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Summary of resources to help you pay for AKEEGA™ [PDF]

Janssen CarePath Savings Program for AKEEGA™

If you are eligible, the Janssen CarePath Savings Program may provide instant savings on your commercial or private health insurance out-of-pocket costs for AKEEGA™. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $0 per month. Maximum program benefit per calendar year shall apply. 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. Offer subject to change or end without notice. Participate without sharing your income information.

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 877-CarePath (877-227-3728).

See program requirements

To enroll in the Janssen CarePath Savings Program

Express Enrollment

If you want to check your eligibility and enroll in the Janssen CarePath Savings Program, visit the Express Enrollment site at MyJanssenCarePath.com/express. There is a "Print a Card" feature to provide you with a Savings Program card.

Or call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), 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.

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 can only refer you to foundations that support 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

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.

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.

Medicare Part D Extra Help — Low-Income Subsidy

Medicare patients who have limited income and resources may qualify for "extra help" to pay for prescription drugs. The Low-Income Subsidy (LIS) program from Medicare provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan.

Those who are eligible for LIS may:

  • Receive assistance paying their monthly premium
  • Have a reduced or no deductible
  • Have reduced or no prescription co-insurance and co-payments
  • Have no gap in coverage

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.

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 can only refer you to foundations that support 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

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.

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.

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 can only refer you to foundations that support 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)

Janssen CarePath Savings Program for AKEEGA™

If you are eligible, the Janssen CarePath Savings Program may provide instant savings on your commercial or private health insurance out-of-pocket costs for AKEEGA™. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $0 per month. Maximum program benefit per calendar year shall apply. 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. Offer subject to change or end without notice. Participate without sharing your income information.

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 877-CarePath (877-227-3728).

See program requirements

To enroll in the Janssen CarePath Savings Program

Express Enrollment

If you want to check your eligibility and enroll in the Janssen CarePath Savings Program, visit the Express Enrollment site at MyJanssenCarePath.com/express. There is a "Print a Card" feature to provide you with a Savings Program card.

Or call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), 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.

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.

Medicare Part D Extra Help — Low-Income Subsidy

Medicare patients who have limited income and resources may qualify for "extra help" to pay for prescription drugs. The Low-Income Subsidy (LIS) program from Medicare provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan.

Those who are eligible for LIS may:

  • Receive assistance paying their monthly premium
  • Have a reduced or no deductible
  • Have reduced or no prescription co-insurance and co-payments
  • Have no gap in coverage

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.

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 can only refer you to foundations that support 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

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

IMPORTANT SAFETY INFORMATION

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What is AKEEGA® (niraparib and abiraterone acetate)?

AKEEGA® is a prescription medicine used with prednisone to treat adults with prostate cancer:

  • who have a certain type of abnormal BRCA gene, and
  • whose prostate cancer has spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (metastatic castration-resistant prostate cancer).

Your healthcare provider will perform a test to make sure AKEEGA® is right for you.

It is not known if AKEEGA® is safe and effective in females.

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

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about AKEEGA®?

AKEEGA® may cause serious side effects including:

  • Bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML). MDS or AML that may lead to death has happened in people treated with niraparib, one of the medicines in AKEEGA®. If you develop MDS or AML, your healthcare provider will stop treatment with AKEEGA®.

Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with AKEEGA® but can also be a sign of serious bone marrow problems, including MDS and AML. Tell your healthcare provider if you have any of the following symptoms during treatment with AKEEGA®:

  • pale skin
  • weakness
  • shortness of breath
  • feeling tired
  • bruising or bleeding more easily
  • fever
  • frequent infections
  • blood in urine or stool
  • weight loss

Your healthcare provider will do blood tests to check your blood cell counts:

  • weekly during the first month of treatment,
  • every 2 weeks for the next 2 months of treatment,
  • monthly for the remainder of the year,
  • then every other month and as needed during treatment with AKEEGA®.

See “What are the possible side effects of AKEEGA®?” for more information about side effects.

Before taking AKEEGA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure or heart problems
  • have low blood potassium levels
  • have liver or kidney problems
  • have a history of adrenal problems
  • have diabetes
  • are receiving any other treatment for prostate cancer
  • are pregnant or plan to become pregnant. AKEEGA® can cause harm to your unborn baby and loss of pregnancy (miscarriage). Females who are or may become pregnant should handle AKEEGA® tablets with protection, such as gloves.
  • have a partner who is pregnant or may become pregnant. Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after the last dose of AKEEGA®.
  • are breastfeeding or plan to breastfeed. It is not known if AKEEGA® passes into your breastmilk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AKEEGA® may affect the way other medicines work, and other medicines may affect how AKEEGA® works.

