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Xofigo® 1100 kBq/mL solution for injection (radium223 dichloride)

Prescribing Information

(Refer to full Summary of Product Characteristics (SmPC) before prescribing)

 

Presentation: Each vial contains 6 mL of solution (6.6 MBq radium223 dichloride at the reference date). Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date. Indication(s): Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment. Posology & method of administration: Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings, and after evaluation of the patient by a qualified physician. Xofigo is for intravenous use and must be administered by slow injection (generally up to 1 minute). The intravenous access lin e or cannula must be flushed with isotonic sodium chloride 9 mg/mL (0.9%) solution for injection before and after injection of Xofigo. Adults: The dose regimen of Xofigo is an activity of 5 5 k Bq per kg body weight, given at 4 week intervals for 6 injections. Hepatic impairment: No dose adjustment is considered necessary in patients with hepatic impairment. Renal impairment: No dose adjustment is considered necessary in patients with renal impairment. Elderly patients: No dose adjustment is considered necessary in elderly patients. Children & adolescents: There is no relevant use of this medicinal product in the paediatric population for prostate cancer. Contra-indications: Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Warnings & precautions: The safety and efficacy of Xofigo in combination with cancer therapies other than LHRH analogues have not been established; an increased risk of mortality and fractures is possible. The combination of radium-223 with other systemic cancer therap ies other than LHRH analogues is not recommended. The use of Xofigo is not recommended for treatment of adults with CRPC and only asymptomatic bone metastases. In adults with CRPC and mildly symptomatic bone metastases the benefit of treatment should be carefully assessed to outweigh the risks considering that high osteoblastic activity is likely to be required for treatment benefit. In clinical studies, patients with fewer than 6 bone metastases had an increased risk of fractures and did not have a statistically significant survival benefit. A pre-specified subgroup analysis also showed that overall survival was not significantly improved in patients with a total ALP < 220 U/L. Therefore, in patients with a low level of osteoblastic bone metastases treatment with radium-223 is not recommended. Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, have been reported in patients treated with Xofigo. Haematological evaluation of patients must be performed at baseline and prior to every dose of Xofigo. In case there is no recovery in values for absolute neutrophil count (ANC), platelets and haemoglobin within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after a careful benefit/risk evaluation. Patients with evidence of compromised bone marrow should be treated with caution. Safety and efficacy of Xofigo have not been studied in patients with Crohn’s disease and ulcerative colitis. Due to faecal excretion of Xofigo, radiation may

