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The safety and tolerability data of EVENITY® are based on an extensive clinical trial programme1,2

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The EVENITY clinical programme included
over 12,000 patients in 9 phase 2 and 3 clinical studies:1

The most common adverse reactions were nasopharyngitis (13.6%) and arthralgia (12.4%)2

 

Hypersensitivity-related events occurred in 6.7% of patients treated with EVENITY2

 

Hypocalcaemia was reported uncommonly (0.4%) in patients treated with EVENITY2

In the ARCH study, EVENITY was generally well-tolerated, with adverse events leading to discontinuation in 3.4% of patients in the double-blind period (12 months)3

 

In the ARCH study, an imbalance in adjudicated serious CV AEs between EVENITY and alendronate
was observed during the double-blind period (2.5% vs 1.9% respectively)3

 

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
Cataract Eye 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.

Contraindications

  • Hypersensitivity to the active substance(s) or to any of the excipients
  • Hypocalcaemia
  • 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.

Online Risk Management Plan Resource

Learn more about how to minimise risk with EVENITY

 

View References
  1. Clinicaltrials.gov. Available at: https://clinicaltrials.gov/ct2/results?term=romosozumab+AND+Osteoporosis&recrs=eh&type=Intr. Accessed June 2019
  2. EVENITY SmPC.
  3. Saag K, et al. N Eng J Med 2017;377:1417-1427.