FREQUENTLY ASKED QUESTIONS
Want to learn more about IgAN and FABHALTA?
Click below to find answers to some frequently asked questions.
About IgAN
IgA nephropathy, or IgAN, is a kidney disease in which a protein called IgA builds up in the kidneys and causes inflammation. Over time, this can damage the kidneys and reduce how well they work. IgAN is also called Berger’s disease.
Berger’s disease is another name for IgA nephropathy (IgAN), a kidney disease in which IgA builds up in the kidneys and causes inflammation that can lead to kidney damage over time.
The exact cause of IgA nephropathy (IgAN) is not fully understood. In IgAN, IgA antibodies that are supposed to fight infections become defective. This causes your immune system to work against itself. That may trigger the immune system to form immune complexes that deposit in the kidneys.
Autoantibodies are a malfunctioning type of antibodies produced by your immune system that attack your own body by mistake instead of protecting it.
An autoimmune disease is a condition in which the immune system attacks the body’s own healthy tissues by mistake instead of protecting them.
IgA nephropathy (IgAN) is diagnosed with a kidney biopsy that shows IgA buildup in the kidneys. Urine tests may detect blood or protein and suggest IgAN, but a biopsy is needed to confirm it.
Common signs and symptoms of IgA nephropathy (IgAN) may include fatigue, blood in the urine (hematuria), foamy urine, swelling in the hands or legs, high blood pressure, and reduced kidney function.
Hematuria means there is blood in the urine. Gross hematuria is blood you can see, while microscopic hematuria can only be detected with a microscope or a urine test.
Important goals of treatment for IgA nephropathy (IgAN) are to lower protein in the urine (proteinuria) and to slow kidney function decline. If proteinuria levels remain high, it is an indicator that IgAN may not be properly managed. If it’s increasing over time, it may be getting worse.
The alternative complement pathway is a part of the immune system that helps the body fight infections by supporting and enhancing immune responses. In IgA nephropathy (IgAN), the alternative complement pathway may play a role in how IgAN develops.
Yes, IgA nephropathy (IgAN) can impact kidney function. In a study of 655 adult patients with primary IgAN, ~1 in 6 lost 50% or more of their kidney function (based on eGFR) within 3 years of diagnosis.
This was from a study that looked back at patient records from a California healthcare system in those diagnosed with IgAN. The purpose of this study was to assess multiple kidney outcomes. At the start of study, patients were on different treatments; 70% were on an ACEi or ARB with limited use of other therapies. At the start of study, the average eGFR was 59.9 mL/min/1.73 m2 and average UPCR 2.5 g/g.
Living with IgA nephropathy (IgAN) can be challenging because it is a chronic disease that may get worse over time. Even with treatment, kidney function can decline, making it important to monitor and manage the condition closely.
About the kidneys
The kidneys filter waste and extra fluid from the blood to make urine and return clean blood to the body. They also help maintain fluid balance and control blood pressure.
Chronic kidney disease (CKD) is a condition in which the kidneys are damaged and cannot filter blood properly. Over time, this can lead to a buildup of waste and fluid and may progress to kidney failure.
In IgA nephropathy (IgAN), IgA antibodies don’t work correctly and can build up in the kidneys. This can activate the complement system and other immune pathways which may lead to inflammation, kidney injury, and scarring. This can reduce how well your kidneys work.
Proteinuria means there is protein in the urine. Ongoing high levels of proteinuria may be a sign of kidney damage and may indicate that the kidneys are not filtering properly.
Proteinuria is commonly measured using a test called urine protein-to-creatinine ratio (UPCR), which shows how much protein is in the urine. It can be measured using a single urine sample from the first urination of the day (called the first morning void, or FMV) or a 24-hour collection (24-hour UPCR).
According to expert guidelines for IgA nephropathy (IgAN), the goal is to keep proteinuria below 0.5 grams per day.
Kidney function is measured using estimated glomerular filtration (eGFR), a simple blood test that estimates how well your kidneys are filtering waste. Higher numbers mean better kidney function. An eGFR of 90 or higher is generally considered normal, though it can vary with age. Tracking eGFR over time shows how kidney function is changing.
Changes in your eGFR over time show how fast your kidneys are losing function. Kidney function decline over time is reflected as a negative value.
eGFR can be tracked over time to calculate the average yearly change
A negative number closer to zero indicates slower decline in kidney function
A negative number further from zero indicates faster decline in kidney function
About FABHALTA
FABHALTA is a prescription medicine used to slow kidney function decline in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease getting worse.
