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 patients 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.
Is ERLEADA considered 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.
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.
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.
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.
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.
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.
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 Erleada cause shortness of breath?
shortness of breath. numbness or weakness of the face, arm, or leg, especially on one side of the body. trouble talking or understanding. trouble seeing in one or both eyes.
How often do you take ERLEADA?
Take your prescribed dose of ERLEADA® 1 time a day, at the same time each day. Take ERLEADA® 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.
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.
Does ERLEADA cause heart problems?
ERLEADA® may cause serious side effects including: Heart Disease, Stroke, or Mini-Stroke.
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.
What is Erleada used for?
ERLEADA®(apalutamide) is a prescription medicine used for the treatment of prostate cancer:
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.
What is LIS in Medicare?
The Low-Income Subsidy (LIS) program provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan
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.
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 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.
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.
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.
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.
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.
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.
How long after erleada can you have sperm?
Do notdonate sperm during treatment with ERLEADA®and for 3 months after the last dose of ERLEADA®. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ERLEADA®. Call your doctor for medical advice about side effects.
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 pass into breast milk?
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 children?
OR. that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone. It is not known if ERLEADA® is safe and effective in females. It is not known if ERLEADA®is safe and effective in children.
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 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.
How long after erleada can you have sperm?
Do notdonate sperm during treatment with ERLEADA®and for 3 months after the last dose of ERLEADA®. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ERLEADA®. Call your doctor for medical advice about side effects.
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 you stop Erleada if you have a seizure?
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.
Is Erleada safe for children?
OR. that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone. It is not known if ERLEADA® is safe and effective in females. It is not known if ERLEADA®is safe and effective in children.
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 The Patient Assistance Program?
The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, non-profit organization that is committed to helping eligible patients without insurance coverage receive prescription products donated by Johnson & Johnson operating companies.
Program Update
Patients may now choose the option of electronic income verification. Instead of submitting a copy of their Federal tax return, they can simply check a box on the updated application form.
Janssen Compass™
- Janssen Compass™ is a free, personalized patient support program that provides one-on-one guidance, information, and educational resources to your patients about their disease. It also may help them understand their insurance coverage and cost support options, as well as tips to help them get started and stay on track with their treatment. Janssen Compass™ Care Navigators of…
Janssen Carepath Patient Account
- Patients and caregivers can create an online account at MyJanssenCarePath.com where they can learn about their health insurance coverage, enroll in the Janssen CarePathSavings Program and manage their benefits, sign up for treatment reminders, and find support throughout their treatment journey.
Support
- Janssen CarePath offers additional support to keep your patients informed about ERLEADA® and provides ongoing resources and services to help them stay on track with their ERLEADA®treatment as you've prescribed. We offer: 1. Personalized, live refill reminder calls 2. Prescription refill reminders for ERLEADA® 3. Resources and techniques to help you...
Specialty Pharmacy and Specialty Distributor Options
- ERLEADA®is available through a limited distribution network of authorized specialty distributors and specialty pharmacy providers. You can order ERLEADA® for your office or hospital from an authorized specialty distributor, or Janssen CarePath can connect you to a specialty pharmacy provider who can ship ERLEADA®directly to your patients. Click here to identify specialty pharm…