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Xofigo 1100 kBq/ml injectable solution

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About the medicine

How to use Xofigo 1100 kBq/ml injectable solution

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the Patient

Xofigo 1100 kBq/ml solution for injection

radium Ra 223 dichloride (223Ra)

This medicine is subject to additional monitoring, which will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, who will be responsible for the procedure.
  • If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

  1. What is Xofigo and what is it used for
  1. What you need to know before you are given Xofigo
  2. How to use Xofigo
  3. Possible side effects
  1. Storage of Xofigo
  2. Contents of the pack and other information

1. What is Xofigo and what is it used for

This medicine contains the active substance radium Ra 223 dichloride (223Ra) (radium-223 dichloride).

Xofigo is used to treat adults with advanced prostate cancer that is resistant to medical or surgical treatments that lower testosterone (hormone) levels, and has spread to the bone, and is causing symptoms (e.g. pain).

Xofigo contains the radioactive substance radium-223, which mimics calcium and is taken up by bone. When injected into the patient, radium-223 reaches the bone where the cancer has spread and emits short-range radiation (alpha particles), which destroys the surrounding cancer cells.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you are given Xofigo

Xofigo must not be given

  • In combination with abiraterone and prednisone/prednisolone (which are used together to treat prostate cancer).

Warnings and precautions

Talk to your doctor before you are given Xofigo

  • Xofigo must not be given in combination with abiraterone and prednisone/prednisolone due to a possible increased risk of bone fractures and deaths. Additionally, there are concerns about the effects of Xofigo when given with other medicines used to treat prostate cancer that has spread. Tell your doctor if you are already taking any of these medicines.
  • If you are going to receive Xofigo after treatment with abiraterone and prednisone/prednisolone, you must wait at least 5 days before starting treatment with Xofigo.
  • If you are going to receive another cancer treatment after Xofigo, you must wait at least 30 days before starting the other treatment.
  • Xofigo is not recommended if the cancer in your bones is not causing symptoms, such as pain.
  • Xofigo may cause a decrease in the number of blood cells and platelets in the blood.

Before starting treatment and before each subsequent dose, your doctor will perform a blood test.Based on the results of these tests, your doctor will decide whether treatment can start, continue, or should be delayed or stopped.

  • If you have decreased production of blood cells in the bone marrow, e.g. if you have received chemotherapy (other medicines used to kill cancer cells) and/or radiation therapy, you may be at higher risk and your doctor will give you Xofigo with caution.
  • If your tumour has spread extensively to the bone, you may be more likely to have a decrease in your blood cells and platelets, and your doctor will give you Xofigo with caution.
  • There are limited data that do not suggest any important difference in blood cell production in patients who receive chemotherapy after Xofigo compared to those who do not receive Xofigo.
  • There are no data on the use of Xofigo in patients with Crohn's disease(a long-term inflammatory disease of the intestines) and ulcerative colitis(a long-term inflammation of the colon). Due to the excretion of Xofigo in the faeces, Xofigo may worsen acute inflammation of the intestines. Therefore, if you have these diseases, your doctor will carefully consider whether you can be treated with Xofigo.
  • If you have untreated or suspected spinal cord compression(pressure on the spinal cord nerves that can be caused by a tumour or other injury), your doctor will first treat this condition with standard treatment before starting or continuing treatment with Xofigo.
  • If you have osteoporosis, or a known increased risk of fractures (e.g. recent bone fracture, fragility) or are taking or have taken corticosteroids(e.g. prednisone/prednisolone), please inform your doctor. You may be at higher risk of bone fractures. Your doctor may prescribe a medicine to prevent bone fractures before starting or continuing treatment with Xofigo.
  • If you experience new or unusual painor swelling in a bone areabefore, during, or after treatment with Xofigo, talk to your doctor.
  • If you have a bone fracture, your doctor will first stabilize the fractured bone before starting or continuing treatment with Xofigo.
  • If you are taking or have taken bisphosphonatesor have received prior chemotherapy before Xofigo, inform your doctor. A risk of osteonecrosis of the jaw(dead tissue in the jawbone, mainly seen in patients who have been treated with bisphosphonates) cannot be excluded (see section 4).
  • Xofigo contributes to your overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may increase your risk of developing cancer (in particular, bone cancer and leukaemia) and genetic abnormalities. No cases of cancer caused by Xofigo have been reported in clinical studies with up to three years of follow-up.

Your doctor will perform tests to determine the health of your bones before deciding whether you can receive Xofigo. During treatment and for 2 years after starting treatment with Xofigo, your doctor will continuously monitor the health of your bones.

Children and adolescents

This medicine is not intended for use in children and adolescents.

Other medicines and Xofigo

No studies have been performed on interactions with other medicines.

Xofigo must not be given in combination with abiraterone and prednisone/prednisolone due to a possible increased risk of bone fractures or deaths. Additionally, there are concerns about the effects of Xofigo when given with other systemic medicines used to treat prostate cancer that has spread. Inform your doctor if you are already taking any of these medicines.

