INDICATION

EVENITY® is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Read More

The anabolic effect of EVENITY® wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY® use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. Close
PRESCRIBING INFORMATION MEDICATION GUIDE IMPORTANT SAFETY INFORMATION INDICATION FOR PATIENTS CONNECT WITH A REP

Patients taking EVENITY® during the first 12 months followed by Prolia® (denosumab) had significantly fewer vertebral fractures than those taking placebo followed by Prolia®1

EVENITY® First Followed by Prolia® vs Placebo Followed by Prolia®1
Fracture Risk Reduction at 12 and 24 Months

NEW VERTEBRAL FRACTURES

Vertebral Fractures
  • The incidence of nonvertebral fractures was not statistically significantly different when comparing EVENITY®-treated women to placebo-treated women at month 12 or month 241

*Absolute and relative risk reduction are based on the Mantel-Haenszel method adjusting for age and prevalent vertebral fracture strata.

†P value based on logistic regression model adjusting for age and prevalent vertebral fracture strata.

  ARR = absolute risk reduction.

EVENITY® rapidly built bone in just 12 months1

Significant BMD gains at key sites1

When followed by Prolia® (denosumab), BMD gains continued to increase through month 241

EVENITY® First Followed by Prolia® vs Placebo Followed by Prolia®1,2

BMD Gains at Month 12 and Month 24

LUMBAR SPINE

Lumbar Spine

‡ P < 0.001 based on ANCOVA model adjusting for treatment, age and prevalent vertebral fracture stratification variables, baseline value, machine type, and baseline value-by-machine type interaction, without adjustment for multiplicity.

TOTAL HIP

Total Hip

§ P < 0.001 based on ANCOVA model adjusting for treatment, age and prevalent vertebral fracture stratification variables, baseline value, machine type, and baseline value-by-machine type interaction, without adjustment for multiplicity.

FEMORAL NECK

Femoral Neck

** P < 0.001 based on ANCOVA model adjusting for treatment, age and prevalent vertebral fracture stratification variables, baseline value, machine type, and baseline value-by-machine type interaction, without adjustment for multiplicity.

Results with EVENITY® you can see in 12 months

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Bone biopsy specimens were obtained during the FRAME substudy of postmenopausal women with osteoporosis. Samples were taken from the iliac crest of the hip from two different women following either 12 monthly doses of EVENITY® or placebo.3 Images shown here are representative of the group average at 12 months.3

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IMPORTANT SAFETY INFORMATION

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.

In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY® compared to those treated with alendronate.

Contraindications: EVENITY® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY®. EVENITY® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.

Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY®.

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITY®.

Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY®. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY®. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.

For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY® should be considered based on benefit-risk assessment.

Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

During EVENITY® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY® therapy should be considered based on benefit-risk assessment.

Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY® were arthralgia and headache.

EVENITY® is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see EVENITY® full Prescribing Information, including Medication Guide.

IMPORTANT SAFETY INFORMATION

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH
EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.

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References: 1. EVENITY® (romosozumab-aqqg) prescribing information, Amgen. 2. Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, et al. One year of romosozumab followed by two years of denosumab maintains fracture risk reductions: results of the FRAME extension study. J Bone Miner Res. 2019;34:419-428. 3. Data on file, Amgen; 2020.