FABHALTA is for adults with primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease worsening.
It is not known if FABHALTA is safe and effective in children with IgAN.
FABHALTA is used to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease getting worse.
FABHALTA targets a part of the immune system called the alternative complement pathway, which is thought to contribute to IgA nephropathy (IgAN). FABHALTA is the first and only oral FDA-approved IgAN treatment to target the alternative complement pathway.
FABHALTA was tested in a large clinical study of 477 adults with primary IgA nephropathy (IgAN) at risk of disease worsening. 238 patients took FABHALTA and 239 patients took placebo (sugar pill).
FABHALTA is used to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN), who are at risk of their disease getting worse.
The change in proteinuria with FABHALTA and placebo (sugar pill) was assessed in the clinical trial.
Oral dosing—taken with or without food. One capsule twice a day can fit in your daily routine
The only oral IgAN treatment targeting the alternative pathway within the complement system, a part of the immune system that is thought to contribute to IgAN"
Used to slow kidney function decline in adults with primary IgAN at risk of disease worsening
Backed by clinical evidence. Tested in a large clinical study of 477 adults with primary IgAN over 24 months
FABHALTA is a medicine that affects part of your immune system and may lower your ability to fight infections.
FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b. These serious infections may quickly become life-threatening or cause death if not recognized and treated early.
You must complete or update your vaccinations against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of FABHALTA
If you have not completed your vaccinations and FABHALTA must be started right away, you should receive the required vaccinations as soon as possible.
If you have not been vaccinated and FABHALTA must be started right away, you should also receive antibiotics to take for as long as your health care provider tells you.
If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting FABHALTA. Your health care provider will decide if you need additional vaccinations.
Vaccines do not prevent all infections caused by encapsulated bacteria. Tell your health care provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection:
Fever with or without shivers or chills
Fever with chest pain and cough
Fever with high heart rate
Headache and fever
Confusion
Clammy skin
Fever and rash
Fever with breathlessness or fast breathing
Headache with nausea or vomiting
Headache with stiff neck or stiff back
Body aches with flu-like symptoms
Eyes sensitive to light
Your health care provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 2 weeks after your last dose of FABHALTA. Your risk of serious infections may continue for a few weeks after your last dose of FABHALTA. It is important to show this card to any health care provider who treats you. This will help them diagnose and treat you quickly.
FABHALTA is only available through a program called the FABHALTA Risk Evaluation and Mitigation Strategy (REMS). Before you can take FABHALTA, your health care provider must:
Enroll in the FABHALTA REMS program.
Counsel you about the risk of serious infections caused by certain bacteria.
Give you written information about the symptoms of serious infections.
Make sure that you are vaccinated against serious infections caused by encapsulated bacteria.
Make sure you receive antibiotics if you need to start FABHALTA right away and you are not up-to-date on your vaccinations.
Give you a Patient Safety Card about your risk of serious infections.
FABHALTA may cause serious side effects, including:
See “What is the most important information I should know about FABHALTA?"
Increased cholesterol and triglyceride (lipid) levels in your blood. Your healthcare provider will do blood tests to check your cholesterol and triglycerides during treatment with FABHALTA. Your healthcare provider may start you on a medicine to lower your cholesterol if needed.
The most common side effects of FABHALTA in adults include:
Headache
Nasal congestion, runny nose, cough, sneezing, and sore throat (nasopharyngitis)
Diarrhea
Feeling dizzy
Pain in the stomach (abdomen)
Infections (bacterial and viral)
Nausea
Rash
Tell your health care provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of FABHALTA.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.
See "Safety & Side Effects" for additional safety information.
FABHALTA increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type b.
These serious infections may quickly become life-threatening or cause death if not recognized and treated early.
You must complete or update the following vaccinations at least 2 weeks before your first dose of FABHALTA:
Pneumococcal—Helps protect you from the risk of pneumonia caused by Streptococcus pneumoniae infection
Meningococcal—Helps protect you from the risk of meningitis caused by Neisseria meningitidis infection
If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting FABHALTA. Your healthcare provider will decide if you need additional vaccinations.
Ask your doctor about any additional vaccines that may be helpful.
