Amgen is committed to helping your patients and your practice access Prolia®
For Your Patients:
Amgen FIRST STEP™ Program
- 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 $3,000 in assistance per calendar year†
- Contact the Amgen FIRST STEP™ Program at 1-888-65-STEP1 or AmgenFIRSTSTEP.com for full eligibility criteria and limitations
Connections to Independent
Co-pay Foundations‡ for
eligible Medicare and
- For patients covered by Medicare or Medicaid, Amgen can connect patients who need assistance to Independent
- Patient Access Network Foundation
- Patient Advocate Foundation Co-pay Relief
- HealthWell Foundation
- Patients and providers can contact the Independent Co-pay Foundations directly or through Amgen Assist® at 1-888-4ASSIST or www.amgenassistonline.com
The Safety Net Foundation
for eligible uninsured or
- Can provide Prolia® at no cost to
eligible uninsured patients
- Patients and providers can contact the Safety Net Foundation directly or through Amgen Assist® at 1-888-4ASSIST or www.amgenassistonline.com
*Eligibility Criteria: Patient must be prescribed Prolia®. Patient must have private commercial health insurance that covers medication costs for Prolia®. 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-STEP1 (1-888-657-8371) 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 Prolia® only. Program does not cover any other costs related to office visit or administration of Prolia®. No out-of-pocket for first dose; $25 out-of-pocket cost for subsequent dose; maximum benefit of $3,000 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.
The Amgen FIRST STEPTM Prepaid MasterCard® is issued by Comerica Bank pursuant to license by MasterCard® International Incorporated. No cash or ATM access. MasterCard® is a registered trademark of MasterCard® International Incorporated. This card can be used only to cover the co-payment for eligible prescriptions covered under the program at participating merchant locations where Debit MasterCard® is accepted.
‡Amgen provides donations to various nonprofit independent entities but has no influence over the distribution of the funds.
For Your Practice:
Amgen Assist® provides top-rated* comprehensive support services
counselor for your practice, with
expertise in reimbursement
policies in your area
Reimbursement support services,
including insurance verification
and prior authorization assistance
Referral to appropriate
patient assistance programs
*Based on survey of oncology office practice managers Q4 2012 (n=88).
Click for direct access to reimbursement resources, or call 1-888-4-ASSIST (1-888-427-7478).
For comprehensive reimbursement support, contact Amgen Assist®.
- 1-888-4-ASSIST (1-888-427-7478)
- Fax: 1-888-407-9787
Prolia® is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.1
Prolia® is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.1
Prolia® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia®. Prolia® is contraindicated in women who are pregnant and may cause fetal harm. Prolia® is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling and urticaria.
Same Active Ingredient
Prolia® contains the same active ingredient (denosumab) found in XGEVA®. Patients receiving Prolia® should not receive XGEVA®.
Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia®. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia®.
Hypocalcemia may worsen in patients taking Prolia®, especially in patients with severe renal impairment. In patients predisposed to hypocalcemia and disturbances of mineral metabolism, clinical monitoring of calcium and mineral levels is highly recommended within 14 days of Prolia® injection. Adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the Jaw
Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing and has been reported in patients receiving Prolia®. A routine oral exam should be performed by the prescriber prior to initiation of Prolia®. A dental examination with appropriate preventive dentistry is recommended prior to treatment with Prolia® in patients with risk factors for ONJ such as invasive dental procedures, diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders. Good oral hygiene practices should be maintained during treatment.
For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of Prolia® therapy should be considered based on individual benefit-risk assessment.
Atypical Femoral Fractures
Atypical low-energy or low trauma fractures of the shaft have been reported in patients receiving Prolia®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with anti-resorptive agents.
During Prolia® 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 evaluated to rule out an incomplete femur fracture. Interruption of Prolia® therapy should be considered, pending a risk/benefit assessment, on an individual basis.
In a clinical trial (N=7800) in women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the Prolia® group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear were more frequent in patients treated with Prolia®.
Endocarditis was also reported more frequently in Prolia®-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.
Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. In patients who develop serious infections while on Prolia®, prescribers should assess the need for continued Prolia® therapy.
Dermatologic Adverse Reactions
In the same clinical trial in women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema and rashes occurred at a significantly higher rate with Prolia® compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing Prolia® if severe symptoms develop.
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Prolia®. Consider discontinuing use if severe symptoms develop.
Suppression of Bone Turnover
In clinical trials in women with postmenopausal osteoporosis, Prolia® resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment are unknown. Monitor patients for these consequences, including ONJ, atypical fractures, and delayed fracture healing.
It is not known whether Prolia® is excreted into human milk. Measurable concentrations of denosumab were present in the maternal milk of cynomolgus monkeys up to 1 month after the last dose of denosumab (≤0.5% milk:serum ratio). Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Prolia®, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The most common adverse reactions (> 5% and more common than placebo) in women with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. The most common adverse reactions (> 5% and more common than placebo) in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. Pancreatitis has been reported with Prolia®. In women with postmenopausal osteoporosis, the overall incidence of new malignancies was 4.3% in the placebo group and 4.8% in the Prolia® groups. In men with osteoporosis, new malignancies were reported in no patients in the placebo group and 4 (3.3%) patients in the Prolia® group. A causal relationship to drug exposure has not been established. Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity. The most common (per patient incidence ≥ 10%) adverse reactions reported with Prolia® in patients with bone loss receiving ADT for prostate cancer or adjuvant AI therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. Additionally, in Prolia®-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.
Prolia® Postmarketing Active Safety Surveillance Program
The Prolia® Postmarketing Active Safety Surveillance Program is available to collect information from prescribers on specific adverse events.
Please see www.proliasafety.com or call 1-800-772-6436 for more information.
- Prolia® (denosumab) prescribing information, Amgen.