Xofigo Is Recommended In Major Prostate Cancer Guidelines
Recommended as a Category 1 first-line treatment option for patients with symptomatic CRPC with bone metastases and no visceral metastases1
"Strong" recommendation for men with CRPC and bone metastases2
NCCN Guidelines and National Comprehensive Cancer Network are registered trademarks of National Comprehensive Cancer Network, Inc. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer v.2.2019. National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed April 29, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, NCCN, GUIDELINES, and all other NCCN content are trademarks owned by the National Comprehensive Cancer Network, Inc.
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC),
symptomatic bone metastases and no known visceral metastatic disease.
Start Xofigo When Your Patient...
aSerum PSA progression defined as two consecutive increases in PSA over a previous reference. bIn the ALSYMPCA clinical trial, Xofigo was given with best standard of care, which included antiandrogens, ketoconazole, local EBRT, estrogens, estramustine, or treatment with glucocorticoids.
EBRT, external beam radiation therapy.
Xofigo Helps Improve Overall Survival4,5,a
Xofigo was evaluated in a double-blind, randomized, placebo-controlled phase 3 clinical trial of 921 patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases4
Median Overall Survival In an Updated ALSYMPCA Exploratory Analysis4,b
Prespecified interim analysis: median overall survival was 14.0 months for Xofigo (95% CI: 12.1-15.8) vs 11.2 months for placebo (95% CI: 9.0-13.2)4 - P=0.00185; HR=0.695 (95% CI: 0.552-0.875)
aIn the prespecified interim analysis bAn exploratory updated overall survival analysis was performed before patient crossover, incorporating additional events, resulting in findings consistent with the interim analysis.4 cBSOC was defined as: antiandrogens, ketoconazole, local EBRT, estrogens, estramustine, or treatment with glucocorticoids.4
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Xofigo Rebate Starts With the First Patient
Select practice requirements: Only accounts with signed letters of declaration with GPOs that have executed Xofigo contracts with Bayer HealthCare are eligible for participation in the back-end rebate program.
Xofigo Additional Growth Rebate
Note: Parent Accounts must have a minimum of four hundred (400) microcuries or greater in the Initial Baseline/Baseline period.
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
Important Safety Information Contraindications: Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman
Warnings and Precautions:
Bone Marrow Suppression:
In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%),
serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure
Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 x 109/L the platelet count ≥100 x 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 x 109/L and the platelet count ≥50 x 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care
Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued
Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone:
Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not
Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations
Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients' oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia
Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo
Secondary Malignant Neoplasms: Xofigo contributes to a patient`s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of followup for patients on the trial
Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy
Adverse Reactions: The most common adverse reactions (>10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (>10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).
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