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

FOR TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE

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Prolia® Mechanism of Action

Suggested Resources:

Osteoporosis in Men (Patient Identification)
5 indications

Prolia® helps you treat patients at high risk for fracture with 5 indications

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Help lead your patients to stronger bones with Prolia® 1,2

Men with weakening bones should not wait until they fracture to do something about their osteoporosis.

Help men recognize their risk factors for osteoporosis:1,3

  • Less than or equal to 2.5

    Low bone density

  • Excessive alcohol use

    Excessive alcohol use

  • History of fractures

    Parental history of fractures

  • Prior fracture

    Prior fracture

  • 70+

    Advanced age

  • Low testosterone or estrogen levels

    Low testosterone or estrogen levels

  • No glucocorticoid use

    Glucocorticoid Use

Indication

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.

How much did Prolia® increase bone mass in a pivotal phase 3 trial?1,4

How much did Prolia® increase bone mass in a pivotal phase 3 trial?1,4

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An international, multicenter, randomized, phase 3 study to compare the efficacy and safety of denosumab vs placebo in males with osteoporosis. The study was double-blind and placebo-controlled. Eligible subjects were randomized to receive either 60 mg denosumab or placebo as a subcutaneous (SC) injection once every 6 months (Q6M) over a 12-month period at day 1 and month 6. All patients were supplemented with calcium and vitamin D. The primary endpoint was percent change from baseline in lumbar spine BMD at month 12, and secondary endpoints included percent change from baseline in total hip BMD at month 12.1,4,*

*After the 12-month, double-blind treatment, all continuing subjects received open-label 60 mg Q6M SC denosumab for 12 more months.1,4

Study Objective:

To investigate the effects of denosumab compared with placebo in men with low BMD after 1 year of treatment1,4

Primary Endpoint:

Percent change from baseline in lumbar spine BMD at 12 months1,4

Select Secondary Endpoints:

Percent change from baseline in BMD of the total hip and femoral neck at month 121,4

Important Safety Information

Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia®. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue Prolia®.


Prolia® resulted in significant increases in BMD at lumbar spine and total hip1,4

Percent Change from Baseline (BL) in Lumbar Spine BMD at 12 Months4

Percent change from baseline in lumbar spine at 12 months with Prolia® (denosumab)

*p < 0.0001 vs placebo.

Difference between Prolia® and placebo is calculated with treatment group as main effect and baseline BMD T-score as covariate.

Important Safety Information

ONJ and atypical femoral fracture have been reported in patients with Prolia®. The risk of ONJ may increase with duration of exposure to Prolia®. Patients should be monitored for adverse outcomes.

Percent Change from Baseline (BL) in Total Hip BMD at 12 Months4

Percent change from baseline in total hip at 12 months with Prolia® (denosumab)

*p < 0.0001 vs placebo.

Difference between Prolia® and placebo is calculated with treatment group as main effect and baseline BMD T-score as covariate.

Important Safety Information

ONJ and atypical femoral fracture have been reported in patients with Prolia®. The risk of ONJ may increase with duration of exposure to Prolia®. Patients should be monitored for adverse outcomes.

What dosing schedule should you follow for patients on Prolia®?

For treatment to increase bone mass in men with osteoporosis at high risk for fracture

Be confident your Prolia® patients are receiving 6 months of therapy with each injection1

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Prolia® (denosumab) injection schedule

Single-use prefilled 1 mL syringe

The image above is for illustration purposes only and represents a snapshot in time. Actual dosing and duration of a particular patient's therapy should be based upon the product's approved labeling and the independent clinical decision of the provider.

Important Safety Information

Following discontinuation of Prolia® treatment, fracture risk increases, including the risk of multiple vertebral fractures. Evaluate an individual's benefit/risk before initiating treatment with Prolia®. If Prolia® treatment is discontinued, consider transitioning to an alternative antiresorptive therapy.

Prolia® is administered as 1 shot every 6 months1

  • 60 mg subcutaneous injection in the upper arm, upper thigh, or abdomen by a healthcare professional
    • - Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia®
    • - Adequately supplement all patients with calcium and vitamin D
    • - Multiple vertebral fractures have been reported following Prolia® discontinuation
  • As a subcutaneous injection, Prolia® does not undergo first-pass metabolism5
  • May lessen patient pill burden

IMPORTANT SAFETY INFORMATION

SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE:

Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating Prolia in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Prolia in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD.

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.

Severe Hypocalcemia and Mineral Metabolism Changes: Prolia can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia. Adequately supplement all patients with calcium and vitamin D.

In patients without advanced chronic kidney disease who are predisposed to hypocalcemia and disturbances of mineral metabolism (e.g. treatment with other calcium lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after Prolia injection.

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®.

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), 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: 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: 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 consequences, including ONJ, atypical fractures, and delayed fracture healing.

Adverse Reactions: The most common adverse reactions (>5% and more common than placebo) are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. Pancreatitis has been reported with Prolia®.

The overall incidence of new malignancies was 4.3% in the placebo group and 4.8% 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.

Indication: 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.

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

IMPORTANT SAFETY INFORMATION
SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE: Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following Prolia administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating
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References: 1. Prolia® (denosumab) prescribing information, Amgen. 2. Keaveny TM, McClung MR, Genant HK, et al. Fermonal and vertebral strength improvements in postmenopausal women with osteoporosis treated with denosumab. J Bone Min Res. 2014;29(1):158-165. 3. National Osteoporosis Foundation. Bone density exam/testing. https://www.nof.org/patients/diagnosis-information/bone-density-examtesting/. Accessed September 22, 2023. 4. Orwoll E, Teglbjaerg CS, Langdahl BL, et al. A randomized, placebo-controlled study of the effects of denosumab for the treatment of men with low bone mineral density. J Clin Endocrinol Metab. 2012;97:3161-3169. 5. Turner PV, Brabb T, Pekow C, Vasbinder MA. Administration of substances to laboratory animals: routes of administration and factors to consider. J Am Assoc Lab Anim Sci. 2011;50:600–613.