General MedicationsSUBCUTANEOUSBlack Box

Boncresa

DENOSUMAB-MOBZ

Standard Dose

2 DOSAGE AND ADMINISTRATION Pregnancy must be ruled out prior to administration of Boncresa. (2.1) Before initiating Boncresa 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) Boncresa 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 Boncresa Pregnancy must be ruled out prior to administration of Boncresa. Perform pregnancy testing in all females of reproductive potential prior to administration of Boncresa. 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 Boncresa 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 Boncresa 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 Boncresa should be administered by a healthcare provider. The recommended dose of Boncresa is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Boncresa 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 Boncresa 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. Boncresais a clear, colorless to pale 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, Boncresamay 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 Boncresain any other way [see How Supplied/Storage and Handling (16) ] . Instructions for Administration of Boncresa Prefilled Syringe with Needle Safety Guard IMPORTANT: In order to minimize accidental needlesticks, the Boncresasingle-dose prefilled syringe has a transparent safety guard, which is automatically activated after the injection. DO NOT attempt to activate the transparent safety guard before injection. Step 1: Remove Gray Needle Cap Step 2: Administer Subcutaneous Injection Choose an injection site. The recommended injection sites for Boncresa include: the upper arm OR the upper thigh OR the abdomen. Insert needle and inject all the liquid subcutaneously into pinched skin. Do not administer into muscle or blood vessels. Slowly push the plunger all the way down until all the liquid is injected and the transparent safety guard is automatically activated. Step 3: Release Plunger and Remove the Syringe From Skin Release your thumb upwards from the plunger. This will allow the needle to move automatically up into the transparent safety guard. Then lift the syringe from the skin. Immediately dispose of the syringe and gray needle cap in the nearest sharps container. Do not put the needle cap back on the used syringe. first figure step 1 step 2a step 2b step 3a step 3b

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Boncresa 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) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Boncresa 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.

Summary

In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures [see Clinical Studies (14.1) ] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Boncresa 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) ] . 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Boncresa 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.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Boncresa 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) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Boncresa 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) ] . 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Boncresa 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) ] . 1.3 Treatment of Glucocorticoid-Induced Osteoporosis Boncresa 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) ] . 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Boncresa 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) ] . 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Boncresa 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) ] . Dosage and administration 2 DOSAGE AND ADMINISTRATION Pregnancy must be ruled out prior to administration of Boncresa. (2.1) Before initiating Boncresa 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) Boncresa 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 Boncresa Pregnancy must be ruled out prior to administration of Boncresa. Perform pregnancy testing in all females of reproductive potential prior to administration of Boncresa. 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 Boncresa 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 Boncresa 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 Boncresa should be administered by a healthcare provider. The recommended dose of Boncresa is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Boncresa 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 Boncresa is missed, administer the inj

Boxed Warning

WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m 2 ), 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 [see Warnings and Precautions (5.1) ] . The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients [see Warnings and Precautions (5.1) ] . Prior to initiating Boncresa in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Boncresa in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE See full prescribing information for complete boxed warning. Patients with advanced chronic kidney disease 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. (5.1) The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. (5.1) Prior to initiating Boncresa in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Boncresa in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. (2.2) , (5.1)

Monitoring

• 5 WARNINGS AND PRECAUTIONS Same Active Ingredient: Patients receiving Boncresa should not receive other denosumab products concomitantly.
• (5.2) Hypersensitivity including anaphylactic reactions may occur.
• Discontinue permanently if a clinically significant reaction occurs.
• (5.3) Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Boncresa.

Interaction Notes

• Review official label interaction section.