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Summary of resources to help you pay for DARZALEX® [PDF]

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The following program is affiliated with Janssen.

Janssen CarePath Savings Program for DARZALEX®

If you are eligible, you may be able to lower your out-of-pocket medication costs for DARZALEX®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. With the Janssen CarePath Savings Program for DARZALEX®, eligible patients pay $5 for each infusion for your medication costs, with a $20,000 maximum program benefit each calendar year. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give you your infusion.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 844-55DARZA (844-553-2792).

See program requirements

To enroll in the Janssen CarePath Savings Program

Visit MyJanssenCarePath.com to create an online account, check your eligibility, enroll in the Savings Program, manage your Savings Program benefits, and receive timely alerts and program updates.

Or call a Janssen CarePath Care Coordinator at 844-55DARZA (844-553-2792), Monday–Friday, 8:00 AM to 8:00 PM ET.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

The following program is affiliated with Janssen.

Janssen CarePath Savings Program for DARZALEX®

If you are eligible, you may be able to lower your out-of-pocket medication costs for DARZALEX®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. With the Janssen CarePath Savings Program for DARZALEX®, eligible patients pay $5 for each infusion for your medication costs, with a $20,000 maximum program benefit each calendar year. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement. Program does not cover the cost to give you your infusion.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 844-55DARZA (844-553-2792).

See program requirements

To enroll in the Janssen CarePath Savings Program

Visit MyJanssenCarePath.com to create an online account, check your eligibility, enroll in the Savings Program, manage your Savings Program benefits, and receive timely alerts and program updates.

Or call a Janssen CarePath Care Coordinator at 844-55DARZA (844-553-2792), Monday–Friday, 8:00 AM to 8:00 PM ET.

The following programs are not affiliated with Janssen.

Be sure to contact the programs directly to get details on eligibility and application requirements, and to see if they have funding available to help you.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 800-652-6227 (Monday through Friday, 8:00 AM to 8:00 PM ET).

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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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