Romosozumab

EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption.

• EVENITY is a sclerostin inhibitor 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. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses.ICD-10: M81.0

• EVENITY is contraindicated in patients with: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY [see Warnings and Precautions (5.3) , Adverse Reactions (6.1) and Use in Specific Populations (8.7) ].contraindicated

Two separate subcutaneous injections are needed to administer the total dose of 210 mg. Inject two syringes, one after the other. ( 2.1 ) Should be administered by a healthcare provider. ( 2.1 ) Administer 210 mg subcutaneously once every month for 12 doses in the abdomen, thigh, or upper arm. ( 2.2 ) Adequately supplement calcium and vitamin D during treatment. ( 2.2 ) 2.1 Important Dosage and Administration Instructions Two separate syringes (and two separate subcutaneous injections) are needed to administer the total dose of 210 mg of EVENITY. Inject two 105 mg/1.17 mL prefilled syringes, one after the other. EVENITY should be administered by a healthcare provider. 2.2 Recommended Dosage The recommended dose of EVENITY is 210 mg administered subcutaneously in the abdomen, thigh or upper arm. Administer EVENITY once every month. The treatment duration for EVENITY is 12 monthly doses. Patients should be adequately supplemented with calcium and vitamin D during treatment with EVENITY [see Warnings and Precautions (5.3) and Clinical Studies (14.1) ] . If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter, EVENITY can be scheduled every month from the date of the last dose. 2.3 Preparation and Administration Instructions Administration instructions: Prefilled syringe with automatic needle guard: Step 1: Prior to Administration: Remove two syringes from the carton. Visually inspect EVENITY for particles and discoloration prior to administration. EVENITY is a clear to opalescent, colorless to light yellow solution.

Major Adverse Cardiac Events (MACE): Monitor for symptoms of MI and stroke and seek prompt medical attention if symptoms occur. ( 5.1 ) Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria. Discontinue EVENITY if a clinically significant allergic reaction occurs. ( 5.2 ) Hypocalcemia: Adequately supplement calcium and vitamin D during treatment with EVENITY. ( 5.3 ) Osteonecrosis of the Jaw: Monitor for symptoms. Consider discontinuation of therapy based on benefit-risk assessment. ( 5.4 ) Atypical Femoral Fracture: Evaluate new or unusual thigh, hip, or groin pain to rule out an incomplete femur fracture. ( 5.5 ) 5.1 Major Adverse Cardiac Events (MACE) 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 [see Boxed Warning and Adverse Reactions (6.1) ] . 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.

The following adverse reactions are discussed in greater detail in other sections of the label: Major adverse cardiac events [see Boxed Warning and Warnings and Precautions (5.1) ] Hypersensitivity [see Contraindications (4) and Warnings and Precautions (5.2) ] Hypocalcemia [see Contraindications (4) and Warnings and Precautions (5.3) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4) ] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions (5.5) ] The most common adverse reactions (≥ 5%) reported with EVENITY in clinical trials were arthralgia and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EVENITY for the treatment of postmenopausal osteoporosis was evaluated in a multicenter, randomized, double-blind, placebo-controlled study (Study 1, NCT01575834) of 7180 postmenopausal women aged 55 to 90 years (mean age of 71 years). A total of 3581 and 3576 women received at least one dose of EVENITY and placebo, respectively, administered once every month during the 12-month double-blind study period.

Renal Impairment: Patients with severe renal impairment or receiving dialysis are at greater risk of developing hypocalcemia. Monitor serum calcium and supplement with calcium and vitamin D. ( 5.3 , 8.7 ) 8.1 Pregnancy Risk Summary EVENITY is not indicated for use in women of reproductive potential. In animal reproduction studies, weekly administration of romosozumab-aqqg to pregnant rats during the period of organogenesis at exposures greater than 31 times the clinical exposure produced skeletal abnormalities in the offspring. Administration of romosozumab-aqqg to rats prior to mating and through to the end of lactation produced minimal to slight decreases in femoral bone mineral density and/or cortical circumferences in the offspring at 1.4 to 54 times the expected exposure in humans [see Data ] . Data Animal Data Reproductive and developmental effects of romosozumab-aqqg were assessed in the rat in a preliminary and definitive embryo-fetal development study, a combined fertility and embryo-development study, and a pre and postnatal development study.