How should I take AKEEGA®?

  • Take AKEEGA® and prednisone exactly as your healthcare provider tells you.
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with AKEEGA® if you have certain side effects.
  • Do not change or stop taking your prescribed dose of AKEEGA® or prednisone without talking with your healthcare provider first.
  • Take your prescribed dose of AKEEGA® 1 time a day.
  • Take AKEEGA® on an empty stomach. Do not eat food 2 hours before and 1 hour after taking AKEEGA®. Taking AKEEGA® with food may cause more of the medicine to be absorbed by the body than is needed and this may cause side effects.
  • Swallow AKEEGA® tablets whole with water. Do not break, crush, or chew tablets.
  • If you miss a dose of AKEEGA®, take the dose as soon as possible on the same day. Return to your normal schedule on the following day. Do not take extra tablets to make up the missed dose.
  • You should start or continue a gonadotropin-releasing hormone (GnRH) analog therapy during your treatment with AKEEGA® unless you have had a surgery to lower the amount of testosterone in your body (surgical castration).
  • If you take too much AKEEGA®, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of AKEEGA®?

AKEEGA® may cause serious side effects, including:

  • See “What is the most important information I should know about AKEEGA®?”
  • Low blood potassium levels (hypokalemia), fluid retention (edema), high blood pressure (hypertension) and heart problems. To decrease the chance of this happening, you must take prednisone with AKEEGA® exactly as your healthcare provider tells you. Your healthcare provider will check your blood pressure, do blood tests to check your potassium levels, and check for any signs and symptoms of fluid retention at least weekly for the first 2 months of treatment, then 1 time a month during treatment with AKEEGA®. Tell your healthcare provider if you have any of the following symptoms:
  • dizziness
  • fast or irregular heartbeats
  • feel faint or lightheaded
  • headache
  • confusion
  • muscle weakness
  • pain in your legs
  • swelling in your hands, ankles, legs or feet
  • Liver problems. Severe liver problems, liver failure and death has happened in people treated with abiraterone acetate, one of the medicines in AKEEGA®. Your healthcare provider will do blood tests to check your liver function before starting treatment with AKEEGA®, every 2 weeks for the first 3 months of treatment, and then monthly thereafter during treatment with AKEEGA®. Tell your healthcare provider right away if you develop any symptoms of liver problems, including:
  • yellowing of the skin or eyes
  • darkening of the urine
  • severe nausea or vomiting
  • Adrenal problems. Adrenal problems may happen if you stop taking prednisone, get an infection, or are under stress. Tell your healthcare provider right away if you develop any symptoms of adrenal problems, including:
  • feeling tired
  • weakness
  • feeling dizzy or lightheaded
  • nausea or vomiting
  • weight loss
  • Low blood sugar (hypoglycemia). AKEEGA® may cause low blood sugar in people taking medicines for diabetes. Severe low blood sugar has happened in people who take certain medicines for diabetes and were treated with abiraterone acetate, one of the medicines in AKEEGA®. You and your healthcare provider should check your blood sugar levels during treatment and after you stop treatment with AKEEGA®. Your healthcare provider may need to change the dose of your diabetes medicine to decrease your risk of low blood sugar. Tell your healthcare provider right away if you have any of the following signs or symptoms of low blood sugar, including:
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heartbeat
  • sweating
  • feeling jittery
  • Increased risk of bone fracture and death when abiraterone acetate, one of the medicines in AKEEGA®, and prednisone or prednisolone is used in combination with a type of radiation called Radium 223 (Ra-223) dichloride. You should not receive treatment with Ra-223 dichloride for at least 5 days after your last dose of AKEEGA® with prednisone. Tell your healthcare provider about any other treatments you are taking for prostate cancer.
  • Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a condition that affects the brain and may happen during treatment with AKEEGA®. If you have headache, vision changes, confusion, or seizure with or without high blood pressure, please contact your healthcare provider.

The most common side effects of AKEEGA® include:

  • muscle and bone pain
  • tiredness
  • changes in liver function blood tests
  • constipation
  • high blood pressure
  • nausea
  • changes in kidney function blood tests
  • increased potassium level in the blood
  • decreased potassium level in the blood
  • swelling in your legs or feet
  • shortness of breath
  • decreased appetite
  • vomiting
  • dizziness
  • Coronavirus disease 2019 (COVID-19)
  • headache
  • stomach area pain
  • bleeding
  • urinary tract infection
  • cough
  • trouble sleeping
  • decreased weight
  • irregular heartbeat (arrhythmia)
  • falls
  • fever

AKEEGA® may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of AKEEGA®.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information for AKEEGA®.

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