Kevzara (sarilumab)

Kevzara^® (sarilumab) is an injectable prescription treatment for adults with moderately to severely active rheumatoid arthritis (RA) who have not had a good response to at least one other disease-modifying antirheumatic drugs (DMARDs).

Kevzara is classified as a biologic, as it is a human monoclonal antibody that is an interleukin-6 (IL-6) receptor antagonist.¹

What are the ingredients in Kevzara?

The active ingredient in Kevzara is sarilumab.¹

How does Kevzara work?

In autoimmune diseases like RA, the body’s immune system begins to attack itself and creates chronic inflammation that can damage tissues in the joints. One of the proteins that stimulate the inflammatory response is interleukin (IL)-6. Kevzara binds to the IL-6 receptor, blocking the chemical signal for inflammation.^1,2

What are the possible side effects?

The most common side effects of Kevzara include:¹

• Low white blood cell counts (neutropenia)
• Redness at the site of injection
• Upper respiratory infections (nasal congestion, sore throat, runny nose)
• Urinary tract infections
• Increased levels of the liver enzyme ALT (alanine aminotransferase)

Kevzara has a black box warning, the strictest warning from the US Food and Drug Administration (FDA), because of its potential to cause serious infections (bacterial, viral, fungal or other opportunistic infections) that can lead to hospitalizations or death. Some cases of tuberculosis (TB) have been reported in people being treated with Kevzara. People receiving treatment with Kevzara should be monitored for signs and symptoms of infection, including:

• Fever, sweat, or chills
• Achy muscles
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Sores on the body that are warm, red, or painful
• Diarrhea or stomach pain
• Burning during urination or more frequent urination
• Feeling very tired¹

If a serious infection develops, treatment with Kevzara should be discontinued until the infection is under control.¹

Kevzara may cause tears in the stomach or intestines, causing fever and abdominal pain that does not go away.^1,2

Kevzara may increase the risk of developing certain cancers.^1,2

Serious allergic reactions have occurred in some people using Kevzara. Get medical help right away if you experience any of the following symptoms:^1,2

• Difficulty breathing or shortness of breath
• Feeling faint or dizzy
• Chest pain
• Abdominal pain or vomiting
• Swelling of the lips, tongue, or face

These are not all the possible side effects of Kevzara. Talk to your doctor about what to expect when taking Kevzara. You also should call your doctor if you have any changes that concern you when taking Kevzara.

Other things to know

Kevzara affects the way the immune system works, and it may reduce your body’s ability to fight infections. Kevzara should not be used by anyone who has an active infection. If you have any signs of an infection, call your doctor right away.¹

Before taking Kevzara, you should talk to your doctor about all your medical conditions, including:

• Diabetes
• HIV or a weakened immune system
• TB or have been in close contact with someone who has TB
• Current or history of hepatitis or liver problems
• History of diverticulitis or ulcers in the stomach or intestines
• Plans for surgery or a medical procedure
• Pregnancy
• Breastfeeding
• Recent vaccinations^1,2

In addition, tell your doctor if you live or have lived, or have traveled to certain parts of the country where there’s an increased risk of certain fungal locations, such as the Ohio or Mississippi River Valleys or the Southwest.^1,2

Before taking Kevzara, your doctor will run blood tests to check for tuberculosis, neutrophil (white blood cells that fight infections) counts, platelet (blood cells that stop bleeding and form clots) counts, cholesterol, and certain liver function tests. Kevzara may impact your blood test results, and your dosage of Kevzara may be reduced or stopped if blood cells get too low or cholesterol or liver enzymes get too high.^1,2

People who have a known allergy or hypersensitivity to sarilumab or any of the ingredients in Kevzara should not take Kevzara.^1,2

People taking Kevzara should not take live vaccines. Talk to your doctor before receiving any vaccines if you are unsure about what kind of vaccine you are getting.¹

Before beginning treatment for RA, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.”