Xofigo

Xofigo is a radiopharmaceutical agent used to treat men who have prostate cancer that has spread exclusively to the bones (metastasis).

Radiopharmaceutical agents are drugs that contain radioactive elements and are used to diagnose or treat certain medical conditions.

Xofigo injection is administered by a doctor or a health professional in the presence of a doctor. It is available in a solution form.

If you are about to start using Xofigo, speak with your doctor about what you need to know.

Take care of the following factors before using this medicine:

Allergies: Inform your doctor if are allergic to this medicine, any other medicines or foods, dyes, or preservatives.

Pediatric: Safety and efficacy of this medicine in children have not been well documented.

Geriatric: It may be used in elderly after assessing risks and benefits of the use.

Pregnancy: It falls under pregnancy category X for all trimesters meaning that it should not be used in pregnancy as the risks to the baby in the womb are higher than the benefits of the use.

Breastfeeding: Assess risks and benefits of the use of using a nursing mother.

Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions.

Inform your doctor about your intake of other prescription or nonprescription medicines, if any.

Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions.

Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe.

Inform your doctor about the following conditions, if any:

• Bone marrow disorders
• Leukopenia (low white blood cell count)
• Thrombocytopenia (low platelet count): Use cautiously

Proper usage of Xofigo requires strict adherence to your doctor’s orders. This medicine is injected into your vein by a doctor or other health professional.

Here are some points to consider:

• Do not let your family members or anyone come in contact with your body fluids, to avoid radiation exposure.
• Follow proper hygiene measures during and at least one week after the completion of therapy.
• Properly clean your toilet with excess water after each use.
• Keep aside and properly wash your clothes that have been contaminated with your body fluids.

Before using Xofigo, there are some precautions you must take. Your progress should be regularly monitored to determine if you are responding to the treatment. You may also need blood tests to detect any undesirable effects. Remember:

Fetus in a woman who had become pregnant while the father was using this medicine is also affected. Therefore, avoid pregnancy for at least six months after the completion of therapy. If a pregnancy is suspected, call your doctor immediately.

This medicine can affect your white blood cell as well as platelet count thereby increasing your chances of acquiring infections or bleeding.

So, call your doctor immediately if:

• You suspect you have acquired an infection or have symptoms of infection, such as fever or chills, cough or hoarseness, pain in lower back or side, or urinary problems. Avoid getting infected as far as possible. Practice proper hygiene and stay away from ill people.
• Have any abnormal bleeding or bruising, black, tar-like stools, bloody urine or stools, or red dots on your skin. Take care while using any sharp instruments such as a razor or a nail clipper, to avoid the risk of bleeding.

Consult your doctor immediately if you:

• Experience any symptom of dehydration, such as confusion, decreased urine volume or frequency, dizziness, dryness of mouth, fainting, rapid heartbeat, fast breathing, depressed eyes, excessive, or abnormal tiredness.
• Notice symptoms of kidney impairment such as blood in urine, decreased urine volume, swollen face, fingers, or lower legs, breathing difficulties, or abnormal weight gain.

Make sure you meet with your doctor in using Xofigo to avoid unwanted potential side effects.

Consult your doctor immediately if you experience any of the following side effects:

More common:

• Black, tar-like stools
• Bleeding from gums
• Swollen face, extremities or glands
• Bloody urine or stools
• Pain in throat, chest, lower back or side
• Cough
• Fever with or without chills
• Pain while urinating
• Paleness
• Red dots on the skin
• Rapid weight gain
• Rapid, shallow breath
• Tingling sensations in the limbs
• Breathing difficulties
• Abnormal bleeding or bruising
• Excessive tiredness

Less common:

• Confusion
• Less frequent urination
• Decreased urine output
• Dizziness
• Dry mouth
• Tendency to faint
• High fever
• Hoarseness
• Rapid heartbeat
• Elevated blood pressure
• Excessive thirst
• Decreased appetite
• Nausea and vomiting
• Fast breathing
• Depressed eyes
• Weight gain
• Wrinkles on the skin

Mild and non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

More common:

• Diarrhea

Less common:

• Red, painful, and swollen injection site

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.