Does Evenity Cause Weight Gain or Appetite Changes?
At a glance
- Drug / romosozumab-aqqg (Evenity), a sclerostin inhibitor given by subcutaneous injection [1]
- Approved use / postmenopausal women at high risk for fracture, for up to 12 monthly doses [1]
- Most common reactions / arthralgia and headache, each 5% or more [1]
- Trial size / FRAME 7,180 women; ARCH 4,093 women [2][3]
- Boxed warning / myocardial infarction, stroke and cardiovascular death [1]
Does Evenity cause weight gain?
Weight gain is not listed in the Evenity label's table of adverse reactions occurring in at least 2% of Evenity-treated women in at least one of the two large trials, FRAME and ARCH [1][2][3]. That table includes arthralgia, headache and muscle spasms [1]. Because the table covers only reactions at 2% or more, it says nothing about less frequent events [1].What side effects does the Evenity label list?
The label says the most common adverse reactions, at 5% or more, were arthralgia and headache [1]. In FRAME, arthralgia occurred in 13.1% on Evenity vs 12.1% on placebo, headache in 6.6% vs 5.8%, and muscle spasms in 4.6% vs 3.9% [1]. In ARCH, arthralgia occurred in 8.1% on Evenity vs 9.6% on alendronate and headache in 5.2% vs 5.5% [1]. Across both trials, injection site reactions such as pain and erythema occurred in 4.9% on Evenity vs 2.8% in controls and led to discontinuation in 0.1% [1]. Hypersensitivity reactions occurred in 6.5% of both Evenity and control patients [1].What about hypocalcemia?
The label lists pre-existing hypocalcemia as a contraindication and says it must be corrected before starting Evenity [1]. The label says to supplement calcium and vitamin D during treatment and to monitor patients for signs and symptoms of hypocalcemia; patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or on dialysis are at greater risk [1]. In the two trials, albumin-adjusted calcium fell below 8.3 mg/dL in 0.2% of both Evenity and control patients; none went below 7.5 mg/dL, and the nadir came by month 1 [1].What is the main safety warning?
The boxed warning is for potential myocardial infarction, stroke and cardiovascular death [1]. It says Evenity should not be initiated in patients who have had a myocardial infarction or stroke in the preceding year, and should be discontinued if either occurs during therapy [1]. In ARCH, adjudicated major adverse cardiac events were 2.0% on Evenity vs 1.1% on alendronate, hazard ratio 1.87 (95% CI 1.11 to 3.14); in FRAME they were 0.8% vs 0.8%, hazard ratio 1.03 (95% CI 0.62 to 1.72) [1].The label also warns about hypocalcemia, hypersensitivity, osteonecrosis of the jaw and atypical femoral fractures [1].
Frequently asked questions
Does Evenity cause weight gain?
Weight gain is not listed in the Evenity label's table of adverse reactions occurring in at least 2% of treated women [1].
What are the most common side effects of Evenity?
The label says arthralgia and headache occurred in 5% or more [1]. In FRAME, arthralgia was 13.1% vs 12.1% placebo and headache 6.6% vs 5.8%; in ARCH, arthralgia was 8.1% vs 9.6% alendronate and headache 5.2% vs 5.5% [1]. Injection site reactions occurred in 4.9% vs 2.8% in controls across both trials [1].
What is the boxed warning for Evenity?
The boxed warning is for potential myocardial infarction, stroke and cardiovascular death [1]. It says Evenity should not be initiated in patients who had a myocardial infarction or stroke in the preceding year, and should be discontinued if either occurs during therapy [1]. In ARCH, adjudicated major adverse cardiac events were 2.0% vs 1.1% on alendronate, hazard ratio 1.87; in FRAME they were 0.8% vs 0.8%, hazard ratio 1.03 [1].
How long is Evenity treatment?
The label limits treatment to 12 monthly doses because the anabolic effect wanes after 12 doses [1]. After stopping without an anti-resorptive agent, bone mineral density returns to about baseline within 12 months [1].
References
- U.S. National Library of Medicine, DailyMed. Evenity (romosozumab-aqqg) injection prescribing information. Evenity (romosozumab-aqqg) injection label
- Cosman F, Crittenden DB, Adachi JD, Binkley N, Czerwinski E, Ferrari S, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016;375(16):1532-1543. Romosozumab Treatment in Postmenopausal Women with Osteoporosis
- Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017;377(15):1417-1427. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis