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Stoboclo is a brand name for Denosumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Stoboclo 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…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Pregnancy must be ruled out prior to administration of Stoboclo. 1 ) Before initiating Stoboclo 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.
6 ) Stoboclo should be administered by a healthcare provider. 3 ) Administer 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. 3 ) Instruct patients to take calcium 1000 mg daily and at least 400 IU vitamin D daily.
1 Pregnancy Testing Prior to Initiation of Stoboclo Pregnancy must be ruled out prior to administration of Stoboclo. Perform pregnancy testing in all females of reproductive potential prior to administration of Stoboclo. 3 )] . 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 Stoboclo treatment.
1) ] . 3 Recommended Dosage Stoboclo should be administered by a healthcare provider. The recommended dose of Stoboclo is 60 mg administered as a single subcutaneous injection once every 6 months. Administer Stoboclo via subcutaneous injection in the upper arm, the upper thigh, or the abdomen.
1) ] . If a dose of Stoboclo 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. 4 Preparation and Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Stoboclo is a clear, colorless to pale yellow solution. Do not use if the solution is discolored or cloudy or if the solution contains particles or foreign particulate matter. Prior to administration, Stoboclo may be removed from the refrigerator and brought to room temperature up to 25°C (77°F) by standing in the original carton.
This generally takes 15 to 30 minutes. Do not warm Stoboclo in any other way [see How Supplied/Storage and Handling (16) ] .
Instructions for Administration of Prefilled Syringe with Safety Guard IMPORTANT:
8) ] The most common adverse reactions reported with denosumab products in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. The most common adverse reactions reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis.
The most common adverse reactions reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache. The most common (per patient incidence ≥ 10%) adverse reactions reported with denosumab products in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain.
Pain in extremity and musculoskeletal pain have also been reported in clinical trials. The most common adverse reactions leading to discontinuation of denosumab products in patients with postmenopausal osteoporosis are back pain and constipation.
Postmenopausal osteoporosis:
Most common adverse reactions (> 5% and more common than placebo) were: back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. 1 ) Male osteoporosis: Most common adverse reactions (> 5% and more common than placebo) were: back pain, arthralgia, and nasopharyngitis.
1 ) Glucocorticoid-induced osteoporosis: Most common adverse reactions (> 3% and more common than active-control group) were: back pain, hypertension, bronchitis, and headache. 1 ) Bone loss due to hormone ablation for cancer: Most common adverse reactions (≥ 10% and more common than placebo) were: arthralgia and back pain.
Pain in extremity and musculoskeletal pain have also been reported in clinical trials. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
5 WARNINGS AND PRECAUTIONS Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating Stoboclo. 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. 1 ) Same Active Ingredient: Patients receiving Stoboclo should not receive other denosumab products concomitantly.
2 ) Hypersensitivity including anaphylactic reactions may occur. Discontinue permanently if a clinically significant reaction occurs. 3 ) Osteonecrosis of the jaw: Has been reported with denosumab products. Monitor for symptoms. 4 ) Atypical femoral fractures: Have been reported.
Evaluate patients with thigh or groin pain to rule out a femoral fracture. 5 ) Multiple vertebral fractures have been reported following treatment discontinuation. Patients should be transitioned to another antiresorptive agent if Stoboclo is discontinued.
6 ) 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. 7 ) Dermatologic reactions: Dermatitis, rashes, and eczema have been reported.
Consider discontinuing Stoboclo if severe symptoms develop. 8 ) Severe bone, joint, muscle pain may occur. Discontinue use if severe symptoms develop. 9 ) Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone over-suppression.
1 Severe Hypocalcemia and Mineral Metabolism Changes Denosumab products can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Stoboclo. 1) ] . g.
1) ] .
Pregnant women:
Denosumab products may cause fetal harm when administered to a pregnant woman. 1) ] .
Patients with hypersensitivity to denosumab products:
Stoboclo is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. 2) ] . 3 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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To reduce the risk of accidental needle stick injury, each prefilled syringe has a safety guard that is automatically activated to cover the needle after you have given the injection. Do not pull back on the plunger rod at any time.
Step 1:
Remove the Needle Cap Dispose of the needle cap right away in the nearest sharps disposal container. DO NOT re-cap the prefilled syringe.
Image Image Step 2:
Administer Subcutaneous Injection Choose an appropriate injection site. The recommended injection sites for Stoboclo include: the outer area of the upper arms OR the upper legs (thighs) OR around the stomach area (abdomen). Inject all of the liquid by using your thumb to push the plunger rod all the way down.
If the plunger rod is not fully pressed, the safety guard will not extend to cover the needle when it is removed.
Image Image Step 3:
Remove the prefilled syringe from the injection site After the prefilled syringe is empty, slowly remove the needle by lifting your thumb from the plunger rod until the needle is completely covered by the safety guard. Do not rub the injection site.
Immediately dispose of the prefilled syringe in the nearest sharps disposal container. Image
Treatment of Postmenopausal Women with Osteoporosis The safety of denosumab in the treatment of postmenopausal osteoporosis was assessed in a 3-year, randomized, double-blind, placebo-controlled, multinational study of 7808 postmenopausal women aged 60 to 91 years.
