Kevzara (sarilumab) is a prescription medication used to treat certain inflammatory and autoimmune conditions. This article provides a comprehensive overview of Kevzara, including its uses, mechanism of action, potential side effects, and important precautions.
What is Kevzara?
Kevzara (sarilumab) is a brand-name prescription medication and a human monoclonal antibody. It is an FDA-approved biological medication given to adults for the treatment of rheumatoid arthritis (RA). Kevzara is used long term to treat moderate to severe RA in adults who haven’t achieved the desired response from other drugs that treat autoimmune and inflammatory diseases (disease-modifying anti-rheumatic drugs). The drug may be prescribed if you have tried one or more disease-modifying antirheumatic drugs (DMARDs) that have not eased your symptoms enough or if you have had a reaction to a DMARD. Kevzara (sarilumab) is also used to treat polymyalgia rheumatica (disorder that causes muscle pain and weakness) in adults when other medications did not help or could not be tolerated. Sarilumab injection is also used to treat polyarticular juvenile idiopathic arthritis (PJIA; a type of childhood arthritis that affects five or more joints during the first six months of the condition, causing pain, swelling, and loss of function) in children weighing 139 pounds (63 kg) or more.
Fast facts about Kevzara:
- Active ingredient: sarilumab, which is a biologic
- Drug class: interleukin-6 receptor antagonist
- Drug form: liquid solution in a prefilled pen or prefilled syringe, given as a subcutaneous injection
- FDA approval year: 2017
Kevzara Uses
Kevzara (sarilumab) is commonly used for the following conditions:
- Rheumatoid arthritis (RA): Kevzara is used to treat moderate-to-severe rheumatoid arthritis in adults. Rheumatoid arthritis (RA) is a chronic autoimmune and inflammatory disease that causes swelling, pain, and inflammation in the affected joints.
- A condition called polymyalgia rheumatica (PMR)
- A specific type of arthritis that occurs in children, called polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing 63 kg or greater with active pJIA.
Kevzara may also be used for other conditions as determined by your healthcare provider.
How Kevzara Works
Kevzara works by blocking a protein called interleukin-6 (IL-6) from binding to its receptors in the body. Sarilumab injection is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It works by blocking the activity of interleukin-6, a substance in the body that causes inflammation. People with certain conditions, such as rheumatoid arthritis and polymyalgia rheumatica, have too much IL-6 activity. IL-6 contributes significantly to the symptoms of rheumatoid arthritis and PMR. It is found in abundance in the synovial fluid and serum of people with RA and levels of IL-6 are higher during periods of increased disease activity and joint destruction. It also contributes to other symptoms of RA, such as anemia, osteoporosis, and fatigue. This can cause swelling (inflammation) in different parts of the body. Blocking IL-6 from working can decrease the swelling that causes these conditions.
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Dosage and Administration
The usual dose of Kevzara is 200 mg injected under the skin (subcutaneous) every 2 weeks. Sarilumab injection comes as a prefilled syringe and a prefilled pen to inject subcutaneously (under the skin). It is usually used once every 2 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use sarilumab injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Kevzara is given as a subcutaneous injection, meaning an injection under the skin in your upper arm, front of your thigh, or your belly (at least 2 inches away from your belly button). You may inject sarilumab injection on the front of the thighs or anywhere on your stomach except your navel (belly button) and the area 2 inches around it. If another person is injecting your medication, the outer area of the upper arms also may be used. Do not inject the medication into skin that is tender, bruised, damaged, or scarred. Choose a different spot each time you inject the medication. Your provider might give you the first few doses in an office or clinic. Your doctor will show you or the person who will be injecting the medication how to inject it. You or the person who will be injecting the medication should also read the written instructions for use that come with the medication. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.
