1.7 ml pre-filled syringe:
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Indications
Denosis is a RANK ligand (RANKL) inhibitor indicated for:
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture: Denosis 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, Denosis reduces the incidence of vertebral, nonvertebral, and hip fractures.
Treatment to Increase Bone Mass in Men with Osteoporosis: Denosis 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.
Treatment of Glucocorticoid-Induced Osteoporosis: Denosis 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.
Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: Denosis is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Denosis also reduced the incidence of vertebral fractures.
Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer: Denosis is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Treatment of Multiple Myeloma and Bone Metastasis from Solid Tumors: Denosis is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Treatment of Giant Cell Tumor of Bone: Denosis is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Treatment of Hypercalcemia of Malignancy: Denosis is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture: Denosis 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, Denosis reduces the incidence of vertebral, nonvertebral, and hip fractures.
Treatment to Increase Bone Mass in Men with Osteoporosis: Denosis 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.
Treatment of Glucocorticoid-Induced Osteoporosis: Denosis 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.
Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: Denosis is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Denosis also reduced the incidence of vertebral fractures.
Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer: Denosis is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Treatment of Multiple Myeloma and Bone Metastasis from Solid Tumors: Denosis is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Treatment of Giant Cell Tumor of Bone: Denosis is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Treatment of Hypercalcemia of Malignancy: Denosis is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Pharmacology
Denosumab is a human lgG2 monoclonal antibody with affinity and specificity for human RANKL.Denosumab binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Denosumab prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone.
Dosage & Administration
Denosumab should be administered by a healthcare professional. Denosumab is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.
Treatment of Osteoporosis and Bone Loss: Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. If a dose of Denosumab 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.
Multiple Myeloma and Bone Metastasis from Solid Tumors: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen
Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.
Hypercalcemia of Malignancy: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.
Treatment of Osteoporosis and Bone Loss: Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily. If a dose of Denosumab 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.
Multiple Myeloma and Bone Metastasis from Solid Tumors: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen
Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen. Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia.
Hypercalcemia of Malignancy: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen.
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Interaction
In subjects with postmenopausal osteoporosis, Denosis (60 mg subcutaneous injection) did not affect the pharmacokinetics of midazolam, which is metabolized by cytochrome P450 3A4 (CYP3A4), indicating that it should not affect the pharmacokinetics of drugs metabolized by this enzyme in this population
Contraindications
Hypocalcemia: Pre-existing hypocalcemia must be corrected prior to initiating therapy with Denosumab.
Pregnancy: Denosumab may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Denosumab.
Hypersensitivity: Denosumab is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reaction includes anaphylaxis, facial swelling and urticaria.
Pregnancy: Denosumab may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with Denosumab.
Hypersensitivity: Denosumab is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reaction includes anaphylaxis, facial swelling and urticaria.
Side Effects
Postmenopausal osteoporosis- Most common adverse reactions (>5%) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials.
Male osteoporosis- Most common adverse reactions (>5%) were: back pain, arthralgia, and nasopharyngitis.
Glucocorticoid-induced osteoporosis- Most common adverse reactions (>3%) were: back pain, hypertension, bronchitis, and headache.
Bone loss due to hormone ablation for cancer- Most common adverse reactions (>10%) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
Bone metastasis from solid tumors- Most common adverse reactions (>25%) were fatigue/asthenia, hypophosphatemia, and nausea.
Multiple myeloma- Most common adverse reactions (>10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
Giant cell tumor of bone- Most common adverse reactions (>10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
Hypercalcemia of malignancy- Most common adverse reactions (>20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.
Male osteoporosis- Most common adverse reactions (>5%) were: back pain, arthralgia, and nasopharyngitis.
Glucocorticoid-induced osteoporosis- Most common adverse reactions (>3%) were: back pain, hypertension, bronchitis, and headache.
Bone loss due to hormone ablation for cancer- Most common adverse reactions (>10%) were: arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
Bone metastasis from solid tumors- Most common adverse reactions (>25%) were fatigue/asthenia, hypophosphatemia, and nausea.
Multiple myeloma- Most common adverse reactions (>10%) were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.
Giant cell tumor of bone- Most common adverse reactions (>10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity.
Hypercalcemia of malignancy- Most common adverse reactions (>20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.
Pregnancy & Lactation
Pregnant women and females of reproductive potential: Denosumab may cause fetal harm when administered to pregnant women. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of Denosumab.
Lactation: Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Denosumab treatment and any potential adverse effects on the breastfed child from Denosumab or from the underlying maternal condition.
Lactation: Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Denosumab treatment and any potential adverse effects on the breastfed child from Denosumab or from the underlying maternal condition.
Precautions & Warnings
Hypersensitivity: Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs.
Hypocalcemia: Denosis can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct hypocalcemia prior to initiating Denosis. May worsen, especially in patients with renal impairment. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the jaw: Has been reported with Denosis. Perform an oral examination prior to starting Denosis. Monitor for symptoms. Avoid invasive dental procedures during treatment with Denosis.
Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
Multiple Vertebral Fractures (MVF) following treatment discontinuation: When Denosis treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures. Patients should be transitioned to another antiresorptive agent if Denosis is discontinued.
Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Denosis if severe symptoms develop.
Severe pain: Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.
Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression.
Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate.
Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.
Hypocalcemia: Denosis can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct hypocalcemia prior to initiating Denosis. May worsen, especially in patients with renal impairment. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D.
Osteonecrosis of the jaw: Has been reported with Denosis. Perform an oral examination prior to starting Denosis. Monitor for symptoms. Avoid invasive dental procedures during treatment with Denosis.
Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture.
Multiple Vertebral Fractures (MVF) following treatment discontinuation: When Denosis treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures. Patients should be transitioned to another antiresorptive agent if Denosis is discontinued.
Serious infections including skin infections: May occur, including those leading to hospitalization. Advise patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis.
Dermatologic reactions: Dermatitis, rashes, and eczema have been reported. Consider discontinuing Denosis if severe symptoms develop.
Severe pain: Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop.
Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression.
Hypercalcemia following treatment discontinuation in patients with giant cell tumor of bone and in patients with growing skeletons: Monitor patients for signs and symptoms of hypercalcemia, and manage as clinically appropriate.
Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception.
Use in Special Populations
Pediatric patients: Denosis is not approved for use in pediatric patients. Recommended only for treatment of skeletally mature adolescents with giant cell tumor of bone.
Geriatric patients: No overall differences in safety or efficacy were observed between these patients and younger patients.
Renal impairment: No dose adjustment is necessary in patients with renal impairment. Patients with creatinine clearance <30 mL/min or receiving dialysis are at risk for hypocalcemia. Supplement with calcium and vitamin D, and consider monitoring serum calcium.
Hepatic Impairment: No clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of Denosis.
Geriatric patients: No overall differences in safety or efficacy were observed between these patients and younger patients.
Renal impairment: No dose adjustment is necessary in patients with renal impairment. Patients with creatinine clearance <30 mL/min or receiving dialysis are at risk for hypocalcemia. Supplement with calcium and vitamin D, and consider monitoring serum calcium.
Hepatic Impairment: No clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of Denosis.
Therapeutic Class
Inhibiting bone resorption
Storage Conditions
Store Denosis in a refrigerator at 2°C to 8°C in the original carton. Do not freeze. Once removed from the refrigerator, Denosis must not be exposed to temperatures above 25°C or direct light and must be used within 14 days. Discard Denosis if not used within the 14 days. Protect Denosis from direct light and heat. Avoid vigorous shaking of Denosis.
Pack Image: Denosis 120 mg Injection