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

FAQs about DARZALEX FASPRO® AND DARZALEX®

Here are some of the more frequently asked questions about DARZALEX FASPRO® and DARZALEX®. Click on the question to reveal the answer.

DARZALEX FASPRO® is a prescription medicine that is used to treat adults with multiple myeloma. You may receive DARZALEX FASPRO® by itself or in combination with other multiple myeloma treatments, depending on the number of prior treatments you’ve received, or if you’re a newly diagnosed patient who can or cannot receive a stem cell transplant that uses your own stem cells.

DARZALEX® is a prescription medicine that is used as part of a treatment plan for patients with multiple myeloma. You may receive DARZALEX® in combination with other multiple myeloma treatments, or alone, depending on the type and number of prior treatments you’ve received, or if you are a newly diagnosed patient who can or cannot receive a stem cell transplant that uses your own stem cells.

DARZALEX FASPRO® is a subcutaneous injection given in the stomach area (abdomen) that takes about 3 to 5 minutes. This refers to the injection administration time and does not account for all aspects of treatment.

DARZALEX® is an intravenous (IV) infusion, given through a needle place in a vein by a healthcare professional. On average, the first DARZALEX® infusion may take about 7 hours. However, your doctor may choose to give the first dose as 2 shorter infusions over 2 consecutive days. Future infusions will take less time and last 3 to 5 hours, not including check-in and check-out time.

After the initial rounds, DARZALEX FASPRO® and DARZALEX® treatments are needed only once every 4 weeks.

You’ll be given a physical. You will also be given medicines before and after treatment to help reduce the risk of side effects and injection- or infusion-related reactions. A healthcare professional will monitor you after your first few injections of DARZALEX FASPRO® or during your infusion of DARZALEX®.

DARZALEX FASPRO® and DARZALEX® were both studied as combination therapies with other medicines and as monotherapies (by themselves). You can find information about each of the studies on this site.

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

DARZALEX FASPRO® 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®, 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.

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 do blood tests to match your blood type before you start 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 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 counts

These are not all the possible side effects of DARZALEX FASPRO®. Call your doctor for medical advice about 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 of the people treated with DARZALEX® experience an infusion-related reaction, most likely 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

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.

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® 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.

Once you and your doctor have decided that DARZALEX FASPRO® or DARZALEX® is right for you, Janssen Compass® will help you find the resources you may need to get started and stay on track. Janssen Compass® will give you information on insurance coverage and treatment support, and identify options that may help make your treatment more affordable – whether you have commercial or private health insurance, government coverage such as Medicare or Medicaid, or have no insurance coverage.