Childhood-onset idiopathic nephrotic syndrome is a kidney condition that causes the filters in the kidneys to leak too much protein into the urine. This can lead to swelling (edema) in the feet, legs, face, and belly, along with changes in blood tests. It usually starts in children between the ages of 2 and 7 years, but it can affect children of any age. Idiopathic means there is no known cause.
Most children respond well to corticosteroid (steroid) medicines at first. However, many can have a return of symptoms (relapse) or may need repeated or ongoing steroid courses to stay in remission. Over time, using steroids can take a toll on a child's growth, bones, and overall health, which is why health care providers may look for ways to help kids stay in remission with less reliance on steroids.
Gazyva (obinutuzumab) is a prescription medicine given as an infusion into a vein (IV). It belongs to a group of medicines called monoclonal antibodies. Gazyva has been used for years to treat certain cancers and, more recently, lupus nephritis (inflammation of the kidneys caused by lupus). In September 2026, the FDA approved a new use for Gazyva: to reduce the risk of relapse in adults and children who are 2 years and older with certain forms of nephrotic syndrome.
This article covers how Gazyva works for childhood-onset nephrotic syndrome, who it's approved for, how you receive it, what clinical studies found, and the possible side effects and interactions.
How Does Gazyva Work for Childhood-Onset Nephrotic Syndrome?
Researchers believe that certain immune cells, called B cells, play a role in causing frequently relapsing and steroid dependent nephrotic syndrome. Gazyva works by attaching to a protein called CD20, found on the surface of B cells. Once attached, Gazyva signals the body's immune system to destroy these B cells. This is known as B-cell depletion.
Gazyva was engineered to attach to B cells in a way that may trigger stronger depletion than some older medicines in this class, such as rituximab. By reducing the number of B cells in the body, Gazyva may help people with childhood-onset nephrotic syndrome stay in remission for longer and need fewer steroids over time.
Is Gazyva Right for Me?
Gazyva is approved to reduce the risk of relapse in adults and children who are 2 years and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission.
- Frequently relapsing nephrotic syndrome generally means a child has had two or more relapses within six months of their first episode or three or more relapses within any 12-month period.
- Steroid dependent nephrotic syndrome generally means a child relapses twice in a row while still taking steroids or shortly after stopping them.
Gazyva should not be used in anyone who has had a serious allergic reaction to it in the past, including a condition called serum sickness.
Your health care provider will consider factors such as how often relapses happen, how much steroid medicine has been needed in the past, and whether other treatments have been tried before recommending Gazyva.
How Do I Receive Gazyva?
Gazyva is given as an IV infusion in a health care setting, such as a clinic or infusion center. For children and young adults weighing 45 kg or more (about 99 pounds or more), the usual dose is 1,000 mg. For those weighing less than 45 kg, the dose is based on body weight (20 mg per kg).
The typical schedule is four infusions:
- Dose 1: Day 1
- Dose 2: Two weeks later
- Dose 3: 24 weeks later
- Dose 4: Two weeks after that (week 26)
Before each infusion, you or your child will likely receive other medicines to help lower the chance of a reaction during the infusion. If you or your child is already taking an oral steroid when Gazyva is started, your health care provider will typically plan a gradual taper of that steroid. Don't stop or adjust any steroid dose without your health care provider's guidance.
If a scheduled dose of Gazyva is missed, it should be given as soon as possible. Don't wait for the next planned dose. Your health care provider will adjust the schedule to keep the right amount of time between doses.
How Was Gazyva Studied?
Gazyva's efficacy and safety for this use was evaluated in a clinical trial called INShore.
How was the study designed?
INShore enrolled 85 children and young adults (2 years and older) with frequently relapsing or steroid dependent idiopathic nephrotic syndrome. To join the study, participants had to be in complete remission, meaning they had no swelling and their urine protein levels were very low at the time they enrolled. They had to have had at least one relapse in the six months before enrollment.
Participants were randomly assigned to receive either Gazyva or a different medicine called mycophenolate mofetil (MMF), a pill taken twice a day. This was an open-label study, meaning both participants and their health care providers knew which medicine was being given. There was no placebo (a look-alike medicine with no active ingredient) used in this study.
Participants who were taking an oral steroid at the start of the study had it gradually tapered off by week 8 and had to stay off steroids through the rest of the main study period. The study's main question was whether participants stayed in remission, without a relapse, through one year (52 weeks) of treatment.
What types of people were included in the study?
At the start of the study, the median (midpoint) age of participants was about 9 years (ranging from 2 to 22 years), and about 64% were between the ages of 2 and 12 years. About 65% were male. About 55% were White, 27% were Asian, and 14% were Black or African American; 25% identified as Hispanic or Latino.
