Xofigo

Pronunciation: zoh-FEE-goh (Xofigo); RAY-dee-um (radium).

Generic name
radium Ra 223 dichloride
Drug class
Alpha particle-emitting radioactive therapeutic agent (radiopharmaceutical)
Form
Solution for injection, 1,100 kBq/mL
Route
Intravenous injection (administered by a healthcare professional only)
Legal status
Prescription-only; administered only by, or under the supervision of, personnel authorised to handle radiopharmaceuticals

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Xofigo (6) · Full directory

What radium Ra 223 dichloride is and how it works

Xofigo (radium Ra 223 dichloride) is a radioactive medicine given by injection into a vein. It is used to treat prostate cancer that no longer responds to hormone (castration) therapy and has spread to the bones, causing symptoms, but has not spread to other organs. The radium in Xofigo acts like calcium and travels to areas of bone where the cancer has spread, releasing short-range radiation (alpha particles) that damages the DNA of nearby cancer cells while affecting less bone marrow and surrounding healthy tissue than some other forms of radiation. (1) (2) (3)

Xofigo is given only in a hospital or specialist clinic by staff trained and authorised to handle radioactive medicines -- you cannot take it at home. Two safety issues are especially important: it can suppress your bone marrow's ability to make blood cells (so blood tests are required before every dose), and it must not usually be combined with the medicines abiraterone acetate plus prednisone or prednisolone, because that combination has been linked to more bone fractures and, in trial data, a trend toward more deaths. Because it is radioactive, there are also specific precautions about handling your urine, stool, and bodily fluids for a period after each dose.

Mechanism of action: how radium Ra 223 dichloride works

Radium-223 is an alpha-particle-emitting isotope (half-life 11.4 days) that behaves as a calcium mimetic, forming complexes with bone mineral hydroxyapatite preferentially at sites of increased bone turnover such as bone metastases. The high linear energy transfer of alpha particles produces double-strand DNA breaks in adjacent tumour cells over a very short range (typically less than 100 micrometres), limiting damage to surrounding normal tissue, including bone marrow, relative to beta- or gamma-emitting radiopharmaceuticals -- though clinically significant bone marrow suppression still occurs. (1) (2)

What radium Ra 223 dichloride is used for

Castration-resistant prostate cancer with symptomatic bone metastases

Used to treat adult men with prostate cancer that continues to progress despite medical or surgical castration (castration-resistant prostate cancer), where the cancer has spread to bone and is causing symptoms, and there is no known spread to other organs (visceral metastases). In the UK and EU, this is specifically for men who have already had at least two other treatments for this stage of prostate cancer (not counting hormone therapy) or who cannot receive any other such treatment. (1) (2) (3)

Before taking radium Ra 223 dichloride

Do not take / not appropriate for

  • Xofigo is not recommended together with abiraterone acetate plus prednisone/prednisolone in the United States, and is contraindicated in combination with these medicines in the United Kingdom and European Union -- tell your oncologist about every medicine you are taking, especially these. (all countries) (1) (2) (3)
  • Xofigo is not used in women; it is not to be given to women who are, or may become, pregnant, or who are breastfeeding. (all countries) (2)

Tell your clinician about

  • Any recent blood test results, especially if you have low blood counts, bone marrow problems, or reduced bone marrow reserve (for example from previous chemotherapy or radiation to a large part of your bones).
  • If you are taking, or have recently taken, abiraterone acetate with prednisone or prednisolone.
  • Whether you have osteoporosis or fewer than 6 areas of bone metastasis, since fracture risk may be higher.
  • Any plans regarding fertility -- discuss contraception, since men should use effective contraception during treatment and for 6 months afterward.
  • Any kidney or liver problems.
  • Any recent infections, unusual bleeding or bruising, or severe fatigue.
(1) (2)

How to take radium Ra 223 dichloride

  • Xofigo is given only by slow injection into a vein by a healthcare professional trained and authorised to handle radioactive medicines -- it is never self-administered or taken at home.
  • The usual course is 6 injections, one every 4 weeks; blood tests are taken before treatment starts and before every single dose to check it is safe to continue.
  • Because Xofigo is radioactive, you will be given specific instructions about handling urine, stool, and other bodily fluids for a period after each injection, and your caregivers may be advised to wear gloves when in contact with these.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Xofigo is given on a fixed hospital/clinic schedule set by your oncology team. If you are unable to attend an appointment, contact the treating centre as soon as possible to reschedule -- do not attempt to make up a missed dose on your own, since eligibility for each dose depends on that day's blood test results.

Overdose

An overdose of Xofigo would be administered by a healthcare professional, not by the patient. If an overdose is suspected, general supportive care should be given, along with monitoring and, if needed, management of bone marrow suppression, potentially including growth factor support or blood product transfusion, under specialist supervision. There is no specific antidote. (2)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Diarrhoea.

What to notice: Diarrhoea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Vomiting.

What to notice: Vomiting.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Peripheral (leg/ankle) swelling.

What to notice: Peripheral (leg/ankle) swelling.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Low blood-cell counts: anaemia, low lymphocytes, low white blood cells, low platelets (thrombocytopenia), low neutrophils.

