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Does Xofigo (radium Ra 223) cause side effects?
Xofigo (radium Ra 223) is a radioactive medicine (radiotherapeutic drug) used to treat male patients with symptoms of advanced prostate cancer that has spread to the bones, but not to other parts of the body.
The radioactive particles emitted by Xofigo help kill cancer cells in the bone by damaging their DNA. Xofigo causes minimal damage to the nearby healthy cells. Xofigo can help some patients live longer.
Common side effects of Xofigo include
Serious side effects of Xofigo include
- bone marrow suppression (a potentially serious condition in which blood cell counts decrease),
- a drop in red blood cells,
- white blood cells, and
Information on potential drug-drug interactions with Xofigo is not available as no formal drug interaction studies have been performed.
Xofigo can cause harm to a fetus and should not be used in women who are or may become pregnant.
Women who are pregnant or who may become pregnant should not handle Xofigo without wearing gloves or proper protection. Male patients who are sexually active should use condoms and their female partners should use a highly effective method of birth control (for example, birth control pills) during treatment and for 6 months after stopping treatment.
Xofigo should not be used by women. It is not known if Xofigo is excreted in breast milk.
What are the important side effects of Xofigo (radium Ra 223)?
The most common side effects of radium Ra 223 are:
Radium Ra 223 can cause bone marrow suppression, a potentially serious condition in which blood cell counts decrease.
In clinical studies, use of radium Ra 223 caused a drop in red blood cells, white blood cells, and platelets in some patients. Because of serious bone marrow problems, some patients had to permanently discontinue treatment, required blood transfusions, and some deaths were reported.
Xofigo (radium Ra 223) side effects list for healthcare professionals
The following serious adverse reactions are discussed in greater detail in another section of the label:
- Bone Marrow Suppression
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the randomized clinical trial in patients with metastatic castration-resistant prostate cancer with bone metastases,
- 600 patients received intravenous injections of 55 kBq/kg (1.49 microcurie/kg) of Xofigo and best standard of care and
- 301 patients received placebo and best standard of care once every 4 weeks for up to 6 injections.
Prior to randomization, 58% and 57% of patients had received docetaxel in the Xofigo and placebo arms, respectively. The median duration of treatment was 20 weeks (6 cycles) for Xofigo and 18 weeks (5 cycles) for placebo.
The most common adverse reactions (≥ 10%, Table 3) in patients receiving Xofigo were
- vomiting, and
- peripheral edema.
Grade 3 and 4 adverse events were reported among 57% of Xofigo-treated patients and 63% of placebotreated patients. The most common hematologic laboratory abnormalities in Xofigo-treated patients (≥ 10%, Table 4) were
Treatment discontinuations due to adverse events occurred in 17% of patients who received Xofigo and 21% of patients who received placebo. The most common hematologic laboratory abnormalities leading to discontinuation for Xofigo were anemia (2%) and thrombocytopenia (2%).
Table 3 shows adverse reactions occurring in ≥ 2% of patients and for which the incidence for Xofigo exceeds the incidence for placebo.
Table 3: Adverse Reactions in the Randomized Trial
|System/Organ Class Preferred Term||Xofigo|
|Grades 1-4 %||Grades 3-4 %||Grades 1-4 %||Grades 3-4 %|
|Blood and lymphatic system disorders|
|General disorders and administration site conditions|
|Renal and urinary disorders|
|Renal failure and impairment||3||1||1||1|
Table 4 shows hematologic laboratory abnormalities occurring in > 10% of patients and for which the incidence for Xofigo exceeds the incidence for placebo.
Table 4: Hematologic Laboratory Abnormalities
|Hematologic Laboratory Abnormalities||Xofigo|
|Grades 1-4 %||Grades 3-4 %||Grades 1-4 %||Grades 3-4 %|
- Laboratory values were obtained at baseline and prior to each 4-week cycle.
- As an adverse reaction, grade 3-4 thrombocytopenia was reported in 6% of patients on Xofigo and in 2% of patients on placebo.
- Among patients who received Xofigo, the laboratory abnormality grade 3-4 thrombocytopenia occurred in 1% of docetaxel naive patients and in 4% of patients who had received prior docetaxel.
- Grade 3-4 neutropenia occurred in 1% of docetaxel naive patients and in 3% of patients who have received prior docetaxel.
- Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo.
- Xofigo increases adverse reactions such as
- 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 (<1% vs. 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow up for patients on the trial.
Subsequent Treatment With Cytotoxic Chemotherapy
- In the randomized clinical trial, 16% patients in the Xofigo group and 18% 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.
