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RADIUM 223 TREATMENT TRIAL

General disorders and administration site conditions

RADIUM 223 TREATMENT TRIAL

Table 3: Adverse Reactions in the Randomized Trial System/Organ Class Preferred Term Table 3 shows adverse reactions occurring in ≥ 2% of patients and for which the incidence for Xofigo exceeds the incidence for placebo. The most common hematologic laboratory abnormalities leading to discontinuation for Xofigo were anemia (2%) and thrombocytopenia (2%). 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 in Xofigo-treated patients (≥ 10%, Table 4) were Grade 3 and 4 adverse events were reported among 57% of Xofigo-treated patients and 63% of placebotreated patients. The most common adverse reactions (≥ 10%, Table 3) in patients receiving Xofigo were The median duration of treatment was 20 weeks (6 cycles) for Xofigo and 18 weeks (5 cycles) for placebo. Prior to randomization, 58% and 57% of patients had received docetaxel in the Xofigo and placebo arms, respectively.

301 patients received placebo and best standard of care once every 4 weeks for up to 6 injections.

600 patients received intravenous injections of 55 kBq/kg (1.49 microcurie/kg) of Xofigo and best standard of care and.

In the randomized clinical trial in patients with metastatic castration-resistant prostate cancer with bone metastases, The following serious adverse reactions are discussed in greater detail in another section of the label:īecause 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. Xofigo (radium Ra 223) side effects list for healthcare professionals It is not known if Xofigo is excreted in breast milk. 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. Women who are pregnant or who may become pregnant should not handle Xofigo without wearing gloves or proper protection.

Xofigo can cause harm to a fetus and should not be used in women who are or may become pregnant. Information on potential drug- drug interactions with Xofigo is not available as no formal drug interaction studies have been performed.

bone marrow suppression (a potentially serious condition in which blood cell counts decrease),.

Xofigo can help some patients live longer.

Xofigo causes minimal damage to the nearby healthy cells. The radioactive particles emitted by Xofigo help kill cancer cells in the bone by damaging their DNA. 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. Does Xofigo (radium Ra 223) cause side effects?