INDICATIONS AND USAGE

Multiple Myeloma and Bone Metastasis from Solid Tumors

Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

Giant Cell Tumor of Bone

Xgeva is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Hypercalcemia of Malignancy

Xgeva is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

DOSAGE

Important Administration Instructions

Xgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.

Multiple Myeloma and Bone Metastasis from Solid Tumors

The recommended dose of Xgeva is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen.

Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.

Giant Cell Tumor of Bone

The recommended dose of Xgeva is 120 mg administered every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.

Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.

Hypercalcemia of Malignancy

The recommended dose of Xgeva is 120 mg administered every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.

ADVERSE REACTIONS

Hypersensitivity

Hypocalcemia

Osteonecrosis of the Jaw

Atypical Subtrochanteric and Diaphyseal Femoral Fracture

Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons

Multiple vertebral fractures (MVF) following treatment discontinuation

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/628f0998-1206-4001-aeee-18133aa9f3bf/spl-doc?hl=Xgeva

Xgevainformation