5 INDICATIONS

Prolia® is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, See More

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Prolia® Mechanism of Action

Suggested Resources:

Help your patients get Prolia® with two pathways to fulfillment

97% of all patients have access* to Prolia®1,† 

Fulfill Through Buy & Bill

Find resources and support for offices that purchase Prolia® through authorized wholesalers (or schedule treatment at alternate sites of care).

Fulfill Through Pharmacy

Explore resources and support for offices that obtain Prolia® through a retail or specialty pharmacy.

*Access is defined as the ability for a patient to obtain Prolia®, although patient out-of-pocket cost and insurance requirements may vary.

†Access data based on DRG covered lives as of Q2 2018.

Search Prolia Finder™ for alternate sites of care and pharmacies with this extensive database to help your patients get their Prolia® treatment.


With the Prolia® Co-pay Card, eligible patients with commercial insurance pay $25 or less*

For Commercial Insurance Coverage

  • Up to a maximum benefit of $1,500 per patient, per calendar year
  • Out-of-pocket cost reduced under the medical or pharmacy benefit
  • Can be applied to deductible, co-insurance, and/or co-pay for Prolia®, but not costs associated with office visit or the administration of Prolia®
  • No income eligibility requirement
  • At ProliaSupport.com, registered offices can help patients enroll with a 4-step process
  • To enroll by phone, call 1-844-369-9962

*See eligibility requirements for the Prolia® Co-pay Program.

Additionally, if patients become aware that their health plan or pharmacy benefit manager does not allow the use of manufacturer co-pay support as part of their health plan design, patients agree to comply with their obligations, if any, to disclose their use of the card to their insurer.

The Prolia® Co-pay Program 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 co-payment for eligible prescriptions covered under the program at participating merchant locations where Debit MasterCard is accepted.

Eligibility Requirements for the Prolia® Co-pay Program

Eligibility requirements for the Prolia® Co-pay Program

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Eligibility Criteria: Open to patients with a Prolia® (denosumab) prescription and commercial insurance for Prolia®. Patients may not seek reimbursement for value received from the Prolia® Co-pay Program from any third-party payers, including a flexible spending account or healthcare savings account. This program is not open to uninsured patients or patients receiving prescription reimbursement under 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, or where prohibited by law. If at any time patients begin receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patients will no longer be able to use this card and you must call the Prolia® Co-pay Program at 1-844-369-9962 (9:00 am- 8:00 pm EST, Monday-Friday) to stop participation. Restrictions may apply. Amgen reserves the right to revise or terminate this program, in whole or in part, without any notice at any time. This is not health insurance. Program invalid where otherwise prohibited by law.

Program Details: The Prolia® Co-pay Program provides financial support for eligible commercially insured patients. The program does not provide support for supplies, procedures, or any physician-related services associated with Prolia®. For eligible patients, the program covers the amount of OOP cost for Prolia® that exceeds $25 for each dose, up to a maximum benefit of $1,500 per patient, per calendar year. Patient is responsible for costs above this amount. Patient card is reset every January 1. Patients need to re-verify their eligibility on a yearly basis.

Other Financial Assistance Options are Available for Your Patients

Referrals to Independent Co-pay Foundations

Amgen Assist® can refer patients, as a courtesy, to independent co-pay foundations.*

*Provided through independent charitable patient assistance programs; program eligibility is based on the charity's criteria. Amgen has no control over independent, third-party programs and provides referrals as a courtesy only.

Referrals to Amgen Safety Net Foundation

Amgen Safety Net Foundation is an independent, nonprofit patient assistance program that provides Prolia® at no cost to qualifying patients who have a financial need and who are uninsured or have insurance that excludes Prolia®.

IMPORTANT SAFETY INFORMATION

Contraindications: 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. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Prolia®. 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®.

Hypersensitivity: 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: Hypocalcemia may worsen with the use of Prolia®, especially in patients with severe renal impairment. In patients predisposed to hypocalcemia and disturbances of mineral metabolism, including treatment with other calcium-lowering drugs, clinical monitoring of calcium and mineral levels is highly recommended within 14 days of Prolia® injection. Concomitant use of calcimimetic drugs may worsen hypocalcemia risk and serum calcium should be closely monitored. Adequately supplement all patients with calcium and vitamin D.

Osteonecrosis of the Jaw (ONJ): 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®. An 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 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 with Prolia®. The risk of ONJ may increase with duration of exposure to Prolia®.

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® 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 antiresorptive 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.

Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia® Treatment: Following discontinuation of Prolia® treatment, fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia®. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia® discontinuation. Evaluate an individual's benefit/risk before initiating treatment with Prolia®. If Prolia® treatment is discontinued, consider transitioning to an alternative antiresorptive therapy.

Serious Infections: In a clinical trial (N=7808) 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.

Musculoskeletal Pain: 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.

Adverse Reactions: 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® group. 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.

The most common adverse reactions (>3% and more common than active-control group) in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache.

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.

Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see Prolia® full Prescribing Information, including Medication Guide

IMPORTANT SAFETY INFORMATION
Contraindications: 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. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Prolia®. Prolia® is contraindicated in patients with
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Reference: 1. Data on file, Amgen. 2018 (1).