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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.

 

Personalized Support

Schedule a call with a Care Navigator for one-on-one support

 

JanssenCompass.com - Receive free, personalized resources to help you get started on treatment. A dedicated Janssen Compass™ Care Navigator can help you find options that may lower your medication costs and personalized educational resources to help you feel confident on your DARZALEX® therapy.

Janssen Compass™ is limited to education for patients about their Janssen therapy, its administration, and/or their disease. It is intended to supplement a patient's understanding of their therapy and is not intended to provide medical advice, replace a treatment plan from the patient's doctor or nurse, provide case management services, or serve as a reason to prescribe DARZALEX® (daratumumab).

 

Authorization

Patient Authorization Form [PDF] - Allows you to authorize the use of your personal information for certain Janssen Patient Support Programs.

 

Cost Support

Janssen CarePath Savings Program Overview [PDF] - Provides information on the Janssen CarePath Savings Program for DARZALEX® and eligibility requirements for enrolling in the program.

Janssen CarePath Savings Program Patient Assignment of Benefits [DOCX] - Allows you to authorize your provider to receive your Janssen CarePath Savings Program rebate on your medication on your behalf.

Patient Affordability Options for DARZALEX® [PDF] - Gives information on options that can make your treatment more affordable.

 

Coverage

Health Insurance Open Enrollment Guide [PDF] - Even if you keep the same health plan, your benefits can change. This guide can help you review your coverage and make changes if needed during the open enrollment period so you can stay on treatment in the new benefit period.

Medicare Resource Guide [PDF] - Provides information on sources for cost support that may be available to patients enrolled in Medicare.

Medicare Part D and Coverage Gap Guide [PDF] - Helps you understand the 4 phases of coverage (Deductible, Initial Coverage, Coverage Gap, and Catastrophic Coverage), and when you will enter the Coverage Gap (formerly known as the Donut Hole).

Medicare Low-Income Subsidy (LIS) Brochure [PDF] - Offers information about extra help with prescription drug costs that is available to low-income residents of the United States enrolled in Medicare Prescription Drug Plans.

 

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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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