Kefdensis®▼ solution for injection in pre-filled syringe Prescribing Information
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Kefdensis.
Presentation: Each pre-filled syringe contains 60 mg of denosumab in 1 mL of solution (60 mg/mL).
Indication(s): Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, in men with prostate cancer receiving hormone ablation, in bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Dosage and administration: 60 mg denosumab as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm. Patients must be adequately supplemented with calcium and vitamin D. Not suitable for children <18. Administration should be performed by an individual who has been adequately trained in injection techniques.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Hypocalcaemia.
Warnings and precautions: 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. Renal impairment: Adequate intake of calcium, vitamin D and regular monitoring of calcium is especially important. Patients with severe renalimpairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia. Patients receiving denosumab may develop skin infections and should seek medical attention if they develop symptoms. Osteonecrosis of the jaw (ONJ) has been reported in patients taking denosumab, treatment should be delayed in patients with unhealed open soft tissue lesions in the mouth, good oral hygiene should be maintained. Advise patients to immediately report any oral symptoms. Consider temporary interruption of Kefdensis treatment until ONJ resolvesand risk factors mitigated. Consider possibility of osteonecrosis of the external auditory canal in patients on steroids and chemotherapy and/or localrisk factors such as infection. Discontinue in patients suspected to have atypical femur fractures pending benefit-risk assessment. Atypical femoral fractures have been reported. Long-term antiresorptive treatment could increase risk of ONJ and atypical femur fractures. Advise patients to report any new or unusual thigh, hip or groin pain. Decrease in bone mineral density, leading to increased risk of fractures is expected following denosumabdiscontinuation, monitoring of BMD is recommended and alternative treatment should be considered according to clinical guidelines. Patients treated with denosumab should not be treated concomitantly with other denosumab-containing medicinal products. For full list of warnings see SmPC.
Fertility, pregnancy and breastfeeding: Not recommended for use in pregnant women and women of child-bearing potential not using contraception. Advised to not become pregnant for at least 5 months following treatment. Risk to the breastfed infant cannot be excluded, assess risks versus benefits of breastfeeding for the infant and treatment for the woman.
Undesirable effects: Serious side effects: Diverticulitis, cellulitis, anaphylactic reaction, hypersensitivity vasculitis, osteonecrosis of the jaw, osteonecrosis of the external auditory canal, atypical femoral fractures. Very common side effects: Pain in extremity, musculoskeletal pain. Common side effects: Urinary tract infection, upper respiratory tract infection, sciatica, constipation, abdominal discomfort, rash, eczema, alopecia. For full list of side effects, consult SmPC.
Legal Category: POM
Pack size and price: One pre-filled syringe – £128.10
MA number(s): PL 06831/0450
MA Holder: Genus Pharmaceuticals Ltd. (trading as STADA), Linthwaite, Huddersfield, HD7 5QH, UK
Date of Preparation: November 2025
Unique ID: UK-Kef-1
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Thornton and Ross Limited by emailing thorntonross@medinformation.co.uk or by calling 01484 848164.
UK-Kef-1a | November 2025