What to notice: Low blood-cell counts: anaemia, low lymphocytes, low white blood cells, low platelets (thrombocytopenia), low neutrophils.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Bone fractures.

What to notice: Bone fractures.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of bone marrow suppression (low blood counts) — high caution

Symptoms: Unusual tiredness, infections that do not go away, fever, unusual bruising or bleeding.

Action: Contact your oncology team promptly -- blood counts are checked before every dose specifically because of this risk. In the pivotal trial, 2% of patients treated with Xofigo experienced bone marrow failure or ongoing pancytopenia (compared with none on placebo); this included 2 deaths from bone marrow failure, and in most of those affected, bone marrow failure was still present at the time of death. Treatment is stopped if blood counts do not recover within 6-8 weeks. (1) (2)

Combined use with abiraterone acetate plus prednisone/prednisolone — emergency

Symptoms: This is a warning about a medicine combination, not a symptom to watch for.

Action: This combination is not recommended in the United States and is a formal contraindication in the United Kingdom and European Union. In the ERA-223 clinical trial, combining Xofigo with abiraterone acetate plus prednisone/prednisolone was associated with more bone fractures (28.6% vs 11.4% with placebo) and a trend toward more deaths (38.5% vs 35.5%); the trial was stopped early because of this finding. Tell your oncologist about every medicine you take before and during Xofigo treatment. (1) (2) (3) (5)

Increased risk of bone fractures — high caution

Symptoms: New bone pain, especially after a fall or minor injury.

Action: Xofigo can increase the risk of bone fractures, particularly in people with osteoporosis or fewer than 6 areas of bone metastasis. Your clinician may recommend bone-protecting treatment (such as a bisphosphonate or denosumab) before and during Xofigo treatment. (2)

Radiation safety precautions for you and people around you — high caution

Symptoms: Not a symptom -- a handling precaution because Xofigo is radioactive.

Action: Flush the toilet several times after each use for a period following treatment (as instructed by your care team). Wash any clothing or linen soiled with urine, stool, or other bodily fluids promptly and separately. Caregivers should wear gloves when handling these fluids and follow universal precautions during and for a period after your treatment course, as instructed by your clinical team. (1) (2)

Risk to a partner's pregnancy (embryo-fetal toxicity) — high caution

Symptoms: Not applicable -- a preventive precaution.

Action: Xofigo can cause harm to an unborn baby. Male patients should use condoms, and their female partners should use effective contraception, during treatment and for 6 months after the last dose. (1) (2)

Interactions

  • Must not usually be combined with abiraterone acetate plus prednisone/prednisolone (not recommended in the US; contraindicated in the UK/EU) -- see Serious warnings. (1) (2) (3)
  • Use with other medicines that suppress bone marrow function (such as chemotherapy) may increase the risk of blood-count problems -- discuss timing with your oncology team. (2)
  • Calcium- and phosphate-containing medicines/supplements should be used cautiously, since radium behaves like calcium in the body; discuss any calcium or vitamin D supplements with your care team. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Xofigo is not indicated for use in women and must not be given to a woman who is, or may be, pregnant. Male patients should use condoms and ensure their partners use effective contraception during treatment and for 6 months afterward, because Xofigo can cause harm to an unborn baby. (1) (2) (3) (4) (5) (6)

Breastfeeding

Xofigo is not indicated for use in women and must not be used by a woman who is breastfeeding. (1) (2) (3) (4) (5) (6)

Children

Safety and effectiveness in children have not been established; animal studies showed effects on developing bone and teeth at clinically relevant exposure levels. (1) (2) (3) (4) (5) (6)

Elderly

Most patients treated in clinical trials were older adults (median age in the late 60s to early 70s), consistent with typical age at diagnosis of castration-resistant prostate cancer; no separate elderly-specific dose adjustment is described. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

No dose adjustment described for mild hepatic impairment; data are insufficient for moderate-to-severe hepatic impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

No dose adjustment needed for mild-to-moderate renal impairment; data are insufficient to recommend a specific approach in severe renal impairment. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Full blood count (haemoglobin, absolute neutrophil count, platelets) before the first dose
  • Review of any concurrent abiraterone acetate/prednisone or prednisolone use
  • Assessment of fracture risk (osteoporosis, extent of bone disease)

During treatment

  • Full blood count before every dose, since bone marrow suppression can occur at any point during the 6-injection course.
  • Ongoing assessment for signs of infection, bleeding, or bruising.
  • Monitoring for new bone pain or fractures.
  • Radiation-safety precautions followed for the duration of the treatment course and for a period after, as instructed by the treating centre.
(1) (2)

Storage

Xofigo is stored, prepared, and administered only by the treating hospital or clinic under radiation-safety regulations; patients do not store or handle the medicine themselves. The healthdirect.gov.au consumer record notes storage below 40 degC in the original container with a 28-day shelf life for the Australian-supplied product.

Professional information

Clinician-facing context only, sourced from the current US FDA and UK SmPC labels; verify against the current full label before prescribing or administering.