Your care team is your best source of information. If you still have questions, Novartis Patient Support™ can help you locate vaccination centers and offer other assistance along the way.
Your doctor’s office will send information to your insurance company to request approval. This is called a prior authorization and is a common step. Most prior authorizations are approved within a few weeks. If you haven’t heard anything in 2 weeks, call your doctor’s office to check on the status.
Most patients are able to get coverage. In fact, 90% of prior authorizations are approved, though your plan may have specific requirements.
What you pay depends on your insurance, but many patients pay very little. 96% of patients paid $10 or less per month.
There are programs that may help reduce what you pay. Ask your pharmacist about programs you may qualify for. You can also sign up for Novartis Patient Support™, which may help you understand your options and find programs you may be eligible for.
FABHALTA is shipped to you by a specialty pharmacy. After your prescription is approved, they will call you to schedule delivery. Be sure to answer or return their call so there are no delays.
Novartis Patient Support™ can connect you with financial assistance, support groups, and educational materials. Contact Novartis Patient Support for more information.
Patient Support
Yes, Novartis Patient Support™ can help you figure out your insurance coverage. Supporting your start on FABHALTA is our number one priority.
You'll work with an experienced team member who can:
Help you navigate the insurance process
Work with your health care provider to manage insurance forms
Assist you if there are changes to your health plan
The insurance approval process begins with benefits verification. Benefits verification is the process of confirming how your insurance covers your medication. This often includes predetermination, which means checking with your health insurance to find out what it will cover and what you may need to pay. Typically, it will take 2-3 business days, but it may take longer if we need more information.
Prior authorization is an approval from your health insurance that a service or prescription is covered. This approval may be required before you get a service or prescription filled.
If you lose your job or change insurance, Novartis Patient Support™ wants to help you navigate that. We’ll work with your health care provider to manage insurance forms and coverage updates. Call us at 833-99FABHA (833-993-2242) for more information.
The amount you'll pay for FABHALTA depends on your pharmacy benefits or prescription insurance plan. You can call the number, usually located on the back of your card, and ask for the following:
Deductible
Out-of-pocket max
Co-pay/Co-insurance
How much of each has been met/what is remaining
What is the coverage after the above has been met
You may not have a separate card for your pharmacy benefits, so be sure to check your insurance card to see if they have those details.
If you’re privately or commercially insured, you may be eligible for Co-Pay Plus.* Eligible patients may pay as little as $0 per prescription. Additional eligibility requirements and limitations apply.
Novartis Patient Support™ can verify your coverage and explain expected costs. Most people use insurance, which may cover part of the cost. You may owe a co-pay or co-insurance, depending on your plan. Typically, coverage verification will take 2-3 business days, but it may take longer if we need more information.
Call 833-99FABHA (833-993-2242) if you have questions about your costs.
*Co-Pay Plus: Limitations apply. Patients with commercial insurance coverage for FABHALTA may receive up to $20,000 in annual co-pay benefits for the cost of FABHALTA and up to $1,000 for qualifying vaccination costs (excluding administrative fees). Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient’s insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient’s insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States, Puerto Rico, and select territories. Void where prohibited by law. Additional restrictions may apply. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.
Co-Pay Plus* is financial support offered by Novartis Patient Support™. It may help you pay for your FABHALTA, including refills, if eligible. Co-Pay Plus is not health insurance but can help cover out-of-pocket expenses related to your prescription.
*Co-Pay Plus: Limitations apply. Patients with commercial insurance coverage for FABHALTA may receive up to $20,000 in annual co-pay benefits for the cost of FABHALTA and up to $1,000 for qualifying vaccination costs (excluding administrative fees). Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient’s insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient’s insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States, Puerto Rico, and select territories. Void where prohibited by law. Additional restrictions may apply. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.
Delays and denials can happen, and while they are disruptive, there are steps you can take. Talk to your health care provider about what makes the most sense for your situation.
Co-Pay* Plus can help you get FABHALTA if your coverage is delayed, for up to 12 months of FABHALTA for free while we continue to seek coverage, if you have private insurance and are eligible.
*Co-Pay Plus: Limitations apply. Patients with commercial insurance coverage for FABHALTA may receive up to $20,000 in annual co-pay benefits for the cost of FABHALTA and up to $1,000 for qualifying vaccination costs (excluding administrative fees). Patient is responsible for any costs once limit is reached in a calendar year. Program not valid (i) under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, (ii) where patient is not using insurance coverage at all, (iii) where the patient’s insurance plan reimburses for the entire cost of the drug, or (iv) where product is not covered by patient’s insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program. Valid only in the United States, Puerto Rico, and select territories. Void where prohibited by law. Additional restrictions may apply. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer. Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.
