Radium-223 Dichloride

Radium-223 Dichloride is a radiotherapeutic medication used for the treatment of men with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

• Radium-223 Dichloride is available under the following different brand names: Xofigo

Common side effects of Radium-223 Dichloride include:

• nausea
• diarrhea
• vomiting
• swelling of the legs and feet
• low red and white blood cell count as well as low platelets

Serious side effects of Radium-223 Dichloride include:

• peripheral edema
• renal failure and impairment

Rare side effects of Radium-223 Dichloride include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

IV solution

• 1100 kBq/mL (30 microcurie/mL)
• Available as 6 mL/single-use vial

Prostate Cancer

Adult dosage

• 55 kBq (1.49 microcurie) per kg IV infused over 1 minute; repeat every 4 weeks for 6 cycles total
• Dosage calculation must be based on the decay correction factor of radium-223

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Radium-223 Dichloride has no noted severe interactions with other drugs
• Radium-223 Dichloride has no noted serious interactions with other drugs
• Radium-223 Dichloride has no noted moderate interactions with other drugs
• Radium-223 Dichloride has no noted minor interactions with other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Pregnancy; radium-223 can cause fetal harm when administered to a pregnant woman based on its mechanism of action; not indicated for use in women and is contraindicated in women who are or may become pregnant

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Radium-223 Dichloride?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Radium-223 Dichloride?”

Cautions

• May cause myelosuppression and bone marrow failure; perform a hematologic evaluation at baseline and prior to every dose; discontinue if life-threatening complications occur despite supportive care for bone marrow failure
• Safety and efficacy of concomitant chemotherapy have not been established; outside of a clinical trial, concomitant use with chemotherapy is not recommended due to the potential for additive myelosuppression
• Not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials; increased fractures and mortality reported
• Because of the potential effects on spermatogenesis associated with radiation, advise men who are sexually active to use condoms and their female partners of reproductive potential to use a highly effective contraceptive method during and for 6 months after completing treatment

Pregnancy and Lactation

• Safety and efficacy have not been established in women; based on the mechanism of action, the drug can cause fetal harm when administered to a pregnant woman; while there are no human or animal data on use in pregnancy, maternal use of a radioactive therapeutic agent could affect the development of a fetus; Advise pregnant women and women of reproductive potential of the potential risk to the fetus
• Lactation
  • Safety and efficacy are not established in women; there is no data on the presence of Radium-223 Dichloride in human milk, its effects on breastfed child, or on milk production