What is Xofigo: Side Effects, Dosage, Warnings

What is Xofigo: Side Effects, Dosage, Warnings

What is Xofigo?

Radium 223 Radium Dichloride, an alpha-particle drug, is a radiotherapy drug.

Xofigo is presented as a clear, non-colored, isotonic, and sterile solution for intravenous infusion with a pH between 6 and 8.

Each milliliter of the solution containing 1100 kg of 223 dicar chloride (30 μg), which corresponds to 0.58 ng of radium 223, is on reference date. Radium is present in the solution as a free binary cation.

Each bottle contains 6 ml of solution (6,600 kilobytes (178 micrograms) of dicy chloride of 223 dB at the reference date). Inactive ingredients include: USP (tonicity agent), sodium chloride sodium 6.3 mg / ml, USP (for pH adjustment), 0.2 mg / ml hydrochloric acid (for pH adjustment) and water for USP injection.

Radium 223 has a half-life of 11.4 days. The specific activity of radium is 223 times 1.9 MBq (51.4 micrograms) / ng.

The molecular weight of dicyclohexylamine 223, 223 RaCl 2, is 293.9 g / mol.

The collapse of six steps of the 223 radium to lead 207 is sustained through short-term girls and is mainly due to alpha release. There is also emission of beta and gamma gases with different energies and release probability. The fraction of the energy released from radium 223 and its daughters as alpha particles is 95.3% (the energy range is 5.5 MW). The fraction due to beta particles is 3.6% (average energy 0.445 MeV and 0.492 MeV), and 1.1% gamma ray (energy range 0.01 to 1.27 MeV).

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Dosage of Xofigo

The dose of Xofigo is 55 kilobytes (1.49 micrograms) per kilogram of body weight, given for 6 weeks for 4 weeks. Safety and efficacy of more than 6 injections with Xofigo have not been studied.

The volume given to a patient should be calculated using:

Patient body weight (kg)

The dose level is 55 kb / kg body weight or 1.49 micrograms per kilogram body weight

The radioactive concentration of the product (1100 kg / ml, 30 μg / ml) on the reference date

Correction factor correction factor for physical degradation of radium 223.

Symptoms of over dose 

There is no particular antidote. In case of Xofigo's indirect misuse, use general supportive measures, including monitoring of potential hematologic and digestive toxicity and the use of medical measures such as aluminum hydroxide, barium sulfate, calcium carbonate, calcium gluconate, calcium phosphate or alginate.

Side effects of Xofigo

Since clinical trials are conducted under very variable conditions, the unwanted response rate seen in clinical trials of a drug cannot be directly compared to the clinical trials of another drug and may reflect the rates Observed in action.

In a randomized clinical trial in patients with metastatic prostate cancer with bone metastases, 600 patients received intravenous injection of 55 Kg / kg (1.49 micrograms / kg) Xofigo and the best standard of care and 301 placebo patients and the best standard of care once per one 4 weeks to 6 injections. Before the accident, 58% and 57% of patients received docetaxel in Xofigo and placebo, respectively. The median time was 20 weeks (6 cycles) for Xofigo and 18 weeks (5 cycles) for placebo.

The most common side effects (≥ 10%) in patients receiving Xofigo were nausea, diarrhea, vomiting and edema.

Drugs that may interact with Xofigo

The subgroup analysis indicated that co-administration of bisphosphonates or calcium channel blockers on Xofigo's safety and efficacy did not affect the randomized clinical trial.

Warnings of Xofigo

In a randomized trial, 2% of patients experienced Xofigo, bone marrow deficiency or persistent pancytopenia, while no treatment with placebo was treated. Two deaths were due to bone marrow deficiency and in 7 of the 13 patients treated with Xofigo, while brain death continued. Of the 13 patients with bone marrow deficiency, 54% had bleeding. Four percent (4%) of patients in the Xofigo arm and 2% in the arm of the placebo were permanently discontinued due to bone marrow suppression.

Xofigo

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