What Xofigo is and what it is used for
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 developing after at least two other cancer treatments except treatment to maintain reduced levels of male sex hormone (hormone therapy), or when another cancer treatment is not possible. Castration-resistant prostate cancer is cancer that does not respond to treatment that reduces male sex hormones. Xofigo is only used when the disease has spread to the bones and is causing symptoms (eg pain), but without known spread to other internal organs.
Xofigo contains the radioactive substance radium-223, which is similar to calcium found in the skeleton. When injected into the patient, radium-223 reaches the bone where cancer has spread and sends out short-range radiation (alpha radiation) that kills the surrounding tumor cells.
What you need to know before using Xofigo
Xofigo must not be given
- in combination with abiraterone acetate and prednisone/prednisolone (used together to treat prostate cancer).
Warnings and precautions
Talk to your doctor before you are given Xofigo
- Xofigo should not be given in combination with abiraterone acetate and prednisone/prednisolone due to a possible increased risk of bone fractures and death. In addition, there is uncertainty about the effects of Xofigo in combination with other drugs used to treat prostate cancer. Tell your doctor if you are already taking any of these medicines.
- If you plan to take Xofigo after treatment with abiraterone and prednisone/prednisolone, you must wait 5 days before starting treatment with Xofigo.
- If you plan to take other cancer medicines after treatment with Xofigo, you must wait at least 30 days before starting treatment.
- Xofigo is not recommended if the bone cancer does not cause any symptoms, e.g. pain.
- Xofigo can reduce the number of blood cells and platelets. Before starting treatment and before each subsequent dose, the doctor will take blood samples. Depending on the results of these tests, the doctor will decide whether the treatment can be started, or continued, or whether it needs to be postponed or stopped.
- If you have reduced production of blood cells in the bone marrow, e.g. due to previous chemotherapy (other medicines used to kill cancer cells) and/or radiotherapy, you may be at greater risk and your doctor will give you Xofigo with caution.
- If your tumor has spread to a large part of the bone, you may also be at higher risk of having a drop in your blood cell and platelet count , so your doctor will give you Xofigo with caution.
- The limited amount of data available does not suggest any major differences in blood cell production in patients who received chemotherapy after treatment with Xofigo compared to those who did 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 intestine) or with ulcerative colitis (a long-term inflammation of the large intestine). As Xofigo is excreted in the feces, acute inflammation of the intestine may worsen. The doctor will therefore carefully consider whether you can be treated with Xofigo if you suffer from any of these conditions.
- If you have untreated spinal cord compression or are likely to develop spinal cord compression (pressure on the spinal cord which may be due to a tumor or other injury), your doctor will first treat this condition with standard treatment before starting or continuing treatment with Xofigo.
- Tell the doctor if you have osteoporosis or a known increased risk of fracture (eg, a recent bone fracture, or fragility ) or are taking or have taken steroids (eg, prednisone/prednisolone). You may have a higher risk of bone fractures. The doctor may prescribe a medicine that prevents bone fractures before starting or resuming treatment with Xofigo.
- Talk to your doctor if you experience new or unusual pain or swelling in the bone area before, during, or after treatment with Xofigo.
- If you have a bone fracture, your doctor will first stabilize the fracture before starting or continuing treatment with Xofigo.
- Tell the doctor if you are taking or have taken bisphosphonates or have received chemotherapy before treatment with Xofigo. The risk of osteonecrosis of the jaw (dead tissue in the jawbone mainly seen in patients treated with bisphosphonates) cannot be excluded (see section 4).
- Xofigo adds to your overall long-term cumulative exposure to radiation. Long-term cumulative exposure to radiation can increase the risk of developing cancer (especially bone cancer and leukemia ) and hereditary abnormalities. No case of cancer caused by Xofigo has been reported in clinical studies with a follow-up period of up to three years.
The doctor will examine your bone health before deciding whether you can take Xofigo. During treatment and for 2 years after starting treatment with Xofigo, the doctor will continuously monitor your bone health.
Children and young people
This medicine is not intended for children and adolescents.
Other medicines and Xofigo
No interaction studies with other drugs have been performed.
Xofigo should not be given in combination with abiraterone acetate and prednisone/prednisolone due to a possible increased risk of bone fractures and death. In addition, there is uncertainty about the effects of Xofigo in combination with other systemic drugs used to treat metastatic prostate cancer. Tell your doctor if you are already taking any of these medicines.
Talk to your doctor before treatment with Xofigo if you are taking or have taken bisphosphonates or other medicines to protect bone health or if you are taking or have taken steroids (eg prednisone/prednisolone). You may have a higher risk of bone fractures.
If you take calcium, phosphate, and/or vitamin D, your doctor will carefully assess whether you should temporarily stop taking these substances before you can 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).
If Xofigo and chemotherapy are used together, the decrease in the number of blood cells and platelets may be increased.
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Pregnancy and breastfeeding
Xofigo is not intended for women and must not be given to women who are or may be pregnant or who are breastfeeding.
Contraception in men and women
If you have sex with a woman who could become pregnant, you should use an effective method of contraception during and up to 6 months after treatment with Xofigo.
Fertility
There is a potential risk that radiation from Xofigo can affect your fertility. Ask your doctor how this may affect you, especially if you plan to have children in the future. You may wish to seek advice on sperm preservation before treatment.