Before joining the study, half of the people in the study had had the disease for less than 46 months (nearly four years), and half had had it for longer. About 45% had frequently relapsing nephrotic syndrome, and 55% had steroid dependent nephrotic syndrome. Most (75%) had already tried other nonsteroidal medicines for their condition.
What Are the Main Benefits of Gazyva Based on Studies?
The study looked at how many participants stayed in complete remission, without a relapse, after week 8 through week 52.
- About 95% of participants who received Gazyva met this goal.
- About 73% of participants who received MMF met this goal.
This means that, compared with MMF, a higher percentage of children and young adults who received Gazyva were able to stay in remission for a full year without a relapse.
Your results may differ from what was seen in clinical studies.
Are There Additional Potential Benefits of Gazyva Based on Studies?
The study also tracked how many participants had at least one relapse and how many total relapses happened over the year.
- About 7 out of every 100 person-years of Gazyva treatment included a first relapse, compared with about 33 out of every 100 person-years of MMF treatment.
- In total, only four relapses were reported among all participants who received Gazyva, compared with 24 relapses among those who received MMF.
The study also found that participants who received Gazyva were less likely to need steroids again after week 8. About 98% of the Gazyva group avoided further steroid use, compared with about 73% of the MMF group.
Your results may differ from what was seen in clinical studies.
How Long Were the Studies? Is There Longer-Term Data?
The main part of the INShore study compared Gazyva with MMF over 52 weeks.
After this main period, participants may continue to be followed in an extension period, with study visits about every three months, to gather more information about how the medicines performed over a longer stretch of time.
Researchers also tracked how many participants stopped their assigned treatment early. Only about 2% of the Gazyva group stopped treatment during the 52-week period, compared with about 22% of the MMF group.
What Are the Possible Side Effects of Gazyva?
Common side effects
In the INShore study, the most common side effects reported in children and young adults who received Gazyva were:
- Upper respiratory tract infection (such as a cold)
- Infusion-related reactions
- Ear infection
- Pneumonia
- Influenza (flu)
- Low white blood cell counts (neutropenia)
- Bronchitis
- COVID-19
- Conjunctivitis (pink eye)
- Urinary tract infection
Serious side effects
Gazyva can also cause serious side effects, including:
- Hepatitis B virus reactivation
- Progressive multifocal leukoencephalopathy (PML), a rare brain infection
- Severe infections, such as pneumonia
- Severe decreases in white blood cell levels
If you have symptoms that feel serious or life-threatening, seek medical care right away. This article doesn't include every possible side effect. Tell your health care provider about any symptoms that concern you or don't improve.
How to manage common and serious side effects
Infusion-related reactions
About 36% of children and young adults who received Gazyva in the INShore study had an infusion-related reaction. These happened most often during or shortly after the first infusion. All of the reactions reported in this study were mild or moderate.
Possible symptoms include fever, nausea or vomiting, low blood pressure, a fast heart rate, and trouble breathing, throat irritation, or wheezing.
To help lower the risk of a reaction, you or your child will likely receive other medicines, such as a steroid, an antihistamine, and acetaminophen, shortly before each infusion. During the infusion, a health care provider will watch closely to see how things are going. If you or your child takes a blood pressure medicine, ask whether it should be paused for several hours before and after the infusion because Gazyva can sometimes cause blood pressure to drop. Also tell your health care provider if you or your child has any heart or lung conditions, as these may increase the risk of a severe infusion-related reaction.
Tell your health care provider or the infusion nurse right away if you or your child has any of the above mentioned symptoms during the infusion or within a day afterward. The infusion can be slowed down, paused, or stopped depending on how serious the reaction is.
Infections
Gazyva lowers the number of B cells, which are a part of the immune system that helps fight off infections. Because of this, infections of all kinds were common in the INShore study. About 89% of people in the INShore study who received Gazyva had some type of infection, most often involving the lungs, ears, or sinuses.
Gazyva should not be given to anyone who currently has an active infection. Before each infusion, tell your health care provider about any signs of illness, such as a fever, cough, or ear pain.
To help lower the risk of infection, encourage frequent handwashing, and try to limit close contact with people who are currently sick. Before starting Gazyva, ask your health care provider which vaccines are recommended and when they should be given. Some vaccines should not be given shortly before, during, or for some time after treatment with Gazyva.
Contact your health care provider at the first sign of a possible infection, such as a fever, cough, ear pain, or pain with urination (peeing). Seek medical care right away for a high fever, trouble breathing, or any symptom that feels serious.
Low white blood cell counts (neutropenia)
Gazyva can lower the number of neutrophils, a type of white blood cell that helps the body fight infection. In the INShore study, this happened in about 18% of people who received Gazyva, and it was often more serious than what was seen in the people taking MMF.
