The U.S. Food and Drug Administration (FDA) has approved Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antagonist indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
Important information
Kevzara can cause serious side effects including:
Serious Infections. Kevzara is a prescription medicine that affects your immune system. It can lower the ability of your immune system to fight infections. Some people have serious infections while using Kevzara, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting treatment.
Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment. You should not start treatment if you have any kind of infection unless your healthcare provider says it is okay.
Before starting treatment, tell your healthcare provider if you:
think you have an infection or have symptoms of an infection, with or without a fever:
sweats or chills
muscle aches
cough
shortness of breath
blood in your phlegm
weight loss
warm, red or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinating more often than normal
feeling very tired
are being treated for an infection.
get a lot of infections or have infections that keep coming back.
have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance of getting infections.
have TB, or have been in close contact with someone with TB.
live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen more often or become more severe if you use Kevzara. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
have or have had hepatitis.
After starting Kevzara, call your healthcare provider right away if you have any symptoms of an infection.
Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start Kevzara, four to eight weeks after starting Kevzara, and then every three months during treatment to check for:
low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections. A low neutrophil count is common with Kevzara, and can be severe.
low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
increase in certain liver function tests. An increase in certain liver function tests is common with Kevzara, and can be severe.
Your healthcare provider may not prescribe Kevzara if your neutrophil or platelet counts are too low, or your liver function tests are too high. Your healthcare provider may stop your treatment for a period of time or change your dose if needed because of changes in these blood test results. Your healthcare provider should do blood tests four to eight weeks after starting Kevzara and then every six months during treatment to check for an:
increase in blood cholestero
l levels.
Tears (perforation) of the stomach or intestines. Tell your healthcare provider if you have had a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people using Kevzara get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal antiinflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Call your healthcare provider right away if you have fever and stomach (abdominal) pain that does not go away.
Cancer. Kevzara may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.
Kevzara side effects
Kevzara can cause serious side effects, including:
Serious allergic reactions. Serious allergic reactions can happen with Kevzara. Get medical attention right away if you have any of the following signs of a serious allergic reaction:
shortness of breath or trouble breathing
swelling of the lips, tongue, or face
chest pain
feeling dizzy or faint
moderate or severe stomach (abdominal) pain or vomiting
Common side effects of Kevzara include:
injection site redness
upper respiratory tract infection
urinary tract infection
nasal congestion, sore throat, and runny nose
These are not all of the possible side effects. Call your doctor for medical advice about side effects.
What are the ingredients in Kevzara?
Active Ingredient: sarilumab
Inactive Ingredients: arginine, histidine, polysorbate 20, sucrose, and Water for Injection, USP.
Source: drugs.com