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Conexxence (denosumab-bnht)
denosumab
Black Box Warnings .
Severe Hypocalcemia in Advanced CKD Pts
pts w/ advanced CKD (eGFR <30), incl. dialysis-dependent pts, at higher risk of severe hypocalcemia; severe cases resulting in hospitalization, life-threatening events, and death have occurred; CKD-mineral bone disorder (CKD-MBD) markedly incr. risk; eval. for CKD-MBD in pts w/ advanced CKD before tx start; tx in these pts should be supervised by provider w/ expertise in CKD-MBD
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 60 mg per mL
Special Note
- [formulation clarification]
- Info: nonproprietary name = denosumab-bnht
osteoporosis, postmenopausal
- [60 mg SC q6mo]
- Info: for pts w/ high fracture risk; calcium and vitamin D supplementation required; reassess need for tx in 5-10y; transition to other antiresorptive tx if denosumab D/C
osteoporosis, male
- [60 mg SC q6mo]
- Info: for pts w/ high fracture risk; calcium and vitamin D supplementation required; transition to other antiresorptive tx if denosumab D/C
osteoporosis, steroid-induced
- [60 mg SC q6mo]
- Info: for pts w/ anticipated use of >2.5 mg/day prednisone or equivalent >3mo and incr. fracture risk; refer to ACR guidelines; calcium and vitamin D supplementation required; transition to other antiresorptive tx if denosumab D/C
bone loss, cancer tx-induced
- [60 mg SC q6mo]
- Info: for pts at high fracture risk receiving androgen deprivation tx for nonmetastatic prostate CA or adjuvant aromatase inhibitor tx for breast CA; calcium and vitamin D supplementation required; transition to other antiresorptive tx if denosumab D/C
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
- pregnancy
- hypocalcemia
- caution: corticosteroid use, concurrent
- caution: chemotherapy use, concurrent
- caution: angiogenesis inhibitor use, concurrent
- caution: eGFR <30
- caution: vertebral fracture hx
- caution: renal osteodystrophy
- caution: mineral metabolism disturbance
- caution: hypocalcemia risk
- caution: hypoparathyroidism
- caution: parathyroid surgery
- caution: thyroid surgery
- caution: malabsorption syndrome
- caution: small intestine excision
- caution: long-term use
- caution: malignancy
- caution: immunocompromised pts
- caution: infection
- caution: anemia
- caution: coagulation disorder
- caution: oral hygiene, poor
- caution: dental dz
- caution: periodontal dz
- caution: invasive dental procedure
- caution: pts of childbearing potential
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
- hypocalcemia, severe
- hypersensitivity rxn
- anaphylaxis
- drug rxn w/ eosinophilia and systemic sx
- vasculitis
- infection, serious
- malignancy
- osteonecrosis, jaw
- musculoskeletal pain, severe
- femur fractures, atypical
- multiple vertebral fractures (upon tx D/C)
- pancreatitis
Common Reactions
- back pain
- arthralgia
- extremity pain
- dermatologic rxn
- musculoskeletal pain
- hypercholesterolemia
- URI sx
- cystitis
- vertigo
- peripheral edema
- malignancy
- sciatica
- infection, serious
- bronchitis
- HTN
- headache
- anemia
- abdominal pain
- insomnia
- dyspepsia
- UTI
- constipation
- angina
- vomiting
- hypocalcemia
- dizziness
- asthenia
- flatulence
- pruritus
- osteoarthritis, spinal
- GERD
Safety/Monitoring .
Monitoring Parameters
oral exam, pregnancy test at baseline; Ca at baseline, then if eGFR <30, qwk x1mo, then qmo; iPTH, 25-hydroxyvitamin D, 1,25 dihydroxyvitamin D before tx start if eGFR <30; Ca, Mg, PO4 10-14 days after admin. if hypocalcemia risk or mineral metabolism disturbance; consider bone turnover eval. before tx start if eGFR <30; consider dental exam before tx start if jaw osteonecrosis risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
contraindicated 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 50x 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: 25.4 days
Subclass: Calcium Disorders ; Osteoporosis: RANKL Inhibitors
Mechanism of Action
binds to receptor activator of nuclear factor kappa-B ligand (RANKL), inhibiting osteoclast formation, maintenance, and survival and reducing bone resorption and turnover (monoclonal antibody)
Formulary .
No Formulary Selected
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