Kevzara® (sarilumab)

Kevzara 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. Kevzara also contains several inactive ingredients: arginine, histidine, polysorbate 20, sucrose, and Water for Injection, USP.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 stimulates 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 of Kevzara?

The most common side effects experienced by people taking Kevzara in clinical trials were low white blood cell counts (neutropenia), redness at the site of injection, upper respiratory infections (nasal congestion, sore throat, runny nose), urinary tract infections, and increased levels of the enzyme ALT (alanine aminotransferase), which measures liver function.1

Kevzara has a black box warning, the strictest warning from the U.S. 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. Patients 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. Immediate medical attention should be sought if you experience any of the following symptoms: difficulty breathing or shortness of breath, feeling faint or dizzy, chest pain, abdominal pain, vomiting, or swelling of the lips, tongue or face.1,2

Things to know about Kevzara

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 vaccinations1,2

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 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
Talk to your doctor or pharmacist about all prescription and over-the-counter medications you are taking, as well as any vitamins, nutritional supplements, and herbal products you take, as some of these may interact with Kevzara. In particular, be sure to tell your doctor about all medications you take for RA.1,2
Dosing information
Kevzara may be used alone (monotherapy) or in combination with methotrexate or other DMARDs. The recommended dose of Kevzara is 200 mg once every two weeks. Kevzara is given as an injection under the skin (subcutaneously). It comes as a pre-filled syringe, which can be self-injected at home.1,2

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