lead to aggravation of acute inflammatory bowel disease. Therefore, Xofigo should only be administered after a careful benefit-risk assessment in patients with acute inflammatory bowel disease. In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting or resuming treatment with Xofigo. Xofigo increases the risk of bone fractures, especially in patients with medical history of osteoporosis and in patients with <6 bone metastases. Prior to starting radium-223 bone status and baseline risk of fractures of patients (e.g. osteoporosis, less than 6 bone metastases, medication increasing fracture risk, low body mass index) should be carefully assessed, and closely monitored for at least 24 months. Preventive measures should be considered before starting or resuming treatment with Xofigo. In patients with a high baseline risk of fracture, the benefit of treatment should be carefully assessed to outweigh the risk. In patients with bone fractures, orthopaedic stabilisation of fractures should be performed before starting or resuming treatment with Xofigo. In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded. Xofigo contributes to a patient’s overall long-term cumulative radiation exposure which may be associated with an increased risk of cancer and hereditary defects. In particular, the risk for osteosarcoma, myelodysplastic syndrome and leukaemias may be increased. Xofigo increases the incidence of diarrhoea, nausea, and vomiting which may result in dehydration. Oral intake and fluid status of patients should be carefully monitored. Patients should be advised to seek medical advice if they experience severe or persistent diarrhoea, nausea, vomiting. Patients who display signs or symptoms of dehydration or hypovolemia should be promptly treated. This medicinal product can contain up to 2.35 mmol (54 mg) sodium per dose, depending on the required volume, and must be taken into consideration by patients on a controlled sodium diet. Interactions: No clinical interaction studies have been performed. Interactions with calcium and phosphate cannot be excluded. Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Fertility, pregnancy & lactation: Xofigo is not indicated in women. Results from animal studies, indicate there is a potential risk that radiation from Xofigo could cause adverse effects on fertility. Male patients should seek advice on conservation of sperm prior to treatment. Due to potential effects on spermatogenesis associated with radiation, men should be advised to use effective contraceptive methods during and up to 6 months after treatment with Xofigo. Effects on ability to drive and use machines: There is no evidence, nor is it expected, that Xofigo will affect the ability to drive or use machines. Undesirable effects: Very common: Thrombocytopenia, diarrhoea, vomiting, nausea, bone fracture. Common: Neutropenia, pancytopenia, leukopenia and injection site reactions. Uncommon: Lymphopenia, osteoporosis. Serious: Thrombocytopenia and neutropenia. Prescribers should consult the SmPC in relation to other side effects. Overdose: No specific antidote. In the event of an inadvertent overdose, general supportive measures, including monitoring for potential haematological and gastrointestinal toxicity should be undertaken. Incompatibilities: Do not mix with other medicinal products. Special Precautions for Storage: Store in accordance with national regulation on radioactive materials. Legal Category: POM. Package Quantities & Basic NHS Costs: Single vial pack £4040. MA Number(s): EU/1/13/873/001. Further information available from: Bayer plc, 400 South Oak Way, Reading, Berkshire, RG2 6AD United Kingdom. Telephone: 01182063000. Date of preparation: October 2018

 

Xofigo® is a trademark of the Bayer Group

Xofigo® 1100 kBq/mL solution for injection (radium223 dichloride)

Prescribing Information

(Refer to full Summary of Product Characteristics (SmPC) before prescribing)

 

