BILDYOS Denosumab 60 mg/mL Injection, Solution, 1 syringe

1 INDICATIONS AND USAGE Bildyos is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture. ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture. ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.

( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. ( 1.5 )

1.1Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture 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, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies ( 14.1 )] .

1.2Treatment to Increase Bone Mass in Men with Osteoporosis 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 [see Clinical Studies ( 14.2 )] .

1.3Treatment of Glucocorticoid-Induced Osteoporosis 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 [see Clinical Studies ( 14.3 )] .

1.4Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer 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 also reduced the incidence of vertebral fractures [see Clinical Studies ( 14.4 )] .

1.5Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer 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 [see Clinical Studies ( 14.5 )] .

2 DOSAGE AND ADMINISTRATION 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 )

2.1Pregnancy 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 )] .

2.2Laboratory 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 )] .

2.3Recommended 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.

2.4Preparation 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…

3 DOSAGE 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 )

17 PATIENT COUNSELING INFORMATION 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.…

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 08/2025 MEDICATION GUIDE BILDYOS ® [bil' dee ose] (denosumab-nxxp) Injection, for subcutaneous use What is the most important information I should know about Bildyos?

If you receive Bildyos, you should not receive other denosumab products at the same time. Bildyos can cause serious side effects including: Increased risk of severe low calcium levels in your blood (hypocalcemia). Bildyos may lower the calcium levels in your blood.

If you have low blood calcium before you start receiving Bildyos, it may get worse during treatment. Your low blood calcium must be treated before you receive Bildyos. Talk to your doctor before starting Bildyos.

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Bildyos. Take calcium and vitamin D as your doctor tells you to. If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Bildyos may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events and death.

A mineral and bone disorder associated with kidney disease called chronic kidney disease-mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start Bildyos and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms.

Call your doctor right away if you have symptoms of low blood calcium such as: spasms, twitches, or cramps in your muscles numbness or tingling in your fingers, toes, or around your mouth Serious allergic reactions. Serious allergic reactions have happened in people who take denosumab products. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction.

Symptoms of a serious allergic reaction may include: low blood pressure (hypotension) trouble breathing throat tightness swelling of your face, lips, or tongue rash itching hives Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take Bildyos. Your doctor should examine your mouth before you start Bildyos.

Your doctor may tell you to see your dentist before you start Bildyos. It is important for you to practice good mouth care during treatment with Bildyos. Ask your doctor or dentist about good mouth care if you have any questions.

Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Bildyos. Talk with your doctor before starting Bildyos treatment. After your treatment with Bildyos is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased.

Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking Bildyos without first talking with your doctor. If your Bildyos treatment is stopped, talk to your doctor about other medicine that you can take.

Serious infections. Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Bildyos. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Bildyos.

You may need to go to the hospital for treatment if you develop an infection. Bildyos is a medicine that may affect the ability of your body to fight infections. People who have a weakened immune system or take medicines that affect the immune system may have an increased risk for developing serious infections.

Call your doctor right away if you have any of the following symptom…