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Xofigo

"The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

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Xofigo

Xofigo

Xofigo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Xofigo (radium Ra 223 dichloride) is a radiotherapeutic drug used to treat patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Common side effects include nausea, diarrhea, vomiting, and swelling of the legs and feet.

The dose regimen of Xofigo is 50 kBq (1.35 microcurie) per kg body weight, given at 4 week intervals for 6 injections. Xofigo may interact with other drugs. Tell your doctor all medications and supplements you use. Xofigo is not indicated for use in women, and is therefore unlikely to be used during pregnancy or breastfeeding.

Our Xofigo (radium Ra 223 dichloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Xofigo FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in another section of the label:

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 50 kBq/kg (1.35 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%) in patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema (Table 3). Grade 3 and 4 adverse events were reported among 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in Xofigo-treated patients ( ≥ 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia (Table 4).

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 (n=600) Placebo (n=301)
Grades 1-4 % Grades 3-4 % Grades 1-4 % Grades 3-4 %
Blood and lymphatic system disorders
Pancytopenia 2 1 0 0
Gastrointestinal disorders
Nausea 36 2 35 2
Diarrhea 25 2 15 2
Vomiting 19 2 14 2
General disorders and administration site conditions
Peripheral edema 13 2 10 1
Renal and urinary disorders
Renal failure and impairment 3 1 1 1

Laboratory Abnormalities

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 (n=600) Placebo (n=301)
Grades 1-4 % Grades 3-4 % Grades 1-4 % Grades 3-4 %
Anemia 93 6 88 6
Lymphocytopenia 72 20 53 7
Leukopenia 35 3 10 < 1
Thrombocytopenia 31 3 22 < 1
Neutropenia 18 2 5 < 1

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 na´ve patients and in 4% of patients who had received prior docetaxel. Grade 3-4 neutropenia occurred in 1% of docetaxel na´ve patients and in 3% of patients who have received prior docetaxel.

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 [see Nonclinical Toxicology]. 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.

Read the entire FDA prescribing information for Xofigo (Radium Ra 223 Dichloride) »

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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.


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