Bildyos

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Pregnancy must be ruled out prior to administration of Bildyos. ( 2.1 ) Before initiating Bildyos in patients with advanced chronic kidney disease, including dialysis patients, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone, serum calcium, 25(OH) vitamin D, and 1,25 (OH) 2 vitamin D. ( 2.2 , 5.1 , 8.6 ) Bildyos should be administered by a healthcare provider. ( 2.3 ) Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. ( 2.3 ) Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. ( 2.3 ) 2.1 Pregnancy Testing Prior to Initiation of Bildyos Pregnancy must be ruled out prior to administration of Bildyos. Perform pregnancy testing in all females of reproductive potential prior to administration of Bildyos. Based on findings in animals, denosumab products can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 , 8.3 )] . 2.2 Laboratory Testing in Patients with Advanced Chronic Kidney Disease Prior to Initiation of Bildyos In patients with advanced chronic kidney disease [i.e., estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m 2 ], including dialysis-dependent patients, evaluate for the presence of chronic kidney disease mineral and bone disorder (CKD-MBD) with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25 (OH) 2 vitamin D prior to decisions regarding Bildyos treatment. Consider also assessing bone turnover status (serum markers of bone turnover or bone biopsy) to evaluate the underlying bone disease that may be present [see Warnings and Precautions ( 5.1 )] . 2.3 Recommended Dosage Bildyos should be administered by a healthcare provider. 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 calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions ( 5.1 )] . If a dose of Bildyos is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection. 2.4 Preparation and Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Bildyos is clear to slightly opalescent, colorless to slightly yellow solution.
• Do not use if the solution is discolored or cloudy or if the solution contains visible particles or foreign particulate matter. Prior to administration, Bildyos may be removed from the refrigerator and brought to room temperature up to 25°C (77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Bildyos in any other way [see How Supplied/Storage and Handling ( 16 )]. Instructions for Administration of Bildyos Prefilled Syringe with Needle Safety Guard
• Bildyos single-dose prefilled syringe contains a safety guard that activates to cover the needle after the injection is finished. The safety guard helps to prevent needlesticks. Step 1:
• Remove Needle Cap Carefully pull the black needle cap straight out and away from your body. Step 2:
• Administer Subcutaneous Injection Choose an injection site. The recommended injection sites for Bildyos include the upper arm, OR the upper thigh, OR the abdomen. Pinch your injection site to create a firm surface. Hold the pinch. Insert the needle into the skin at 45 to 90 degrees. Push the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap. Release your thumb. Then lift the syringe off skin. After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle. Immediately dispose of the syringe and needle cap in the nearest sharps container. Do not put the needle cap back on the used syringe. Figure 1 Figure 2 Figure 3 Figure 4 Figure 5

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

• The safety and effectiveness of Bildyos have not been established in pediatric patients.
• In one multicenter, open-label study with denosumab conducted in 153 pediatric patients with osteogenesis imperfecta, aged 2 to 17 years, evaluating fracture risk reduction, efficacy was not demonstrated.
• Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products.
• Some cases required hospitalization and were complicated by acute renal injury [see Warnings and Precautions ( 5.11 )] .
• Clinical studies in pediatric patients with osteogenesis imperfecta were terminated early due to the occurrence of life-threatening events and hospitalizations due to hypercalcemia.
• Safety and effectiveness were not demonstrated for the treatment of glucocorticoid-induced osteoporosis in one multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in 24 pediatric patients with glucocorticoid-induced osteoporosis, aged 5 to 17 years, evaluating change from baseline in lumbar spine BMD Z-score.
• Based on results from animal studies, denosumab may negatively affect long-bone growth and dentition in pediatric patients below the age of 4 years.
• Juvenile Animal Toxicity Data Treatment with denosumab products may impair long-bone growth in children with open growth plates and may inhibit eruption of dentition.
