EVFRAXY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60MG/ML [SIN17564P]

Product Info

EVFRAXY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60MG/ML

[SIN17564P]

Indication

4.1 Therapeutic indications
Treatment of postmenopausal women with osteoporosis at high risk for fracture. Evfraxy is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other osteoporosis therapy. In postmenopausal women with osteoporosis, Evfraxy reduces the incidence of vertebral, nonvertebral, and hip fractures.
Treatment of men with osteoporosis at high risk of fracture
Evfraxy is indicated for the treatment of men with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other osteoporosis therapy.
Treatment of bone loss in men receiving androgen deprivation therapy for prostate cancer
Evfraxy 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 Evfraxy also reduced the incidence of vertebral fractures.
Treatment of bone loss in women receiving adjuvant aromatase inhibitor therapy for breast cancer
Evfraxy is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer.
Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

Dosing

4.2 Dosage and Administration

Administration
Administration should be performed by an individual who has been adequately trained in injection techniques.

Dosage
The recommended dose of Evfraxy is 60 mg administered as a single subcutaneous injection once every 6 months.
All patients should receive calcium 1,000 mg daily and at least 400 international units vitamin D daily whilst undergoing treatment.
If a dose of Evfraxy 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.

Populations
Paediatric population
Evfraxy is not indicated for use in paediatric patients. In clinical trials, hypercalcemia has been reported very commonly in paediatric patients with osteogenesis imperfecta treated with denosumab. Some cases required hospitalisation and were complicated by acute renal injury (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). In animal studies, inhibition of RANK/RANK ligand (RANKL) with a construct of osteoprotegerin bound to Fc (OPG-Fc) has been coupled to inhibition of bone growth and lack of tooth eruption (see Pre-Clinical Safety Data – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, treatment with denosumab may impair bone growth in children with open growth plates and may inhibit eruption of dentition. Currently available data for children aged 2 to 17 years are described in sections Pharmacodynamics and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Elderly
Based on the available safety and efficacy data in the elderly, no dosage adjustment is required (see Pharmacokinetics: Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment
Based on the available safety and efficacy data in the elderly, no dosage adjustment is required in patients with renal impairment (see Pharmacokinetics: Special Patient Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
No data is available in patients with long-term systemic glucocorticoid therapy and severe renal impairment (Glomerular filtration rate, GFR < 30 mL/min). Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia. Severe and fatal cases have been reported. Adequate intake of calcium and vitamin D is important in patients with severe renal impairment or receiving dialysis.

Hepatic Impairment
The safety and efficacy of Evfraxy have not been studied in patients with hepatic impairment.

Contraindications

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Hypocalcaemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).