JUBBONTI denosumab 60 mg/mL Injection, 1 syringe

1 INDICATIONS AND USAGE Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti 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 Jubbonti. ( 2.1 ) • Before initiating Jubbonti 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 ) • Jubbonti 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 Jubbonti Pregnancy must be ruled out prior to administration of Jubbonti. Perform pregnancy testing in all females of reproductive potential prior to administration of Jubbonti. 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 Jubbonti 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 Jubbonti 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 Jubbonti should be administered by a healthcare provider. The recommended dose of Jubbonti is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Jubbonti 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 Jubbonti 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. Jubbonti is a clear to slightly opalescent and colorless to slightly yellowish to slightly brownish 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, Jubbonti 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 Jubbonti in any other way [see How Supplied/Storage and Handling ( 16 )] .

Instructions for Administration of Prefilled Syringe with Needle Safety Guard • The prefilled syringe has a safety guard that activates to cover the needle after the injection is finished. The safety guard helps to prevent needle stick injuries to anyone who handles the prefilled syringe after injection. • Do not touch the safety guard wings before use. Touching them may cause the safety guard to activate too early.

Step 1: Remove Needle Cap Step 2: Administer Subcutaneous Injection Choose an injection site The recommended injection sites for Jubbonti include: upper arm, upper thigh, or the abdomen. Do not press the plunger while inserting the needle. Start injection Pinch the skin and insert the needle.

Slowly press the plunger as far as it will go. This will ensure that a full dose is injected. Complete injection Confirm that the plunger head is between the safety guard wings as shown.

This will ensure that the safety…

3 DOSAGE FORMS AND STRENGTHS • Injection: 60 mg/mL clear to slightly opalescent and colorless to slightly yellowish to slightly brownish 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 Jubbonti [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 Jubbonti 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 Jubbonti, 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 Jubbonti and to inform their dentist prior to dental procedures that they are receiving Jubbonti. 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 Jubbonti 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 Jubbonti.

Advise the patient to contact their physician immediately if pregnancy does occur during these times. Advise patients not to take Jubbonti 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 Jubbonti is missed, the injection should be administered as soon as convenient. Thereafter, schedule injections every 6 months from the date of the last injection.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 10/2025 Medication Guide JUBBONTI ® (Jue bon' tee) (denosumab-bbdz) Injection, for subcutaneous use What is the most important information I should know about Jubbonti?

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

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

Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Jubbonti. 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), Jubbonti 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 Jubbonti 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: o spasms, twitches, or cramps in your muscles o 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: o low blood pressure (hypotension) o trouble breathing o throat tightness o swelling of your face, lips, or tongue o rash o itching o hives • Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take Jubbonti. Your doctor should examine your mouth before you start Jubbonti.

Your doctor may tell you to see your dentist before you start Jubbonti. It is important for you to practice good mouth care during treatment with Jubbonti. 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 Jubbonti. Talk with your doctor before starting Jubbonti treatment.

After your treatment with Jubbonti 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 Jubbonti without first talking with your doctor.

If your Jubbonti 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 Jubbonti. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Jubbonti.

You may need to go to the hospital for treatment if you develop an infection. Jubbonti 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 doct…