This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00010/0710.
Xofigo 1100 kBq/mL solution for injection
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Xofigo 1100 kBq/mL solution for injection
radium Ra 223 dichloride
▼This medicine is subject to additional monitoring. This 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.
1. What Xofigo is and what it is used for
2. What you need to know before Xofigo is used
3. How Xofigo is used
4. Possible side effects
5. How Xofigo is stored
6. Contents of the pack and other information
This medicine contains the active substance radium Ra 223 dichloride (radium-223 dichloride).
Xofigo is used to treat adults with advanced castration-resistant prostate cancer in progression after at least two other cancer treatments apart from treatments to maintain reduced levels of male hormone (hormone therapy), or who cannot take any other cancer treatment. Castration-resistant prostate cancer is a cancer of the prostate (a gland of the male reproductive system) that does not respond to treatment that reduces male hormones. Xofigo is only used when the disease has spread to the bone but is not known to have spread to other internal organs, and is causing symptoms (e.g. pain).
Xofigo contains the radioactive substance radium-223 which mimics the calcium found in bones. When injected into the patient, radium-223 reaches the bone where the cancer has spread to and emits short-range radiation (alpha particles) which kills the surrounding tumour cells.
Talk to your doctor before you are given Xofigo
Your doctor will test your bone health before deciding whether you can be given Xofigo. During treatment and for 2 years after starting treatment with Xofigo, your doctor will continuously monitor your bone health.
This medicine is not for use in children and adolescents.
No interaction studies with other medicines have been done.
Xofigo must not be given in combination with abiraterone and prednisone/prednisolone due to a possible increase in the risk of bone fracture or death. Additionally, there are uncertainties about the effects of Xofigo in combination with other systemic medicines used to treat metastatic prostate cancer. If you are already taking one of those medicines, please tell your doctor.
If you take or have taken bisphosphonates or other medicines to protect your bone health or steroids (e.g. prednisone/prednisolone) prior to treatment with Xofigo, please tell your doctor. You might be at a higher risk for bone fractures.
If you are taking calcium, phosphate and/or Vitamin D, your doctor will carefully consider if you need to temporarily stop taking these substances before you start 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). Xofigo and chemotherapy used together may further decrease the number of your blood cells and blood platelets.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Xofigo is not for use in women and must not be given to women who are, or may be, pregnant or who are breast-feeding.
If you are engaged in sexual activity with a woman who could become pregnant you are advised to use effective birth control methods during and up to 6 months after treatment with Xofigo.
There is a potential risk that radiation from Xofigo could affect your fertility. Please ask your doctor how this may affect you, especially if you are planning to have children in the future. You may wish to seek advice on conservation of sperm before treatment starts.
It is considered unlikely that Xofigo will affect your ability to drive or to use machines.
Depending on the volume administered, this medicine can contain up to 54 mg sodium (main component of cooking/table salt) per dose. This is equivalent to 2.7% of the recommended maximum daily dietary intake of sodium for an adult.
There are strict laws on the use, handling and disposal of medicines like Xofigo. It will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions.
The dose you receive depends on your body weight. The doctor supervising the procedure will calculate the quantity of Xofigo to be used in your case.
The recommended dose of Xofigo is 55 kBq (Becquerel, the unit used to express radioactivity) per kilogram body weight.
No dose adjustment is necessary if you are 65 years of age or older or if you have reduced kidney or liver function.
Xofigo will be injected slowly via a needle into one of your veins (intravenously). The healthcare professional will flush the intravenous access line or cannula before and after injection with a saline solution.
An overdose is unlikely.
However, in the case of an accidental overdose, your doctor will start appropriate supportive treatment and will check you for changes in the number of blood cells, and for gastrointestinal symptoms (e.g. diarrhoea, nausea [feeling sick], vomiting).
If you have any further questions on the use of Xofigo, please ask the doctor who supervises the procedure.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects in patients receiving Xofigo are
Contact your doctor immediately if you notice the following symptoms as they may be signs of thrombocytopenia or neutropenia (see above):
Your doctor will perform blood tests before starting treatment and before each injection to check your number of blood cells and platelets (see also section 2).
The most frequent side effects in patients receiving Xofigo (very common [may affect more than 1 in 10 people]) are:
Risk of dehydration: tell your doctor if you have any of the following symptoms: dizziness, increased thirst, decreased urination or dry skin as these can all be symptoms of dehydration. It is important to avoid dehydration by drinking plenty of fluids.
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Xofigo contributes to your overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may increase your risk of developing cancer (in particular of bone cancer and leukaemia) and hereditary abnormalities. No cases of cancer caused by Xofigo have been reported in clinical trials with a follow-up of up to three years.
If you have symptoms of pain, swelling or numbness of the jaw, a “heavy jaw feeling” or loosening of a tooth, please contact your doctor. Cases of osteonecrosis of the jaw (dead tissue in the jaw bone which is 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 receiving bisphosphonates prior to or at the same time of treatment with Xofigo and chemotherapy prior to treatment with Xofigo.
If you get any side effects talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmaceuticals will be in accordance with national regulations on radioactive materials.
Xofigo must not be used after the expiry date which is stated on the vial and the lead pot.
This medicine does not require any special temperature storage conditions.
Xofigo must not be used if discolouration, the occurrence of particulate matter or a defective container is noticed.
Xofigo is a clear and colourless solution for injection. It is supplied in a colourless glass vial closed with a grey rubber stopper and aluminium seal. The vial contains 6 mL of solution. It is stored in a lead pot.
For any information about this medicine, please contact Bayer plc, Tel: 0118 206 3000.
This booklet was last revised in January 2021.
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