• In neonatal rats, inhibition of RANKL (the target of denosumab therapy) with a construct of osteoprotegerin bound to Fc (OPG-Fc) at doses ≤ 10 mg/kg was associated with inhibition of bone growth and tooth eruption.
• Adolescent primates treated with denosumab at doses 10 and 50 times (10 and 50 mg/kg dose) higher than the recommended human dose of 60 mg administered every 6 months, based on body weight (mg/kg), had abnormal growth plates, considered to be consistent with the pharmacological activity of denosumab [see Nonclinical Toxicology ( 13.2 )] .
• Cynomolgus monkeys exposed in utero to denosumab exhibited bone abnormalities, an absence of axillary, inguinal, mandibular, and mesenteric lymph nodes, reduced hematopoiesis, tooth malalignment, and decreased neonatal growth.
• Some bone abnormalities recovered once exposure was ceased following birth; however, axillary, and inguinal lymph nodes remained absent 6 months post-birth [see Use in Specific Populations ( 8.1 )] .

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Of the total number of patients in clinical studies of denosumab, 9943 patients (76%) were ≥ 65 years old, while 3576 (27%) were ≥ 75 years old.
• Of the patients in the osteoporosis study in men, 133 patients (55%) were ≥ 65 years old, while 39 patients (16%) were ≥ 75 years old.
• Of the patients in the glucocorticoid-induced osteoporosis study, 355 patients (47%) were ≥ 65 years old, while 132 patients (17%) were ≥ 75 years old.
• No overall differences in safety or efficacy were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following serious adverse reactions are discussed below and also elsewhere in the labeling:
• Severe Hypocalcemia and Mineral Metabolism Changes [see Warnings and Precautions ( 5.1 )] Hypersensitivity [ see Warnings and Precautions ( 5.3 ) ] Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.4 )] Atypical Subtrochanteric and Diaphyseal Femoral Fractures [see Warnings and Precautions ( 5.5 )] Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation [see Warnings and Precautions ( 5.6 )] Serious Infections [see Warnings and Precautions ( 5.7 )] Dermatologic Adverse Reactions [see Warnings and Precautions ( 5.8 )] The most common adverse reactions reported with denosumab products in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
• The most common adverse reactions reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis.
• The most common adverse reactions 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.
• Postmenopausal osteoporosis:
• Most common adverse reactions (> 5% and more common than placebo) were:
• back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis.
• Pancreatitis has been reported in clinical trials.
• ( 6.1 ) Male osteoporosis:
• Most common adverse reactions (> 5% and more common than placebo) were:
• back pain, arthralgia, and nasopharyngitis.
• ( 6.1 ) Glucocorticoid-induced osteoporosis:
• Most common adverse reactions (> 3% and more common than active-control group) were:
• back pain, hypertension, bronchitis, and headache.
• ( 6.1 ) Bone loss due to hormone ablation for cancer:
• Most common adverse reactions (≥ 10% and more common than placebo) were:
• arthralgia and back pain.
• Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
• Treatment of Postmenopausal Women with Osteoporosis The safety of denosumab in the treatment of postmenopausal osteoporosis was assessed in a 3-year, randomized, double-blind, placebo-controlled, multinational study of 7808 postmenopausal women aged 60 to 91 years.
• A total of 3876 women were exposed to placebo and 3886 women were exposed to denosumab administered subcutaneously once every 6 months as a single 60 mg dose.
• All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day.
• The incidence of all-cause mortality was 2.3% (n = 90) in the placebo group and 1.8% (n = 70) in the denosumab group.
• The incidence of nonfatal serious adverse events was 24.2% in the placebo group and 25.0% in the denosumab group.
• The percentage of patients who withdrew from the study due to adverse events was 2.1% and 2.4% for the placebo and denosumab groups, respectively.
• The most common adverse reactions reported with denosumab in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
• Adverse reactions reported in ≥ 2% of postmenopausal women with osteoporosis and more frequently in the denosumab-treated women than in the placebo-treated women are shown in the table below.
• Table 1.
