PERTINENT WARNINGS & PRECAUTIONS

• DARZALEX can cause severe and/or serious infusion-related reactions.¹
  • In case of infusion-related reactions of any severity, your healthcare provider will interrupt or permanently discontinue DARZALEX treatment if anaphylactic reactions or life-threatening infusion-related reactions occur.
  • You should 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.
• DARZALEX may cause ocular adverse reactions. If ocular symptoms occur, your healthcare provider will interrupt DARZALEX treatment and you will need to seek immediate ophthalmologic evaluation prior to restarting DARZALEX.¹
• DARZALEX may interfere with the results of blood tests that determine what your blood type is.¹
  • Your healthcare provider will notify blood transfusion centers and blood blanks after you have received DARZALEX. Your healthcare provider will determine your blood type and screen prior to starting DARZALEX.¹
• DARZALEX may cause reduction in the number of white blood cells and platelets. Your healthcare provider will monitor complete blood cell counts periodically during DARZALEX treatment.¹
  • If you are diagnosed with neutropenia (when you have a fever) or thrombocytopenia (when you have bruising or bleeding), your healthcare provider may decide to withhold treatment with DARZALEX to allow for complete recovery of neutrophils and platelets.
• DARZALEX can cause fetal harm.¹
  • DARZALEX may have a potential risk to the fetus.
  • Females of reproductive potential must use effective contraception while receiving DARZALEX and for 3 months after the last dose of DARZALEX.

summary

Here is a passage from the DARZALEX MEDICATION GUIDE which may be helpful to address your question¹:

What are the possible side effects of DARZALEX?

• DARZALEX may cause serious reactions, including¹:
  • Infusion-related reactions: Infusion-related reactions are common with DARZALEX. Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death, can happen with DARZALEX. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX if you have infusion-related reactions. Get medical help right away if you get any of the following symptoms:
    • Shortness of breath or trouble breathing
    • Dizziness or lightheadedness (hypotension)
    • Cough
    • Wheezing
    • Heart beating faster than usual
    • Low oxygen in the blood (hypoxia)
    • Throat tightness or irritation
    • Runny or stuffy nose
    • Headache
    • Itching
    • High blood pressure
    • Eye pain
    • Nausea
    • Vomiting
    • Chills
    • Fever
    • Chest discomfort
    • Blurred vision
  • Changes in blood tests: DARZALEX can affect the results of blood tests to match your blood type. These changes can last for up to 6 months after your final dose of DARZALEX. Your healthcare provider will do blood tests to match your blood type before you start treatment with DARZALEX. Tell all of your healthcare providers that you are being treated with DARZALEX before receiving blood transfusions.
  • Decreases in blood cell counts: DARZALEX can decrease white blood cell counts which help fight infections and blood cells called platelets which help to clot blood. Decreases in blood cell counts are common with DARZALEX, but can be severe. Your healthcare provider will check your blood cell counts during treatment with DARZALEX. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.
• The most common side effects of DARZALEX include¹:
  • Cold-like symptoms (upper respiratory infection)
  • Diarrhea
  • Constipation
  • Decreased red blood cells
  • Nerve damage causing tingling, numbness or pain
  • Tiredness
  • Swollen hands ankles or feet
  • Nausea
  • Cough
  • Fever
  • Shortness of breath
  • Feeling weak
• These are not all the possible side effects of DARZALEX. Call your doctor for medical advice about side effects.¹
• You may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.¹

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the PATIENT MEDICATION GUIDE for DARZALEX.¹