How to take KEVZARA

What to know about taking KEVZARA

KEVZARA is taken once every 2 weeks in combination with a tapering course of steroids and as monotherapy after tapering and discontinuing treatment with steroids.

Your doctor will guide you on how to gradually lower your dose of steroids. Your doctor should show you the right way to prepare and inject KEVZARA before you inject KEVZARA at home.

pre-filled syringe icon

KEVZARA is given as an injection. KEVZARA is available as a single-use pre-filled syringe or single-use pre-filled pen.

calendar icon

Sticking to your schedule is important. It may help to think about keeping an “injection calendar” and marking the dates and times of your injections so that you don’t forget.

pre-filled pen

How to use the pre-filled pen

The KEVZARA pre-filled pen was designed to be comfortably gripped with a cap that’s large and without a button.

Follow the step-by-step instructions

    • Read all of the instructions carefully before using the pre-filled pen
    • Keep unused pens in the original carton and store in the refrigerator between 36°F and 46°F (2°C and 8°C)
    • Keep the carton in an insulated bag with an ice pack when traveling
    • Let the pen warm up at room temperature for at least 60 minutes before using
    • Use the pen within 14 days after taking it out of the refrigerator or insulated bag
    • Keep the pen and all medicines out of the reach of children
    • Do not use the pre-filled pen if it has been damaged or if the orange cap is missing or not attached. Return the pen and the package it came in to your pharmacy
    • Do not remove the orange cap until just before you are ready to inject
    • Do not touch the yellow needle cover
    • Do not try to put the orange cap back on the pen
    • Do not reuse the pen
    • Do not freeze or heat up the pen
    • Do not expose the pen to direct sunlight
    • Do not inject through your clothes

This subcutaneous injection should be taken once every 2 weeks.

What you’ll need for your injection:

pre-filled pen icon

An unused KEVZARA pre-filled pen

wipe icon

Alcohol wipe

cotton ball and gauze icon

Cotton ball or gauze

waste icon

Sharps disposal container

Step A: Get ready for an injection

    pen

    checkmark icon

    Take 1 pen out of the packaging by holding the middle of the pen body

    do not icon

    Do not remove the orange cap until you are ready to inject

    checkmark icon

    Keep the remaining pens in the carton in the refrigerator

    eye looking at packaging

    checkmark icon

    Check that you have the correct medicine and the correct dose

    checkmark icon

    Check the expiration date. This is shown on the side of the pen

    do not icon

    Do not use the pen if the expiration date has passed

    eyes looking at clear and yellow liquid

    checkmark icon

    Check that the liquid in the window is clear and colorless to pale yellow

    checkmark icon

    You may see air bubbles. This is normal

    do not icon

    Do not inject if the liquid is cloudy, discolored, or contains particles. Safely throw away (dispose of) the pen in a sharps container and get a new one

    checkmark icon

    The window is clear when the pen is unused. The window will turn solid yellow after the pen has been used

    do not icon

    Do not use if the window is solid yellow. Safely dispose of the pen in a sharps container and get a new one

    lay pen flat for 60 minutes

    checkmark icon

    Using the pen at room temperature may make the injection more comfortable

    do not icon

    Do not use the pen if it has been out of the refrigerator for more than 14 days

    do not icon

    Do not try to warm the pen in any other way

    injection sites on body

    checkmark icon

    You can inject into your thigh or belly (abdomen), except for the area 2 inches (5 cm) around your belly button (navel)

    checkmark icon

    If somebody else gives you the injection, they can also use the outer area of the upper arm

    checkmark icon

    Change the injection site each time you inject

    do not icon

    Do not inject into skin that is tender, damaged, or has bruises or scars

    checkmark icon

    Wash your hands

    checkmark icon

    Clean the skin at the injection site with an alcohol wipe and let it air dry before injecting

    do not icon

    Do not touch the injection site again before injection

Step B: Give the injection

(Complete Step B after completing all steps in Step A)

    twist or pull off orange cap

    do not icon

    Do not remove the orange cap until you are ready to inject

    do not icon

    Do not touch the yellow needle cover

    do not icon

    Do not put the orange cap back on

    needle cover on skin at 90-degree angle

    checkmark icon

    Make sure you can see the window

    hold pen against skin and listen for first click

    checkmark icon

    There will be a “click” when the injection starts

    hold pen and wait up to 15 seconds for injection

    checkmark icon

    The window will start to turn solid yellow

    checkmark icon

    The injection can take up to 15 seconds

    listen for second click and wait for solid yellow window before removing pen

    checkmark icon

    If you do not hear the second click, you should still check to see if the entire window has turned solid yellow