• Adverse Reactions Occurring in ≥ 2% of Patients with Osteoporosis and More Frequently than in Placebo-treated Patients Preferred Term Denosumab (N = 3886) n (%) Placebo (N = 3876) n (%) Back pain Pain in extremity Musculoskeletal pain Hypercholesterolemia Cystitis Vertigo Upper respiratory tract infection Edema peripheral Sciatica Bone pain Abdominal pain upper Anemia Insomnia Myalgia Angina pectoris Rash Pharyngitis Asthenia Pruritus Flatulence Spinal osteoarthritis Gastroesophageal reflux disease Herpes zoster 1347 (34.7) 453 (11.7) 297 (7.6) 280 (7.2) 228 (5.9) 195 (5.0) 190 (4.9) 189 (4.9) 178 (4.6) 142 (3.7) 129 (3.3) 129 (3.3) 126 (3.2) 114 (2.9) 101 (2.6) 96 (2.5) 91 (2.3) 90 (2.3) 87 (2.2) 84 (2.2) 82 (2.1) 80 (2.1) 79 (2.0) 1340 (34.6) 430 (11.1) 291 (7.5) 236 (6.1) 225 (5.8) 187 (4.8) 167 (4.3) 155 (4.0) 149 (3.8) 117 (3.0) 111 (2.9) 107 (2.8) 122 (3.1) 94 (2.4) 87 (2.2) 79 (2.0) 78 (2.0) 73 (1.9) 82 (2.1) 53 (1.4) 64 (1.7) 66 (1.7) 72 (1.9) Hypocalcemia Decreases in serum calcium levels to less than 8.5 mg/dL at any visit were reported in 0.4% women in the placebo group and 1.7% women in the denosumab group.
• The nadir in serum calcium level occurred at approximately day 10 after denosumab dosing in subjects with normal renal function.
• In clinical studies, subjects with impaired renal function were more likely to have greater reductions in serum calcium levels compared to subjects with normal renal function.
• In a study of 55 subjects with varying degrees of renal function, serum calcium levels < 7.5 mg/dL or symptomatic hypocalcemia were observed in 5 subjects.
• These included no subjects in the normal renal function group, 10% of subjects in the creatinine clearance 50 to 80 mL/min group, 29% of subjects in the creatinine clearance < 30 mL/min group, and 29% of subjects in the hemodialysis group.
• These subjects did not receive calcium and vitamin D supplementation.
• In a study of 4550 postmenopausal women with osteoporosis, the mean change from baseline in serum calcium level 10 days after denosumab dosing was -5.5% in subjects with creatinine clearance < 30 mL/min vs. -3.1% in subjects with creatinine clearance ≥ 30 mL/min.
• Serious Infections Receptor activator of nuclear factor kappa-B ligand (RANKL) is expressed on activated T and B lymphocytes and in lymph nodes.
• Therefore, a RANKL inhibitor such as denosumab products may increase the risk of infection.
• In the clinical study of 7808 postmenopausal women with osteoporosis, the incidence of infections resulting in death was 0.2% in both placebo and denosumab treatment groups.
• However, the incidence of nonfatal serious infections was 3.3% in the placebo and 4.0% in the denosumab groups.
• Hospitalizations due to serious infections in the abdomen (0.7% placebo vs. 0.9% denosumab), urinary tract (0.5% placebo vs. 0.7% denosumab), and ear (0.0% placebo vs. 0.1% denosumab) were reported.
• Endocarditis was reported in no placebo patients and 3 patients receiving denosumab.
• Skin infections, including erysipelas and cellulitis, leading to hospitalization were reported more frequently in patients treated with denosumab (< 0.1% placebo vs. 0.4% denosumab).
• The incidence of opportunistic infections was similar to that reported with placebo.
• Dermatologic Adverse Reactions A significantly higher number of patients treated with denosumab developed epidermal and dermal adverse events (such as dermatitis, eczema, and rashes), with these events reported in 8.2% of the placebo and 10.8% of the denosumab groups (p < 0.0001).
