Names and pronunciation
(den-oh′sue-mab) Prolia, Xgeva
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Drug reference
(den-oh′sue-mab) Prolia, Xgeva
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Func. class.: Bone resorption inhibitor
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Chem. class.: Monoclonal antibody, bone resorption
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ACTION: Neutralizes activity of recep- tor activator nuclear factor kappa-B ligand (RANKL) by binding and blocking its inter- action with cell-surface receptors; use of a RANKL inhibitor may reduce bone turnover and decrease tumor burden
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USES: Prolia: Osteoporosis in post- menopausal women or men at high risk for fractures; increase bone mass in men who are receiving androgen deprivation therapy for prostate cancer and women receiving aromatase inhibitor therapy for breast can- cer at high risk for fractures; Xgeva: pre- vention of skeletal-related events in bone metastases from solid tumors
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CONTRAINDICATIONS: Hyper- sensitivity, hypocalcemia, pregnancy Precautions: Breastfeeding, child/infant/ neonate, anemia, coagulopathy, diabetes mellitus, dialysis, eczema, hypoparathyroid- ism, immunosuppression, latex hypersensi- tivity, malabsorption syndrome, neoplastic disease, pancreatitis, parathyroid disease, dental/renal/thyroid disease, TB, vitamin D deficiency
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SIDE EFFECTS CNS: Headache, vertigo, fatigue, insomnia CV: Angina, atrial fibrillation GI: Abdominal pain, constipation, diar- rhea, flatulence, GERD, vomiting, nau- sea, pancreatitis GU: Cystitis HEMA: Anemia INTEG: Dermatitis, pruritus META: Hypercholesterolemia, hypocal- cemia, hypophosphatemia MS: Back, bone pain; MS pain, myalgia, osteonecrosis of the jaw RESP: Cough, dyspnea SYST: Infection, secondary malignancy, anaphylaxis
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INTERACTIONS Increase: infection, possible—immuno- suppressives (except cytarabine liposo- mal), corticosteroids Drug/Lab Test Increase: cholesterol Decrease: calcium, phosphate
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DOSAGE AND ROUTES Osteoporosis in men and postmenopausal osteoporosis (Prolia) • Adult female: SUBCUT 60 mg q6mo Bone metastases from solid tumors (Xgeva) • Adult: SUBCUT 120 mg q4wk, max 120 mg q4wk Giant cell tumor (bone) (Xgeva) • Adult: SUBCUT (Xgeva) 120 mg on days 1, 8, and 15, then 120 mg q4wk beginning on day 29
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Available forms: Solution for injection 60 mg/mL (Prolia); 120 mg/1.7 mL (Xgeva) Osteoporosis prophylaxis in men at high risk for bone fractures after receiving androgen deprivation therapy for nonmetastatic prostate cancer and in women at high risk for bone fractures after receiving adjuvant aromatase inhibitor ther- apy for breast cancer: • Adults: SUBCUT (Prolia) 60 mg q6mo with 1000 mg of calcium and ≥400 units of vitamin D daily Hypercalcemia of malignancy that is refractory to bisphosphonate therapy: • Adults: SUBCUT (Xgeva) 120 mg on days 1, 8, and 15, then 120 mg q4wk beginning on day 29
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Administer: SUBCUT route D • Give acetaminophen prior to and for 72 hr after to decrease pain • Do not use if particulate matter or discoloration is present; solution is clear and colorless to slightly yellow with small white/opalescent particles; remove from refrigerator and allow to warm to room temperature (15-30 min) • Use of prefilled syringe with needle safety guard: leave green guard in origi- nal position until after use; remove and discard needle cap immediately before injection; give by SUBCUT injection in upper arm/thigh or abdomen; after injec- tion, point needle away from people and slide green guard over needle • Use of single-use vials: use 27-G needle; give in upper arm/thigh or abdo- men; do not reinsert needle in vial; dis- card supplies as appropriate • Store and use out of direct sunlight/ heat; do not freeze; use within 14 days after removal from refrigerator; store unopened containers in refrigerator
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Assess: • Acute phase reaction: fever, myalgia, headache, flulike symptoms for 72 hr af- ter injection; usually resolves after 72 hr • Blood tests: serum calcium, creatinine, BUN, magnesium, phosphate; provide ad- equate calcium, vitamin D, magnesium • Hypocalcemia (may be fatal): pares- thesia, twitching, laryngospasm, Chvostek’s and Trouseau’s signs; preexisting hypocal- cemia should be corrected before treat- ment; patient with vitamin D deficiency may require higher doses of vitamin D • Hypercalcemia: nausea, vomiting, an- orexia, weakness, thirst, constipation, dysrhythmias • Dental status: correct dental compli- cations prior to product use; good oral hygiene should be maintained; if dental work is to be performed, antiinfectives should be given to prevent osteonecrosis of the jaw • Infection: do not start treatment in patients with active infections; infections should be resolved first • Pregnancy: identify whether preg- nancy is planned or suspected; women who become pregnant should enroll in Amgen’s Pregnancy Surveillance Pro- gram (800-772-6436); do not use in preg- nancy, breastfeeding
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Evaluate: • Therapeutic response: increased/ maintained bone density, decreased cal- cium levels
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report hypercalcemic relapse: nau- sea, vomiting, bone pain, thirst • To notify prescriber immediately if rash, infection, cramps, twitching oc- cur • To continue with dietary recommen- dations, including additional Ca 1000 mg/day and vitamin D ≥400 units (Prolia product labeling) • That product must be continued or fractures may occur • To use acetaminophen prior to and for 72 hr after injection to lessen bone pain • About the purpose of this product and its expected results • To avoid OTC, Rx medications, and herbs and supplements unless approved by prescriber • To exercise regularly, stop smoking, and avoid alcohol to maintain bone health • To inform all health care providers of product use; to avoid dental procedures/ surgery if possible; to practice good oral hygiene • That lab tests and follow-up exams will be required • Pregnancy/breastfeeding: not to use during pregnancy and breastfeeding; to notify prescriber if pregnancy is planned, suspected; to use contracep- tion during and for (Xgeva) 5 mo after completion of therapy; that males should use contraception if partner is pregnant
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PHARMACOKINETICS Half-life 25.4 days, bioavailability 62%, max serum concentration 3-21 days
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• Adult female: SUBCUT 60 mg q6mo Bone metastases from solid tumors (Xgeva)
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• Adult: SUBCUT 120 mg q4wk, max 120 mg q4wk Giant cell tumor (bone) (Xgeva)
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• Adult: SUBCUT (Xgeva) 120 mg on days 1, 8, and 15, then 120 mg q4wk beginning on day 29
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