Adult Dosing
Postmenopausal women with osteoporosis, male osteoporosis, CA treatment-induced bone loss (Prolia)
- 60 mg SC q6 months in the upper arm, upper thigh, or abdomen
Skeletal-related events in patients with bone metastases from solid tumors (Xgeva)
- 120 mg SC q4 wks in the upper arm, upper thigh, or abdomen
Giant Cell Tumor of Bone (Xgeva)
- 120 mg SC q4 wks in the upper arm, upper thigh, or abdomen with aadditional 120 mg doses on day 8 and 15 of the first month of therapy
Note:
- Patients should receive adequate vitamin D and calcium supplements to treat or prevent hypocalcemia
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- Prolia: No dose adjustments. CrCl <30 mL/min and those receiving dialysis: Supplement with adequate calcium and vitamin D and monitor serum calcium levels
- Xgeva: Dose adjustments not defined, caution advised. CrCl <30 mL/min and those receiving dialysis: Supplement with adequate calcium and vitamin D
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- Prolia and Xgeva are 2 different brands which contains same active ingredient (denosumab); hence do not use concurrently
- Denosumab may cause severe hypocalcemia. Correct hypocalcemia prior to initiating therapy. Monitor calcium and mineral levels (phosphorus and magnesium) regularly; adequately supplement with calcium, vitamin D, and magnesium. Caution should be exercised in patients with severe renal impairment or those receiving dialysis, as they are at a higher risk of hypocalcemia
- Serious skin infections and infections of the abdomen, urinary tract, and ear, endocarditis, and cellulitis were reported with denosumab (Prolia). If signs/symptoms of severe infection develop, patients should promptly seek medical attention. Patients with impaired immune systems or on concomitant immunosuppressant agents may be at increased risk for serious infections
- Dermatitis, eczema, and rashes have been reported during therapy. Consider discontinuing the drug in case severe symptoms develop
- Osteonecrosis of the jaw (ONJ) may occur spontaneously and is generally associated with tooth extraction and/or local infection with delayed healing. A routine oral examination prior to treatment is recommended. Appropriate preventive dentistry should be performed in patients with risk factors for ONJ such as invasive dental procedures (tooth extraction, oral surgery, and dental implants), diagnosis of cancer, concomitant therapies (e.g., corticosteroids, chemotherapy), poor oral hygiene, and comorbid disorders (e.g., anemia, coagulopathy, ill-fitting dentures, infection, periodontal and/or other preexisting dental disease). Extensive dental surgery to treat ONJ may exacerbate the condition
- Atypical femoral fractures have been reported with therapy. Evaluate patients with thigh or groin pain to rule out an incomplete femoral fracture
- Treatment with Prolia resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry in women with postmenopausal osteoporosis
- The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse reactions such as ONJ, atypical fractures, and delayed fracture healing
- Therapy may cause fetal harm when administered to a pregnant woman, advise females of reproductive potential to use highly effective contraception during therapy and for at least 5 months after following the last dose
- Hypersensitivity including anaphylaxis has been reported; symptoms may include hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritis, and urticaria
Cautions: Use cautiously in
- Severe renal impairment
- Hypoparathyroidism
- Mineral metabolism disturbances
- Parathyroid or thyroid surgery
- Malabsorption syndromes
- Excision of small intestine
Supplemental Patient Information
- Advise patients to promptly contact their physicians if they develop any symptoms of hypocalcemia such as paresthesia or muscle stiffness, twitching, spasms or cramps
- Advise patients to maintain proper oral hygiene and routine dental care
- Inform patients to avoid invasive dental procedures during treatment
- Advise patients to inform their dentist prior to dental procedures about their treatment
- Instruct patients to receive Prolia injection as soon as convenient in case a dose is missed; thereafter, schedule injections q6 months from the date of last injection
Pregnancy Category:C
Breastfeeding: As per manufacturer's data, it is not known whether the drug is excreted in breast milk. Due to the potential for serious adverse reactions in nursing infants, a decision has to be made whether to discontinue nursing or discontinue the drug, analyzing the importance of the drug to the mother. Maternal exposure during pregnancy may impair mammary gland development and lactation.
Pricing data from www.DrugStore.com in U.S.A.
- Xgeva 120 MG/1.7ML SOLN [Vial] (AMGEN)
1.7 1.7ml = $1900.01
5.1 1.7ml = $5499.85
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