This side effect doesn't always cause symptoms on its own, which is why your health care provider will order regular blood tests to check for it. Keep all scheduled lab test appointments, even if you or your child feels well.
Contact your health care provider for a fever or other signs of infection because a low white blood cell count can make infections more likely and more serious. Depending on the severity, your health care provider may delay a dose of Gazyva or prescribe a medicine to help the body make more white blood cells.
Hepatitis B virus reactivation
Gazyva has a boxed warning, the most serious type of warning used by the FDA, for hepatitis B virus (HBV) reactivation. This means that in someone who has been exposed to HBV in the past, even if they seem healthy now, Gazyva can cause the virus to become active again. In some cases, this has led to serious liver damage, liver failure, and death.
Before starting Gazyva, your health care provider will test for current or past HBV infection. If there's evidence of a past or current infection, they will monitor you closely for signs of hepatitis during and for several months after treatment.
Tell your health care provider right away if there is any yellowing of the skin or eyes, dark urine, unusual tiredness, nausea, or stomach pain. If HBV reactivation occurs, Gazyva should be stopped right away.
Progressive multifocal leukoencephalopathy (PML)
Gazyva also has a boxed warning for PML, a rare but serious brain infection caused by a virus called the John Cunningham (JC) virus. PML can be fatal.
Contact your health care provider right away if you or your child has any new or worsening confusion or memory problems, trouble speaking or understanding others, vision changes, weakness on one side of the body, or problems with balance or coordination.
If PML is suspected, your health care provider may recommend seeing a neurologist, having a brain MRI, or a procedure called a lumbar puncture (spinal tap) to help confirm the diagnosis. Gazyva should be stopped if PML happens.
Tell your health care provider right away about any other side effect that concerns you, even if it isn't listed here.
What Medicines or Vaccines Can Interact With Gazyva?
An interaction happens when a substance changes how a medicine works or affects the body. Gazyva doesn't have many of the typical interactions seen with pills that are broken down by the liver. Still, there are a couple of important things to know about using other medicines or getting vaccines during treatment with Gazyva. This isn't a full list of interactions.
Oral steroids (corticosteroids)
If an oral steroid, such as prednisone, is already being taken when Gazyva treatment starts, your health care provider will typically plan a gradual taper to slowly lower that steroid dose. Don't change the steroid dose or stop giving it on your own. Only adjust or stop steroids according to your health care provider's plan. Stopping a steroid too quickly can cause other problems.
Live vaccines
Gazyva lowers the number of B cells, which are part of the immune system that helps the body respond normally to vaccines and fight infections. Because of this, the immune system may not respond normally to vaccines during Gazyva treatment. Live vaccines, which contain a weakened form of a live virus, carry an added risk of causing an infection in someone whose immune system isn't working at full strength. Examples include the measles-mumps-rubella (MMR) vaccine, the chickenpox (varicella) vaccine, and the nasal-spray flu vaccine.
Any needed age-appropriate live vaccines should be given at least 28 days before starting Gazyva. Live vaccines should not be given during treatment or until your health care provider confirms that B cells have recovered. Don't schedule or adjust vaccine doses on your own. Be sure that all health care providers, including pediatricians and those managing Gazyva treatment, coordinate on vaccine timing.
Alcohol and supplements
There's no specific information on whether alcohol affects Gazyva. Ask your health care provider whether alcohol is a concern during treatment. Tell your health care provider and pharmacist about every vitamin, herb, or other supplement you or your child takes.
Other medicines that affect the immune system
Using Gazyva together with other medicines that suppress the immune system may increase the risk of infection. Tell your health care provider about every prescription and over-the-counter (OTC) medicine you or your child takes so they can watch for this and adjust the treatment plan if needed.
Reducing Your Risk of Side Effects and Interactions
You can help reduce the risk of side effects and interactions by following all instructions from your health care provider. Helpful tips include:
- Tell your pharmacist and other health care providers about all prescription drugs, OTC medicines, and any vitamins, herbs, or other supplements you or your child uses.
- Ask before starting or stopping any medicine, vitamin, or supplement.
- Keep all recommended lab test and monitoring appointments.
- Report new or worsening symptoms to your health care provider.
Your health care provider can review the treatment plan and make adjustments if needed to help make sure Gazyva is safe. Don't change or stop treatment on your own.
Is There Any Cost Assistance Available for Gazyva?
Gazyva requires a prescription and is given by a health care provider. The company that makes Gazyva offers a patient support program that may help with the cost of treatment, including options for people without insurance. Your health care provider's office can help you get started, or you can call 877-436-3683 or visit gazyva.com to learn more.