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erleada patient assistance application

by Mrs. Hosea Zulauf I Published 2 years ago Updated 1 year ago
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How can I get help with Erleada® treatment?

Janssen CarePath provides the additional support you may need to help you get started with ERLEADA ® treatment, once you and your doctor have decided that ERLEADA ® is right for you. We understand how important it is for you to take your ERLEADA ® as your doctor prescribed.

What kind of drug is Erleada?

Erleada Prices, Coupons and Patient Assistance Programs. Erleada (apalutamide) is a member of the antiandrogens drug class and is commonly used for Prostate Cancer. This Erleada price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.

How much does Erleada cost?

Erleada (apalutamide) is a member of the antiandrogens drug class and is commonly used for Prostate Cancer. This Erleada price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. The cost for Erleada oral tablet 60 mg is around $12,794 for a supply of 120 tablets, depending on the pharmacy you visit.

What is the prognosis of Erleada ® (dose- interruption therapy)?

Of the patients who had dose interruption, 59% experienced recurrence of rash upon reintroduction of ERLEADA ® .

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Is Erleada covered by Medicare?

Do Medicare prescription drug plans cover Erleada? Yes. 100% of Medicare prescription drug plans cover this drug.

How long do you take Erleada?

Erleada (apalutamide) is usually taken until cancer progresses past a certain point or you start to have unacceptable side effects. In the SPARTAN clinical trial (NCT01946204) using apalutamide for men with castration-resistant metastasis-free prostate cancer, some patients were still using apalutamide at 36 months.

How much does apalutamide cost?

However, monthly costs for apalutamide are estimated at upwards of $3000 per patient, necessitating the demonstration of cost-effectiveness prior to recommendation.

Is Erleada a chemotherapy?

No, Erleada isn't a chemotherapy drug. It's a kind of hormone therapy that works by reducing the levels of androgen hormones, including testosterone, in your body.

What is the success rate of Erleada?

The survival rate at 48 months was 65.1% for ERLEADA ® + ADT patients vs 51.8% for placebo + ADT patients. OS improved regardless of Gleason score, age, high- or low-disease volume, and metastasis stage at diagnosis.

Does Erleada lower PSA?

Erleada achieved an 86 percent reduction in PSA at 12 months in the majority of patients, shows post-hoc analysis of Phase III study.

Is there a generic Erleada?

No. There is currently no therapeutically equivalent version of Erleada available in the United States. Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Erleada.

How effective is Apalutamide?

At 2 years of follow-up, approximately 82% of men who received ADT plus apalutamide were still alive, compared with 74% in men treated with ADT plus placebo, for a 33% reduction in the risk of death.

What is the difference between Erleada and xtandi?

Erleada and Xtandi are both oral anti-androgen medicines used to treat prostate cancer, Erleada treats 2 types of prostate cancer and Xtandi treats 3 types of prostate cancer. Erleada and Xtandi are both oral medications taken as a tablet or capsule.

Can you drink alcohol with apalutamide?

The drinking of alcohol (in small amounts) does not appear to affect the safety or usefulness of apalutamide.

Can I stop taking Erleada?

Your healthcare provider may change your dose if needed. Do not stop taking your prescribed dose of ERLEADA® without talking with your healthcare provider first. Take your prescribed dose of ERLEADA® 1 time a day, at the same time each day.

What class of drug is Erleada?

This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.

Can I stop taking Erleada?

Your healthcare provider may change your dose if needed. Do not stop taking your prescribed dose of ERLEADA® without talking with your healthcare provider first. Take your prescribed dose of ERLEADA® 1 time a day, at the same time each day.

Is apalutamide considered chemotherapy?

Apalutamide (pronounced [a pa LOO ta mide]) is also known by the brand name Erleada. It is an antineoplastic (anti-cancer) drug that belongs to a class called antiandrogen therapy. Erleada is a type of chemotherapy that prevents cancer cells from multiplying and restricts their growth.

