Sign Out
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypersensitivity and Other Administration Reactions: Advise patients to seek immediate medical attention for any of the following signs and symptoms of systemic administration-related reactions: itchy, runny or blocked nose; chills, nausea, throat irritation, cough, headache, shortness of breath or difficulty breathing, and blurred vision [see Hypersensitivity and Other Administration Reactions under Precautions].
Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis: Advise patients to immediately contact their healthcare provider if they have signs or symptoms of cardiac adverse reactions [see Cardiac Toxicity in Patients with Light Chain (AL) Amyloidosis 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 have bruising or bleeding [see Thrombocytopenia under Precautions].
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 Use in Pregnancy: Embryo-Fetal Toxicity under Precautions, 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 SC and for 3 months after the last dose [see Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Advise patients that lenalidomide, thalidomide or pomalidomide have the potential to cause fetal harm and has specific requirements regarding contraception, pregnancy testing, blood and sperm donation, and transmission in sperm [see Pregnancy and Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Interference with Laboratory Tests: Advise patients to inform their healthcare provider, including personnel at blood transfusion centers, that they are taking DARZALEX SC, in the event of a planned transfusion [see Interference with Serological Testing under Precautions].
Advise patients that DARZALEX SC 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 SC could cause hepatitis B virus to become active again [see Clinical Trials Experience under Adverse Reactions].