What drugs interact with Xofigo (radium Ra 223)?
- No formal clinical drug interaction studies have been performed.
- Subgroup analyses indicated that the concurrent use of bisphosphonates or calcium channel blockers did not affect the safety and efficacy of Xofigo in the randomized clinical trial.
Xofigo (radium Ra 223) is a radioactive medicine (radiotherapeutic drug) used to treat male patients with symptoms of advanced prostate cancer that has spread to the bones, but not to other parts of the body. Common side effects of Xofigo include nausea, vomiting, diarrhea, swelling of the arms or legs, and low blood cell counts. Male and female partners should use effective birth control while taking Xofigo. Xofigo should not be used by women. It is not known if Xofigo is excreted in breast milk.
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Prostate Cancer Staging and Survival Rates
The prognosis for prostate cancer, as with any cancer, depends on how advanced the cancer has become, according to established stage designations. The patient's PSA score at diagnosis, as well as their Gleason score (the grading system used to determine the aggressiveness of prostate cancer) determines the prognosis and final stage designation. Prostate cancer has a high survival rate in general, but your chances depend on the stage of the cancer.
Early Prostate Cancer
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Prostate Cancer Early Signs and Symptoms
Difficulty with urination – frequency, weak stream, trouble getting started, etc. – is usually the first sign of prostate cancer. But these and other early symptoms of prostatic cancer can also come from benign prostate conditions, so diagnostic testing is important, including PSA tests and digital rectal exam.
Prostate cancer is the most common cancer in men after skin cancer. Risk factors include age, family history, ethnicity, and diet. Prostate cancer is diagnosed by a digital rectal exam, prostate-specific antigen (PSA) test, and prostate biopsy. Symptoms may include frequent need to urinate, incontinence, pain, blood in the urine, fatigue, and more. Prognosis and treatment depend on cancer staging. Watchful waiting, surgery, radiation, cryotherapy, and other management strategies are available. Research and clinical trials strive to find new and better treatments for prostate cancer.
Prostate Cancer Facts
Prostate cancer is a leading cause of cancer and cancer death in males; in some men, identifying it early may prevent or delay metastasis and death from prostate cancer. The prostate is a walnut-shaped gland that is a part of the male reproductive system that wraps around the male urethra at it exits the bladder. Prostate cancer is common in men over 50 years of age, with the risk of developing prostate cancer increases with aging.
Early-Stage Prostate Cancer Treatment
If prostate cancer is detected early and appears to be slow-growing, invasive procedures, chemotherapy, radiation and other approaches can sometimes do more harm than good. Many prostate cancer treatments come with side effects, like incontinence or impotence, so it’s in the patient’s interest to put off invasive treatments as long as is medically safe. Active surveillance is where doctors "watch and wait" for changes that could prompt medical intervention.
How Is Prostate Cancer Diagnosed?
Prostate cancer is largely a disease of men over 40, so it’s around this age doctors recommend the first prostate screening. The first exam is a blood test to determine if there are abnormal prostate specific antigen (PSA) levels in your blood – PSA is produced by the prostate. If the PSA is high, your doctor will perform a digital rectal exam, during which the doctor feels your prostate from inside your rectum with a gloved finger. Other diagnostic tests include an endoscopic biopsy of tumor tissue for analysis in a lab.
Prostate Cancer: Radical Prostatectomy Surgery
Radical prostatectomy, or surgical removal of the entire prostate gland, isn’t typically the first choice in prostate cancer treatment. Sometimes a radical approach is necessary to keep the cancer from metastasizing, however. Some cases are too severe or diagnosed too late for drugs or radiation to have much effect. In these cases, treatment teams may opt for a radical prostatectomy, despite potential side effects like impotence and incontinence.
Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
Prostate Cancer Treatment: Focal Therapy and Other Experimental Treatments
Several new and experimental treatments for prostate cancer are under study, including treatments that use ultrasound, lasers, tissue-freezing gas, and new ways of administering radiation. These new methods are types of focal therapy, that is, treatment focused on the cancer cells in the prostate, rather than systemic therapy that administers medications or other treatments to the whole body with the aim of treating the prostate.
Prostate Cancer: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
Prostate Cancer Treatment: Chemotherapy, Bone-Targeted and Immune Therapy
Doctors may introduce chemotherapy and immune therapy if other measures fail to cure a case of prostate cancer. However, unlike with other forms of cancer, chemotherapy isn’t the first choice for early prostate cancer. Immune therapy uses the body's own immune system to attack the prostate tumor, while bone-targeted therapy aims to preserve bone and prevent metastasis.
Treatment & Diagnosis
Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.