Our Bridge Program* may be able to help if your insurance coverage is delayed and you have private insurance. It can cover the cost of FABHALTA while you wait. This gives Novartis Patient Support time to work with your doctors and health plan to seek insurance coverage.
*The Bridge Program applies to FABHALTA only. Limitations apply. Patients with commercial insurance, a valid prescription for FABHALTA, and a denial of insurance coverage based on a prior authorization requirement may receive a monthly maintenance dose for up to 12 months or until insurance coverage approval, whichever occurs first. Not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state program, or where prohibited by law. A prior authorization and/or appeal of coverage denial must be submitted within 90 days to remain in the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Additional restrictions may apply. Novartis reserves the right to rescind, revoke, or amend this Program without notice.
Novartis Patient Assistance Foundation, Inc. (NPAF) is an independent, 501(c)(3) non-profit entity that provides certain medications at no cost to eligible patients who cannot afford the cost of Novartis medications supported by NPAF.
Patients may be eligible for NPAF support if they:
Are a resident of the United States or a US territory.
Are prescribed a product on the NPAF formulary.
Meet NPAF income eligibility requirements.
Are uninsured or are a qualifying patient with government insurance who cannot afford their out-of-pocket costs and, in the case of Medicare patients, do not qualify for Medicare's Extra Help Program (Low Income Subsidy).
NPAF does not provide product to individuals having insurance associated with any type of alternative funding program that conditions, restricts, or adjusts coverage based on application to NPAF or to any other free goods program.
Please visit www.PAP.Novartis.com ↗ or call NPAF at 1-800-277-2254 to learn more about eligibility and how to apply.
To receive support through NPAF, applicants must submit all required documentation, including proof of income and evidence of Extra Help denial as deemed necessary. Only the patient or their legal guardian or caregiver may enroll the patient in the program. Health plans, specialty pharmacies, pharmacy benefit managers, and their agents and representatives are prohibited from enrolling patients in the program. Novartis Patient Assistance Foundation, Inc., at its sole and absolute discretion, reserves the right to modify or discontinue the program at any time and to verify the accuracy of enrollment information submitted.
Yes. Once you’ve started treatment, your Novartis Patient Support team will be there for you if you need support.
Live one-on-one support is available to assist you with:
Guidance on your health plan coverage process
Setting up your routine and getting more help with FABHALTA
Call us at 833-99FABHA (833-993-2242), Monday-Friday, 8:00 AM-8:00 PM ET, excluding holidays.
Novartis Patient Support does not provide medical advice and doesn’t replace medical guidance from your health care provider. Our goal is to help you feel informed about your treatment from day one.
You may hear from one of these pharmacies:
Biologics by McKesson: 1-800-850-4306
CareMed: 1-877-227-3405
If you have more questions about FABHALTA or IgAN, support is available.
Patient & Community Liaisons (PCLs) provide education, resources, and personalized support to help you understand and navigate your disease journey. PCLs do not provide medical advice
Novartis Patient Support™ is available for all people who have been prescribed FABHALTA and can offer financial support, insurance support, vaccination support, and ongoing support
A Novartis Patient Support team member will contact you after you enroll. They’ll get to know you and answer questions about your treatment and support needs. You’ll receive personalized, one‑on‑one assistance throughout treatment.
Self-advocacy
If you have more questions about FABHALTA or IgAN, support is available.
FABHALTA Patient & Community Liaisons can provide support and information to you and your care partner, regardless of which treatment you are on.
Novartis Patient Support™ is available for all people who have been prescribed FABHALTA and can offer financial support, insurance support, vaccination support, and ongoing support.
A Novartis Patient Support team member will contact you after you enroll. They’ll get to know you and answer questions about your treatment and support needs. You’ll receive personalized, one‑on‑one assistance throughout treatment.
American Kidney Fund
https://www.KidneyFund.org ↗
IgA Nephropathy Foundation
https://igan.org ↗
National Kidney Foundation
https://www.kidney.org/ ↗
NephCure for Rare Kidney Disease
https://nephcure.org ↗
Still have questions? Novartis Patient Support can help