The recommended dose of BILDYOS is 60 mg administered as a single subcutaneous injection once every 6 months
Administer BILDYOS via subcutaneous injection in the upper arm, the upper thigh, or the abdomen
All patients should receive 1,000 mg of calcium daily and at least 400 IU of vitamin D daily
BILDYOS should be administered by a health care professional
IU, international unit.
Review key components used in the BILDYOS injection process.
For complete preparation, administration, and disposal steps, refer to the full Prescribing Information.
From co-pay assistance to benefits investigations and billing support, The Organon Access Program helps you and your eligible patients navigate coverage for BILDYOS.
BILDYOS 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, BILDYOS reduces the incidence of vertebral, nonvertebral, and hip fractures.
BILDYOS 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.
BILDYOS 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.
BILDYOS is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients, denosumab products also reduced the incidence of vertebral fractures.
BILDYOS is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Patients with advanced chronic kidney disease (eGFR <30mL/min/1.73m2), including dialysis dependent patients, are at greater risk of severe hypocalcemia following denosumab products 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 in these patients.
Prior to initiating BILDYOS in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BILDYOS in these patients should be supervised by a health care provider with expertise in the diagnosis and management of CKD-MBD.
BILDYOS is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating BILDYOS. BILDYOS is contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with BILDYOS. BILDYOS is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria.
Denosumab products can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with BILDYOS. 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 (eg, treatment with other calcium lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after BILDYOS injection.
The active ingredient in BILDYOS is denosumab. Patients receiving BILDYOS should not receive other denosumab products concomitantly.
Clinically significant hypersensitivity, including anaphylaxis, has been reported with denosumab products. 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 BILDYOS.
ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. ONJ has been reported in patients receiving denosumab products. A routine oral exam should be performed by the prescriber prior to initiation of BILDYOS. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery), diagnosis of cancer, concomitant therapies (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (eg, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Good oral hygiene practices should be maintained during treatment with BILDYOS. Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ. The risk of ONJ may increase with duration of exposure to denosumab products.
For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit-risk assessment.
Patients who are suspected of having or who develop ONJ while on BILDYOS should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of BILDYOS should be considered based on individual benefit-risk assessment.
Atypical low-energy, or low trauma fractures of the shaft have been reported in patients receiving denosumab products. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.
During BILDYOS 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 suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Interruption of BILDYOS therapy should be considered, pending a benefit-risk assessment, on an individual basis.
Following discontinuation of denosumab 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 denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab product discontinuation. Evaluate an individual’s benefit-risk before initiating treatment. If BILDYOS treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.
In a clinical trial of over 7800 women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the denosumab 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 denosumab products. Endocarditis was also reported more frequently in denosumab-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. Consider the benefit-risk profile in such patients before treating with BILDYOS. In patients who develop serious infections while on BILDYOS, prescribers should assess the need for continued BILDYOS therapy.
In a clinical trial of over 7800 women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate with denosumab treatment compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing BILDYOS if severe symptoms develop.
In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients during denosumab treatment. Onset of symptoms varied from one day to several months after starting denosumab products. Consider discontinuing use if severe symptoms develop.
In clinical trials in women with postmenopausal osteoporosis, treatment with denosumab 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 with denosumab products are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing.
BILDYOS is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products.
The most common adverse reactions (>5% and more common than placebo) reported with denosumab products 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) reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. Pancreatitis has been reported with denosumab products.
The most common adverse reactions (>3% and more common than active-control group) reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache.
The most common (per patient incidence ≥10%) adverse reactions reported with denosumab products in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
The most common adverse reactions leading to discontinuation of denosumab products in patients with postmenopausal osteoporosis are back pain and constipation.
Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.
Before prescribing BILDYOS, please read the Prescribing Information, including the Boxed Warning about severe hypocalcemia. The Medication Guide also is available.
Please note, BILDYOS is part of the Risk Evaluation and Mitigation Strategy (REMS) program.
References:
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