• Most of these events were not specific to the injection site [see Warnings and Precautions ( 5.8 )].
• Osteonecrosis of the Jaw ONJ has been reported in the osteoporosis clinical trial program in patients treated with denosumab [see Warnings and Precautions ( 5.4 )].
• Atypical Subtrochanteric and Diaphyseal Femoral Fractures In the osteoporosis clinical trial program, atypical femoral fractures were reported in patients treated with denosumab.
• The duration of denosumab exposure to time of atypical femoral fracture diagnosis was as early as 2½ years [see Warnings and Precautions ( 5.5 )] .
• Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation In the osteoporosis clinical trial program, multiple vertebral fractures were reported in patients after discontinuation of denosumab.
• In the phase 3 trial in women with postmenopausal osteoporosis, 6% of women who discontinued denosumab and remained in the study developed new vertebral fractures, and 3% of women who discontinued denosumab and remained in the study developed multiple new vertebral fractures.
• The mean time to onset of multiple vertebral fractures was 17 months (range:
• 7-43 months) after the last injection of denosumab.
• Prior vertebral fracture was a predictor of multiple vertebral fractures after discontinuation [see Warnings and Precautions ( 5.6 )] .
• Pancreatitis Pancreatitis was reported in 4 patients (0.1%) in the placebo and 8 patients (0.2%) in the denosumab groups.
• Of these reports, 1 patient in the placebo group and all 8 patients in the denosumab group had serious events, including one death in the denosumab group.
• Several patients had a prior history of pancreatitis.
• The time from product administration to event occurrence was variable.
• New Malignancies The overall incidence of new malignancies was 4.3% in the placebo and 4.8% in the denosumab groups.
• New malignancies related to the breast (0.7% placebo vs. 0.9% denosumab), reproductive system (0.2% placebo vs. 0.5% denosumab), and gastrointestinal system (0.6% placebo vs. 0.9% denosumab) were reported.
• A causal relationship to drug exposure has not been established.
• Treatment to Increase Bone Mass in Men with Osteoporosis The safety of denosumab in the treatment of men with osteoporosis was assessed in a 1-year randomized, double-blind, placebo-controlled study.
• A total of 120 men were exposed to placebo and 120 men were exposed to denosumab administered subcutaneously once every 6 months as a single 60 mg dose.
• All men were instructed to take at least 1000 mg of calcium and 800 IU of vitamin D supplementation per day.
• The incidence of all-cause mortality was 0.8% (n = 1) in the placebo group and 0.8% (n = 1) in the denosumab group.
• The incidence of nonfatal serious adverse events was 7.5% in the placebo group and 8.3% in the denosumab group.
• The percentage of patients who withdrew from the study due to adverse events was 0% and 2.5% for the placebo and denosumab groups, respectively.
• Adverse reactions reported in ≥ 5% of men with osteoporosis and more frequently with denosumab than in the placebo-treated patients were:
• back pain (6.7% placebo vs. 8.3% denosumab), arthralgia (5.8% placebo vs. 6.7% denosumab), and nasopharyngitis (5.8% placebo vs. 6.7% denosumab).
• Serious Infections Serious infection was reported in 1 patient (0.8%) in the placebo group and no patients in the denosumab group.
• Dermatologic Adverse Reactions Epidermal and dermal adverse events (such as dermatitis, eczema, and rashes) were reported in 4 patients (3.3%) in the placebo group and 5 patients (4.2%) in the denosumab group.
• Osteonecrosis of the Jaw No cases of ONJ were reported.
• Pancreatitis Pancreatitis was reported in 1 patient (0.8%) in the placebo group and 1 patient (0.8%) in the denosumab group.
• New Malignancies New malignancies were reported in no patients in the placebo group and 4 (3.3%) patients (3 prostate cancers, 1 basal cell carcinoma) in the denosumab group.
