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Bildyos is a brand name for Denosumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of…
Verbatim from this product's EMA label. Tap a section to expand.
Posology 3 The recommended dose is 60 mg denosumab administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm. 4). Patients treated with Bildyos should be given the package leaflet and the patient reminder card.
The optimal total duration of antiresorptive treatment for osteoporosis (including both denosumab and bisphosphonates) has not been established. 4). Elderly (age ≥ 65) No dose adjustment is required in elderly patients. 4 for recommendations relating to monitoring of calcium).
No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (Glomerular filtration rate, GFR < 30 mL/min). 2). 3). 2. Method of administration For subcutaneous use.
The Bildyos 60 mg/mL solution in a pre-filled syringe:
The administration using the 60 mg/mL pre-filled syringe can be administered by a patient or caregiver who has been trained in injection techniques by a healthcare professional. The first self- administration with the Bildyos pre-filled syringe should be supervised by a healthcare professional.
The Bildyos 60 mg/mL solution in a single use vial:
The administration of the 60 mg/mL vial should only be performed by a healthcare professional. 6.
Summary of the safety profile The most common side effects with denosumab (seen in more than one patient in ten) are musculoskeletal pain and pain in the extremity. 8 - description of selected adverse reactions) have been observed in patients taking denosumab.
7 Tabulated list of adverse reactions The data in table 1 below describe adverse reactions reported from phase II and III clinical trials in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation; and/or spontaneous reporting.
The following convention has been used for the classification of the adverse reactions (see table 1): very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data).
Within each frequency grouping and system organ class, adverse reactions are presented in order of decreasing seriousness. Table 1 Adverse reactions reported in patients with osteoporosis and breast or prostate cancer patients receiving hormone ablation MedDRA system organ class Frequency category Adverse reactions Infections and infestations Common Urinary tract infection Common Upper respiratory tract infection Uncommon Diverticulitis1 Uncommon Cellulitis1 Uncommon Ear infection Immune system disorders Rare Drug hypersensitivity1 Rare Anaphylactic reaction1 Metabolism and nutrition disorders Rare Hypocalcaemia1 Nervous system disorders Common Sciatica Gastrointestinal disorders Common Constipation Common Abdominal discomfort Skin and subcutaneous tissue disorders Common Rash Common Eczema Common Alopecia Uncommon Lichenoid drug eruptions1 Very rare Hypersensitivity vasculitis Musculoskeletal and connective tissue disorders Very common Pain in extremity Very common Musculoskeletal pain1 Rare Osteonecrosis of the jaw1 Rare Atypical femoral fractures1 Not known Osteonecrosis of the external auditory canal2 1 See section Description of selected adverse reactions.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 4 Calcium and vitamin D supplementation Adequate intake of calcium and vitamin D is important in all patients.
Precautions for use Hypocalcaemia It is important to identify patients at risk for hypocalcaemia. Hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. Clinical monitoring of calcium levels is recommended before each dose and, in patients predisposed to hypocalcaemia within two weeks, after the initial dose.
8 for symptoms) calcium levels should be measured. Patients should be encouraged to report symptoms indicative of hypocalcaemia. In the post-marketing setting, severe symptomatic hypocalcaemia (resulting in hospitalisation, life- threatening events, and fatal cases) have been reported.
While most cases occurred in the first few weeks of initiating therapy, it has also occurred later. Concomitant glucocorticoid treatment is an additional risk factor for hypocalcaemia. Renal impairment Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia.
The risks of developing hypocalcaemia and accompanying parathyroid hormone elevations increase with increasing degree of renal impairment. Severe and fatal cases have been reported. Adequate intake of calcium, vitamin D and regular monitoring of calcium is especially important in these patients, see above.
8). Patients should be advised to seek prompt medical attention if they develop signs or symptoms of cellulitis. 8). The start of treatment/new treatment course should be delayed in patients with unhealed open soft tissue lesions in the mouth.
A dental examination with preventive dentistry and an individual benefit- risk assessment is recommended prior to treatment with denosumab in patients with concomitant risk factors. The following risk factors should be considered when evaluating a patient’s risk of developing ONJ: • potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
1. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Denosumab in European Union.
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4. 7% for placebo. Although this imbalance was identified via a pooled analysis, it was not identified via a stratified analysis. 88 mmol/L) following denosumab administration. 88 mmol/L) were not reported in either the two phase III placebo-controlled clinical trials in patients receiving hormone ablation or the phase III placebo-controlled clinical trial in men with osteoporosis.
8 In the post-marketing setting, rare cases of severe symptomatic hypocalcaemia resulting in hospitalisation, life-threatening events, and fatal cases have been reported, predominantly in patients at increased risk of hypocalcaemia receiving denosumab, with most cases occurring in the first weeks of initiating therapy.
4). Symptoms of hypocalcaemia in denosumab clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps. 4%, 12 out of 860]). 4% (16 out of 4 050) of women receiving denosumab. These cases were predominantly cellulitis.
6%, 5 out of 860) groups in the breast and prostate cancer studies. 4). Thirteen of these ONJ cases occurred in postmenopausal women with osteoporosis during the phase III clinical trial extension following treatment with denosumab for up to 10 years.
44% at 10 years of denosumab treatment. The risk of ONJ increased with duration of exposure to denosumab. The risk of ONJ has also been assessed in a retrospective cohort study among 76 192 postmenopausal women newly initiating treatment with denosumab.
65) among patients using denosumab up to 5 years of follow-up. 4). 2% denosumab, 0% placebo). The incidence of […]
g. anaemia, coagulopathies, infection), smoking. • concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck. g. tooth extractions). All patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or discharge during treatment with denosumab.
While on treatment, invasive dental procedures should be performed only after careful consideration and be avoided in close proximity to denosumab administration. 5 The management plan of the patients who develop ONJ should be set up in close collaboration between the treating physician and a dentist or oral surgeon with expertise in ONJ.
Temporary interruption of treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible. Osteonecrosis of the external auditory canal Osteonecrosis of the external auditory canal has been reported with denosumab.
Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving denosumab who present with ear symptoms including chronic ear infections.
8). Atypical femoral fractures may occur with little or no trauma in the subtrochanteric and diaphyseal regions of the femur. Specific radiographic findings characterise these events. g. g. bisphosphonates, glucocorticoids, proton pump inhibitors).
These events have also occurred without antiresorptive therapy. Similar fractures reported in association with bisphosphonates are often bilateral; therefore, the contralateral femur should be examined in denosumab-treated patients who have sustained a femoral shaft fracture.
Discontinuation of denosumab therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient based on an individual benefit-risk assessment. During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.
Patients presenting with such symptoms should be evaluated for an incomplete femoral fracture. 2). 1), leading to an increased risk for fractures. Thus, […]