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Osenvelt (denosumab-bmwo)
denosumab
Adult Dosing .
Dosage forms: INJ: 120 mg per 1.7 mL
Special Note
- [formulation clarification]
- Info: nonproprietary name = denosumab-bmwo
bone metastases, solid tumor-associated
- [120 mg SC q4wk]
- Info: for skeletal-related events prevention; calcium and vitamin D supplementation recommended
skeletal-related event prevention, multiple myeloma-associated
- [120 mg SC q4wk]
- Info: calcium and vitamin D supplementation recommended
giant cell tumor of bone, unresectable
- [120 mg SC q4wk]
- Start: 120 mg SC qwk x3wk, then starting wk 5, 120 mg SC q4wk; Info: calcium and vitamin D supplementation recommended
hypercalcemia, malignant
- [120 mg SC q4wk]
- Start: 120 mg SC qwk x3wk, then starting wk 5, 120 mg SC q4wk
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ: 120 mg per 1.7 mL
Special Note
- [formulation clarification]
- Info: nonproprietary name = denosumab-bmwo
giant cell tumor of bone, unresectable
- [adolescents w/ skeletal maturity]
- Dose: 120 mg SC q4wk; Start: 120 mg SC qwk x3wk, then starting wk 5, 120 mg SC q4wk; Info: calcium and vitamin D supplementation recommended
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypocalcemia
- pregnancy
- avoid: invasive dental procedure
- caution: immunosuppressant agent use, concurrent
- caution: corticosteroid use
- caution: angiogenesis inhibitor use, concurrent
- caution: pts of childbearing potential
- caution: CrCl <30
- caution: oral hygiene, poor
- caution: gingival infection
- caution: diabetes mellitus
- caution: hypocalcemia risk
- caution: mineral metabolism disturbance
- caution: hypoparathyroidism
- caution: parathyroid surgery
- caution: thyroid surgery
- caution: malabsorption syndrome
- caution: small intestine excision
- caution: osteoporosis
- caution: fracture hx
Drug Interactions .
Overview
denosumab
RANKL inhibitor
- hypocalcemia
- hypophosphatemia
Avoid/Use Alternative
- denosumab
- erdafitinib
Monitor/Modify Tx
- alendronate
- amifostine
- bumetanide
- cabozantinib
- calcitonin-salmon
- cetuximab
- cinacalcet
- cisplatin
- etelcalcetide
- ethacrynic acid
- foscarnet
- furosemide
- gentamicin
- ibandronate
- lenalidomide
- lenvatinib
- necitumumab
- nilotinib
- palopegteriparatide
- pamidronate
- panitumumab
- pentamidine
- pralsetinib
- risedronate
- romidepsin
- romosozumab
- sodium polystyrene sulfonate
- thalidomide
- tobramycin
- torsemide
- zoledronic acid
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- dyspnea
- hypocalcemia, severe
- hypophosphatemia, severe
- osteonecrosis, jaw
- musculoskeletal pain, severe
- femur fractures, atypical
- multiple vertebral fractures (upon tx D/C)
- hypercalcemia after tx D/C (pts w/ skeletal growth or giant cell tumor of bone)
Common Reactions
- asthenia
- fatigue
- nausea
- hypophosphatemia
- diarrhea
- hypocalcemia
- dyspnea
- headache
- cough
- osteonecrosis, jaw
- back pain
- anemia
- peripheral edema
- rash
- hypomagnesemia
- hypokalemia
- arthralgia
- extremity pain
- appetite decr.
- vomiting
- constipation
- nasopharyngitis
- musculoskeletal pain
Safety/Monitoring .
Monitoring Parameters
Cr, pregnancy test at baseline; Ca at baseline, during tx, then in pts w/ skeletal growth or giant cell tumor of bone periodically after tx D/C; oral exam at baseline, then periodically; Mg, PO4 periodically if hypocalcemia risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of fetal harm, incl. absent lymph nodes, abnormal bone development, and embryo-fetal toxicity and death, based on animal data at 25x recommended human dose
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 5mo after D/C in pts of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: unknown; CYP450: unknown
Excretion: unknown; Half-life: 28 days
Subclass: Calcium Disorders ; RANKL Inhibitors, Oncologic
Mechanism of Action
binds to receptor activator of nuclear factor kappa-B ligand (RANKL), inhibiting osteoclast formation, maintenance, and survival, reducing bone resorption and turnover, and inhibiting tumor growth (monoclonal antibody)
Formulary .
No Formulary Selected
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