• Treatment of Glucocorticoid-Induced Osteoporosis The safety of denosumab in the treatment of glucocorticoid-induced osteoporosis was assessed in the 1-year, primary analysis of a 2-year randomized, multi-center, double-blind, parallel-group, active-controlled study of 795 patients (30% men and 70% women) aged 20 to 94 (mean age of 63 years) treated with greater than or equal to 7.5 mg/day oral prednisone (or equivalent).
• A total of 384 patients were exposed to 5 mg oral daily bisphosphonate (active-control) and 394 patients were exposed to denosumab administered once every 6 months as a 60 mg subcutaneous dose.
• All patients were instructed to take at least 1000 mg of calcium and 800 IU of vitamin D supplementation per day.
• The incidence of all-cause mortality was 0.5% (n = 2) in the active-control group and 1.5% (n = 6) in the denosumab group.
• The incidence of serious adverse events was 17% in the active-control group and 16% in the denosumab group.
• The percentage of patients who withdrew from the study due to adverse events was 3.6% and 3.8% for the active-control and denosumab groups, respectively.
• Adverse reactions reported in ≥ 2% of patients with glucocorticoid-induced osteoporosis and more frequently with denosumab than in the active-control-treated patients are shown in the table below.
• Table 2.
• Adverse Reactions Occurring in ≥ 2% of Patients with Glucocorticoid-induced Osteoporosis and More Frequently with Denosumab than in Active-Control-treated Patients * Events of worsening of underlying polymyalgia rheumatica.
• Preferred Term Denosumab (N=394) n (%) Oral Daily Bisphosphonate (Active-Control) (N=384) n (%) Back pain 18 (4.6) 17 (4.4) Hypertension 15 (3.8) 13 (3.4) Bronchitis 15 (3.8) 11 (2.9) Headache 14 (3.6) 7 (1.8) Dyspepsia 12 (3.0) 10 (2.6) Urinary tract infection 12 (3.0) 8 (2.1) Abdominal pain upper 12 (3.0) 7 (1.8) Upper respiratory tract infection 11 (2.8) 10 (2.6) Constipation 11 (2.8) 6 (1.6) Vomiting 10 (2.5) 6 (1.6) Dizziness 9 (2.3) 8 (2.1) Fall 8 (2.0) 7 (1.8) Polymyalgia rheumatica* 8 (2.0) 1 (0.3) Osteonecrosis of the Jaw No cases of ONJ were reported.
• Atypical Subtrochanteric and Diaphyseal Femoral Fractures Atypical femoral fractures were reported in 1 patient treated with denosumab.
• The duration of denosumab exposure to time of atypical femoral fracture diagnosis was at 8.0 months [see Warnings and Precautions ( 5.5 )] .
• Serious Infections Serious infection was reported in 15 patients (3.9%) in the active-control group and 17 patients (4.3%) in the denosumab group.
• Dermatologic Adverse Reactions Epidermal and dermal adverse events (such as dermatitis, eczema, and rashes) were reported in 16 patients (4.2%) in the active-control group and 15 patients (3.8%) in the denosumab group.
• Treatment of Bone Loss in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer or Adjuvant Aromatase Inhibitor Therapy for Breast Cancer The safety of denosumab in the treatment of bone loss in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT) was assessed in a 3-year, randomized, double-blind, placebo-controlled, multinational study of 1468 men aged 48 to 97 years.
• A total of 725 men were exposed to placebo and 731 men were exposed to denosumab administered once every 6 months as a single 60 mg subcutaneous dose.
• All men were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day.
• The incidence of serious adverse events was 30.6% in the placebo group and 34.6% in the denosumab group.
• The percentage of patients who withdrew from the study due to adverse events was 6.1% and 7.0% for the placebo and denosumab groups, respectively.
• The safety of denosumab in the treatment of bone loss in women with nonmetastatic breast cancer receiving aromatase inhibitor (AI) therapy was assessed in a 2-year, randomized, double-blind, placebo-controlled, multinational study of 252 postmenopausal women aged 35 to 84 years.
