Body

Janssen Compass®

Look to Janssen Compass® to help you understand your insurance coverage and cost support options, as well as guide you in navigating educational resources you want and need to feel confident on your Janssen therapy.

Throughout the program you can:

Connect... each time to the same Janssen Compass® Care Navigator who understands and offers education on your cancer and your Janssen medication

Learn... about resources to support you with cost, coverage, your personal wellness, and your emotional well-being throughout your treatment journey and beyond

Simplify... your experience through personalized education, every step of the way, to build confidence in what to expect and support in making decisions about your treatment with your doctor and loved ones

Your Janssen Compass® Care Navigator is a phone call away!

To schedule an introductory call with a Janssen Compass® Care Navigator:

Janssen Compass® is limited to education about your Janssen therapy, its administration, and/or your disease. It is intended to supplement your understanding of your therapy and is not intended to provide medical advice, replace a treatment plan from your doctor or nurse, or serve as a reason for you to start or stay on this medication.

Support Resources

  • Personalized appointment or refill reminders

Get started with a Janssen CarePath Account

Sign Up or Log In to your personal Janssen CarePath Account, so you can learn about your insurance coverage for DARZALEX®; if eligible, enroll in the Janssen CarePath Savings Program; and sign up for treatment support.

Connecting with others in your community

Resources are available online that can offer support and help you connect with others who are living with your condition. These include local support groups, fundraising walks, outreach programs, online communities, and volunteer opportunities. The websites below can help you learn more about your condition and connect with others.

DARZALEX® Website
DARZALEX.com
This website contains additional information about treatment with DARZALEX®. On this website, you can also get helpful information about your condition.

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IMPORTANT SAFETY INFORMATION
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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 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, 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 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 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
  • 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

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

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
  • have hereditary fructose intolerance (HFI). DARZALEX® contains sorbitol. Sorbitol is a source of fructose. People with HFI cannot break down fructose, which may cause serious side effects
  • are pregnant or plan to become pregnant. DARZALEX® 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®
    • 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®. Talk to your healthcare provider about birth control methods that you can use during this time
    • Before starting DARZALEX® in combination with lenalidomide, pomalidomide, or thalidomide, females and males must agree to the instructions in the lenalidomide, pomalidomide, or thalidomide REMS program
      • The lenalidomide, pomalidomide, and thalidomide 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, pomalidomide, and thalidomide REMS about sperm donation and how lenalidomide, pomalidomide, and thalidomide can pass into human semen
    • are breastfeeding or plan to breastfeed. It is not known if DARZALEX® passes into your breast milk. You should not breastfeed during treatment with DARZALEX®. Talk to your healthcare provider about the best way to feed your baby during treatment with DARZALEX®

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-related reactions
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment

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®. 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, or blurred vision
  • 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. 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. 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 pharmacist or healthcare provider for information about DARZALEX® that is written for health professionals.

Active ingredient: daratumumab.

Inactive ingredients: may include glacial acetic acid, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, sorbitol, and water for injection.

Please click here to see the Important Product Information.

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