Xofigo treatment schedule Xofigo is given as 6 separate injections 4 weeks apart. Your last Xofigo injection will be 20 weeks (about 4 and a half months) after your first injection.
How often can I take Xofigo®?
It is given once every 4 weeks for a maximum of 6 doses. The amount of Xofigo® that you will receive depends on many factors, including your weight, and your general health or other health problems. Your doctor will determine your exact dosage and schedule. Important things to remember about the side effects of Xofigo®:
What are the possible side effects of Xofigo®?
The following side effects are common (occurring in greater than 10%) for patients taking Xofigo®: 1 Nausea. 2 Vomiting. 3 Diarrhea. 4 Swelling of the lower legs and hands [ peripheral edema]. 5 Low blood counts. Your white and red blood cells and platelet counts may temporarily decrease...
How will my doctor check my blood work while taking Xofigo®?
You will be checked regularly by your doctor while you are taking Xofigo®, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) these tests will be ordered by your doctor.
What is the concentration of Xofigo in a vial?
Xofigo (radium Ra 223 dichloride injection) is available in single-use vials containing 6 mL of solution 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 referencedate.
Indication
Xofigo ® (radium Ra 223 dichloride) injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body.
Which do you best identify with?
If you select "I'm a caregiver" or "I'm a loved one," please answer the following questions on behalf of the prostate cancer patient that you care for.
How long after Xofigo can you use condoms?
Because of potential effects on spermatogenesis associated with radiation, advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo [see Use in Specific Populations ( 8.1 )]. Infertility.
What is Xofigo used for?
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
How much radium is in Xofigo?
Xofigo is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with pH between 6 and 8. Each milliliter of solution contains 1,100 kBq radium-223 dichloride (30 microcurie), corresponding to 0.58 ng radium-223, at the reference date.
What is the active moiety of Xofigo?
The active moiety of Xofigo is the 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 (see Table 2).
How many microcuries are in Xofigo?
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.
Is Xofigo safe for breastfed babies?
The safety and efficacy of Xofigo have not been established in females. There is no data on the presence of radium-223 dichloride in human milk, the effects on the breastfed child, or the effects on milk production.
Can Xofigo be used in pregnancy?
While there are no human or animal data on the use of Xofigo in pregnancy, maternal use of a radioactive therapeutic agent could affect development of a fetus. Advise pregnant females and females of reproductive potential of the potential risk to a fetus.
What are the side effects of Xofigo?
The most common side effects of Xofigo include: nausea. diarrhea. vomiting. swelling of the arms or legs (peripheral edema) low blood cell counts. Tell your healthcare provider if you have any side effects that bother you or do not go away.
What is Xofigo used for?
Xofigo ® (radium Ra 223 dichloride) injection is used to treat prostate cancer that no longer responds to hormonal or surgical treatment that lowers testosterone. It is for men whose prostate cancer has spread to the bone with symptoms but not to other parts of the body.
What is Xofigo radioactive material?
Xofigo contains the radioactive material. X radioactive material. A substance that gives off radiation as it de cays. radium 223. It goes to areas in your bones that are growing quickly, just like calcium does. Bone metastases. X Bone metastases.
Does Xofigo have a short range?
Even though Xofigo gives off a strong energy, it has a short range that does limited damage to healthy cells around it. Xofigo can be absorbed by other organs, primarily the bone marrow and digestive system, which may result in side effects in those healthy tissues. HOW XOFIGO. MAY HELP.
Is Xofigo safe for women?
It is not known if Xofigo is safe and effective in women. Xofigo can harm unborn babies when given to a pregnant woman. Men should use condoms and make sure female partners who may become pregnant use birth control (contraception) during treatment and for 6 months after completing treatment with Xofigo.
Can you get blood tests before Xofigo?
In addition, there were some deaths and blood transfusions that occurred due to severe bone marrow problems. Your healthcare provider will do blood tests before and during treatment with Xofigo. are receiving any chemotherapy or another extensive radiation therapy.
Can you contact other people after taking Xofigo?
there are no restrictions regarding personal contact ( visual or physical proximity) with other people after receiving Xofigo. people who are handling fluids such as urine, feces, or vomit of a man taking Xofigo should wear gloves and wash their hands as precaution.
What should I do if I spill Xofigo?
In the event of spillage of Xofigo, the local radiation safety officer should be contacted immediately to initiate the necessary measurements and required procedures to decontaminate the area.
What is Xofigo subject to?
The receipt, storage, use, transfer and disposal of Xofigo are subject to the regulations and/or appropriate licenses of the competent official organization. Xofigo should be handled by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
How many microcuries are in Xofigo?
