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

*Bone complications, also known as skeletal-related events (SREs), are defined as radiation to bone, pathologic fracture, surgery to bone, and spinal cord compression. 1

Preparing for treatment 

Patients can use these tools to help prepare for their next XGEVA® appointment, understand what to expect with treatment, and get the support they need.

Appointment Tracker
appointment_tracker
Amgen FIRST STEP Booklet
amgen_first_step
AA360 Patient Brochure
patient_Brochure

Understanding and addressing side effects

These tools can help patients understand possible side effects with their XGEVA® treatment, what to look for, and what they can do to help reduce their risk.

ONJ Education Tool
ONJ_Education_tool
Hypocalcemia Handout
Hypocalcemia Handout

XGEVA® Cares

The XGEVA® Cares program offers a range of personalized services and resources that can provide help wherever your patients need it

  • Three months of FREE calcium and vitamin D supplements
  • A journal for keeping track of treatment, questions, and more
  • Emails and other communications about bones and bone complications
  • One-on-one assistance from an Amgen Nurse Navigator* for help with financial resources, referrals for day-to-day living, and answers to their medication questions while on treatment

*Only available to those who are receiving or have been prescribed XGEVA®.

Frequently asked questions

Answers to have ready when your patient asks about their XGEVA® treatment

  • Why am I being prescribed XGEVA®?

    Bone metastases from solid tumors, such as breast and prostate cancer, and multiple myeloma can pose a significant risk to your bones, which can lead to bone complications, also called serious bone problems. 2-4 These are defined as1:

    • Broken bones
    • Surgery to bone to prevent fractures
    • Radiation treatment to bone
    • Pressure on the spinal cord

    Serious bone problems are very common. Let’s look at how often they occur in people who weren’t treated with a bone-targeting medicine.

    Breast Cancer Breast Cancer

    Breast cancer

    Within 3 months of breast cancer spreading to the bone, ~1 in 3 women suffered a serious bone problem. This likelihood increases to ~2 in 3 women over the entire course of disease. 5,6

    about 1 in 4 men Prostate Cancer

    Prostate cancer

    Within 3 months of prostate cancer spreading to the bone, ~1 in 4 men suffered a serious bone problem. This likelihood increases to ~1 in 2 men over the entire course of disease. 5,6

    about 3 in 5 people Multiple Myeloma

    Multiple myeloma

    ~3 in 5 people will suffer a serious bone problem at some point in their disease. 4

    Advise your patients to be on the lookout for signs and symptoms of a bone complication, including7:

    • Pain
    • Sudden, severe pain that prevents movement
    • Difficulty urinating
    • Constipation
    • Lack of bowel or bladder control
    • Numbness
    • Weakness
    • Paralysis

    Other symptoms could occur.

    Without a proactive prevention plan—like XGEVA®—in place, serious bone problems could occur sooner than you might think. 5

  • How does XGEVA® work?
  • How long do I have to be on XGEVA®?

    Without treatment to prevent bone complications, also called serious bone problems, your bones are especially vulnerable, and the risk continues to increase over time. In fact, people who've experienced one serious bone problem are more likely to experience another.5,9

    Let’s look at how often people experience another serious bone problem after having a first one.

  • Where can I get support while on XGEVA®?

    People taking XGEVA® can sign up for XGEVA® Cares. It’s a program that provides support during your treatment, including information about:

    • Reducing the risk for bone complications (also called serious bone problems)
    • Healthy recipes and exercises to support bone strength
    • Help paying for XGEVA®
    • Free calcium and vitamin D supplements for 3 months
    • Free patient journal to keep track of questions, appointments, and more
  • Are there resources available to help me pay for XGEVA®?

    Through Amgen Assist 360TM, most patients pay $0 out-of-pocket for XGEVA®.12  You may qualify for assistance while paying for your XGEVA®.

    Send patients here so they can find out how

    amgen-360Amgen360

    More on access resources here

  • How do I know if I have osteonecrosis of the jaw (ONJ)?

    Look out for these signs and symptoms1,13:

    • Soft tissue swelling and redness
    • Loose teeth
    • Jaw pain
    • Infection of gums or jaw
    • Slow healing after dental work

    Patients who are suspected of having ONJ should receive care by a dentist or an oral surgeon; extensive dental surgery may exacerbate the condition 1

    Patient toolbox
    onj Education tool

    ONJ Education Tool

    A resource to download or share with your patients taking XGEVA®

Important Safety Information

Hypocalcemia

Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Monitor calcium levels, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be closely monitored. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/minute and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.

