Usual Adult Dose for Osteoporosis

Prolia: 60 mg subcutaneously once every 6 months

• Patients should be adequately supplemented with calcium and vitamin D, suggested as calcium 1000 mg/day and at least 400 IU vitamin D per day

Comments:

• Postmenopausal women at high risk for fracture include those with a history of osteoporotic fracture, or multiple risk factors for fracture; this drug reduces the incidence of vertebral, nonvertebral, and hip fractures.
• Men with osteoporosis at high risk for fracture include those with a history of osteoporotic fracture, or multiple risk factors for fracture.
• Men and women initiating or continuing systemic glucocorticoids at a prednisone equivalent dose of 7.5 mg or greater for 6 months or longer are at high risk of fracture, especially with a history of osteoporotic fracture or multiple risk factors for fracture.
• Men at high-risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer have shown a reduced incidence of vertebral fractures with this drug.

Uses: Treat osteoporosis or increase bone mass in men and women at high risk for fracture or those who have failed or are intolerant to other available osteoporosis therapy, including:

• Postmenopausal women
• Men with osteoporosis
• Men and women receiving daily glucocorticoids
• Men receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Women receiving adjuvant aromatase inhibitor therapy for breast cancer

Usual Adult Dose for Giant Cell Tumor of Bone

Xgeva:
First Month: 120 mg subcutaneously on day 1, day 8, and day 15
Maintenance dose: 120 mg subcutaneously every 4 weeks

Comments:

• Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: For the treatment of patients with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Usual Adult Dose for Osteolytic Bone Metastases of Solid Tumors

Xgeva: 120 mg subcutaneously every 4 weeks

Comments:

• Calcium and vitamin D should be administered to treat or prevent hypocalcemia.

Use: For the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors

Usual Adult Dose for Hypercalcemia of Malignancy

Xgeva:
First Month: 120 mg subcutaneously on day 1, day 8, and day 15
Maintenance dose: 120 mg subcutaneously every 4 weeks

Use: For the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Usual Pediatric Dose for Giant Cell Tumor of Bone

13 years or older and having reached skeletal maturity:

Xgeva:
First Month: 120 mg subcutaneously on day 1, day 8, and day 15
Maintenance dose: 120 mg subcutaneously every 4 weeks

Comments:

• Calcium and vitamin D should be administered to treat or prevent hypocalcemia.
• In clinical trials, skeletal maturity was defined by at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus) and body weight of 45 kg or more.

Use: For the treatment of skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Renal Dose Adjustments

No adjustment recommended; use caution in severe renal impairment as there is a greater risk for hypocalcemia

Liver Dose Adjustments

Data not available

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Prolia. It includes a medication guide, and a communication plan. For additional information: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

CONTRAINDICATIONS:

• Hypersensitivity to the active substance or product ingredients
• Hypocalcemia
• Pregnancy (Prolia)

Safety and efficacy of Prolia have not been established in patients younger than 18 years.
Safety and efficacy of Xgeva have not been established except in skeletally mature adolescents with giant cell tumor of bone.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended; use caution in severe renal impairment as there is a greater risk for hypocalcemia

Other Comments

Administration advice:

• For subcutaneous administration only; do not administer IV, IM, or intradermally
• Subcutaneous administration should be in the upper arm, upper thigh, or abdomen

PROLIA:

• This drug should be administered by a healthcare professional
• Patients should receive 1 dose subcutaneously every 6 months
• Patients should be receiving calcium 1000 mg/day and at least 400 IU vitamin D daily
• Individuals sensitive to latex should not handle the gray needle cap as it contains dry natural rubber (a derivative of latex)
• Missed dose: Administer as soon as convenient, thereafter, schedule injections 6 months from date of last injection

XGEVA:

• Administer subcutaneously every 4 weeks; 2 extra doses may be given in the first month
• Calcium and vitamin D should be administered as needed to treat or prevent hypocalcemia

Storage requirements:

• Store refrigerated 2C to 8C (36F to 46F) in the original carton; do not freeze
• Protect from direct light and heat; avoid vigorous shaking
• Once removed from the refrigerator, do not expose to temperatures above 25C (77F); use within 14 days

Reconstitution/preparation techniques:

• Prior to administration, allow to reach room temperature by standing in original container (this generally takes 15 to 30 minutes); do not warm in any other way
• See product labeling for detailed administration instructions with illustrations

General:

• Hypocalcemia should be corrected prior to initiating therapy.

Monitoring:
Prior to initiating therapy:

• Verify pregnancy status in women of reproductive potential
• Perform an oral examination

During therapy

• Monitor for signs and symptoms of hypocalcemia
• Monitor calcium levels more frequently in patients with severe renal dysfunction, on dialysis, and/or when administered with other drugs that can lower calcium levels
• Prolia: Monitor calcium and mineral levels (phosphorus and magnesium) within 14 days of administration in patients with risk factors for hypocalcemia
• Xgeva: Monitor calcium levels, especially in the first weeks
• Monitor for consequences of bone over suppression such as osteonecrosis of the jaw, atypical fractures, and delayed fracture healing
• With discontinuation, monitor for hypercalcemia

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide- Prolia).
• Patients should be advised of the importance of maintaining adequate calcium levels during therapy which may require taking calcium and vitamin D daily.
• Patients should be advised to seek prompt medical attention for signs or symptoms of hypocalcemia, hypersensitivity reactions, dermatological reactions (dermatitis, rashes, and eczema), infections (including cellulitis), severe bone, joint, and/or muscle pain.
• Women of childbearing potential should be advised on the risks of drug exposure during pregnancy; they should be advised to use effective contraception during therapy and for at least 5 months after last dose.
• Patients should be advised to report new or unusual thigh, hip, or groin pain.
• Patients should be advised to maintain good oral hygiene and get routine dental check-ups; patients should inform their dentist that they are taking this drug, especially if they need dental treatment or dental surgery.
• Patients should immediately report any problems with their mouth or teeth during treatment (e.g., loose teeth, pain, swelling, non-healing sores or discharge).

Frequently asked questions

• How many years should you take Prolia?
• How long should you take Xgeva for?
• Is Xgeva a chemotherapy drug?
• Does Xgeva cause bone pain?
• Does Xgeva cause low blood pressure?