What is Xgeva?
Xgeva, also known as denosumab, is a monoclonal antibody.
Xgeva is made by Amgen Inc.
How is Xgeva used?Xgeva is used to prevent bone complications, like fractures and spinal cord compression, that are commonly seen in patients with multiple myeloma. Because it is not processed through the kidneys like other treatments (called bisphosphonates) for bone complications, Xgeva is an option for patients with kidney insufficiency or kidney failure.
What types of patients can benefit from Xgeva?Xgeva has been studied in patients with newly diagnosed multiple myeloma who have evidence of bone damage (for example, weaker or thinner bone with holes in it). Studies of Xgeva included patients with reduced kidney function (renal impairment).
How does Xgeva work?Xgeva works by interfering with cells that break down bone. These cells are abnormally active in patients with multiple myeloma and interfering with them helps to reduce bone complications, like fractures and spinal cord compression.
How is Xgeva administered?Xgeva is administered as a subcutaneous injection (that is, under the skin). The recommended dose of Xgeva for multiple myeloma is 120 mg every 4 weeks injected in the arm, upper thigh, or abdomen.
What are Xgeva side effects?In clinical studies, the most common side effects seen with Xgeva included:
- Back pain
- Low red blood cells or platelets
- Swelling of hands and feet
- Low blood calcium
- Upper respiratory infection
- Hypersensitivity including life-threatening allergic reactions
- Severely low blood calcium
- Bone tissue death in the jaw (due to lack of blood supply)
- Thigh bone fractures
- Multiple fractures of the spine after treatment is discontinued
- Those with low blood calcium
- Those who take Prolia for osteoporosis
- Women who are pregnant or who plan to become pregnant (due to risk of fetal harm)
How are side effects of Xgeva managed?Your doctor will monitor your calcium levels while you are taking Xgeva. It may be necessary to take calcium, magnesium, and vitamin D supplements to prevent or treat low blood calcium levels.
What have Xgeva clinical trials shown?The efficacy of Xgeva for the prevention of skeletal-related events (for example, fractures or spinal cord compression) in patients with newly diagnosed multiple myeloma was shown in a phase 3 clinical trial (Study 20090482) in which 1,718 multiple myeloma patients with bone lesions participated. One half of the patients received Xgeva and the other half received Zometa (zoledronic acid; Novartis Pharmaceuticals), a bisphosphonate.
Study 20090482 showed the following:
- Xgeva performed as well as Zometa in delaying time to first skeletal-related event (median time to SRE, 22.8 months vs 24 months, respectively)
- Overall survival was the same between the Xgeva and Zometa treatment groups
Drafted November 2020
Please visit the sponsor’s official patient site for up-to-date information on Xgeva