Darzalex Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Infusion-Related Reactions: Advise patients to seek immediate medical attention for any of the following signs and symptoms of infusion-related reactions: itchy, runny or blocked nose; fever, chills, nausea, vomiting, throat irritation, cough, headache, dizziness or lightheadedness, tachycardia, chest discomfort, wheezing, shortness of breath or difficulty breathing, itching, and blurred vision [see Infusion-Related Reactions under Precautions].
Neutropenia: Advise patients to contact their healthcare provider if they have a fever [see Neutropenia under Precautions].
Thrombocytopenia: Advise patients to contact their healthcare provider if they notice signs of bruising or bleeding [see Thrombocytopenia under Precautions].
Interference with Laboratory Tests: Advise patients to inform their healthcare providers, including personnel at blood transfusion centers that they are taking DARZALEX, in the event of a planned transfusion [see Interference with Serological Testing under Precautions].
Advise patients that DARZALEX can affect the results of some tests used to determine complete response in some patients and additional tests may be needed to evaluate response [see Interference with Determination of Complete Response under Precautions].
Hepatitis B Virus (HBV) Reactivation: Advise patients to inform healthcare providers if they have ever had or might have a hepatitis B infection and that DARZALEX could cause hepatitis B virus to become active again [see Clinical Trials Experience under Adverse Reactions].
Embryo-Fetal Toxicity: Advise pregnant women of the potential hazard to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Advise females of reproductive potential to avoid becoming pregnant during treatment with DARZALEX and for at least 3 months after the last dose [see Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Advise patients that lenalidomide, pomalidomide, or thalidomide has the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm. Lenalidomide, pomalidomide, and thalidomide are only available through a REMS program [see Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].