Remicade Patient Counseling Information

Patients or their caregivers should be advised of the potential benefits and risks of REMICADE. Healthcare providers should instruct their patients or their caregivers to read the Medication Guide before starting REMICADE therapy and to reread it each time they receive an infusion.
Infections: Inform patients that REMICADE increases the risk for developing serious infections. Instruct patients of the importance of contacting their healthcare provider if they develop any symptoms of an infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Serious Infections and Hepatitis B Virus Reactivation under Precautions].
Malignancies: Malignancies have been reported among children, adolescents and young adults who received treatment with TNF blockers. Patients should be counseled about the risk of lymphoma and other malignancies while receiving REMICADE [see Malignancies under Precautions].
Hepatotoxicity: Instruct patients to seek medical attention if they develop signs or symptoms of hepatotoxicity (e.g., jaundice) [see Hepatotoxicity under Precautions].
Heart Failure: Instruct patients to seek medical attention and consult their prescriber if they develop signs or symptoms of heart failure [see Contraindications; Heart Failure under Precautions].
Hematologic Reactions: Instruct patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever) while on REMICADE [see Hematologic Reactions under Precautions].
Hypersensitivity: Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Hypersensitivity under Precautions].
Cardiovascular and Cerebrovascular Reactions During and After Infusion: Advise patients to seek immediate medical attention if they develop any new or worsening symptoms of cardiovascular and cerebrovascular reactions which have been reported during and within 24 hours of initiation of REMICADE infusion [see Cardiovascular and Cerebrovascular Reactions During and After Infusion under Precautions].
Neurologic Reactions: Advise patients to seek medical attention if they develop signs or symptoms of neurologic reactions [see Neurologic Reactions under Precautions].
Live Vaccines/Therapeutic Infectious Agents: Instruct REMICADE-treated patients to avoid receiving live vaccines or therapeutic infectious agents [see Vaccinations and Use of Live Vaccines/Therapeutic Infectious Agents under Precautions].