What is the purpose of Erleada?

Generic Name: apalutamide Apalutamide is used to treat men with prostate cancer. This medication belongs to a class of drugs known as anti-androgens (anti-testosterone). It works by blocking the effects of testosterone to slow the growth and spread of prostate cancer.

What is the half life of Erleada?

The apparent oral clearance (CL/F) of apalutamide is 1.3 L/h after single dosing and increases to 2.0 L/h at steady-state after once-daily dosing. The mean effective half-life for apalutamide in patients is about 3 days at steady-state.

Welcome to Janssen CarePath

Once you and your doctor have decided that ERLEADA ® is right for you, Janssen CarePath will help you find the resources you may need to get started and stay on track. We will give you information on your insurance coverage, potential out-of-pocket costs, and treatment support, and identify options that may help make your treatment more affordable.

Getting started

Janssen CarePath provides the additional support you may need to help you get started with ERLEADA ® treatment, once you and your doctor have decided that ERLEADA ® is right for you.

Staying on track

We understand how important it is for you to take your ERLEADA ® as your doctor prescribed. Janssen CarePath provides ongoing support that may help you stay on track with your ERLEADA ® treatment.

Resources

Documents and websites to help you with enrollment, cost support, coverage, and more.

Janssen CarePath Provider Portal

Cerebrovascular and Ischemic Cardiovascular Events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 3.7% of patients treated with ERLEADA ® and 2% of patients treated with placebo.

Forms and Documents

Cerebrovascular and Ischemic Cardiovascular Events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 3.7% of patients treated with ERLEADA ® and 2% of patients treated with placebo.

What is Erleada used for?

ERLEADA®(apalutamide) is a prescription medicine used for the treatment of prostate cancer:

What are the side effects of Erleada?

ERLEADA®may cause serious side effects including: 1 Heart Disease, Stroke, or Mini-Stroke. Bleeding in the brain or blockage of the arteries in the heart or in part of the brain have happened in some people during treatment with ERLEADA®and can lead to death. Your healthcare provider will monitor you for signs and symptoms of heart or brain problems during your treatment with ERLEADA®. Call your healthcare provider or get medical help right away if you get:#N#chest pain or discomfort at rest or with activity#N#shortness of breath#N#numbness or weakness of the face, arm, or leg, especially on one side of the body#N#trouble talking or understanding#N#trouble seeing in one or both eyes#N#dizziness, loss of balance or coordination, or trouble walking 2 Fractures and Falls. ERLEADA®treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA®. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA®. 3 Seizure. Treatment with ERLEADA®may increase your risk of having a seizure. You should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have a loss of consciousness or seizure. Your healthcare provider will stop ERLEADA®if you have a seizure during treatment.

How long after ERLEADA do you use birth control?

Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 3 months after the last dose of ERLEADA®. Males should use a condom during sex with a pregnant female.

Can Erleada pass into breast milk?

are breastfeeding or plan to breastfeed. It is not known if ERLEADA®passes into breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ERLEADA®can interact with many other medicines.

Is Erleada safe for women?

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

Does Erleada cause fractures?

Fractures and Falls. ERLEADA®treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA®. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA®.

What are the most common adverse reactions to Erleada?

Adverse Reactions — The most common adverse reactions (≥10% ) that occurred more frequently in the ERLEADA ® -treated patients (≥2% over placebo) from the randomized placebo-controlled clinical trials (TITAN and SPARTAN) were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.

What are the risks of ERLEADA?

Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Consider discontinuation of ERLEADA ® for Grade 3 and 4 events.

How many patients have fractures with Erleada?

Fractures — In a randomized study (SPARTAN) of patients with nmCRPC, fractures occurred in 12% of patients treated with ERLEADA ® and in 7% of patients treated with placebo. In a randomized study (TITAN) of patients with mCSPC, fractures occurred in 9% of patients treated with ERLEADA ® and in 6% of patients treated with placebo. Evaluate patients for fracture risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents.

