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, lenalidomide, and dexamethasone in newly diagnosed people 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, 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, thalidomide, and dexamethasone in newly diagnosed people 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 one prior medicine, including lenalidomide and a proteasome inhibitor, to treat multiple myeloma
• in combination with the medicines carfilzomib and dexamethasone in people whose multiple myeloma has come back or did not respond to treatment who have received one to three prior medicines 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

Do not receive DARZALEX FASPRO® if you have a history of a severe allergic reaction to daratumumab, hyaluronidase, or any of the ingredients in DARZALEX FASPRO®. See below for a complete list of 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 3 months after your last 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, thalidomide, or pomalidomide, females and males must agree to the instructions in the lenalidomide, thalidomide, or pomalidomide REMS program.
    • The lenalidomide, thalidomide, and pomalidomide REMS have 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, thalidomide, and pomalidomide REMS about sperm donation and how lenalidomide, thalidomide, and pomalidomide can pass into human semen.
• are breastfeeding or plan to breastfeed. It is not known if DARZALEX FASPRO® passes into your breast milk. You should not breastfeed during treatment with DARZALEX FASPRO®. Talk to your healthcare provider about the best way to feed your baby during treatment with DARZALEX FASPRO®.

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 FASPRO®?

• DARZALEX FASPRO® may be given alone or together with other medicines used to treat multiple myeloma.
• DARZALEX FASPRO® will be given to you by your healthcare provider as an injection under the skin in the stomach area (abdomen).
• DARZALEX FASPRO® is injected over 3 to 5 minutes.
• 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 FASPRO® and after each dose of DARZALEX FASPRO® to help reduce the risk of serious allergic reactions and other reactions due to release of certain substances by your body (systemic).

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

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®. 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®.
  • 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 happen 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 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. 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 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® when used in combination therapy include:

• tiredness
• nausea
• diarrhea
• shortness of breath
• trouble sleeping
• headache
• rash
• fever
• cough
• muscle spasms
• back pain
• vomiting
• high blood pressure
• muscle, bone, and joint pain
• 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 of 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 pharmacist or healthcare provider 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