Hypersensitivity

XGEVA® is contraindicated in patients with known clinically significant hypersensitivity to XGEVA®, including anaphylaxis that has been reported with use of XGEVA®. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue XGEVA® therapy permanently.

Drug Products with Same Active Ingredient

Patients receiving XGEVA® should not take Prolia® (denosumab).

Osteonecrosis of the Jaw

Osteonecrosis of the jaw (ONJ) has been reported in patients receiving XGEVA®, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure.

Patients with a history of tooth extraction, poor oral hygiene, or use of a dental appliance are at a greater risk to develop ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.

Perform an oral examination and appropriate preventive dentistry prior to the initiation of XGEVA® and periodically during XGEVA® therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with XGEVA®. Consider temporarily interrupting XGEVA® therapy if an invasive dental procedure must be performed.

Patients who are suspected of having or who develop ONJ while on XGEVA® should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

Atypical Subtrochanteric and Diaphyseal Femoral Fracture

Atypical femoral fracture has been reported with XGEVA®. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.

Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e.g. prednisone) at the time of fracture. During XGEVA® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of XGEVA® therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons

Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in XGEVA®-treated patients with GCTB and in patients with growing skeletons within one year of treatment discontinuation. Monitor patients for signs and symptoms of hypercalcemia after treatment discontinuation and treat appropriately.

Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation

Multiple vertebral fractures (MVF) have been reported following discontinuation of treatment with denosumab. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When XGEVA® treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.

Embryo-Fetal Toxicity

XGEVA® can cause fetal harm when administered to a pregnant woman. Based on findings in animals, XGEVA® is expected to result in adverse reproductive effects.

Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®. Apprise the patient of the potential hazard to a fetus if XGEVA® is used during pregnancy or if the patient becomes pregnant while patients are exposed to XGEVA®.

Adverse Reactions

The most common adverse reactions in patients receiving XGEVA® with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia.

For multiple myeloma patients receiving XGEVA®, the most common adverse reactions were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia. The most common adverse reaction resulting in discontinuation of XGEVA® was osteonecrosis of the jaw.

Indication

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

Please see full Prescribing Information.

 

Important Safety Information

Hypocalcemia

Pre-existing hypocalcemia must be corrected prior to initiating therapy with XGEVA®. XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Monitor calcium levels, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk and serum calcium should be..

References:

  1. XGEVA® (denosumab) prescribing information, Amgen.
  2. Saad F, Gleason DM, Murray R, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst. 2004;96(11):879-882.
  3. Lipton A, Theriault RL, Hortobagyi GN, et al. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer. 2000;88(5):1082-1090.
  4. Melton LJ, Kyle RA, Achenbach SJ, Oberg AL, Rajkumar SV. Fracture risk with multiple myeloma: a population-based study. J Bone Miner Res. 2005;20(3):487-493.
  5. Bhowmik D, Song X, Intorcia M, Gray S, Shi N. Examination of burden of skeletal-related events in patients naive to denosumab and intravenous bisphosphonate therapy in bone metastases from solid tumors population. Curr Med Res Opin. 2019;35(3):513-523.
  6. Oster G, Lamerato L, Glass AG, et al. Natural history of skeletal-related events in patients with breast, lung, or prostate cancer and metastases to bone: a 15-year study in two large US health systems. Support Care Center. 2013;21(12):3279-3286.
  7. Bone metastases. American Cancer Society. Updated August 31, 2021. Accessed September 2, 2021. https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/bone- metastases.html.
  8. Roodman GD. Pathogenesis of multiple myeloma bone disease. Leukemia. 2009;23(3):435-441.
  9. Hussain A, Yong C, Tkaczuk KHR, et al. Prevalence and risk of skeletal complications and use of radiation therapy in elderly women diagnosed with metastatic breast cancer. PLos One. 13(3):e0193661.
  10. Hussain A, Abdulhalim AM, Mullins CD, Qian Y, Arellano J, Balakumaran A. Prevalence of first and subsequent skeletal-related events (SREs) in U.S. elderly patients with metastatic prostate cancer (mPC). J Clin Oncol. 2017;32:abstract e16006.
  11. Saad F, Lipton A, Cook R, Chen Y-M, Smith M, Coleman R. Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer. 2007;110(8):1860-1867.
  12. Data on file, Amgen; 2021.
  13. Campisi G, Fedele S, Fusco V, et al. Epidemiology, clinical manifestations, risk reduction and treatment strategies of jaw osteonecrosis in cancer patients exposed to antiresorptive agents. Future Oncol. 2014;10(2):257-275.