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Indication
Prevention of SREs in patients with bone mets from solid tumors
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Limitation of use
Not indicated for pts with bone mets from multiple myeloma
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Dosage and Admin
120 mg every 4 weeks as SQ injection in upper arm, upper thigh or abdomen
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dosage forms and strengths
120 mg/ 1.7 mg/mL single use vial
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Warnings and Precautions
- Hypocalcemia
- Osteonecrosis of the Jaw
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Warnings re: Hypocalcemia
- Severe Hypocalcemia can occur. Corret hypocalcemia prior to initiating XGEVA. Monitor for Symptoms.
- Monitor Ca levels and supplement with Ca and Vit D
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Warnings re: ONJ
Perform an oral exam prior to starting XGEVA. Monitor for symptoms; Avoid invasive dental procedures during treatment.
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ADVERSE REACTIONS
- Most common:
- Fatigue/Astenia 45 vs 46
- Hypophosphatemia 32 vs 20
- Nausea 31 vs 32
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Serious AEs
Dyspnea 21 vs 18
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Most common AEs leading to DC
- Hypocalcemia 18 vs 9
- ONJ 2.2 vs 1.3
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Special populations
- Pregnancy: may cause fetal harm
- Nursing: May impair mammary gland devt and lactation. d/c drug or nursing
- Peds: Safety/effic not estab
- Renal Impairment: cCl <30 or on dialysis are at risk for hypocalcemia. Suppl w ca or Vit D
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Safety was evaluated in ? randomized, ________, double-dummy trials in _________ patients with bone mets from ? cancer, ? cancer, or other solid tumors, or lytic bony lesions from ______.
- 3
- double-blind
- 2841
- prostate, breast
- multiple myeloma
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Median duration XGEVA exposure was __ months
12
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Of pts receiving XGEVA ___% were female, and ____% were white
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Exclusions for studies
- IV bisphoshonates
- Hx of ONJ or OMJ
- active dental/jaw condition needing surgery
- planned invasive dental procedure
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Other entry criteria
- cCL 30 mL/min or more
- Corr Ca 8-11.5 mg/dL
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incidence of severe hypocalcemia (less than 7) occurred in ___ of XGEVA patients and ___ of zoledronic acid tx'd patients
- 3.1
- 1.3%
- ( OF THOSE 33% had 2+ episodes, 16% had 3+ episodes)
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ONJ in 3 studies was confirmed in ___ of patients with XGEVA and ___ with zoledronic acid.
- 1.8
- 1.3
- extended treatment phase of 4 months= 2.2% with XGEVA
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What color is XGEVA
clear, colorless to pale yellow
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Storage of XGEVA
2-8 degrees C (36-46F) in original carton. Do not freeze. Upon removal from fridge, keep under 77 degrees, do not expose to light, use within 14 days.
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Avoid _____ _____ of XGEVA
vigorous shaking
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Advise patients to contact HCP for:
- Symptoms of Hypocalcemia
- Symptoms of ONJ
- Persistent pain or slow healing of mouth
- Pregnancy or nursing
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Advise pts of need for:
- Proper oral hygeine and routine dental care
- Informing dentist they take XGEVA
- Avoiding dental procedures while taking XGEVA
- Also that marketed as PROLIA.
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Description: XGEVA is a ____ ____ mab that binds to human ____
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RANKL is a ________or soluble _____ essential for ______, _____, and ____ of ______, the cells responsible for bone resorption.
- transmembrane
- formation, function, and survival
- osteoclasts
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Increased ______ ______, stimulated by RANKL is a mediator of bone _____ in solid tumors with osseous ______.
- osteoclast activity
- pathology
- mestastases
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Possible effects of XGEVA in peds
- may impair bone growth in children with open growth plates
- may inhibit eruption of dentition
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DRUG interactions
- NO formal
- All patients were on concomitant chemo
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