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

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Janssen CarePath Savings Program for DARZALEX FASPRO®

If you are eligible, you may be able to lower your out-of-pocket medication costs for DARZALEX FASPRO®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. With the Janssen CarePath Savings Program for DARZALEX FASPRO®, eligible patients pay $5 for each dose 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 treatment.

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.

Express Enrollment

If you only want to check your eligibility and enroll in the Janssen CarePath Savings Program, use the Express Enrollment at MyJanssenCarePath.com/express. There is a "Print a Card" feature to provide you with a Savings Program card. You will not have a Janssen CarePath account and will not be able to view and manage your Savings Program benefits.

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

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.

Additional Affordability Support from Janssen

Patient assistance is available if you have commercial, employer sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfo.com or call 833-742-0791.

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.

Additional Affordability Support from Janssen

Patient assistance is available if you have commercial, employer sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfo.com or call 833-742-0791.

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).

Janssen CarePath Savings Program for DARZALEX FASPRO®

If you are eligible, you may be able to lower your out-of-pocket medication costs for DARZALEX FASPRO®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. With the Janssen CarePath Savings Program for DARZALEX FASPRO®, eligible patients pay $5 for each dose 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 treatment.

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.

Express Enrollment

If you only want to check your eligibility and enroll in the Janssen CarePath Savings Program, use the Express Enrollment at MyJanssenCarePath.com/express. There is a "Print a Card" feature to provide you with a Savings Program card. You will not have a Janssen CarePath account and will not be able to view and manage your Savings Program benefits.

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

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.

Additional Affordability Support from Janssen

Patient assistance is available if you have commercial, employer sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfo.com or call 833-742-0791.

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 FASPRO® (daratumumab and hyaluronidase-fihj)?

DARZALEX FASPRO® is a prescription medicine used to treat adult patients with 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 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, 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 pomalidomide and dexamethasone in people who have received at least one prior medicine, including lenalidomide and a proteasome inhibitor, 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
  • 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

DARZALEX FASPRO® is a prescription medicine also used in combination with the medicines bortezomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed light chain (AL) amyloidosis. For light chain (AL) amyloidosis, DARZALEX FASPRO® is approved based on medical studies that measured how many patients responded to treatment. Continued approval may depend on the benefit demonstrated by additional data from medical studies.

It is not known if DARZALEX FASPRO® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Do not receive DARZALEX FASPRO® if you have a history of a severe allergic reaction to daratumumab, hyaluronidase, or any of the ingredients in DARZALEX FASPRO®. See below for a complete list of 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 3 months after your last 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, thalidomide, or pomalidomide, females and males must agree to the instructions in the lenalidomide, thalidomide, or pomalidomide REMS program.
      • The lenalidomide, thalidomide, and pomalidomide 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, thalidomide, and pomalidomide REMS about sperm donation and how lenalidomide, thalidomide, and pomalidomide can pass into human semen.
  • are breastfeeding or plan to breastfeed. It is not known if DARZALEX FASPRO® passes into your breast milk. You should not breastfeed during treatment with DARZALEX FASPRO®. Talk to your healthcare provider about the best way to feed your baby during treatment with DARZALEX FASPRO®.

Before you receive DARZALEX FASPRO® for light chain (AL) amyloidosis, tell your healthcare provider if you have a history of heart problems. DARZALEX FASPRO® should not be used in light chain (AL) amyloidosis patients with highly advanced heart disease outside of clinical trials.

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 FASPRO®?

  • DARZALEX FASPRO® may be given alone or together with other medicines used to treat multiple myeloma.
  • DARZALEX FASPRO® will be given to you by your healthcare provider as an injection under the skin, in the stomach area (abdomen).
  • DARZALEX FASPRO® is injected over 3 to 5 minutes.
  • 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 FASPRO® and after each dose of DARZALEX FASPRO® to help reduce the risk of serious allergic reactions and other reactions due to release of certain substances by your body (systemic).

If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

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®. Your healthcare provider may temporarily stop or completely stop treatment with DARZALEX FASPRO® if you have a serious reaction. 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 or irritation
    • runny or stuffy nose
    • headache
    • itching
    • high blood pressure
    • eye pain
    • nausea
    • vomiting
    • chills
    • fever
    • chest pain
    • blurred vision
  • Injection site reactions. Skin reactions at or near the injection site (local), including injection site reactions, can happen with DARZALEX FASPRO®. Symptoms at the site of injection may include itching, swelling, bruising, pain, rash, bleeding, or redness of the skin. These reactions sometimes happen more than 24 hours after an injection of DARZALEX FASPRO®.
  • Heart problems in patients with light chain (AL) amyloidosis. Heart problems, in some cases fatal, have occurred. Your healthcare provider will monitor you closely during treatment with DARZALEX FASPRO®. Call your healthcare provider right away if any of the following symptoms occur: chest pain, feeling faint, swollen legs, shortness of breath, or abnormal heart rhythm.
  • 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. Decreases in blood cell counts are common with DARZALEX FASPRO® but can be severe. 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) and decreased red blood cell counts.

The most common side effects of DARZALEX FASPRO® used in combination therapy include:

  • tiredness
  • nausea
  • diarrhea
  • shortness of breath
  • trouble sleeping
  • headache
  • fever
  • cough
  • muscle spasms
  • back pain
  • vomiting
  • high blood pressure
  • cold-like symptoms (upper respiratory infection)
  • nerve damage causing tingling, numbness, or pain
  • constipation
  • lung infection (pneumonia)
  • swollen hands, ankles, or feet
  • decreased red blood cell counts

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 pharmacist or healthcare provider 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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