INDICATIONS AND LIMITATION OF USE
XGEVA® is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
Limitation of use: XGEVA® is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.
XGEVA® is indicated for 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.
XGEVA® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Close Indication
XGEVA® access and reimbursement resources let you put your patients' needs first

Approximately 70% of XGEVA® patients with commercial or Medicare coverage are expected to have $0 out-of-pocket cost11*

Amgen is committed to making XGEVA® accessible to appropriate patients with or without coverage
Commercial

XGEVA FIRST STEP can help your eligible commercially insured patients meet their out-of-pocket costs

The XGEVA FIRST STEP Program may help eligible commercially insured patients meet their deductible, co-insurance, and co-payment.

  • XGEVA FIRST STEP

  • No out-of-pocket cost for the first dose
  • No income eligibility requirement
  • For subsequent doses, Amgen will pay the out-of-pocket amount in excess of $25 per dose, up to $10,000 in assistance per calendar year

Eligibility Criteria: Patient must be prescribed XGEVA®. Patient must have private commercial health insurance that covers medication costs for XGEVA®. Patient must not be a participant in any federal-, state-, or government-funded healthcare program such as Medicare, Medicare Advantage, Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), the Department of Defense (DoD), or TRICARE. Patient may not seek reimbursement for value received from the Amgen FIRST STEP program from any third-party payers, including flexible spending accounts or healthcare savings accounts. If at any time patients begin receiving coverage under any federal-, state-, or government-funded healthcare program, patients will no longer be eligible to participate in the Amgen FIRST STEP Program and must call 1-888-65-STEP11-888-65-STEP1 (1-888-657-83711-888-657-8371) Monday through Friday, 9 am-8 pm EST, to stop participation. Restrictions may apply. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time. This is not health insurance. Program invalid where otherwise prohibited by law. Register before any treatment. Other restrictions apply. Amgen reserves the right to revise or terminate this program, in whole or in part, without notice at any time.

Coverage Limits: Program covers out-of-pocket medication costs for XGEVA® only. Program does not cover any other costs related to office visit or administration of XGEVA®. No out-of-pocket for first dose; $25 out-of-pocket cost for subsequent dose; maximum benefit of $10,000 per patient per calendar year. Patient is responsible for costs above these amounts. Ongoing activation of the Amgen FIRST STEP card is contingent on the submission of the required Explanation of Benefits (EOB) form by the healthcare provider’s office within 45 days of use of the Amgen FIRST STEP card. Patients will be responsible for reimbursing the program for all amounts paid out if the EOB for the date of service is not received within 45 days.

*Estimated amount of Medicare beneficiaries with supplemental coverage and commercially insured patients with no out-of-pocket cost; based on XGEVA® payor mix and coverage of XGEVA® in patients with bone metastases and solid tumors, and other similar products. Does not include costs related to office visit, physician, staff, or administrative charges associated with administering XGEVA®.

Contact XGEVA FIRST STEP Program at 1-886-65-STEP11-886-65-STEP1 or AmgenFIRSTSTEP.com for full program requirements and limitations.

Medicare

Amgen can connect eligible Medicare patients to independent third party co-pay foundations

  • Amgen Assist® can provide information to your patients on the following co-pay foundations
  • Patient Access Network Foundation
  • Patient Advocate Foundation Co-pay Relief
  • HealthWell Foundation

Assistance is provided through third-party 501(c)(3) tax-exempt nonprofit organizations and based on the program eligibility requirement of those organizations.

UnInsured

The Safety Net Foundation helps eligible uninsured or underinsured patients access XGEVA® at no cost

The Safety Net Foundation is a nonprofit patient assistance program that provides Amgen products at no cost to qualifying patients with no or limited drug coverage who meet income eligibility requirements.

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. Monitor levels more frequently when XGEVA® is administered with other drugs that can also lower calcium levels. 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 osseous metastasis, 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 Growing Skeletons

Clinically significant hypercalcemia has been reported in XGEVA® treated patients with growing skeletons, weeks to months following treatment discontinuation. Monitor patients for signs and symptoms of hypercalcemia and treat appropriately.

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 highly 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.

The most common adverse reactions in patients receiving XGEVA® for giant cell tumor of bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. The most common serious adverse reactions were osteonecrosis of the jaw and osteomyelitis. The most common adverse reactions resulting in discontinuation of XGEVA® were osteonecrosis of the jaw and tooth abscess or tooth infection.

The most common adverse reactions in patients receiving XGEVA® for hypercalcemia of malignancy were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.

Please see accompanying 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. Monitor levels more frequently when XGEVA® is administered with other drugs that can also lower calcium levels. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

Reference

  • 1. Data on file, Amgen.

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