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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

EVENITY® VS PLACEBO (FRAME)

Consider the safety profile of EVENITY® in the 12-month double-blind period of the placebo-controlled study

Major Adverse Cardiac Events (MACE)1,*

During the 12-month double-blind treatment period of the placebo-controlled trial (FRAME):

  • Myocardial infarction† occurred in 9 women (0.3%) in the EVENITY® group and 8 women (0.2%) in the placebo group
  • Stroke† occurred in 8 women (0.2%) in the EVENITY® group and 10 women (0.3%) in the placebo arm
  • Cardiovascular death‡ occurred in 17 women (0.5%) in the EVENITY® group and 15 women (0.4%) in the placebo group
  • MACE resulted in incidences of 30 (0.8%) in the EVENITY® group and 29 (0.8%) in the placebo group
  • FRAME MACE Hazard Ratio: 1.03 ([0.62, 1.72]) for EVENITY® compared to placebo

*MACE is a composite endpoint of positively adjudicated myocardial infarction, stroke, and cardiovascular death.

†These events occurred in patients with and without a history of myocardial infarction or stroke.

‡Includes fatal events adjudicated as CV-related or undetermined.

More than 7000 women were included in the pivotal trial, where 3581 patients received EVENITY®1

Adverse Reactions Occurring in ≥ 2% of EVENITY®-treated Women1

FRAME
Preferred Term
Placebo
(N = 3576) n (%)
EVENITY®
(N = 3581) n (%)
Arthralgia
434 (12.1)
468 (13.1)
Headache
208 (5.8)
235 (6.6)
Muscle spasms
140 (3.9)
163 (4.6)
Edema peripheral
67 (1.9)
86 (2.4)
Asthenia
79 (2.2)
84 (2.3)
Neck pain
54 (1.5)
80 (2.2)
Insomnia
68 (1.9)
72 (2.0)
Paresthesia
62 (1.7)
72 (2.0)
Adjudicated Cases of ONJ & AFF
7157 patients were evaluated during the 12-month period1,*
  • One adjudicated case of ONJ1
    – Occurred within 12 months of EVENITY® treatment1,2,†
  • One adjudicated case of AFF1,‡
    – Occurred 3.5 months after the first dose of EVENITY®1,2,§

AFF = atypical femoral fracture; ONJ = osteonecrosis of the jaw.

*The population for the double-blind safety analysis included all the patients who underwent randomization and received at least one dose of placebo or EVENITY® in the 12-month double-blind period; †Occurred in the context of ill-fitting dentures; ‡The events listed include adverse events that were adjudicated as positive by an independent adjudication committee; §The patient had a reported history of prodromal pain at the site of fracture beginning before enrollment.

LEARN MORE ABOUT INTEGRATED SAFETY DATA
(FRAME AND ARCH STUDIES)
EVENITY® VS ALENDRONATE SAFETY EVENITY® VS TERIPARATIDE SAFETY

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. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016;375:1532-1543.