Xofigo

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Serious side effects have been reported with Xofigo, and certain precautions should be followed:

• lowered blood count. This may cause certain symptoms and may increase the risk that you will develop a serious or life-threatening infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.
• Report signs of dehydration, including lowered blood pressure, inability to urinate, or unusual fatige.

Do not receive Xofigo if you:

• are allergic to Xofigo or to any of its ingredients
• are pregnant

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category X. Xofigo can cause harm to the fetus (unborn baby) if you take this and are pregnant. Xofigo is not indicated for use in women. Xofigo is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if you become pregnant while taking this drug, be aware of the potential hazard to the fetus.

Radium Ra 223 dichloride injection is used to treat men with metastatic prostate cancer that has spread to the bones but to no other organs. It is a radiopharmaceutical agent. Radiopharmaceuticals are radioactive agents that are used to find and treat certain diseases.

This medicine is to be given only by or under the direct supervision of a doctor.

A doctor or other trained health professional will give you this medicine in a hospital or cancer clinic. This medicine is given through a needle placed in one of your veins.

Family members must not be exposed to radiation from this medicine. The fluids from your body can transfer radiation to another person who touches them. Practice good hygiene while you receive this medicine and for at least 1 week after your last dose. Flush the toilet several times after each use. Wash clothes that are soiled with stool or urine promptly and separately from other clothes.

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine can cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are sexually active with a female who could become pregnant, use a condom during therapy and for 6 months after the last dose. Your sexual partner must also use an effective form of birth control during therapy and for 6 months after your last dose. If a pregnancy occurs while you are receiving this medicine, tell your doctor right away.

Xofigo® can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have confusion, a decrease in urine, dizziness, dry mouth, fainting, an increased heart rate, lightheadedness, rapid breathing, sunken eyes, thirst, or unusual tiredness or weakness. These may be symptoms of dehydration.

Check with your doctor right away if you have bloody urine, a decrease in urine, swelling of the face, fingers, or lower legs, trouble breathing, or weight gain. These could be symptoms of kidney problems.

You will be exposed to radiation with this medicine. Talk to your doctor if you have concerns about this.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Xofigo is contraindicated in pregnancy.

Xofigo can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Xofigo is not indicated for use in women. Xofigo is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus [see Use in Specific Populations (8.1)].

The most common adverse drug reactions (≥ 10%) in patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema.

The most common hematologic laboratory abnormalities (≥ 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Xofigo can interact with other medications, herbs, or vitamins you might be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. Your healthcare provider will look out for interactions with your current medications. Always be sure to tell your doctor about all medications, herbs, or vitamins you’re taking.

People with blood problems or disorders

Tell your doctor about your blood problems or disorders. This drug can cause dangerous decreases in the levels of your blood cells. This raises your risk of infections, bleeding, and anemia (very low levels of red blood cells).

People with kidney problems

If you have kidney problems or a history of kidney disease, this drug may damage your kidneys more. Tell your doctor about your kidney problems. Your doctor will likely monitor you closely while you take this drug.

Pregnant women

This drug can cause serious harm to a pregnancy. If you have a female sexual partner, you should both use effective birth control during your treatment with this drug. You should keep using birth control for six months after your treatment is complete. Your doctor can tell you more.

For children

This medication has not been studied in children. It should not be used in people younger than 18 years of age.

When to call the doctor

Call your doctor right away if you have a female sexual partner who becomes pregnant.

Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Taking this drug again if you’ve ever had an allergic reaction to it could be fatal (cause death). Be sure to tell your doctor if you’ve ever had an allergic reaction to this drug.