Pertinent WARNINGS and PRECAUTIONS

• DARZALEX FASPRO can cause hypersensitivity and other administration reactions. Your health care provider will permanently discontinue DARZALEX FASPRO in the event of any life-threatening reactions.¹
  • Get medical help right away if you experience any of the following signs and symptoms: itchy, runny, or blocked nose; chills, nausea, throat irritation, cough, headache, shortness of breath or difficulty breathing, and blurred vision.
• Before you receive DARZALEX FASPRO for light chain (AL) amyloidosis, tell your healthcare provider if you have a history of heart problems. DARZALEX FASPRO should not be used in patients with AL amyloidosis with highly advanced heart disease outside of clinical trials.¹
• Your health care provider will monitor complete blood counts periodically during 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 FASPRO to allow for complete recovery of neutrophils or platelets.
• DARZALEX FASPRO may cause fetal harm.¹
  • DARZALEX FASPRO may have a potential risk to the fetus. Females with reproductive potential must use effective contraception while receiving DARZALEX FASPRO and for 3 months after the last dose of DARZALEX FASPRO.
• DARZALEX FASPRO may interfere with crossmatching and red blood cell (RBC) antibody screening.¹
• DARZALEX FASPRO may cause ocular adverse reactions. You should interrupt DARZALEX FASPRO and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO.¹
• Your healthcare provider will notify blood transfusion centers and blood banks after you have received DARZALEX FASPRO. Your healthcare provider will determine your blood type and screen prior to starting DARZALEX FASPRO.¹

summary

Here is a passage from the DARZALEX FASPRO PATIENT INFORMATION which may be helpful in addressing your question¹:

What are the possible side effects of DARZALEX FASPRO?

• DARZALEX FASPRO may cause serious reactions, including the following¹:
  • Serious allergic reactions and other severe injection-related reactions: Serious allergic reactions and reactions due to the release of certain substances by your body (systemic) that can lead to death can occur with DARZALEX FASPRO. Your healthcare provider may temporarily stop or completely stop treatment with DARZALEX FASPRO if you have a serious reaction. Tell your healthcare provider or get medical help right away if you experience any of the following symptoms during or after an injection of DARZALEX FASPRO:
    • 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 Pain
    • Blurred vision
  • Injection site reactions: Skin reactions at or near the injection site (local), including injection site reactions, can occur with DARZALEX FASPRO. Symptoms at the site of injection may include itching, swelling, bruising, pain, rash, bleeding, or redness of the skin. These reactions sometimes occur more than 24 hours after an injection of DARZALEX FASPRO.
  • Heart problems in people with AL amyloidosis: Heart problems, in some cases fatal, have occurred. Your healthcare provider will monitor you closely during treatment with DARZALEX FASPRO. Call your healthcare provider right away if you experience any of the following symptoms: chest pain, feeling faint, swollen legs, shortness of breath, or abnormal heart rhythm.
  • Decreases in blood cell counts: DARZALEX FASPRO can decrease white blood cell (WBC) counts, which help fight infections, and blood cells called platelets, which help to clot blood. Decreases in blood cell counts are common with DARZALEX FASPRO, but can be severe. Your healthcare provider will check your blood cell counts during treatment with DARZALEX FASPRO. Tell your healthcare provider if you develop fever or have signs of bruising or bleeding.
  • Changes in blood tests: DARZALEX FASPRO 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 FASPRO. Your healthcare provider will perform blood tests to match your blood type before starting treatment with DARZALEX FASPRO. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO before receiving blood transfusions.
• The most common side effects of DARZALEX FASPRO when used alone include: coldlike symptoms (upper respiratory infection) and decreased RBC counts.¹
• The most common side effects of DARZALEX FASPRO when used in combination therapy include¹:
  • Tiredness
  • Fever
  • Cold-like symptoms (upper respiratory infection)
  • Nausea
  • Cough
  • Nerve damage causing tingling, numbness, or pain
  • Diarrhea
  • Muscle spasms
  • Constipation
  • Shortness of breath
  • Back pain
  • Lung infection (pneumonia)
  • Trouble sleeping
  • Vomiting
  • Swollen hands, ankles, or feet
  • Headache
  • High blood pressure
  • Decreased RBC counts
  • Rash
  • Muscle, bone, and joint pain
• These are not all of the possible side effects of DARZALEX FASPRO. Call your doctor for medical advice about side effects.¹
• You may report side effects to the Food and Drug Administration (FDA) at 1800FDA-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 team(s) to discuss the information in this response.

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