Indications FOR PROLIA®

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, nonvertebral, and hip fractures.
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, nonvertebral, and hip fractures.
Prolia® is indicated for treatment to increase bone mass in men 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.
Prolia® is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
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.
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. Read Less
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Prescribing Information Medication Guide Important Safety Information Indications
FOR INFORMATION ON HOW TO GET STARTED,
SEE BELOW OR CONTACT ProliaNurseInjection@amgen.com.
PROGRAM ELIGIBILITY AND HOW
IT WORKS GET YOUR PATIENTS STARTED
(INTAKE FORM) PROGRAM FAQs OTHER COVID-19 SUPPORT

FOR US HEALTHCARE PROFESSIONALS

At-Home Nurse Injection Program

Due to the COVID-19 pandemic, you may have concerns about continuity of care for your new or existing Prolia® patients. To help your patients avoid missing or postponing their scheduled injection, Amgen is now offering the temporary Prolia® At-Home Nurse Injection Program for patients who are unable or unwilling to leave home and/or do not have an available treatment site in their area. If eligible, patients can have Prolia® administered right in their homes by a Home Health Registered Nurse (RN).

While Prolia® is typically covered under the patient’s regular pharmacy benefit (with any applicable patient co-pays continuing to apply), the nurse visit and administration of the injection would be provided at no cost.*

*Patient coverage, out-of-pocket cost, and insurance requirements may vary.

PROGRAM ELIGIBILITY AND HOW IT WORKS

The Prolia® At-Home Nurse Injection Program is a temporary option available to new or existing Prolia® patients during the COVID-19 pandemic who:

  • Are unable or unwilling to leave their homes and/or
  • Do not have an available treatment site in their area
  • Patient resides in the contiguous United States, Hawaii, or Alaska
IS YOUR PATIENT A CANDIDATE FOR AT-HOME ADMINISTRATION OF PROLIA®?
Program eligibility requirements
  • New or existing Prolia® patient due for injection.
  • Patient has pharmacy benefit coverage for Prolia® (confirm if patient's health plan mandates a specific specialty pharmacy)
Confirming patient readiness
  • Patient agrees to at-home administration process and allows nurse into the home
  • Patient understands program details and their responsibility in the Prolia® At-Home Nurse Injection Program (eg, refrigerating Prolia® upon home delivery1)
HOW DOES THE PROLIA® AT-HOME NURSE INJECTION PROGRAM WORK?
Your Office's Role
Your Patient's Role
Step 1: Initiation
  • Verify patient is eligible by reviewing the program eligibility requirements listed here and the Intake Form (downloadable below)
  • Send the prescription to the patient’s qualifying pharmacy* for home delivery
    • A prior authorization may be required
    • Let your patient know to expect a call from their qualifying pharmacy*
  • If out-of-pocket (OOP) costs are a concern for your patient, contact Amgen Assist® for information on appropriate financial support options
  • Your patient will receive a call from the pharmacy to:
    • Review OOP costs
    • Collect co-pay
    • Confirm address
  • When Prolia® is delivered, your patient will need to put it in the refrigerator at 36°F to 46°F in the original carton1
Step 2: Administration
  • Send the Intake Form to the UBC Prolia® Support Team (Injection Administration Coordinator)
  • Let your patient know they are to expect a call from the Home Health RN
  • Your patient will receive a call from the Home Health RN to set up an appointment
  • On the day of the appointment, your patient will need to remove Prolia® from the refrigerator at least 30 minutes prior to the Home Health RN's arrival and keep it at room temperature (up to 77°F) in the original carton1
  • Patient receives Prolia® injection from the Home Health RN
Step 3:
Follow-up
  • Your office will receive confirmation from the UBC Prolia® Support Team that Prolia® was administered
  • Contact your patient to set up the next injection
 
  • The process takes approximately 10 days once you’ve sent the intake form to the UBC Prolia® Support Team. The timeline is also dependent on whether your patient is available during this time
  • Depending on your patient’s insurance, Amgen Assist® can provide applicable information on appropriate programs, such as Prolia® Co-pay Card, that can help eligible patients pay for the Prolia® you’ve prescribed. Amgen Assist® can be contacted at 1-866-AMG-ASST (1-866-264-2778)

    •  

    *A qualifying pharmacy is one that is covered by the patient's insurance.

     

    Click the button below for a downloadable version of the Prolia® At-Home Nurse Injection Program details.

    DOWNLOAD THE
    PROGRAM DETAILS download icon download icon
GET YOUR PATIENTS STARTED (INTAKE FORM)

Use this form to get your patients started with the Prolia® At-Home Nurse Injection Program. After sending your patient’s prescription to the qualifying pharmacy, complete the Intake Form and fax to the UBC Prolia® Support Team at the fax number on the form or email to ProliaSupport@ubc.com.

DOWNLOAD THE
INTAKE FORM download icon
PROGRAM FAQs

Get answers to your questions about the Prolia® At-Home Nurse Injection Program.

FREQUENTLY ASKED
QUESTIONS download icon
OTHER COVID-19 SUPPORT

We’re always committed to the health of your patients. And at this challenging time, more than ever, we want to connect with you directly and answer any questions you may have.

For other COVID-19 support and guidance from Amgen®, visit:

Amgen
COVID-19 support

QA

Reference: Prolia® (denosumab) prescribing information, Amgen.

IMPORTANT SAFETY INFORMATION FOR PROLIA®

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, patients should be transitioned 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.

INDICATIONS FOR PROLIA®

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, nonvertebral, and hip fractures.

Prolia® is indicated for treatment to increase bone mass in men 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.

Prolia® is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

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.

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.

Please see Prolia® full Prescribing Information, including Medication Guide.

IMPORTANT SAFETY INFORMATION FOR PROLIA®
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.