Radium Ra 223 dichloride

What is Radium Ra 223 dichloride?

• Radium Ra 223 dichloride (Xofigo) is an alpha particle-emitting radioactive therapeutic agent used for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

What are the uses of this medicine?

• Radium Ra 223 dichloride (Xofigo) is used for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

How does this medicine work?

• Alpha particle-emitting isotope radium-223 (as radium Ra 223 dichloride), which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases.
• The high linear energy transfer of alpha particles (80 keV/micrometer) leads to a high frequency of double-strand DNA breaks in adjacent cells including tumor cells, osteoblasts and osteoclasts, resulting in an anti-tumor effect on bone metastases.
• The alpha particle range from radium-223 dichloride is less than 100 micrometers (less than 10 cell diameters) which limits damage to the surrounding normal tissue.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal clinical drug interaction studies have been performed.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

• Xofigo (an alpha particle-emitting pharmaceutical) should be received, used and administered only by authorized persons in designated clinical settings.
• The receipt, storage, use, transfer and disposal of Xofigo are subject to the regulations and/or appropriate licenses of the competent official organization.

Recommended Dosage:

• The dose regimen of Xofigo is 55 kBq (1.49 microcurie) per kg body weight, given at 4 week intervals for 6 injections.
• Safety and efficacy beyond 6 injections with Xofigo have not been studied.

Administration

• Administer Xofigo by slow intravenous injection over 1 minute.
• Flush the intravenous access line or cannula with isotonic saline before and after injection of Xofigo.
• Discard any unused portion, if applicable

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-dose vial at a concentration of 1,100 kBq/mL (30 microcurie/mL) at the reference date with a total radioactivity of 6,600 kBq/vial (178 microcurie/vial) at the reference date.

This medicine is available in fallowing brand namesː

• Xofigo

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• diarrhea
• vomiting
• peripheral edema

The most common hematologic laboratory abnormalities may include: anemia

• lymphocytopenia
• leukopenia
• thrombocytopenia
• neutropenia

What special precautions should I follow?

• In the randomized trial, 2% of patients on the Xofigo arm experienced bone marrow failure. Measure blood counts prior to treatment initiation and 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. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care measures.
• Xofigo is not recommended in combination with abiraterone acetate plus prednisone/prednisolone.
• Xofigo can cause fetal harm. Advise males with female partners of reproductive potential to use effective contraception.

What to do in case of emergency/overdose?

• There have been no reports of overdosing of Xofigo during clinical studies.

Management of overedosage:

• There is no specific antidote.
• In the event of an inadvertent overdose of Xofigo, utilize general supportive measures, including monitoring for potential hematological and gastrointestinal toxicity, and consider using medical countermeasures such as aluminum hydroxide, barium sulfate, calcium carbonate, calcium gluconate, calcium phosphate, or sodium alginate.

Can this medicine be used in pregnancy?

• The safety and efficacy of Xofigo have not been established in females. Based on mechanism of action, Xofigo can cause fetal harm when administered to a pregnant female.

Can this medicine be used in children?

• The safety and efficacy of Xofigo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient: RADIUM RA-223 DICHLORIDE

Inactive ingredients: SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM HYDROCHLORIC ACID WATER

Who manufactures and distributes this medicine?

• Manufactured for:

Bayer HealthCare Whippany

What should I know about storage and disposal of this medication?

• Store 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.

• Dailymed label info on Radium Ra 223 dichloride
• FDA Radium Ra 223 dichloride

Radium Ra 223 dichloride Resources
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