Can Erleada cause fetal harm?

Based on its mechanism of action, ERLEADA ® can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ERLEADA ® [see Use in Specific Populations (8.1, 8.3)] .

Does Erleada cause falls?

Falls — In a randomized study (SPARTAN), falls occurred in 16% of patients treated with ERLEADA ® compared with 9% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Falls occurred in patients receiving ERLEADA ® with increased frequency in the elderly. Evaluate patients for fall risk.

Is Erleada a strong or weak inducer?

CYP3A4, CYP2C9, CYP2C19, and UGT Substrates — ERLEADA ® is a strong inducer of CYP3A4 and CYP2C19, and a weak inducer of CYP2C9 in humans. Concomitant use of ERLEADA ® with medications that are primarily metabolized by CYP3A4, CYP2C19, or CYP2C9 can result in lower exposure to these medications.

Does Erleada cause thyroid issues?

Hypothyroidism — In 2 randomized studies (SPARTAN and TITAN), hypothyroidism was reported for 8% of patients treated with ERLEADA ® and 2% of patients treated with placebo based on assessments of thyroid-stimulating hormone (TSH) every 4 months. Elevated TSH occurred in 25% of patients treated with ERLEADA ® and 7% of patients treated with placebo. The median onset was at the first scheduled assessment. There were no Grade 3 or 4 adverse reactions. Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted.

How to take Erleada?

Take your prescribed dose of ERLEADA ® 1 time a day, at the same time each day. Take ER LEADA ® with or without food. Swallow ERLEADA ® tablets whole. If you miss a dose of ERLEADA ®, take your normal dose as soon as possible on the same day. Return to your normal schedule on the following day.

What is Erleada used for?

ERLEADA ® (apalutamide) is a prescription medicine used for the treatment of prostate cancer: that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone,

What to do if you take too much Erleada?

If you take too much ERLEADA ®, call your healthcare provider or go to the nearest hospital emergency room.

Does Erleada cause falls?

ERLEADA ® treatment can cause bones and muscles to weaken and may increase your risk for falls and fractures. Falls and fractures have happened in people during treatment with ERLEADA ®. Your healthcare provider will monitor your risks for falls and fractures during treatment with ERLEADA ® . Seizure.

Can Erleada interact with other medications?

ERLEADA ® can interact with many other medicines. You should not start or stop any medicine before you talk with the healthcare provider that prescribed ERLEADA ® . Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

Can Erleada cause miscarriage?

ERLEADA ® can cause harm to your unborn baby and loss of pregnancy (miscarriage). have a partner who is pregnant or may become pregnant. Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 3 months after the last dose of ERLEADA ® .

Is Erleada safe for women?

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

What is Erleada used for?

Erleada (apalutamide) is a member of the antiandrogens drug class and is commonly used for Prostate Cancer.

What is the Erleada Janssen rebate number?

Erleada Janssen CarePath Savings Program Rebate: If the pharmacy cannot process the Savings Card the patient may submit a request for a rebate; for additional information contact the program at 833-375-3232.

Can you order Erleada samples?

Erleada Samples: Your healthcare provider may order FREE samples on the website .

Is Erleada a generic?

Erleada is available as a brand name drug only, a generic version is not yet available. For more information, read about generic Erleada availability . This Erleada price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.

Step 1

Check to see if you’re eligible for the program or view eligibility requirements.

Step 4

Have your doctor complete their sections of the application, and sign and date in the "HCP Authorization" section (s) for the product (s) they have prescribed.

Step 5

Submit completed page 2 and the pages your HCP has completed for your prescribed product (s) with documentation to:

Next Steps

Once we receive your application, it will take about three days to review. If the application is missing information, it will take longer. Upon completion of review, we’ll send you a letter to let you know whether you’re eligible. When you apply, please be sure to include all your supporting documents.

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