A total of 3876 women were exposed to placebo and 3886 women were exposed to denosumab administered subcutaneously once every 6 months as a single 60 mg dose. All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day.
8% (n = 70) in the denosumab group. 0% in the denosumab group. 4% for the placebo and denosumab groups, respectively. The most common adverse reactions reported with denosumab in patients with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.
Adverse reactions reported in ≥ 2% of postmenopausal women with osteoporosis and more frequently in the denosumab-treated women than in the placebo-treated women are shown in the table below. Table 1. 7% women in the denosumab group.
The nadir in serum calcium level occurred at approximately day 10 after denosumab dosing in subjects with normal renal function. In clinical studies, subjects with impaired renal function were more likely to have greater reductions in serum calcium levels compared to subjects with normal renal function.
5 mg/dL or symptomatic hypocalcemia were observed in 5 subjects. These included no subjects in the normal renal function group, 10% of subjects in the creatinine clearance 50 to 80 mL/min group, 29% of subjects in the creatinine clearance < 30 mL/min group, and 29% of subjects in the hemodialysis group.
These subjects did not receive calcium and vitamin D supplementation. 5% in subjects with creatinine clearance < 30 mL/min vs. 1% in subjects with creatinine clearance ≥ 30 mL/min. Serious Infections Receptor activator of nuclear factor kappa-B ligand (RANKL) is expressed on activated T and B lymphocytes and in lymph nodes.
Therefore, a RANKL inhibitor such as denosumab products may increase the risk of infection. 2% in both placebo and denosumab treatment groups. 0% in the denosumab groups. 7% placebo vs. 5% placebo vs. 0% placebo vs. 1% denosumab) were reported.
Endocarditis was reported in no placebo patients and 3 patients receiving denosumab. 1% placebo vs. 4% denosumab). The incidence of opportunistic infections was similar to that reported with placebo. 0001). 8) ] . 4) ] . Atypical Subtrochanteric and Diaphyseal Femoral Fractures In the osteoporosis clinical trial program, atypical femoral fractures were reported in patients treated with denosumab.
5) ] . Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation In the osteoporosis clinical trial program, multiple vertebral fractures were reported in patients after discontinuation of denosumab. In the phase 3 trial in women with postmenopausal osteoporosis, 6% of women who discontinued denosumab and remained in the study developed new vertebral fractures, and 3% of women who discontinued denosumab and remained in the study developed multiple new vertebral fractures.
The mean time to onset of multiple vertebral fractures was 17 months (range: 7-43 months) after the last injection of denosumab. 6) ] . 2%) in the denosumab groups. Of these reports, 1 patient in the placebo group and all 8 patients in the denosumab group had serious events, including one death in the denosumab group.
Several patients had a prior history of pancreatitis. The time from product administration to event occurrence was variable. 8% in the denosumab groups. 7% placebo vs. 2% placebo vs. 6% placebo vs. 9% denosumab) were reported. A causal relationship to drug exposure has not been established.
Treatment to Increase Bone Mass in Men with Osteoporosis The safety of denosumab in the treatment of men with osteoporosis was assessed in a 1-year randomized, double-blind, placebo-controlled study. A total of 120 men were exposed to placebo and 120 men were exposed to denosumab administered subcutaneously once every 6 months as a single 60 mg dose.
All men were instructed to take at least 1000 mg of calcium and 800 IU of vitamin D supplementation per day. 8% (n = 1) in the denosumab group. 3% in the denosumab group. 5% for the placebo and denosumab groups, respectively. 7% placebo vs.
8% placebo vs. 8% placebo vs. 7% denosumab). 8%) in the placebo group and no patients in the denosumab group. 2%) in the denosumab group. Osteonecrosis of the Jaw No cases of ONJ were reported. 8%) in the denosumab group. 3%) patients (3 prostate cancers, 1 basal cell carcinoma) in the denosumab group.
5 mg/day oral prednisone (or equivalent). A total of 384 patients were exposed to 5 mg oral daily bisphosphonate (active-control) and 394 patients were exposed to denosumab administered once every 6 months as a 60 mg subcutaneous dose.
All patients were instructed to take at least 1000 mg of calcium and 800 IU of vitamin D supplementation per day. 5% (n = 6) in the denosumab group. The incidence of serious adverse events was 17% in the active-control group and 16% in the denosumab group.
8% for the active-control and denosumab groups, respectively. Adverse reactions reported in ≥ 2% of patients with glucocorticoid-induced osteoporosis and more frequently with denosumab than in the active-control-treated patients are shown in the table below.
Table 2. 8) Polymyalgia rheumatica Events of worsening of underlying polymyalgia rheumatica. 3) Osteonecrosis of the Jaw No cases of ONJ were reported. Atypical Subtrochanteric and Diaphyseal Femoral Fractures Atypical femoral fractures were reported in 1 patient treated with denosumab.
