{
 "query": "romosozumab",
 "ingredient": "romosozumab",
 "slug": "romosozumab",
 "rxcui": "2123126",
 "brands": [],
 "names": [
  "romosozumab"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "SUBCUTANEOUS",
  "route_counts": {
   "SUBCUTANEOUS": 1
  },
  "boxed_warning": "WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . 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. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning. EVENITY may increase the risk of myocardial infarction, stroke and cardiovascular death. ( 5.1 ) 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. ( 5.1 ) If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. ( 5.1 )",
  "indications_and_usage": "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. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. ( 1.2 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture 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. 1.2 Limitations of Use 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 anti-resorptive agent should be considered [see Dosage and Administration (2.2) and Clinical Studies (14.1) ] .",
  "contraindications": "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) ]. A history of systemic hypersensitivity to romosozumab-aqqg or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Hypocalcemia ( 4 ) Known hypersensitivity to EVENITY ( 4 )",
  "warnings_and_cautions": "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. Consi...",
  "warnings": "",
  "adverse_reactions": "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 (\u2265 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-control...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration ( 2.3 ) 1/2026",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Major Adverse Cardiac Events Advise patients to seek immediate medical attention if they experience signs or symptoms of a myocardial infarction or stroke [see Boxed Warning , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction including angioedema, erythema multiforme, dermatitis, rash, and urticaria [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . Calcium and Vitamin D Supplements to Prevent Hypocalcemia Advise patients to take calcium and vitamin D supplements daily to reduce the risk of hypocalcemia . Advise patients to seek immediate medical attention for symptoms of hypocalcemia [see Dosage and Administration (2.1) , Warnings and Precautions (5.3) and Adverse Reactions (6.1) ]. Osteonecrosis of the Jaw Advise patients to practice good oral hygiene during treatment with EVENITY and tell their dentist that they are receiving EVENITY before having dental work. [see Warnings and Precautions (5.4) and Adverse Reactions (6.1) ] ...",
  "spl_medguide": "MEDICATION GUIDE EVENITY \u00ae (E-ven-i-tee) (romosozumab-aqqg) Injection, for subcutaneous use What is the most important information I should know about EVENITY ? EVENITY can cause serious side effects, including: increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem . Call your healthcare provider or get emergency help right away if you have any of the symptoms listed below. Symptoms of heart attack may include: chest pain or pressure shortness of breath feeling light-headed or dizzy Symptoms of stroke may include: headache numbness or weakness in face, arm, or legs difficulty talking changes in vision or loss of balance Before you receive EVENITY, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year. See \u201cWhat are the possible side effects of EVENITY ?\u201d below for other side effects of EVENITY. What is EVENITY? EVENITY is a prescription medicine used to: treat osteoporosis (thinning and weakening of bone) in women after menopause (\u201cchange of life\u201d) who: are at high risk of fracture (broken bone), or cannot use another osteoporosis medicine or other osteoporosis...",
  "clinical_studies": "14.1 Treatment of Osteoporosis in Postmenopausal Women Study 1 (NCT01575834) was a randomized, double-blind, placebo-controlled study of postmenopausal women aged 55 to 90 years (mean age of 71 years) with bone mineral density (BMD) T-score less than or equal to \u22122.5 at the total hip or femoral neck. Women were randomized to receive subcutaneous injections of either EVENITY (N = 3589) or placebo (N = 3591) for 12 months. At baseline, 18% of women had a vertebral fracture. After the 12-month treatment period, women in both arms transitioned to open-label anti-resorptive therapy (denosumab) for 12 months while remaining blinded to their initial treatment. Women received 500 to 1000 mg calcium and 600 to 800 international units vitamin D supplementation daily. The coprimary efficacy endpoints were new vertebral fracture at month 12 and month 24. Effect on Fractures EVENITY significantly reduced the incidence of new vertebral fractures through month 12 compared to placebo. In addition, the significant reduction in fracture risk persisted through the second year in women who received EVENITY during the first year and transitioned to denosumab compared to those who transitioned from plac...",
  "brand_name": "Evenity",
  "manufacturer": "Amgen, Inc",
  "application_number": "BLA761062",
  "pharm_class_epc": [],
  "route": [
   "SUBCUTANEOUS"
  ],
  "effective_time": "20260716",
  "set_id": "471baba2-7154-4488-9891-0db2f46791e7",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 680,
  "serious": 627,
  "death": 95,
  "hospitalization": 141,
  "primary_suspect": 679,
  "top_reactions": [
   [
    "Spinal Fracture",
    58
   ],
   [
    "Death",
    51
   ],
   [
    "Fall",
    39
   ],
   [
    "Osteoporotic Fracture",
    35
   ],
   [
    "Fracture",
    33
   ],
   [
    "Hip Fracture",
    32
   ],
   [
    "Off Label Use",
    32
   ],
   [
    "Pathological Fracture",
    32
   ],
   [
    "Injection Site Pain",
    30
   ],
   [
    "Headache",
    24
   ],
   [
    "Humerus Fracture",
    23
   ],
   [
    "Arthralgia",
    21
   ],
   [
    "Osteoporosis",
    21
   ],
   [
    "Wrist Fracture",
    21
   ],
   [
    "Injection Site Reaction",
    19
   ]
  ],
  "by_year": {
   "2019": 14,
   "2020": 25,
   "2021": 50,
   "2022": 54,
   "2023": 60,
   "2024": 160,
   "2025": 165,
   "2026": 136
  },
  "by_year_primary": {
   "2019": 14,
   "2020": 25,
   "2021": 50,
   "2022": 54,
   "2023": 60,
   "2024": 159,
   "2025": 165,
   "2026": 136
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 49,
  "completed": 25,
  "terminated": 1,
  "with_results": 22,
  "industry": 30,
  "phase3": 12,
  "results_share": 0.88,
  "terminated_share": 0.02040816326530612
 },
 "pubmed": {
  "rct": 41,
  "meta": 18,
  "recent_rct": 21,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "romosozumab"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": {
  "section": "Haematology",
  "names": [
   "romosozumab"
  ],
  "reason": "Romosozumab is authorised for severe postmenopausal osteoporosis, on the basis of a trial in several thousand women that showed a slightly lower risk of clinical fractures than with alendronic acid. This slight gain must be weighed against a possible increase in the risk of cardiovascular events, with higher mortality among patients aged 75 years and older ( Prescrire Int n\u00b0 223). Miscellaneous. A number of other drugs used for specific types of pain or in rheumatology are best avoided.",
  "edition": "2026",
  "qualifier": null,
  "qualified": false,
  "matched": "romosozumab"
 },
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 60,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 42,
   "letter": "F",
   "why": [
    "41 randomized trials and 18 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 65,
 "grade": "C",
 "questions": [
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are spinal fracture, death, fall, osteoporotic fracture. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}