• A total of 120 women were exposed to placebo and 129 women were exposed to denosumab administered once every 6 months as a single 60 mg subcutaneous dose.
• All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day.
• The incidence of serious adverse events was 9.2% in the placebo group and 14.7% in the denosumab group.
• The percentage of patients who withdrew from the study due to adverse events was 4.2% and 0.8% for the placebo and denosumab groups, respectively.
• Adverse reactions reported in ≥ 10% of denosumab-treated patients receiving ADT for prostate cancer or adjuvant AI therapy for breast cancer, and more frequently than in the placebo-treated patients were:
• arthralgia (13.0% placebo vs. 14.3% denosumab) and back pain (10.5% placebo vs. 11.5% denosumab).
• Pain in extremity (7.7% placebo vs. 9.9% denosumab) and musculoskeletal pain (3.8% placebo vs. 6.0% denosumab) have also been reported in clinical trials.
• Additionally, in denosumab-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed (1.2% placebo vs. 4.7% denosumab).
• Hypocalcemia (serum calcium < 8.4 mg/dL) was reported only in denosumab-treated patients (2.4% vs. 0.0%) at the month 1 visit.
• 6.2 Postmarketing Experience Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• The following adverse reactions have been identified during post-approval use of denosumab products:
• Drug-related hypersensitivity reactions:
• anaphylaxis, rash, urticaria, facial swelling, and erythema.
• Hypocalcemia:
• severe symptomatic hypocalcemia resulting in hospitalization, life-threatening events and fatal cases.
• Musculoskeletal pain, including severe cases.
• Parathyroid hormone (PTH):
• Marked elevation in serum PTH in patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis.
• Multiple vertebral fractures following treatment discontinuation.
• Cutaneous and mucosal lichenoid drug eruptions (e.g., lichen planus-like reactions).
• Alopecia.
• Vasculitis (e.g., ANCA positive vasculitis, leukocytoclastic vasculitis).
• Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling ( Medication Guide ).
• Hypocalcemia Advise the patient to adequately supplement with calcium and vitamin D and instruct them on the importance of maintaining serum calcium levels while receiving Bildyos [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.6 )] .
• Advise patients to seek prompt medical attention if they develop signs or symptoms of hypocalcemia.
• Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease Advise patients with advanced chronic kidney disease, including those who are dialysis-dependent, about the symptoms of hypocalcemia and the importance of maintaining serum calcium levels with adequate calcium and activated vitamin D supplementation.
• Advise these patients to have their serum calcium measured weekly for the first month after Bildyos administration and monthly thereafter [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.6 )].
• Drug Products with Same Active Ingredient Advise patients that if they receive Bildyos, they should not receive other denosumab products concomitantly [see Warnings and Precautions ( 5.2 )] .
• Hypersensitivity Advise patients to seek prompt medical attention if signs or symptoms of hypersensitivity reactions occur.
• Advise patients who have had signs or symptoms of systemic hypersensitivity reactions that they should not receive denosumab products [see Warnings and Precautions ( 5.3 ), Contraindications ( 4 )] .
• Osteonecrosis of the Jaw Advise patients to maintain good oral hygiene during treatment with Bildyos and to inform their dentist prior to dental procedures that they are receiving Bildyos.
• Patients should inform their physician or dentist if they experience persistent pain and/or slow healing of the mouth or jaw after dental surgery [see Warnings and Precautions ( 5.4 )] .
• Atypical Subtrochanteric and Diaphyseal Femoral Fractures Advise patients to report new or unusual thigh, hip, or groin pain [see Warnings and Precautions ( 5.5 )].
• Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation Advise patients not to interrupt Bildyos therapy without talking to their physician [see Warnings and Precautions ( 5.6 )].
• Serious Infections Advise patients to seek prompt medical attention if they develop signs or symptoms of infections, including cellulitis [see Warnings and Precautions ( 5.7 )] .