Storage
Kevzara should be kept in its original carton to protect it from light. Store Kevzara in a refrigerator (36°F to 46°F) in the original carton to protect it from light. It must be stored in the refrigerator, between 36 F to 46 F (2 C to 8 C). Do not shake or freeze the medicine. Kevzara can be stored at room temperature up to 77 F (25 C) for up to 14 days, if needed. Once it has been stored at room temperature, it cannot be placed back into the refrigerator. If it is not used within 14 days of being stored at room temperature, it should be thrown away. Remove the prefilled syringe or prefilled pen from the refrigerator, place it on a flat surface, and allow it to reach room temperature (30 minutes for the prefilled syringe and 60 minutes for the prefilled pen) before your are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in warm water or in direct sunlight, or through any other method. Do not remove the cover from the prefilled syringe or the cap from the prefilled pen while the medication is warming. You should remove the cover or cap just before you inject the medication. Always look at sarilumab solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless to slightly yellow. The liquid should not contain visible particles. Do not use if it is expired or if the liquid is cloudy, discolored, or contains particles. Use each syringe and pen only once. Throw away used syringes and pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of thepuncture-resistant container.
Potential Side Effects
Like other drugs, Kevzara can cause side effects. Kevzara can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. But if they last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Common Side Effects
The most common side effects of Kevzara are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- High levels of an enzyme (ALT) that is made by the liver
- Kidney and bladder infection
- Blood disorders
- Pain, itching, swelling, or redness near the injection site
- Neutropenia (low level of neutrophils, a type of white blood cell)
- Infections, such as urinary tract infections and upper respiratory infections (including colds)
- Short-term changes in the results of liver function tests, which could be a sign of liver damage
Serious Side Effects
While less common, the most serious side effects of Kevzara are described below, along with what to do if they happen.
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Severe Allergic Reactions: Kevzara may cause allergic reactions, which can be serious. Stop using Kevzara and get help right away if you have any of the following symptoms of a serious allergic reaction:
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Disorders: Kevzara can cause blood disorders, such as low platelet levels (thrombocytopenia), and low white blood cell levels (neutropenia and leukopenia). Keep all appointments so that your healthcare provider can monitor your blood work. Stop using Kevzara and get help right away if you have any of the following symptoms of blood disorders:
- Fever
- Easy bruising or bleeding
- Frequent infection
- Unusual weakness or tiredness
- Swollen lymph nodes
- Wounds that do not heal
- bruising or bleeding easily
- nosebleeds
- blood in your vomit or stool
Cancer: A small number of people who used Kevzara and other drugs similar to Kevzara have developed cancer. It is not clear if Kevzara increases the risk for cancer. Let your healthcare provider know if you or your family has a history of cancer. Symptoms can include:
- unusual lumps or skin changes
- unexpected change in body weight
- fatigue
Infection: Kevzara can increase the risk of infections, including serious infections. It can also make current infections worse. Call your healthcare provider right away if you have an infection or any of the following symptoms:
- Burning or stinging when you pee
- Cough or coughing up blood
- Feeling very tired
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Warm, red, or painful skin or sores on your body
- Weight loss
High Cholesterol Levels: Kevzara can cause changes in your lipid levels, such as high cholesterol and high triglyceride levels. Keep all appointments with your healthcare provider to check your lipid levels after you start using Kevzara.
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Liver Damage: Liver damage, also called hepatotoxicity, can happen when using Kevzara. Call your healthcare provider right away if you have any of the following symptoms of liver damage:
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Reactivated Infections: Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after a person recovers from that infection. When a microbe stays in the body but does not cause an infection, it is a “latent” microbe. Kevzara may increase your risk of reactivating a latent microbe, causing an infection. Before you start treatment with Kevzara, let your healthcare provider know if you have ever had tuberculosis (TB), hepatitis B, or any other serious infections.