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.
Is Xofigo radiation safe?
Radiation protection. The administration of Xofigo is associated with potential risks to other persons ( e.g., medical staff, care givers and patient’s household members) from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit.
Can Xofigo be mixed with a solution?
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Xofigo is a ready-to-use solution and should not be diluted or mixed with any solutions. Each vial is for single use only.
How often can you take Xofigo?
It is given once every 4 weeks for a maximum of 6 doses. The amount of Xofigo® that you will receive depends on many factors, including your weight, and your general health or other health problems. Your doctor will determine your exact dosage and schedule.
How is Xofigo given?
How Xofigo® Is Given: Xofigois given through a vein (intravenously, IV), as a slow [intravenous] injection, over about 1 minute. There is no pill form of Xofigo®. It is given in a clinic or facility where healthcare providers or technicians have been trained to give radiation therapy.
What is Xofigo 223?
Xofigo®. Radium 223 Dichloride is the generic name for the trade name drug Xofigo®. In some cases, health care professionals may use the trade name Xofigo® when referring to the generic drug name radium 223 dichloride.
How often should I drink fluid?
Use gloves when touching body fluids. Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise. You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
Can Xofigo be given to pregnant women?
Pregnancy category X (Xofigo® may cause fetal harm when given to a pregnant woman). This drug must not be given to a pregnant woman or a woman who intends to become pregnant. If a woman becomes pregnant while taking Xofigo®, the medication must be stopped immediately and the woman given appropriate counseling).
Is Xofigo a side effect?
Xofigo® side effects are often predictable in terms of their onset, duration, and severity. Xofigo® side effects will improve after therapy is complete. Xofigo® side effects may be quite manageable. There are many options to minimize or prevent the side effects of Xofigo®.
Can you take aspirin with Xofigo?
Do not take aspirin, products containing aspirin unless your doctor specifically permits this. Xofigo® is not currently indicated for use in women. However, if Xofigo® is given to a woman, getting pregnant should be avoided and the woman should not breast feed.
Indications and Usage For Xofigo
Xofigo Dosage and Administration
- 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. The volume to be administered to a given patient should be calculated using the: • 1. Pa… - 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 [see Dosage and Administration (2.3)].
Dosage Forms and Strengths
- Xofigo (radium Ra 223 dichloride injection) is available in single-dose vials containing 6 mL of clear, colorless solution 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 referencedate.
Warnings and Precautions
- Bone Marrow Suppression
In the randomized trial, 2% of patients on the Xofigo arm experienced bone marrow failure or ongoing pancytopenia compared to no patients treated with placebo. There were two deaths due to bone marrow failure and for 7 of 13 patients treated with Xofigo, bone marrow failure was on… - Increased Fractures and Mortality in Combination with Abiraterone plus Prednisone/Prednisolone
Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. The clinical efficacy and safety of concurrent initiation of Xofigo treatment and abiraterone acetate plus prednisone/prednisolone treatment w…
Adverse Reactions
- The following serious adverse reactions are discussed in greater detail in another section of the label: • 1. Bone Marrow Suppression [see Warnings and Precautions (5.1)]
Drug Interactions
- No formal clinical drug interaction studies have been performed. Subgroup analyses indicated that the concurrent use of bisphosphonates or calcium channel blockers did not affect the safety and efficacy of Xofigo in the randomized clinical trial.
Use in Specific Populations
- 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 [see Clinical Pharmacology (12.1)]. While there are no human or animal data on the use of Xofigo in pregnan… - Lactation
Risk Summary The safety and efficacy of Xofigo have not been established in females. There is no data on the presence of radium-223 dichloride in human milk, the effects on the breastfed child, or the effects on milk production.
Overdosage
- There have been no reports of inadvertent overdosing of Xofigo during clinical studies. 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 …
Xofigo Description
- Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug. Xofigo is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with pH between 6 and 8. Each milliliter of solution contains 1,100 kBq radium-223 dichloride (30 microcurie), corresponding to 0.58 ng radium-223, at the reference date. Radium i…
Xofigo - Clinical Pharmacology
- Mechanism of Action
The active moiety of Xofigo is the 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 (see Table 2). The high linear energ… - Pharmacodynamics
Compared with placebo, there was a difference in favor of Xofigo for all five serum biomarkers for bone turnover studied in a phase 2 randomized study (bone formation markers: bone alkaline phosphatase [ALP], total ALP and procollagen I N propeptide [PINP], bone resorption markers: C …