The EVENITY clinical programme included
over 12,000 patients in 9 phase 2 and 3 clinical studies:1
|Frequency||Adverse reaction||MedDRA System Organ Class2|
|Very common||Nasopharyngitis||Infections and infestations|
|Arthralgia||Musculoskeletal and connective tissue disorders|
|Common||Sinusitis||Infections and infestations|
|Hypersensitivity*||Immune system disorders|
|Rash||Immune system disorders|
|Dermatitis||Immune system disorders|
|Headache||Nervous system disorders|
|Neck pain||Musculoskeletal and connective tissue disorders|
|Muscle spasms||Musculoskeletal and connective tissue disorders|
|Injection site reactions†||Administration site conditions|
|Uncommon||Urticaria||Immune system disorders|
|Hypocalcaemia‡||Metabolism and nutrition disorders|
|Stroke§||Nervous system disorders|
|Myocardial infarction§||Cardiac disorders|
|Rare||Angioedema||Immune system disorders|
|Erythema multiforme||Immune system disorders|
|Atypical femoral fracture|
|Osteonecrosis of the jaw|
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000). *Please refer to Contraindications and Special warnings and precautions in the Summary of Product Characteristics for more information. †The most frequent injection site reactions were pain and erythema. ‡Defined as albumin adjusted serum calcium that was below the lower limit of normal. §Please refer to Myocardial infarction, stroke and death in the Summary of Product Characteristics for more information.
- Hypersensitivity to the active substance(s) or to any of the excipients
- History of myocardial infarction or stroke
Special Warnings and precautions for use
Myocardial infarction and stroke
In randomised controlled studies, an increase in serious cardiovascular events (myocardial infarction and stroke) has been observed in EVENITY treated patients compared to controls.
EVENITY is contraindicated in patients with previous myocardial infarction or stroke.
When determining whether to use EVENITY 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).
EVENITY 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.
Patients treated with EVENITY should be given the package leaflet and the Patient Alert Card.
For other warnings and precautions please see the prescribing information.
- Clinicaltrials.gov. Available at: https://clinicaltrials.gov/ct2/results?term=romosozumab+AND+Osteoporosis&recrs=eh&type=Intr. Accessed June 2019
- EVENITY SmPC.
- Saag K, et al. N Eng J Med 2017;377:1417-1427.