Darzalex®

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DARZALEX® Patient Support

Welcome to Janssen CarePath

Information you may need to help you get started and stay on track

Janssen CarePath is here to help answer your questions about treatment with DARZALEX®. Once your doctor has prescribed DARZALEX®, we will give you resources that may help you get started and stay on track. Create a Janssen CarePath Account where you can: learn about your insurance coverage for DARZALEX®; if eligible, enroll in the Janssen CarePath Savings Program; and sign up for nurse support or treatment reminders.

Paying for DARZALEX®

If you have commercial or private health insurance and need help paying for DARZALEX®, the Janssen CarePath Savings Program may be able to help. If you don’t have commercial or private health insurance, you may find help from the programs and resources found on the Janssen Prescription Assistance Web site.

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Getting Started

Janssen CarePath can give you resources that may help you get started with DARZALEX® treatment. Sign up or log in to your personal Janssen CarePath Account – MyJanssenCarePath.com, so you can learn about your insurance coverage, learn about programs that may help you pay for your medication, and find other support resources.

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Staying on Track

In addition, Janssen CarePath offers support to help you stay on track with your DARZALEX® treatment as prescribed by your doctor.

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What is DARZALEX®?

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

  • In combination with the medicines lenalidomide and dexamethasone or 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 to treat multiple myeloma, 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®

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)
  • 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 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 on the first day 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. Your healthcare provider may temporarily stop your infusion or completely stop treatment with DARZALEX® if you have infusion reactions. Tell your healthcare provider 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. 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
  • constipation
  • vomiting
  • muscle spasms
  • joint pain
  • back pain
  • fever
  • chills
  • dizziness
  • insomnia
  • cough
  • shortness of breath
  • swollen hands, ankles or feet
  • nerve damage causing tingling, numbness or pain
  • cold-like symptoms (upper respiratory infection)

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.

Please see Important Product Information

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