5) ] . 3%) in the denosumab group. 8%) in the denosumab group. Treatment of Bone Loss in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer or Adjuvant Aromatase Inhibitor Therapy for Breast Cancer The safety of denosumab in the treatment of bone loss in men with nonmetastatic prostate cancer receiving androgen deprivation therapy (ADT) was assessed in a 3-year, randomized, double-blind, placebo-controlled, multinational study of 1468 men aged 48 to 97 years.
A total of 725 men were exposed to placebo and 731 men were exposed to denosumab administered once every 6 months as a single 60 mg subcutaneous dose. All men were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day.
6% in the denosumab group. 0% for the placebo and denosumab groups, respectively. The safety of denosumab in the treatment of bone loss in women with nonmetastatic breast cancer receiving aromatase inhibitor (AI) therapy was assessed in a 2-year, randomized, double-blind, placebo-controlled, multinational study of 252 postmenopausal women aged 35 to 84 years.
A total of 120 women were exposed to placebo and 129 women were exposed to denosumab administered once every 6 months as a single 60 mg subcutaneous dose. All women were instructed to take at least 1000 mg of calcium and 400 IU of vitamin D supplementation per day.
7% in the denosumab group. 8% for the placebo and denosumab groups, respectively. 0% placebo vs. 5% placebo vs. 5% denosumab). 7% placebo vs. 8% placebo vs. 0% denosumab) have also been reported in clinical trials. 2% placebo vs. 7% denosumab).
4% vs. 0%) at the month 1 visit. 2 Postmarketing Experience Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
g. ANCA positive vasculitis, leukocytoclastic vasculitis) Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome
history of hypoparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, excision of small intestine, treatment with other calcium-lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after Stoboclo injection.
In some postmarketing cases, hypocalcemia persisted for weeks or months and required frequent monitoring and intravenous and/or oral calcium replacement, with or without vitamin D. 73 m 2 ] including dialysis-dependent patients are at greater risk for severe hypocalcemia following denosumab products administration.
Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. The presence of underlying chronic kidney disease-mineral bone disorder (CKD-MBD, renal osteodystrophy) markedly increases the risk of hypocalcemia.
Concomitant use of calcimimetic drugs may also worsen hypocalcemia risk. To minimize the risk of hypocalcemia in patients with advanced chronic kidney disease, evaluate for the presence of chronic kidney disease mineral and bone disorder with intact parathyroid hormone (iPTH), serum calcium, 25(OH) vitamin D, and 1,25(OH) 2 vitamin D prior to decisions regarding Stoboclo 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. Monitor serum calcium weekly for the first month after Stoboclo administration and monthly thereafter.
Instruct all 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.
Treatment with Stoboclo in these patients should be supervised by a healthcare provider who is experienced in diagnosis and management of CKD-MBD. 2 Drug Products with Same Active Ingredient Patients receiving Stoboclo should not receive other denosumab products concomitantly.
3 Hypersensitivity Clinically significant hypersensitivity including anaphylaxis has been reported with denosumab products. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria.
2) ] . 4 Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. 1) ] . A routine oral exam should be performed by the prescriber prior to initiation of Stoboclo treatment.
g. g. g. periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Good oral hygiene practices should be maintained during treatment with Stoboclo. Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ.
The risk of ONJ may increase with duration of exposure to denosumab products. For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit-risk assessment.
Patients who are suspected of having or who develop ONJ while on Stoboclo should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of Stoboclo therapy should be considered based on individual benefit-risk assessment.
1) ] . These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.
Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral, and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.
g. prednisone) at the time of fracture. During Stoboclo treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.
Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of Stoboclo therapy should be considered, pending a benefit-risk assessment, on an individual basis.
6 Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. Treatment with denosumab results in significant suppression of bone turnover and cessation of denosumab treatment results in increased bone turnover above pretreatment values 9 months after the last dose of denosumab.
Bone turnover then returns to pretreatment values 24 months after the last dose of denosumab. 1) ] . New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab discontinuation.
Evaluate an individual's benefit-risk before initiating treatment with Stoboclo. 1) ] . 1) ] . Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with denosumab.
Endocarditis was also reported more frequently in denosumab-treated patients. The incidence of opportunistic infections was similar between placebo and denosumab groups, and the overall incidence of infections was similar between the treatment groups.
Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections.
Consider the benefit-risk profile in such patients before treating with Stoboclo. In patients who develop serious infections while on Stoboclo, prescribers should assess the need for continued Stoboclo therapy. 8 Dermatologic Adverse Reactions In a large clinical trial of over 7800 women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate in the denosumab group compared to the placebo group.
1) ] . Consider discontinuing Stoboclo if severe symptoms develop. 2) ] . The time to onset of symptoms varied from one day to several months after starting denosumab products. Consider discontinuing use if severe symptoms develop [see Patient Counseling Information (17) ] .
1) ] . The significance of these findings and the effect of long-term treatment with denosumab products are unknown. The long-term consequences of the degree of suppression of bone remodeling observed with denosumab may contribute to adverse outcomes such as osteonecrosis of the jaw, atypical fractures, and delayed fracture healing.
Monitor patients for these consequences. 11 Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta Stoboclo is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products.
4) ].