Driving ability and use of machinery
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 (the main ingredient in common/table salt) per dose. This corresponds to 2.7% of the maximum recommended daily intake of sodium for adults.
How Xofigo is used
There are strict laws regarding the use, handling, and destruction of medicines such as Xofigo. It will only be used within specially controlled areas. This medicine will only be handled and given to you by staff trained and qualified to use it safely. The staff will take special care to ensure that the medicine is used safely and will keep you informed of what they are doing.
The dose you receive depends on your body weight. The doctor responsible for the treatment will calculate how much Xofigo should be used for you.
The recommended dose of Xofigo is 55 kBq (becquerel, the unit used to express radioactivity) per kilogram of your body weight.
Does one not need to be adjusted if you are 65 years of age or older or if you have reduced kidney or liver function?
Administration of Xofigo and how the procedure is performed
Xofigo will be injected slowly with a needle into one of your veins ( intravenously ). The healthcare professional will flush the intravenous catheter or needle with saline before and after the injection.
Duration of treatment
- Xofigo is given once every 4 weeks until you have received a total of 6 injections.
- There are no safety and efficacy data available for treatment with more than 6 Xofigo injections.
After administration with Xofigo
- Care should be taken when handling materials, such as bedding, which comes into contact with body fluids (such as spillage of urine, feces, vomit, etc.). Xofigo is mainly excreted in feces. The doctor will tell you if you need to take any special precautions after receiving this medicine. Contact the doctor if you have any questions.
If you have been given too much Xofigo
An overdose is unlikely.
If an accidental overdose occurs, the doctor will institute appropriate supportive treatment and monitor you for changes in blood cell counts and gastrointestinal symptoms (eg diarrhea, nausea, vomiting).
If you have further questions about the use of Xofigo, contact the doctor responsible for the treatment.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects in patients receiving Xofigo are :
- decreased number of blood platelets ( thrombocytopenia )
- reduced number of neutrophils , a type of white blood cell ( neutropenia , which can lead to an increased risk of infection).
Contact your doctor immediately if you notice the following symptoms as they may be signs of thrombocytopenia or neutropenia (see above):
- abnormal bruising
- more bleeding than normal after an injury
- fever
- or if you seem to get many infections .
The doctor will take blood samples before starting treatment and before each injection to check the number of blood cells and platelets (see also section 2).
The most common side effects in patients receiving Xofigo (very common [may affect more than 1 in 10 people]) are :
- diarrhea, nausea, vomiting, thrombocytopenia (reduced number of blood platelets ), bone fracture.
Risk of dehydration: tell the doctor if you have any of the following symptoms: dizziness, increased thirst, decreased urine production, or dry skin as these may be symptoms of dehydration. It is important to avoid dehydration by drinking plenty of water.
Other side effects are listed below according to how common they are:
Common (may affect up to 1 in 10 people)
- decreased number of white blood cells ( leukopenia )
- reduced number of neutrophils , a type of white blood cell ( neutropenia , which can lead to an increased risk of infection)
- reduced number of red and white blood cells and platelets (pancytopenia)
- injection site reactions (eg skin redness ( erythema ), pain and swelling)
Uncommon (may affect up to 1 in 100 people)
- decreased number of lymphocytes , a type of white blood cell (lymphopenia)
- osteoporosis _ _
Xofigo adds to your overall long-term cumulative exposure to radiation. Long-term cumulative exposure to radiation can increase the risk of developing cancer (especially bone cancer and leukemia ) and hereditary abnormalities. No case of cancer caused by Xofigo has been reported in clinical studies with a follow-up period of up to three years.
Contact a doctor if you experience symptoms such as pain, swelling, or numbness in the jaw, “a heavy feeling in the jaw” or tooth loss. Cases of osteonecrosis of the jaw (dead tissue in the jaw bone mainly seen in patients treated with bisphosphonates) have occurred in patients treated with Xofigo. All cases have only occurred in patients who received bisphosphonates before or at the same time as Xofigo treatment and chemotherapy before treatment with Xofigo.
How to store Xofigo
You do not need to store this medicine. The specialist is responsible for this medicine being stored in suitable premises. Storage of radioactive medicines will take place by national regulations for radioactive material.
The following information is intended for the specialist only:
Xofigo must not be used after the expiry date stated on the vial and lead container.
No special temperature instructions.
Xofigo must not be used if it is discolored, contains particles, or if the container is damaged.
Contents of the packaging and other information
Contents declaration
- The active substance is: radium Ra-223 dichloride (radium-223‑dichloride).
One ml of solution contains 1100 kBq radium-223 dichloride, corresponding to 0.58 ng radium-223 at the reference date.
One vial contains 6 ml of solution (6600 kBq of radium-223 dichloride at the reference date). - The other ingredients are water for injections, sodium citrate, sodium chloride, and hydrochloric acid (see the end of section 2 for more information about sodium ).
Appearance and package sizes of the medicine
Xofigo is a clear and colorless solution for injection . It is supplied in a clear glass vial closed with a gray rubber stopper and aluminum seal. The vial contains 6 ml of solution. It is stored in a lead container.
Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Bayer AS
Drammensveien 288
NO-0283 Oslo
Norway