Stomach Bleeding: Kevzara can increase your risk of tears (perforation) in your gut. The risk is higher if you have a history of a condition called diverticulitis or if you take certain other medicines, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get emergency help right away if you have any of the following symptoms:
- Nausea and vomiting
- Black or tarry poop
- Stomach pain that does not go away or is severe
- Fever
Tear in the stomach or intestines: Symptoms of these tears may include:
- intense pain or pressure in your abdomen
- nausea or vomiting
- fever
- chills
- dizziness
Injection Site Reactions
Injection site reactions can occur during Kevzara treatment. This was a common side effect in the drug’s clinical trials. Sometimes you may have a reaction near the site where you injected the drug. This is known as an injection site reaction. Common symptoms of injection site reactions can include pain, reddening or deepening of skin color, itching, and irritation. These symptoms are mild and temporary in most people. In rare cases, injection site reactions can be severe. Injection site reactions from Kevzara should go away within a few days. There are ways to help minimize discomfort from Kevzara injections. It’s important to allow the drug to come to room temperature before you inject it. If you inject Kevzara when it’s still cold, it can be painful. You should also rotate the injection site for each dose, which means choosing a different spot for each injection. Repeated use of the same exact spot may increase the risk of injection site reactions. Also, be sure to avoid injecting into skin that’s scarred, bruised, tender, or damaged. If you have severe injection site reactions, talk with your doctor. They may recommend ways to relieve your symptoms. In some cases, your doctor may suggest changes in your treatment plan. This could include changing your dosage or switching to a different medication.
Boxed Warning: Risk of Serious Infections
Kevzara comes with a boxed warning about a risk of serious infections. A boxed warning is the most serious type of warning from the Food and Drug Administration (FDA). The warning alerts patients and healthcare professionals about drug effects that may be dangerous. Using Kevzara may decrease your immune system’s ability to fight germs that can cause infections. Also, taking certain other drugs with Kevzara to treat rheumatoid arthritis can further weaken your immune system. Examples of these drugs include methotrexate (Trexall) and corticosteroids such as prednisone (Rayos). Due to weakened immune systems, serious bacterial, viral, and fungal infections have occurred in people using Kevzara. In some cases, the serious infections were life threatening. Symptoms of serious infections vary, but they generally include: fever, chills, coughs, sore throat, body aches, skin rash or areas that are swollen, discolored, oozing, or painful. Before you start Kevzara treatment, your doctor may test you for TB. If you test positive, they’ll likely treat the TB before prescribing Kevzara. If you think you have any type of infection before you use Kevzara, be sure to tell your doctor. If you think you have an infection while you’re using Kevzara, immediately talk with your doctor or seek medical attention. You’ll likely be prescribed treatment for it. Your doctor may have you stop using Kevzara until your infection clears up.
Increased Levels of Fats in the Blood
Kevzara may increase the levels of lipids (fats) in your blood, including: low-density lipoprotein (LDL), also known as “bad“ cholesterol; high-density lipoprotein (HDL), also known as “good“ cholesterol; triglycerides. In clinical trials, these increases were seen within the first 4 weeks of Kevzara treatment. No additional increases were seen after that. Having too much fat in your blood doesn’t cause any symptoms. But it can increase your risk of heart disease. During your treatment with Kevzara, your doctor will order blood tests called lipid panels. These tests measure the levels of fats in your blood. If your cholesterol or triglyceride levels become too high, your doctor may prescribe a statin drug. They may also suggest exercise, diet changes, or other medications to manage the levels of fat in your blood.
Warnings and Precautions
Who Should Not Use Kevzara?
People who are allergic to any of the following should not use Kevzara:
- Kevzara
- Sarilumab
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Kevzara.
What to Tell Your Healthcare Provider Before Using Kevzara?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Kevzara is right for you. In particular, make sure that you discuss any of the following.
Current and Past Health Conditions
Tell your healthcare provider if you have any of the following:
Cancer
Diabetes
Stomach problems, including diverticulitis or ulcers
HIV/AIDS
History of a fungal infection, such as histoplasmosis
History of tuberculosis (TB)
Liver problems, including a history of hepatitis
Upcoming surgery
Weak immune system
Risk for Infection: Before starting Kevzara, it is important to talk to your healthcare provider about any serious infections you have had in the past as well as any infections you have currently. You should also let your healthcare provider know if you have any of the following issues that might increase your chance of having an infection:
- A current infection
- Get a lot of infections or have infections that come back
- Been in close contact with someone who has tuberculosis (TB)
- Living in, have lived in, or traveled to countries where there is a risk for TB
- Living in or traveled to the Ohio or Mississippi River valleys or the Southwest United States
Other Medicines and Supplements: Kevzara should not be used while you are using certain other medicines. Before using Kevzara, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Vaccines: Let your healthcare provider know if you have recently received or are scheduled to receive any vaccinations. There are certain vaccines (live vaccines) that you should not receive either right before receiving Kevzara or once you have started using Kevzara. Your healthcare provider will confirm whether any upcoming vaccinations are safe.