Metabolism

Administration of a single dose of 210 mg EVENITY in healthy volunteers resulted in a mean (standard deviation [SD]) maximum romosozumab-aqqg serum concentration (C max ) of 22.2 (5.8) mcg/mL and a mean (SD) AUC of 389 (127) mcg*day/mL. Steady-state concentrations were achieved by month 3 following the monthly administration of 210 mg to postmenopausal women.

• Apr 9, 2019BLABLA761062Amgen Inc

1. 1Fall7295.8%
2. 2Fracture6455.1%
3. 3Arthralgia5794.6%
4. 4Injection Site Pain5364.2%
5. 5Off Label Use4763.8%
6. 6Bone Density Abnormal4613.7%
7. 7Hospitalisation4373.5%
8. 8Headache4213.3%
9. 9Product Storage Error3532.8%
10. 10Pain In Extremity2862.3%
11. 11Spinal Fracture2832.2%
12. 12Death2812.2%
13. 13Injection Site Swelling2802.2%
14. 14Pain2742.2%
15. 15Femur Fracture2702.1%

The 10 most recently updated of 45 ClinicalTrials.gov registrations naming Romosozumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
  Withdrawn · Phase 2 · Interventional · 0 enrolled · University of Pittsburgh
  NCT06973109updated 2026-06-04
• Contribution of Bone to Urine Citrate
  Enrolling by invitation · Observational · 25 enrolled · University of Texas Southwestern Medical Center
  NCT06811363updated 2026-06-03
• MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis
  Recruiting · Interventional · 42 enrolled · Istituto Auxologico Italiano
  NCT07616401updated 2026-06-01
• Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
  Active not recruiting · Phase 3 · Interventional · 111 enrolled · Amgen
  NCT05972551updated 2026-05-27
• Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
  Recruiting · Phase 3 · Interventional · 71 enrolled · Amgen
  NCT07366086updated 2026-05-08
• Romosozumab Versus Denosumab in Glucocorticoid-induced Osteoporosis: an Extended Observation of a Randomized Controlled Trial at 48 Months
  Completed · Phase 4 · Interventional · 54 enrolled · Tuen Mun Hospital
  NCT06472050updated 2026-05-05
• Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea
  Recruiting · Phase 3 · Interventional · 114 enrolled · Massachusetts General Hospital
  NCT06533865updated 2026-04-23
• Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
  Active not recruiting · Phase 2 · Interventional · 36 enrolled · VA Office of Research and Development
  NCT04232657updated 2026-04-20
• Combined Anabolic Therapy
  Recruiting · Phase 4 · Interventional · 50 enrolled · Massachusetts General Hospital
  NCT06558188updated 2026-04-17
• Anabolic Therapy in Postmenopausal Osteoporosis
  Active not recruiting · Phase 4 · Interventional · 50 enrolled · Massachusetts General Hospital
  NCT05010590updated 2026-04-15

Frequently asked questions

How does Romosozumab work?

EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption.

What is Romosozumab used for?

According to FDA labeling, Romosozumab carries indications including: EVENITY is a sclerostin inhibitor 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. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Romosozumab?

Romosozumab is classified as Other drugs affecting bone structure and mineralization, Antibody-Receptor Interactions, Bone Formation Stimulation, Bone Resorption Inhibition.

What are the brand names for Romosozumab?

Romosozumab is marketed under brand names including Evenity.

What are the contraindications for Romosozumab?

Romosozumab labeling lists contraindications including: EVENITY is contraindicated in patients with: Hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY [see Warnings and Precautions (5.3) , Adverse Reactions (6.1) and Use in Specific Populations (8.7) ].. Always consult the full prescribing information and a clinician.