Indications & Important Safety Information

What is DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)?

DARZALEX FASPRO is a prescription medicine used to treat adult patients with multiple myeloma:

  • in combination with the medicines bortezomib, melphalan, and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
  • in combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people whose multiple myeloma has come back or did not respond to treatment, who have received at least one prior medicine to treat multiple myeloma
  • in combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma
  • alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

It is not known if DARZALEX FASPRO is safe and effective in children.

Important Safety Information for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)

Do not receive DARZALEX FASPRO if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX FASPRO.

Before you receive DARZALEX FASPRO, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of breathing problems
  • have had shingles (herpes zoster)
  • have ever had or might now have a hepatitis B infection as DARZALEX FASPRO could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during, and for some time after treatment with DARZALEX FASPRO. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes.
  • are pregnant or plan to become pregnant. DARZALEX FASPRO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with DARZALEX FASPRO.
    • Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of DARZALEX FASPRO. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Before starting DARZALEX FASPRO in combination with lenalidomide and dexamethasone, females and males must agree to the instructions in the lenalidomide REMS program.
      • The lenalidomide REMS has more information about effective methods of birth control, pregnancy testing, and blood donation for females who can become pregnant.
      • For males who have female partners who can become pregnant, there is information in the lenalidomide REMS about sperm donation and how lenalidomide can pass into human semen.
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX FASPRO passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

DARZALEX FASPRO may cause serious reactions, including:

  • Serious allergic reactions and other severe injection-related reactions. 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. 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.
    • 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
    • runny or stuffy nose
    • headache
    • itching
    • high blood pressure
    • nausea
    • vomiting
    • chills
    • fever
    • chest pain
  • Injection site reactions. Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX FASPRO. Symptoms may include itching, swelling, bruising, or redness of the skin. These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO.
  • Decreases in blood cell counts. DARZALEX FASPRO can decrease white blood cell counts, which help fight infections, and blood cells called platelets, which help to clot blood. 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 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).

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

  • tiredness
  • nausea
  • diarrhea
  • shortness of breath
  • trouble sleeping
  • fever
  • cough
  • muscle spasms
  • back pain
  • vomiting
  • cold-like symptoms (upper-respiratory infection)
  • nerve damage causing tingling, numbness, or pain
  • constipation
  • lung infection (pneumonia)

These are not all the possible side effects of DARZALEX FASPRO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DARZALEX FASPRO

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about DARZALEX FASPRO that is written for health professionals.

Active ingredient: daratumumab and hyaluronidase-fihj
Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, water for injection

Please click here to see the Product Information.

cp-143282v1

What is DARZALEX® (daratumumab)?

DARZALEX® is a prescription medicine used to treat adults with multiple myeloma:

  • In combination with the medicines lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant) and in people who have received at least one prior medicine to treat multiple myeloma
  • In combination with the medicines bortezomib, melphalan and prednisone in people with newly diagnosed multiple myeloma who cannot receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
  • In combination with the medicines bortezomib, thalidomide, and dexamethasone in people with newly diagnosed multiple myeloma who are eligible to receive a type of stem cell transplant that uses their own stem cells (autologous stem cell transplant)
  • In combination with the medicines bortezomib and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma
  • In combination with the medicines pomalidomide and dexamethasone in people who have received at least two prior medicines to treat multiple myeloma, including lenalidomide and a proteasome inhibitor
  • Alone in people who have received at least three prior medicines, including a proteasome inhibitor and an immunomodulatory agent, or did not respond to a proteasome inhibitor and an immunomodulatory agent

It is not known if DARZALEX® is safe and effective in children.

Important Safety Information for DARZALEX® (daratumumab)

Do not receive DARZALEX® if you have a history of a severe allergic reaction to daratumumab or any of the ingredients in DARZALEX®. See the ingredients for DARZALEX® below.

What should I tell my healthcare provider before taking DARZALEX®?

Before you receive DARZALEX®, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of breathing problems
  • have had shingles (herpes zoster)
  • have ever had or might now have a hepatitis B infection as DARZALEX® could cause hepatitis B virus to become active again. Your healthcare provider will check you for signs of this infection before, during and for some time after treatment with DARZALEX®. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes
  • are pregnant or plan to become pregnant. DARZALEX® may harm your unborn baby
    • Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 3 months after your final dose of DARZALEX®. Talk to your healthcare provider about birth control methods that you can use during this time
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX® passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive DARZALEX®?

  • DARZALEX® may be given alone or together with other medicines used to treat multiple myeloma
  • DARZALEX® will be given to you by your healthcare provider by intravenous (IV) infusion into your vein
  • Your healthcare provider will decide the time between doses as well as how many treatments you will receive
  • Your healthcare provider will give you medicines before each dose of DARZALEX® and after each dose of DARZALEX® to help reduce the risk of infusion reactions
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment

What are the possible side effects of DARZALEX®?

DARZALEX® may cause serious reactions, including:

  • Infusion reactions. Infusion reactions are common with DARZALEX® and can be severe or serious. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX® if you have infusion 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
  • throat tightness
  • runny or stuffy nose
  • headache
  • itching
  • nausea
  • vomiting
  • chills
  • fever

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. 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:

  • tiredness
  • nausea
  • diarrhea
  • shortness of breath
  • trouble sleeping
  • feeling weak
  • decreased appetite
  • fever
  • cough
  • muscle spasms
  • back pain
  • joint pain
  • vomiting
  • bronchitis
  • cold-like symptoms (upper respiratory infection)
  • nerve damage causing tingling, numbness or pain
  • swollen hands, ankles or feet
  • constipation
  • chills
  • dizziness
  • lung infection (pneumonia)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of DARZALEX®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of DARZALEX®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your healthcare provider or pharmacist for information about DARZALEX® that is written for health professionals.

What are the ingredients in DARZALEX®

Active ingredient: daratumumab

Inactive ingredients: glacial acetic acid, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, and water for injection

Please click here to see the Important Product Information.

cp-109238v1