Pregnancy: It is not known if or how Kevzara could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should take Kevzara while you are pregnant or trying to get pregnant.
Breastfeeding: It is not known if Kevzara passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
Other Precautions
Be sure to talk with your doctor about your health history before you start using Kevzara. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:
- Infections, including tuberculosis. Using Kevzara may decrease your ability to fight infections. If you’re being treated for an infection, even a minor one, or think you may have an infection, tell your doctor. They’ll likely wait to prescribe Kevzara until your infection has gone away. Also, be sure to talk with your doctor if you’ve had tuberculosis (TB) or have any infections that keep returning. They can help determine if Kevzara is right for you.
- Use of corticosteroids or NSAIDs. It’s possible to develop a gastrointestinal perforation while you use Kevzara. If you already take a corticosteroid or nonsteroidal anti-inflammatory drug (NSAID), you may have an increased risk of a tear. Examples of corticosteroids include prednisone (Rayos) and dexamethasone (Hemady). Examples of NSAIDs include aspirin and ibuprofen (Motrin, Advil). If you take a corticosteroid or an NSAID, talk with your doctor. They can help you weigh the risks and benefits of Kevzara.
- Diverticulitis. During Kevzara treatment, it’s possible to develop a gastrointestinal perforation (hole or tear in an intestine or the stomach). If you have a condition called diverticulitis, you may have an increased risk of this tear. Your doctor can help you weigh the pros and cons of Kevzara treatment.
- Liver problems. Kevzara isn’t recommended if you have a liver problem, such as hepatitis. This is because using this drug may worsen your liver problem. Before prescribing Kevzara, your doctor will likely check the health of your liver with a liver function test. If your liver isn’t functioning as well as it should, your doctor may not prescribe Kevzara. They can suggest a different treatment.
- Allergic reaction. If you’ve had an allergic reaction to Kevzara or any of its ingredients, your doctor will likely not prescribe Kevzara. Ask them what other medications may be better options for you.
Interactions
Kevzara and Foods or Drinks
There are no known interactions between Kevzara and foods or drinks. It is unknown if drinking alcohol will affect Kevzara. However, drinking too much can lead to liver problems. And it may not be safe to use Kevzara if you have a liver problem. So if you consume too much alcohol and use Kevzara, this could make your liver problem worse. If you’d like to know how much alcohol, if any, is safe to drink while you use Kevzara, talk with your doctor.
Kevzara and Other Medicines (Drug Interactions)
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using any of the following before using Kevzara:
- A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which are in many prescription and OTC products for pain, swelling, and fever
- A corticosteroid, which is a medicine for certain inflammatory conditions
- Methotrexate (Trexall and others), which is a medicine commonly used for rheumatoid arthritis or certain types of cancer
- Medicines that can affect liver function
- Any other medicines that suppress your immune system that are being used to treat your condition
Kevzara may alter the blood levels of some other medicines. Tell your healthcare provider about all medicines that you take or have recently taken. This may not be a complete list of medicines that can interact with Kevzara. Always check with your healthcare provider.
Does Kevzara Cause Weight Gain or Loss?
Weight gain is not a side effect of Kevzara, and it has not been reported in patients on Kevzara drug therapy. Weight changes weren’t seen in people who took the drug in clinical trials. However, some other medications that are given to treat RA, such as prednisone, have a higher chance of causing weight gain as a side effect in some patients. The symptoms of rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), and active polyarticular juvenile idiopathic arthritis (pJIA) can make people tired and make it hard for them to move and exercise, which may contribute to weight gain. Be sure to tell your doctor about any changes in your weight while you’re using Kevzara. They can help determine whether the drug or another factor is the cause. Your doctor can also recommend ways to maintain a weight that’s healthy for you.
Overdose
Kevzara overdose can lead to serious side effects as it is an injectable drug. It is crucial to take only one dose of up to 200 mg every 2 weeks or as prescribed by your provider. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Additional Information
- Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sarilumab injection.
- Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
- Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital.
- This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.