If you are taking or have taken bisphosphonates or other medicines to protect the health of your bones or corticosteroids (e.g. prednisone/prednisolone) before Xofigo, inform your doctor. You may be at higher risk of bone fractures.

If you are taking calcium, phosphate, and/or vitamin D, your doctor will carefully consider whether you should temporarily stop taking these before starting treatment with Xofigo.

There are no data on the use of Xofigo at the same time as chemotherapy(other medicines used to kill cancer cells). The combined use of Xofigo and chemotherapy may further decrease the number of blood cells and platelets in the blood.

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pregnancy and breast-feeding

Xofigo must not be used in women and must not be given to women who are, or may be, pregnant or breast-feeding.

Contraceptive methods in women and men

If you have sexual intercourse with a woman who could become pregnant, you are advised to use effective contraceptive methods during treatment with Xofigo and for 6 months after treatment.

Fertility

There is a potential risk that the radiation emitted by Xofigo may affect your fertility. Ask your doctor how this may affect you, especially if you plan to have children in the future. If you wish, ask for advice on sperm preservation before starting treatment.

Driving and using machines

Xofigo is unlikely to affect your ability to drive or use machines.

Xofigo contains sodium

Depending on the volume administered, this medicine may contain up to 54 mg of sodium (a major component of cooking/table salt) per dose unit. This is equivalent to 2.7% of the maximum recommended daily intake of sodium for an adult.

3. How to use Xofigo

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

There is strict legislation on the use, handling, and disposal of medicines like Xofigo. It will only be used in special controlled areas. This radiopharmaceutical will only be handled and administered by trained and qualified personnel in safe conditions. These personnel will take special care to use this radiopharmaceutical safely and will keep you informed of their actions.

The dose you receive will depend on your body weight. The doctor responsible for the procedure will calculate the amount of Xofigo to be used in your case.

The recommended amount of Xofigo is 55 kBq (Becquerel, the unit used to express radioactivity) per kilogram of body weight.

No dose adjustment is needed if you are 65 years of age or older or if you have reduced kidney or liver function.

Administration of Xofigo and procedure

Xofigo will be slowly injected through a needle inserted into one of your veins (intravenously). The healthcare professional will flush the intravenous access line or cannula before and after the injection with a sodium chloride solution.

Duration of the procedure

  • Xofigo is given every 4 weeks for a total of 6 injections.
  • There are no data available on the safety and efficacy of treatment with more than 6 injections of Xofigo.

After administration of Xofigo

  • Be careful when handling materials such as bedding that come into contact with body fluids (e.g. urine spill, faeces, vomit, etc.). Xofigo is mainly excreted in the faeces. Your doctor will tell you if you need to take any special precautions after receiving this medicine. If you have any doubts, talk to your doctor.

If you are given more Xofigo than you should

Overdose is unlikely to occur. However, in case of accidental overdose, your doctor will start the relevant supportive treatment and examine you for changes in blood cell counts and gastrointestinal symptoms (e.g. diarrhoea, nausea [feeling sick], vomiting).

If you have any further questions on the use of Xofigo, ask the doctor responsible for the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effectsin patients treated with Xofigo are

  • decrease in the number of platelets in the blood(thrombocytopenia),
  • decrease in the number of neutrophils, a specific type of white blood cell(neutropenia, which can increase the risk of infection).

Contact your doctor immediately if you noticethe following symptoms, as they may be signs of thrombocytopenia or neutropenia (see above):

  • any unusual bruising,
  • bleedingmore than usual after an injury,
  • fever,
  • if you seem to be getting many infections.

Your doctor will perform blood tests before starting treatment and before each injection to check the number of blood cells and platelets (see also section 2).

The most common side effectsin patients treated with Xofigo (very common [may affect more than 1 in 10 people]) are:

  • diarrhoea, nausea (feeling sick), vomiting, thrombocytopenia (decrease in the number of platelets in the blood), and bone fractures.

Risk of dehydration: tell your doctor if you have any of the following symptoms: dizziness, increased thirst, decreased urination (urine output) or dry skin, as these can be symptoms of dehydration. It is important to avoid dehydration by drinking plenty of fluids.

Other possible side effects are listed below by frequency:

Common(may affect up to 1 in 10 people)

  • decrease in the number of white blood cells (leucopenia)
  • decrease in the number of neutrophils, a specific type of white blood cell (neutropenia, which can increase the risk of infection)
  • decrease in the number of red and white blood cells and platelets in the blood (pancytopenia)
  • reactions at the injection site (e.g. skin redness [erythema], pain, and swelling)

Uncommon(may affect up to 1 in 100 people)

  • decrease in the number of lymphocytes, a specific type of white blood cell (lymphopenia)
  • weak bones (osteoporosis)

Xofigo contributes to your overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may increase your risk of developing cancer (in particular, bone cancer and leukaemia) and genetic abnormalities. No cases of cancer caused by Xofigo have been reported in clinical studies with up to three years of follow-up.

