Zvogra®▼ 120mg solution for injection Prescribing Information
Please refer to the Summary of Product Characteristics (SmPC) before prescribing Zvogra.
Presentation: Each vial contains 120 mg of denosumab in 1.7ml of solution
Indication(s): Prevention of skeletal related events in adults with advanced malignancies involving bone. Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Dosage and administration: Subcutaneous use. Administer under supervision of an HCP. Supplement with at least 500 mg calcium and 400 IU vitamin D daily unless hypercalcaemia present. Prevention of skeletal related events in adults with advanced malignancies involving bone: 120 mg administered in a single subcutaneous injection once every 4 weeks to thigh, abdomen or upper arm. Giant cell tumour of bone: 120 mg administered as a single subcutaneous injection once every 4 weeks into the thigh, abdomen or upper arm with additional 120 mg doses on days 8 and 15 of treatment of the first month of therapy. Not suitable for children <18, other than skeletally mature adolescents (aged 12-17 years) with giant cell tumour of bone.
Contraindications: Hypersensitivity to the active substance or any of the excipients. Severe, untreated hypocalcaemia, unhealed lesions from dental or oral surgery.
Warnings and precautions: Supplementation with calcium and vitamin D is required in all patients unless hypercalcaemia is present. Correct pre-existing hypocalcaemia before initiating therapy. Monitor calcium levels prior to initial dose, within 2 weeks after initial dose, if suspected symptoms of hypocalcaemia occur, in patients at additional risk of hypocalcaemia and in patients with renal impairment due to risk of developing hypocalcaemia and accompanying elevation in parathyroid hormone. Patients with severe renal impairment (creatinine clearance < 30 mL/min) or receiving dialysis are at greater risk of developing hypocalcaemia, regular monitoring of calcium levels is especially important in these patients. Osteonecrosis of the jaw (ONJ) has been reported in patients taking denosumab, delay treatment start 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. Good oral hygiene should be maintained. Advise patients to immediately report any oral symptoms. Consider temporary interruption of Zvogra treatment until ONJ resolves and risk factors mitigated. Consider possibility of osteonecrosis of the external auditory canal in patients on steroids and chemotherapy and/or local risk factors such as infection. Discontinue in patients suspected to have atypical femur fractures pending benefit-risk assessment. Atypical femoral fractures have been reported. Advise patients to report any new or unusual thigh, hip or groin pain, evaluate patients with symptoms for an incomplete femoral fracture. In patients with giant cell tumour of bone and growing skeletons, significant hypercalcaemia requiring hospitalisation and complicated with renal injury has been reported. Monitor patients after discontinuation of treatment for symptoms of hypercalcaemia. Consider periodic assessment of serum calcium and re-evaluate calcium and vitamin D supplementation requirements. Zvogra is not recommended in patients with growing skeletons. Concomitant treatment with other denosumab medicines, and bisphosphonates should be avoided. Monitor patients for radiological signs of malignancy, new radiolucency or osteolysis. For full list of warnings see SmPC.
Fertility, pregnancy and breastfeeding: Not for use in pregnant women and women of child-bearing potential not using contraception. Women should be advised not to become pregnant during or for 5 months after treatment. Breast-feeding: 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 common side effects: Osteonecrosis of the jaw. Other serious side effects: Anaphylactic reaction, atypical femoral fracture, osteonecrosis of the external auditory canal, cellulitis. Other very common side effects: Hypocalcaemia, dyspnoea, diarrhoea, musculoskeletal pain. Other common side effects: New primary malignancy, hypophosphataemia, tooth extraction, hyperhidrosis. For full list of side effects, consult SmPC.
Legal Category: POM
Pack size and price: 1 x vial – £278.87
MA number(s): PL 06831/0451
MA Holder: Genus Pharmaceuticals Ltd. (trading as STADA), Linthwaite, Huddersfield, HD7 5QH, UK
Date of Preparation: October 2025
Unique ID number: UK-Zvo-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-Zvo-1a | November 2025