United States / United Kingdom / European Union / Canada / Australia

Indication: Castration-resistant prostate cancer, symptomatic bone metastases, no known visceral metastases

Dose summary: 55 kBq (1.49 microcurie) per kg body weight, slow IV injection over ~1 minute, every 4 weeks for 6 injections. Not studied beyond 6 injections.

Renal context: No adjustment for mild-to-moderate renal impairment; insufficient data for severe impairment. (1) (2)

Mechanism of action

Hepatic guidance

No dose adjustment described for mild hepatic impairment; not specifically studied in moderate-to-severe impairment.

Overdose note

No specific antidote; manage supportively with monitoring of blood counts and management of any resulting bone marrow suppression under specialist/haematology guidance. (1) (2)

Frequently asked questions

Is Xofigo available in the US, UK, Europe, Canada, and Australia?

Yes. It is authorised and confirmed currently marketed in the United States, United Kingdom, European Union, Canada, and Australia via direct regulator sources. Its availability in New Zealand could not be confirmed in this research and is shown as unable to verify. (1) (2) (3) (4) (6)

Why can't Xofigo be combined with abiraterone and prednisone?

A large clinical trial (ERA-223) found that combining Xofigo with abiraterone acetate plus prednisone/prednisolone led to more bone fractures (28.6% vs 11.4% with placebo) and a trend toward more deaths (38.5% vs 35.5%), leading the trial to stop early. Because of this, the combination is not recommended in the US and is a formal contraindication in the UK and EU. (1) (2) (3)

Why do I need blood tests before every dose of Xofigo?

Xofigo can suppress bone marrow function and reduce blood cell counts, which in rare cases has been serious or fatal. Blood counts must meet specific thresholds before the first dose and before every subsequent dose, and treatment is stopped if counts do not recover as expected. (1) (2)

Is Xofigo safe to be around family members after treatment?

Xofigo is radioactive, so your care team will give you specific instructions about handling urine, stool, and other bodily fluids for a period after each dose (such as flushing the toilet multiple times and washing soiled clothing separately), and caregivers may be advised to wear gloves during this period. Follow your treating centre's specific radiation-safety instructions. (1) (2)

What is the mechanism of action of radium Ra 223 dichloride?

Radium-223 is an alpha-particle-emitting isotope (half-life 11.4 days) that behaves as a calcium mimetic, forming complexes with bone mineral hydroxyapatite preferentially at sites of increased bone turnover such as bone metastases. The high linear energy transfer of alpha particles produces double-strand DNA breaks in adjacent tumour cells over a very short range (typically less than 100 micrometres), limiting damage to surrounding normal tissue, including bone marrow, relative to beta- or gamma-emitting radiopharmaceuticals -- though clinically significant bone marrow suppression still occurs. (1) (2)

What is the generic name of Xofigo?

The generic name is radium Ra 223 dichloride. (1) (2)

What class of drug is radium Ra 223 dichloride?

Xofigo is classed as: Alpha particle-emitting radioactive therapeutic agent (radiopharmaceutical). (1) (2)

References

  1. XOFIGO (radium Ra 223 dichloride) injection, for intravenous use -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Bayer HealthCare Pharmaceuticals · United States · accessed 2026-07-30 · source 1
  2. Xofigo 1100 kBq/mL solution for injection -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Bayer plc · United Kingdom · accessed 2026-07-30 · source 2
  3. Xofigo (radium-223 dichloride) -- EPAR medicine overview / current authorisation statusEuropean Medicines Agency (EMA) · European Union · accessed 2026-07-30 · source 3
  4. XOFIGO -- Drug Product Database record (live JSON API)Health Canada Drug Product Database (DPD) API · Canada · accessed 2026-07-30 · source 4
  5. XOFIGO (radium Ra 223 dichloride): increased incidence of fractures and a trend for increased deaths when used with abiraterone acetate and prednisone/prednisoloneHealth Canada -- health professional risk communication · Canada · accessed 2026-07-30 · source 5
  6. XOFIGO radium (223Ra) dichloride 6.6 MBq per 6 mL solution for injection vial -- TGA eBS Product Information / ARTG entryTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 6
  7. No Medsafe record located for Xofigo/radium-223 dichlorideN/A -- absence-of-evidence record, not a source · New Zealand · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient radium Ra 223 dichloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Xofigo30 uCi/mL · bayer healthcare pharmaceuticals inc.

United Kingdom

  • Xofigo (2)MHRA licensed emc smpc confirmed · 1,100 kBq/mL solution for injection · Bayer plc

Canada

  • Xofigo (4) (5)Health Canada DPD API marketed confirmed DIN 02418398 · radiopharmaceutical solution for injection · Bayer Inc

Australia

  • Xofigo (6)TGA eBS current PI and ARTG confirmed · 6.6 MBq per 6 mL solution for injection vial · Bayer Australia Ltd
View brands in additional countries.

European Union

Xofigo (3)

This page provides general reference information about Xofigo (radium Ra 223 dichloride) and is not a substitute for advice from the oncology team managing your treatment. All dosing, scheduling, and treatment decisions, including any decision to change or stop treatment, should be made with your prescriber.

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