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Evenity (romosozumab-aqqg)
romosozumab
Black Box Warnings .
Potential Myocardial Infarction, Stroke and Cardiovascular Death Risk
may incr. risk of MI, stroke, and cardiovascular death; should not be initiated if MI or stroke w/in 12mo; weigh risk/benefit in patients w/ other cardiovascular risks; D/C if MI or stroke occurs during tx
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 105 mg per 1.17 mL
Special Note
- [drug name clarification]
- Info: nonproprietary name = romosozumab-aqqg
osteoporosis tx, postmenopausal
- [210 mg SC qmo x12mo]
- Info: for patients w/ osteoporotic fracture history, w/ multiple fracture risk factors, or have failed or intolerant to other osteoporosis tx; calcium and vitamin D supplementation recommended if inadequate dietary intake
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypocalcemia, uncorrected
- stroke w/in 12mo
- MI w/in 12mo
- caution: cardiac disease risk
- caution: eGFR <30
- caution: invasive dental procedure
- caution: oral hygiene, poor
- caution: dental disease
- caution: infection
- caution: anemia
- caution: coagulation disorder
- caution: corticosteroid use
- caution: malignancy
- caution: cancer chemotherapy use, recent
- caution: angiogenesis inhibitor use, concurrent
- caution: XRT
Drug Interactions .
Overview
romosozumab
sclerostin inhibitor
- hypocalcemia
Monitor/Modify Tx
- alendronate
- amifostine
- bumetanide
- cabozantinib
- calcitonin-salmon
- cetuximab
- cinacalcet
- cisplatin
- denosumab
- dinutuximab
- etelcalcetide
- ethacrynic acid
- foscarnet
- fosfomycin injection
- furosemide
- gentamicin
- ibandronate
- lenalidomide
- lenvatinib
- necitumumab
- nilotinib
- palopegteriparatide
- pamidronate
- panitumumab
- pentamidine
- pralsetinib
- risedronate
- romidepsin
- sodium polystyrene sulfonate
- thalidomide
- tobramycin
- torsemide
- zoledronic acid
Adverse Reactions .
Serious Reactions
- MI risk
- stroke risk
- cardiovascular death risk
- hypocalcemia
- osteonecrosis, jaw
- femur fractures, atypical
- hypersensitivity reaction
- angioedema
- erythema multiforme
Common Reactions
- arthralgia
- headache
- injection site reaction
- muscle spasm
- peripheral edema
- asthenia
- neck pain
- insomnia
- paresthesia
Safety/Monitoring .
Monitoring Parameters
dental exam at baseline; Ca at baseline, then if eGFR <30 continue periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
N/A; drug unlikely to be used during pregnancy based on indication
Lactation
Clinical Summary
N/A; drug unlikely to be used while breastfeeding based on indication
Pharmacology .
Metabolism: for romosozumab: other; CYP450: unknown
Excretion: for romosozumab: other; Half-life: 12.8 days
Subclass: Osteoporosis: Sclerostin Inhibitors
Mechanism of Action
for romosozumab: inhibits sclerostin, increasing new bone formation and decreasing bone resorption (monoclonal antibody)
Formulary .
No Formulary Selected
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