Generic name: radium 223 dichloride
Dosage form: intravenous injection
Drug class: Therapeutic radiopharmaceuticals
What is Xofigo?
Xofigo (radium 223 dichloride) is an intravenous injection used for the treatment of prostate cancer when hormonal or surgical treatment that lowers testosterone is no longer working, and the prostate cancer has spread to bones but has not spread to other parts of the body. Xofigo contains a radioactive ingredient called radium 233 that concentrates in the bone where there is cancer and kills the cancer cells.
Xofigo works as it acts like calcium and goes to areas of bone that are growing quickly, which is where the bone cancer is in the body. Once Xofigo is attached to the bone cancer, it gives off radiation that breaks the DNA of the cancer cells, which kills the prostate cancer cells.
The half-life of Xofigo is 11.4 days.
Bone Marrow Suppression: Blood counts should be measured before the first treatment and also before every dose of Xofigo. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after treatment. Monitor patients with compromised bone marrow reserve closely. This medicine should be discontinued in patients who experience life-threatening complications despite supportive care measures.
Before taking this medicine
Pregnancy and male fertility:
The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. It is important to warn pregnant females and females of reproductive potential of the potential risk to a fetus. Pregnancy is contraindicated.
Male patients should not get female partners pregnant during treatment with Xofigo and for 6 months after stopping treatment. Male patients should use condoms and their female partners (of reproductive potential) should use effective contraception during and for 6 months after completing treatment with Xofigo.
Based on how Xofigo works it may impair a male's ability to father children if they are of reproductive potential.
Bone Marrow Suppression:
It is important to be compliant with blood cell count monitoring appointments while receiving Xofigo. You should report signs of bleeding or infections to your health care provider.
Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone:
Patients using Xofigo have an increase in bone fractures and mortality when used in combination with abiraterone acetate and prednisone/prednisolone. You should talk to your healthcare provider about any other medications they are currently taking for prostate cancer.
It is important to stay well hydrated and to monitor oral intake, fluid status, and urine output while being treated with Xofigo. You should report signs of dehydration, hypovolemia, urinary retention, or renal failure / insufficiency to your doctor.
Personal contact and radiation exposure to others:
There are no restrictions regarding personal contact (visual or physical proximity) with other people after receiving Xofigo. You should follow good hygiene practices while receiving Xofigo and for at least 1 week after the last injection in order to minimize radiation exposure from bodily fluids to household members and caregivers. Whenever possible, when you use a toilet the toilet should be flushed several times after each use. Clothing soiled with patient fecal matter or urine should be washed promptly and separately from other clothing. Caregivers should use universal precautions for patient care such as gloves and barrier gowns when handling bodily fluids to avoid contamination. When handling bodily fluids, wearing gloves and hand washing will protect caregivers.
How will I receive Xofigo?
You will be given Xofigo as one minute injection into a vein, every 4 weeks for a total 6 injections. You will have your treatment in a healthcare facility.
After your treatment, you can leave the healthcare facility and go about your daily activities. There are no restrictions regarding personal contact (visual or physical) with other people, this means you are able to hug your friends and family.
The dose regimen of Xofigo is 50 kBq (1.35 microcurie) per kg body weightDosage Forms and Strengths
Single-use vial at a concentration of 1,000 kBq/mL (27 microcurie/mL) at the reference date with a total radioactivity of 6,000 kBq/vial (162 microcurie/vial) at the reference date.
Xofigo side effects
A serious side effect of Xofigo is bone marrow suppression. It is important to have your regular blood tests. You should report signs of bleeding or infections to your health care provider.
The most common side effects affecting 10% or more of patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema.
The most common hematologic laboratory abnormalities (≥ 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.
To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What other drugs will affect Xofigo?
No formal clinical drug interaction studies have been performed.
Subgroup analyses indicated that using of bisphosphonates or calcium channel blockers at the same time as Xofigo did not affect the safety and efficacy of Xofigo in the randomized clinical trial.
Efficacy and Safety Data of Xofigo
The approval of Xofigo (radium 223 dichloride, radium 223) is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, radium 223 significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875), p=0.00185]; median OS was 14.0 months with radium 223 plus best standard of care vs. 11.2 months with placebo plus best standard of care. Additionally, at the interim analysis there was a delay in the time to first symptomatic skeletal event (SSE) for patients treated with radium 223 vs. placebo.
An updated analysis, conducted after the study was unblinded, showed a further improvement in overall survival (OS) for patients treated with radium 223 vs. placebo, with a median OS of 14.9 months vs. 11.3 months; HR=0.695 (95% CI 0.581-0.832).
The most common adverse reactions (greater than or equal to 10%) in patients receiving radium 223 in the ALSYMPCA trial were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.
About the ALSYMPCA Trial
The ALSYMPCA trial was a Phase III, randomized, double-blind, placebo-controlled international study of radium 223 dichloride with best standard of care vs. placebo with best standard of care in symptomatic CRPC patients with bone metastases. The trial enrolled 921 patients in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous injections of radium 223 or placebo each separated by an interval of four weeks.
The primary endpoint of the study was overall survival (OS). A key secondary endpoint was time to first symptomatic skeletal event (SSE), as defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.
Active Ingredient: Radium RA-223 dicloride (Radium RA-223 Cation) 30 uCi in 1 mL
Inactive Ingredients: sodium chloride USP (tonicity agent), sodium citrate USP (for pH adjustment), hydrochloric acid USP (for pH adjustment), and water for injection USP.
Storage and disposal
Store Xofigo at room temperature, below 40° C (104° F). Store Xofigo in the original container or equivalent radiation shielding.
This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.
Follow procedures for proper handling and disposal of radioactive pharmaceuticals.
Bayer HealthCare, Whippany, NJ 07981
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