If you have symptoms of pain, swelling, or numbness of the jaw, a "heavy jaw feeling" or tooth loss, contact your doctor. Cases of osteonecrosis of the jaw(dead tissue in the jawbone, mainly seen in patients who have been treated with bisphosphonates) have occurred in patients treated with Xofigo. All these cases were only seen in patients who received bisphosphonates before or at the same time as Xofigo and chemotherapy before Xofigo.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Xofigo

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

This information is intended only for the specialist:

Xofigo must not be used after the expiry date stated on the vial and lead container.

This medicine does not require any special storage temperature.

Do not use Xofigo if you notice discolouration, particles, or defects in the container.

6. Container contents and additional information

Xofigo composition

  • The active ingredientis: radium chloride Ra 223 (223Ra) (radium chloride-223 (223Ra)). Each ml of solution contains 1100 kBq of radium chloride-223 (223Ra), corresponding to 0.58 ng of radium-223 on the calibration date. Each vial contains 6 ml of solution (6600 kBq of radium chloride-223 (223Ra) on the calibration date).
  • The other componentsare: water for injectable preparations, sodium citrate, sodium chloride, and diluted hydrochloric acid (see the end of section 2 for additional information on sodium).

Product appearance and container contents

Xofigo is a clear and colorless injectable solution. It is supplied in a clear glass vial closed with a gray rubber stopper and an aluminum seal. The vial contains 6 ml of solution and is stored in a lead container.

Marketing authorization holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AS

Drammensveien 288

NO-0283 Oslo

Norway

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Belgium / Belgium / Belgium

Bayer SA-NV

Tel: +32-(0)2-535 63 11

Lithuania

UAB Bayer

Tel: +37 05 23 36 868

Bulgaria

Bayer Bulgaria EOOD

Tel: +359 (0)2-424 72 80

Luxembourg / Luxembourg

Bayer SA-NV

Tel: +32-(0)2-535 63 11

Czech Republic

Bayer s.r.o.

Tel: +420 266 101 111

Hungary

Bayer Hungária KFT

Tel: +36 14 87-41 00

Denmark

Bayer A/S

Tlf: +45-45 23 50 00

Malta

Alfred Gera and Sons Ltd.

Tel: +35 621 44 62 05

Germany

Bayer Vital GmbH

Tel: +49 (0)214-30 513 48

Netherlands

Bayer B.V.

Tel: +31-23-799 1000

Estonia

Bayer OÜ

Tel: +372 655 8565

Norway

Bayer AS

Tlf: +47 -23 13 05 00

Greece

Bayer Hellas ABE

Tel: +30 210 61 87 500

Austria

Bayer Austria Ges. m. b. H.

Tel: +43-(0)1-711 46-0

Spain

Bayer Hispania S.L.

Tel: +34-93-495 65 00

Poland

Bayer Sp. z o.o.

Tel: +48 22 572 35 00

France

Bayer HealthCare

Tél (N° vert): +33-(0)800 87 54 54

Portugal

Bayer Portugal, Lda.

Tel: +351 21 416 42 00

Croatia

Bayer d.o.o.

Tel: + 385-(0)1-6599 900

Romania

SC Bayer SRL

Tel: +40 21 529 59 00

Ireland

Bayer Limited

Tel: +353 1 216 3300

Slovenia

Bayer d. o. o.

Tel: +386 (0)1 58 14 400

Iceland

Icepharma hf.

Tel: +354 540 8000

Slovak Republic

Bayer, spol. s r.o.

Tel: +421 2 59 21 31 11

Italy

Bayer S.p.A.

Tel: +39 02 397 81

Finland

Bayer Oy

Tel: +358 20 785 21

Cyprus

NOVAGEM Limited

Tel: +357 22 48 38 58

Sweden

Bayer AB

Tel: +46 (0) 8 580 223 00

Latvia

SIA Bayer

Tel: +371 67 84 55 63

Date of the last revision of this leaflet {MM/YYYY}.

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.

<-----------------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

The Summary of Product Characteristics or the Product Characteristics of Xofigo is included in its entirety in a section at the end of the printed leaflet in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Online doctors for Xofigo 1100 kBq/ml injectable solution

Discuss questions about Xofigo 1100 kBq/ml injectable solution, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Frequently Asked Questions

Is a prescription required for Xofigo 1100 kBq/ml injectable solution?
Xofigo 1100 kBq/ml injectable solution requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in Xofigo 1100 kBq/ml injectable solution?
The active ingredient in Xofigo 1100 kBq/ml injectable solution is radium (223Ra) dichloride. This information helps identify medicines with the same composition but different brand names.
Who manufactures Xofigo 1100 kBq/ml injectable solution?
Xofigo 1100 kBq/ml injectable solution is manufactured by Bayer Ag. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of Xofigo 1100 kBq/ml injectable solution online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether Xofigo 1100 kBq/ml injectable solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to Xofigo 1100 kBq/ml injectable solution?
Other medicines with the same active substance (radium (223Ra) dichloride) include LUTATHERA 370 MBq/mL SOLUTION FOR INFUSION, PLUVICTO 1000 MBq/mL Injectable Solution and Perfusion Solution, ZEVALIN 1.6 mg/ml, REACTIVE KIT FOR THE PREPARATION OF A RADIOPHARMACEUTICAL FOR PERFUSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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