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Important Safety Information

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.

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