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)

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

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How many men are losing valuable bone strength due to osteoporosis?

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

  • Height loss of 1/2 inch or more within one year2
  • Advanced age
  • Low bone mineral density (BMD)
  • Family history of osteoporosis or fractures
  • Prior fracture
  • Low testosterone or estrogen levels3

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?4,5

How much did Prolia® increase bone mass in a pivotal phase 3 trial?4,5

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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 12.4,5,*

*After the 12-month, double-blind treatment, all continuing subjects received open-label 60 mg Q6M SC denosumab for 12 more months.4,5

Study Objective:

To investigate the effects of denosumab compared with placebo in men with low BMD after 1 year of treatment4,5

Primary Endpoint:

Percent change from baseline in lumbar spine BMD at 12 months4,5

Select Secondary Endpoints:

Percent change from baseline in BMD of the total hip and femoral neck at month 124,5

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 hip4,5

Percent Change from Baseline (BL) in Lumbar Spine BMD at 12 Months5

*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 Months5

*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 injection4

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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 months4

  • 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 metabolism6
  • May lessen patient pill burden

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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References: 1. National Osteoporosis Foundation. The Man’s Guide to Osteoporosis. Washington, DC: National Osteoporosis Foundation; 2011. 2. National Osteoporosis Foundation. Bone density exam/testing. https://www.nof.org/patients/diagnosis-information/bone-density-examtesting/. Accessed October 10, 2019. 3. International Osteoporosis Foundation. Invest in your bones. Osteoporosis in men: the ‘silent epidemic’ strikes men too. https://www.iofbonehealth.org/sites/default/files/PDFs/WOD%20Reports/osteoporosis_in_men_2004_english.pdf. Accessed July 8, 2019. 4. Prolia® (denosumab) prescribing information, Amgen. 5. 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. 6. 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.