Renseignements supplémentaires sur l'innocuité de XOFIGO®
XOFIGO® (chlorure de radium 223) est indiqué pour le traitement des patients atteints de cancer de la prostate résistant à la castration qui sont porteurs de métastases osseuses symptomatiques et chez qui il n’y a pas de maladie métastatique viscérale connue.
Contre-indications
XOFIGO® should be administered under the supervision of a qualified health professional experienced in the use of therapeutic radiopharmaceuticals.
Geriatrics (>65 years of age): No dosage adjustment is considered necessary in elderly patients. Although no overall differences in safety or efficacy were observed between elderly (aged ≥65 years) and younger patients (aged <65 years), the potential for greater sensitivity of some older individuals cannot be ruled out.
Contraindications
XOFIGO® is contraindicated in pregnancy. XOFIGO® can cause fetal harm. XOFIGO® is not indicated for use in women.
Serious Warnings and Precautions:
Use of Radiopharmaceuticals: Should be used only by those health professionals who are appropriately qualified in the use of radioactive-prescribed substances in or on humans.
Bone Marrow Suppression: Measure blood counts prior to treatment initiation and before every dose.
Other Relevant Warnings and Precautions
- XOFIGO® should be received, stored, used, transferred, administered and disposed of by authorized persons.
- In patients with untreated, imminent, or established spinal cord compression.
- In patients with bone fractures.
- Not recommended for use in combination with abiraterone plus prednisone/prednisolone.
- Caregivers should take precautions to avoid risk of contamination.
- In patients with inflammatory bowel disease and increased risk of bowel obstruction.
- In patients with Crohn’s disease or ulcerative colitis.
- Bone marrow suppression has been reported.
- Men who are sexually active should use condoms. Female partners of reproductive potential should use effective contraception during, and for 6 months after their partner’s treatment with XOFIGO®.
- Adverse effects on testes.
For More Information
See Product Monograph here for important information relating to adverse reactions, drug interactions and dosing information that has not been discussed in this piece. The Product Monograph is also available by calling Bayer Medical Information at 1-800-265-7382.
PP-XOF-CA-0331-1
PP-XOF-CA-0333-1