What Is Gazyva and What Is the Approval For?
The FDA has approved Gazyva (obinutuzumab) for adults and children aged 2 years or older who have a kidney disorder called idiopathic nephrotic syndrome. This approval is for people whose kidney disease started in childhood and either returns frequently or must be managed with steroid medicines.
Idiopathic nephrotic syndrome causes the kidneys to leak large amounts of protein into the urine. This leak lowers protein levels in the blood and causes swelling throughout the body. It can also lead to high cholesterol, infections, and blood clots. This condition is the most common form of nephrotic syndrome in children, usually starting between 2 and 7 years of age.
Gazyva works by targeting and removing specific immune cells called B cells. By removing these B cells, Gazyva helps prevent the illness from returning. Patients must already be in complete remission before starting the drug, meaning they have no signs of swelling and have normal protein levels in their urine.
Why Was Gazyva Approved?
The FDA approved Gazyva based on a clinical trial with 85 patients aged 2 or older. All patients had childhood-onset nephrotic syndrome that was in complete remission at the start of the study. Researchers compared patients who received Gazyva infusions to patients who took oral mycophenolate twice daily, which is a common standard treatment.
The main goal of the study was to see how many patients stayed in complete remission without a disease relapse for one year. In the Gazyva group, 95% of patients stayed in remission without relapsing for the full year. In comparison, only 73% of patients in the other group stayed in remission without relapsing. This showed that Gazyva worked better than oral mycophenolate at keeping the kidney disease from coming back (relapsing).
Safety findings showed that the most common side effects of Gazyva were infections, low white blood cell counts, and reactions during drug infusions. Severe infections occurred in 11% of patients receiving Gazyva compared to 5% taking the standard drug. Pneumonia was the most common severe infection reported with Gazyva. There were no life-threatening or fatal infections in either group during the study.
What Do I Need to Know About Taking Gazyva?
Gazyva is given as an infusion into a vein by a healthcare provider. Treatment consists of four total doses given on day 1, week 2, week 24, and week 26. To help prevent infusion reactions, your healthcare provider will give you other medicines before each dose. Inform them right away if you get a fever, nausea, or vomiting during an infusion.
The most common side effects include respiratory infections, ear infections, urinary tract infections, and low white blood cell counts. Because this medicine weakens the immune system, you should avoid live vaccines during treatment and until your immune cells recover. Work with your healthcare provider to make sure you receive all age-appropriate live vaccines at least 28 days before starting treatment.
This medicine carries warnings for certain rare but severe risks. It can reactivate a virus called hepatitis B, so your healthcare provider will test your blood for hepatitis B before you start treatment. It can also cause a rare, fatal brain infection called progressive multifocal leukoencephalopathy. Contact your healthcare provider immediately if you experience new changes in your thinking, eyesight, or movement.
Gazyva can harm a fetus. If you can get pregnant, you must use effective birth control during treatment and for six months after your last dose. Breastfeeding should also be avoided while receiving Gazyva and for six months after the final dose.