• Dermatologic Adverse Reactions Advise patients to seek prompt medical attention if they develop signs or symptoms of dermatological reactions (such as dermatitis, rashes, and eczema) [see Warnings and Precautions ( 5.8 )] .
• Musculoskeletal Pain Inform patients that severe bone, joint, and/or muscle pain have been reported in patients taking denosumab products.
• Patients should report severe symptoms if they develop [see Warnings and Precautions ( 5.9 )] .
• Pregnancy/Nursing Counsel females of reproductive potential to use effective contraceptive measure to prevent pregnancy during treatment and for at least 5 months after the last dose of Bildyos.
• Advise the patient to contact their physician immediately if pregnancy does occur during these times.
• Advise patients not to take Bildyos while pregnant or breastfeeding.
• If a patient wishes to start breastfeeding after treatment, advise her to discuss the appropriate timing with her physician [see Contraindications ( 4 ), Use in Specific Populations ( 8.1 )] .
• Schedule of Administration Advise patients that if a dose of Bildyos is missed, the injection should be administered as soon as convenient.
• Thereafter, schedule injections every 6 months from the date of the last injection.
• Bildyos (denosumab-nxxp) Manufactured by: Shanghai Henlius Biotech, Inc.
• Room 901, 9th Floor, Building 1, No. 367 Shengrong Road, China (Shanghai) Pilot Free Trade Zone.
• U.S.
• License No. 2354 Manufactured for:
• Organon LLC, a subsidiary of ORGANON & Co., Jersey City, NJ 07302, USA.
• PROLIA ® is a registered trademark of Amgen Inc.
• BD UltraSafe Plus TM is a trademark of Becton, Dickinson and Company.
• Figure 8

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 60 mg/mL clear to slightly opalescent, colorless to slightly yellow solution in a single-dose prefilled syringe. Injection:
• 60 mg/mL solution in a single-dose prefilled syringe. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• How Supplied Bildyos (denosumab-nxxp) injection is a clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous administration.
• Each Bildyos single-dose prefilled syringe contains 60 mg/mL of denosumab in a 1 mL single-dose syringe with a 29 gauge 1/2 inch needle with a BD UltraSafe Plus TM passive safety guard;
• The prefilled syringe with safety guard is not made with natural rubber latex. 60 mg/mL in a single-dose prefilled syringe 1 per carton NDC 78206-193-01 Storage and Handling Store Bildyos refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Prior to administration, Bildyos may be allowed to reach room temperature up to 25°C (77°F) in the original container.
• Once removed from the refrigerator, Bildyos must not be exposed to temperatures above 25°C (77°F) and must be used within 30 days.
• Discard Bildyos if not used within the 30 days.
• Do not use Bildyos after the expiry date printed on the label.
• Protect Bildyos from direct light and heat.
• Avoid vigorous shaking of Bildyos.

Quoted from the official label, section “How Supplied”.

How to store it

• Store Bildyos refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Prior to administration, Bildyos may be allowed to reach room temperature up to 25°C (77°F) in the original container.
• Once removed from the refrigerator, Bildyos must not be exposed to temperatures above 25°C (77°F) and must be used within 30 days.
• Discard Bildyos if not used within the 30 days.
• Do not use Bildyos after the expiry date printed on the label.
• Protect Bildyos from direct light and heat.
• Avoid vigorous shaking of Bildyos.

Quoted from the official label, section “Storage and Handling”.

What is in it

• Denosumab-nxxp is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand).
• Denosumab-nxxp has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
• Bildyos (denosumab-nxxp) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use.
• Each 1 mL single-dose prefilled syringe of Bildyos contains 60 mg denosumab-nxxp (60 mg/mL solution), glacial acetic acid (1.02 mg), polysorbate 20 (0.1 mg), sorbitol (47.0 mg), Water for Injection (USP), and sodium hydroxide to a pH of 5.2.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Denosumab