Darzalex

Darzalex Patient Counseling Information

daratumumab

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Patient Counseling Information
Advise the patient to read the approved patient labeling (Patient Information).
Infusion Reactions: Advise patients to seek immediate medical attention for any of the following signs and symptoms of infusion reactions: itchy, runny or blocked nose; chills, nausea, throat irritation, cough, headache, shortness of breath or difficulty breathing (see Infusion Reactions under Precautions and Adverse Reactions).
Neutropenia: Advise patients that if they have a fever, they should contact their healthcare professional (see Neutropenia under Precautions and Adverse Reactions).
Thrombocytopenia: Advise patients to inform their healthcare professional if they notice signs of bruising or bleeding (see Thrombocytopenia under Precautions and Effects of Daratumumab on Laboratory Tests under Interactions).
Interference with Laboratory Tests: Advise patients to inform healthcare providers including blood transfusion centers/personnel that they are taking DARZALEX, in the event of a planned transfusion (see Interference with Serological Testing under Precautions and Effects of Daratumumab on Laboratory Tests under Interactions).
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 and Effects of Daratumumab on Laboratory Tests under Interactions).
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 Adverse Reactions].
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