Denosumab-mobz
Generic Name: denosumab-mobz
Brand Names:
Boncresa
11 DESCRIPTION Denosumab-mobz is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-mobz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Boncresa(denosumab-mobz) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use.
Overview
11 DESCRIPTION Denosumab-mobz is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-mobz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Boncresa(denosumab-mobz) injection is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous use.
Uses
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...
Dosage
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.
Side Effects
6 ADVERSE REACTIONS 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,...
Warnings
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) ] . 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. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium. (5.1) Osteonecrosis of the jaw: Has been reported with denosumab products. Monitor for symptoms. 4 CONTRAINDICATIONS Boncresa is contraindicated in: Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Boncresa [see Warnings and Precautions (5.1) ] . Pregnant women: Denosumab products may cause fetal harm when administered to a pregnant woman.
Pregnancy
8.1 Pregnancy Risk Summary Boncresa is contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data with denosumab products use in pregnant women to inform any drug-associated risks for adverse developmental outcomes.
Storage
16 HOW SUPPLIED How Supplied Boncresa(denosumab-mobz) injection is a clear, colorless to pale yellow solution supplied in a single-dose prefilled syringe with needle safety guard. The prefilled syringe is not made with natural rubber latex.
Frequently Asked Questions
What is Denosumab-mobz used for?▼
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...
What are the side effects of Denosumab-mobz?▼
6 ADVERSE REACTIONS 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,...
Can I take Denosumab-mobz during pregnancy?▼
8.1 Pregnancy Risk Summary Boncresa is contraindicated for use in pregnant women because it may cause harm to a fetus. There are insufficient data with denosumab products use in pregnant women to inform any drug-associated risks for adverse developmental outcomes.
What are the important warnings for Denosumab-mobz?▼
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) ] . 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. May worsen, especially in patients with renal impairment. Adequately supplement all patients with calcium and vitamin D. Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. Evaluate for presence of chronic kidney disease mineral-bone disorder. Monitor serum calcium. (5.1) Osteonecrosis of the jaw: Has been reported with denosumab products. Monitor for symptoms. 4 CONTRAINDICATIONS Boncresa is contraindicated in: Patients with hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Boncresa [see Warnings and Precautions (5.1) ] . Pregnant women: Denosumab products may cause fetal harm when administered to a pregnant woman.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.