Presentation: Each vial contains 6 mL of solution (6.6 MBq radium223 dichloride at the reference date). Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date. Indication(s): Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no known visceral metastases, in progression after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available systemic mCRPC treatment. Posology & method of administration: Xofigo should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings, and after evaluation of the patient by a qualified physician. Xofigo is for intravenous use and must be administered by slow injection (generally up to 1 minute). The intravenous access lin e or cannula must be flushed with isotonic sodium chloride 9 mg/mL (0.9%) solution for injection before and after injection of Xofigo. Adults: The dose regimen of Xofigo is an activity of 5 5 k Bq per kg body weight, given at 4 week intervals for 6 injections. Hepatic impairment: No dose adjustment is considered necessary in patients with hepatic impairment. Renal impairment: No dose adjustment is considered necessary in patients with renal impairment. Elderly patients: No dose adjustment is considered necessary in elderly patients. Children & adolescents: There is no relevant use of this medicinal product in the paediatric population for prostate cancer. Contra-indications: Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone. Warnings & precautions: The safety and efficacy of Xofigo in combination with cancer therapies other than LHRH analogues have not been established; an increased risk of mortality and fractures is possible. The combination of radium-223 with other systemic cancer therap ies other than LHRH analogues is not recommended. The use of Xofigo is not recommended for treatment of adults with CRPC and only asymptomatic bone metastases. In adults with CRPC and mildly symptomatic bone metastases the benefit of treatment should be carefully assessed to outweigh the risks considering that high osteoblastic activity is likely to be required for treatment benefit. In clinical studies, patients with fewer than 6 bone metastases had an increased risk of fractures and did not have a statistically significant survival benefit. A pre-specified subgroup analysis also showed that overall survival was not significantly improved in patients with a total ALP < 220 U/L. Therefore, in patients with a low level of osteoblastic bone metastases treatment with radium-223 is not recommended. Bone marrow suppression, notably thrombocytopenia, neutropenia, leukopenia and pancytopenia, have been reported in patients treated with Xofigo. Haematological evaluation of patients must be performed at baseline and prior to every dose of Xofigo. In case there is no recovery in values for absolute neutrophil count (ANC), platelets and haemoglobin within 6 weeks after the last administration of Xofigo despite receiving standard of care, further treatment with Xofigo should only be continued after a careful benefit/risk evaluation. Patients with evidence of compromised bone marrow should be treated with caution. Safety and efficacy of Xofigo have not been studied in patients with Crohn’s disease and ulcerative colitis. Due to faecal excretion of Xofigo, radiation may lead to aggravation of acute inflammatory bowel disease. Therefore, Xofigo should only be administered after a careful benefit-risk assessment in patients with acute inflammatory bowel disease. In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting or resuming treatment with Xofigo. Xofigo increases the risk of bone fractures, especially in patients with medical history of osteoporosis and in patients with <6 bone metastases. Prior to starting radium-223 bone status and baseline risk of fractures of patients (e.g. osteoporosis, less than 6 bone metastases, medication increasing fracture risk, low body mass index) should be carefully assessed, and closely monitored for at least 24 months. Preventive measures should be considered before starting or resuming treatment with Xofigo. In patients with a high baseline risk of fracture, the benefit of treatment should be carefully assessed to outweigh the risk. In patients with bone fractures, orthopaedic stabilisation of fractures should be performed before starting or resuming treatment with Xofigo. In patients treated with bisphosphonates and Xofigo, an increased risk of development of osteonecrosis of the jaw (ONJ) cannot be excluded. Xofigo contributes to a patient’s overall long-term cumulative radiation exposure which may be associated with an increased risk of cancer and hereditary defects. In particular, the risk for osteosarcoma, myelodysplastic syndrome and leukaemias may be increased. Xofigo increases the incidence of diarrhoea, nausea, and vomiting which may result in dehydration. Oral intake and fluid status of patients should be carefully monitored. Patients should be advised to seek medical advice if they experience severe or persistent diarrhoea, nausea, vomiting. Patients who display signs or symptoms of dehydration or hypovolemia should be promptly treated. This medicinal product can contain up to 2.35 mmol (54 mg) sodium per dose, depending on the required volume, and must be taken into consideration by patients on a controlled sodium diet. Interactions: No clinical interaction studies have been performed. Interactions with calcium and phosphate cannot be excluded. Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Fertility, pregnancy & lactation: Xofigo is not indicated in women. Results from animal studies, indicate there is a potential risk that radiation from Xofigo could cause adverse effects on fertility. Male patients should seek advice on conservation of sperm prior to treatment. Due to potential effects on spermatogenesis associated with radiation, men should be advised to use effective contraceptive methods during and up to 6 months after treatment with Xofigo. Effects on ability to drive and use machines: There is no evidence, nor is it expected, that Xofigo will affect the ability to drive or use machines. Undesirable effects: Very common: Thrombocytopenia, diarrhoea, vomiting, nausea, bone fracture. Common: Neutropenia, pancytopenia, leukopenia and injection site reactions. Uncommon: Lymphopenia, osteoporosis. Serious: Thrombocytopenia and neutropenia. Prescribers should consult the SmPC in relation to other side effects. Overdose: No specific antidote. In the event of an inadvertent overdose, general supportive measures, including monitoring for potential haematological and gastrointestinal toxicity should be undertaken. Incompatibilities: Do not mix with other medicinal products. Special Precautions for Storage: Store in accordance with national regulation on radioactive materials. Legal Category: POM. Package Quantities & Basic NHS Costs: Single vial pack £4040. MA Number(s): EU/1/13/873/001. Further information available from: Bayer plc, 400 South Oak Way, Reading, Berkshire, RG2 6AD United Kingdom. Telephone: 01182063000. Date of preparation: October 2018

 

Xofigo® is a trademark of the Bayer Group

Report Adverse Events
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. Adverse events should also be reported to Bayer plc. Tel.: 0118 206 3500, Fax.: 0118 206 3703, Email: pvuk@bayer.com