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Side Effects | DARZALEX® & DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

TREATMENT SIDE EFFECTS

You may experience side effects from treatment. Side effects are an unwanted or unexpected reaction to a drug that can occur anywhere in the body due to the administration of treatment. Tell your healthcare provider if you have any side effects that are bothersome or that do not go away.

Side effects

Serious allergic reactions and reactions due to release of certain substances by your body (systemic) that can lead to death can happen 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 get any of these symptoms during or after an injection of DARZALEX FASPRO®. Signs and symptoms of serious allergic reactions include:

  • 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

Skin reactions at or near the injection site (local), including injection-site reactions, can happen with DARZALEX FASPRO®. Symptoms may include:

  • Itching
  • Swelling
  • Bruising
  • Pain
  • Rash
  • Bleeding
  • Redness of the skin

These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO®.

In a safety analysis of patients from clinical studies, 8% (72 out of 898) of patients had local injection-site reactions with injection-site redness (erythema) being the most frequent.

The most common side effects of DARZALEX FASPRO® when used alone include cold-like symptoms (upper respiratory infection) and decreased red blood cell counts.

The most common side effects of DARZALEX FASPRO® used in combination therapy include:

  • Tiredness
  • Nausea
  • Diarrhea
  • Shortness of breath
  • Trouble sleeping
  • Headache
  • Fever
  • Cough
  • Muscle spasms
  • Back pain
  • Vomiting
  • High blood pressure
  • Cold-like symptoms (upper respiratory infection)
  • Nerve damage causing tingling, numbness, or pain
  • Constipation
  • Lung infection (pneumonia)
  • Swollen hands, ankles, or feet
  • Decreased red blood cell count

Tell your healthcare provider if you have any side effects that are bothersome or that do not go away.

These are not all the possible side effects of DARZALEX FASPRO®. Call your doctor for medical advice about side effects.

Have questions about treatment with DARZALEX FASPRO®? See our FAQs

Side effects

DARZALEX® may cause serious reactions, including 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®. About half the patients treated with DARZALEX® experience an infusion-related reaction. This is most likely to happen during the first infusion and less likely with future infusions.

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

The most common side effects of DARZALEX® include:

  • 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.

DARZALEX FASPRO® and DARZALEX® can also cause:

bloodtests

Changes in blood tests

DARZALEX FASPRO® and 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 FASPRO® or DARZALEX®. Your healthcare provider will do blood tests to match your blood type before you start treatment. Tell all of your healthcare providers that you are being treated with DARZALEX FASPRO® or DARZALEX® before receiving blood transfusions.

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Decreases in blood cell counts

DARZALEX FASPRO® and 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 FASPRO® and DARZALEX® but can be severe. Your healthcare provider will check your blood cell counts during treatment. Tell your healthcare providers if you develop fever or have signs of bruising or bleeding.

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