozumab in paediatric patients (age <18 years) have not yet been established and no data are available. Contraindications: Hypersensitivity to the active substance or to any of the excipients, hypocalcaemia and history of myocardial infarction or stroke. Special warnings and precautions for use: In randomised controlled studies, an increase in serious cardiovascular events (myocardial infarction and stroke) has been observed romosozumab-treated patients compared to controls. Romosozumab is contraindicated in patients with previous myocardial infarction or stroke. When determining whether to use romosozumab for an individual patient, consideration should be given to her fracture risk over the next year and her cardiovascular risk based on risk factors (e.g. established cardiovascular disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking, severe renal impairment, age). Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk. If a patient experiences a myocardial infarction or stroke during therapy, treatment with romosozumab should be discontinued. Transient hypocalcaemia has been observed in patients receiving romosozumab. Hypocalcaemia should be corrected prior to initiating therapy with romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia. If any patient presents with suspected symptoms of hypocalcaemia during treatment, calcium levels should be measured. Patients should be adequately supplemented with calcium and Vitamin D. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 ml/min/1.73 m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients is limited. Calcium levels should be monitored in these patients. Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the romosozumab group in clinical trials. If an anaphylactic or other clinically significant allergic reaction occurs, appropriate therapy should be initiated and use of romosozumab should be discontinued. Osteonecrosis of the jaw (ONJ) has been reported rarely in patients receiving romosozumab. The following risk factors should be considered when evaluating a patient’s risk of developing ONJ: potency of the medicinal product that inhibits bone resorption (the risk increases with the antiresorptive potency of the compound), and cumulative dose of antiresorptive therapy, cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking, concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck, poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions. All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or discharge during treatment with romosozumab. Patients who are suspected of having or who develop ONJ while on romosozumab should receive care by a dentist or an oral surgeon with expertise in ONJ. Discontinuation of romosozumab therapy should be considered until the condition resolves and contributing risk factors are mitigated where possible. Atypical low-energy or low trauma fracture of the femoral shaft, which can occur spontaneously, has been reported rarely in patients receiving romosozumab. Any patient who presents with new or unusual thigh, hip, or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of romosozumab therapy should be considered, based on an individual benefit-risk assessment. This medicine contains 0.070 mg of polysorbate 20 in each pre-filled pen and each pre-filled syringe. Polysorbates may cause allergic reactions. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free. Interaction with other medicinal products and other forms of interaction: No drug interaction studies have been performed with romosozumab. No pharmacokinetic drug interactions are expected with romosozumab. Pregnancy: romosozumab is not indicated for use in women of child-bearing potential or in pregnant women. There are no data from the use of romosozumab in pregnant women. Skeletal malformations (including syndactyly and polydactyly) were observed at a low incidence in a single study with romosozumab in rats. A risk for malformations of developing digits in the human foetus is low following romosozumab exposure due to the timing of digit formation in the first trimester in humans, a period when placental transfer of immunoglobulins is limited. Breast-feeding: romosozumab is not indicated for use in breast-feeding women. No data are available on excretion of romosozumab in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Fertility: No data are available on the effect of romosozumab on human fertility. Animal studies in female and male rats did not show any effects on fertility endpoints. Effects on ability to drive and use machines: romosozumab has no or negligible influence on the ability to drive and use machines. Undesirable effects: In randomised controlled studies, the most common adverse reactions were nasopharyngitis (13.6%) and arthralgia (12.4%). Hypersensitivity-related reactions occurred in 6.7% of patients treated with romosozumab. Hypocalcaemia was reported uncommonly (0.4% of patients treated with romosozumab). An increase in serious cardiovascular events (myocardial infarction and stroke) has been observed in romosozumab treated patients compared to controls. Very common adverse reactions (≥ 1/10) included nasopharyngitis and arthralgia, common adverse reactions (≥ 1/100 to < 1/10) included sinusitis, hypersensitivity, rash, dermatitis, headache, neck pain, muscle spasms and injection site reactions, uncommon adverse reactions (≥ 1/1,000 to < 1/100) included urticaria, hypocalcaemia, stroke, cataract, myocardial infarction and rare adverse reactions (≥ 1/10,000 to < 1/1,000) included angioedema and erythema multiforme. In postmenopausal women dosed with monthly romosozumab, the incidence of anti-romosozumab antibodies was 18.6% (1162 of 6244) for binding antibodies and 0.9% (58 of 6244) for neutralizing antibodies. The earliest onset of anti-romosozumab antibodies was 3 months after first dosing. The majority of antibody responses were transient. The presence of anti-romosozumab binding antibodies decreased romosozumab exposure by up to 25%. No impact on the efficacy of romosozumab was observed in the presence of anti-romosozumab antibodies. Limited safety data show that the incidence of injection site reactions was numerically higher in female patients with neutralizing antibodies. In the active-controlled trial of romosozumab for the treatment of severe osteoporosis in postmenopausal women during the 12-month double-blind romosozumab treatment phase, 16 women (0.8%) had myocardial infarction in the romosozumab arm versus 5 women (0.2%) in the alendronate arm and 13 women (0.6%) had stroke in the romosozumab arm versus 7 women (0.3%) in the alendronate arm. These events occurred in patients with and without a history of myocardial infarction or stroke. Cardiovascular death occurred in 17 women (0.8%) in the romosozumab group and 12 (0.6%) women in the alendronate group. The number of women with major adverse cardiac events (MACE = positively adjudicated cardiovascular death, myocardial infarction or stroke) was 41 (2.0%) in the romosozumab group and 22 (1.1%) in the alendronate group, yielding a hazard ratio of 1.87 (95% confidence interval [1.11, 3.14]) for romosozumab compared to alendronate. All-cause death occurred in 30 women (1.5%) in the romosozumab group and 22 (1.1%) women in the alendronate group. In the placebo-controlled trial of romosozumab for the treatment of osteoporosis in postmenopausal women (including women with severe and less severe osteoporosis) during the 12-month double-blind romosozumab treatment phase, there was no difference in positively adjudicated MACE; 30 (0.8%) occurred in the romosozumab group and 29 (0.8%) in the placebo group. All-cause death occurred in 29 women (0.8%) in the romosozumab group and 24 (0.7%) women in the placebo group. Overdose: There is no experience with overdose in clinical trials. There is no known antidote to romosozumab or specific treatment for overdose. In case of overdose, it is recommended that patients are monitored closely and given appropriate treatment.
The European Commission decision for EVENITY®’s marketing authorisation was renewed on 22 August 2024. Refer to the full prescribing information in your country before prescribing. Marketing authorisation holder: UCB Pharma, SA. Allée de la Recherche 60, B-1070 Brussels, Belgium. Marketing authorisation number(s): EU/1/19/1411/001; EU/1/19/1411/002; EU/1/19/1411/003; EU/1/19/1411/004. Date of issue of marketing authorisation valid throughout the European Union: 09/12/2019. Legal classification: Prescription only medicine.
References:
1. EVENITY (romosozumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf. Accessed May 2026. 2. EVENITY (romosozumab) UK SmPC. https://www.emcpi.com/pi/37322. Accessed May 2026. 3. Saag KG, et al. N Engl J Med. 2017;377(15):1417-27. 4. Rosen CJ. N Engl J Med. 2017;377(15):1479-80. 5. Ferrari SL. Nat Rev Rheumatol. 2018;14(3):128. 6. Hartz MC, et al. J Clin Endocrinol Metab. 2025;110(5):e1640-52.
© UCB Biopharma SRL, 2026. All rights reserved
GL-RM-2600048 | Date of preparation: May 2026