    checkmark icon

    If the entire window does not turn solid yellow, this means that you may not have received your full dose of medicine. Call your healthcare provider right away

    remove pen from skin

    checkmark icon

    After you remove the pen from your skin, the needle will be covered automatically

    checkmark icon

    If you see any blood at the injection site, press a cotton ball or gauze on the site

    do not icon

    Do not rub the injection site

    throw away pen in sharps disposal container

    do not icon

    The KEVZARA pre-filled pen should not be reused

    checkmark icon

    Put the used pen into your FDA-cleared sharps disposal container or a puncture-resistant container

    do not icon

    Do not put the orange cap back on

    How should I throw away (dispose of) KEVZARA pre-filled pens?

    checkmark icon

    Put the used pen in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the pen in your household trash

    checkmark icon

    If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.

    do not icon

    Do not reuse the pen

    do not icon

    Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container

waste icon

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

Important: Always keep the sharps disposal container out of the reach of children.

cool temperature icon

Keep KEVZARA cool

When you fill your prescription for KEVZARA, it’s important to keep it in your refrigerator. But once it reaches room temperature, you’ll have to use the pen within 14 days or throw it away.

pre-filled syringe

How to use the pre-filled syringe

Some people feel more comfortable with the idea of injecting with a syringe. That’s why KEVZARA also comes in a pre-filled syringe.

Follow the step-by-step instructions

    • Read all of the instructions carefully before using the pre-filled syringe
    • Keep unused syringes in the original carton and store in the refrigerator between 36°F and 46°F (2°C and 8°C)
    • Keep the carton in an insulated bag with an ice pack when traveling
    • Let the syringe warm up at room temperature for at least 30 minutes before using
    • Use the syringe within 14 days after taking it out of the refrigerator or insulated bag
    • Keep the syringe and all medicines out of the reach of children
    • Do not use the pre-filled syringe if it has been damaged or if the needle cap is missing or not attached. Return the syringe and the package it came in to your pharmacy
    • Do not remove the needle cap until just before you are ready to inject
    • Do not touch the needle
    • Do not try to put the cap back on the syringe
    • Do not reuse the syringe
    • Do not freeze or heat up the syringe
    • Once removed from the refrigerator, do not store the syringe above 77ºF
    • Do not expose to direct sunlight
    • Do not inject through your clothes

This subcutaneous injection should be taken once every 2 weeks.

What you’ll need for your injection:

pre-filled syringe icon

An unused KEVZARA pre-filled syringe

wipe icon

Alcohol wipe

cotton ball and gauze icon

Cotton ball or gauze

waste icon

Sharps disposal container

Step A: Get ready for an injection

    take syringe out of package

    checkmark icon

    Take 1 syringe out of the package by holding the middle of the syringe body

    do not icon

    Do not hold the syringe by the plunger, finger grip, or needle cap

    do not icon

    Do not pull off the needle cap until you are ready to inject

    checkmark icon

    Keep the remaining syringe in the carton in the refrigerator

    look at syringe label

    checkmark icon

    Check that you have the correct medicine and the correct dose

    checkmark icon

    Check the expiration date

    do not icon

    Do not use the syringe if the expiration date has passed

    look at medicine

    checkmark icon

    Check to see if the liquid in the syringe is clear and colorless to pale yellow

    checkmark icon

    You may see air bubbles. This is normal

    do not icon

    Do not use if the liquid is cloudy, discolored, or contains particles. Safely dispose of the syringe in a sharps container and get a new one

    lay syringe flat for 30 minutes

    checkmark icon

    Using the syringe at room temperature may make the injection more comfortable

    do not icon

    Do not use the syringe if it has been out of the refrigerator for more than 14 days

    do not icon

    Do not try to warm the syringe in any other way

    injection sites on body

    checkmark icon

    You can inject into the front of your thigh or your belly (abdomen), except for the area 2 inches (5 cm) around your belly button (navel)

    checkmark icon

    If somebody else gives you the injection, they can also use the upper arm

    checkmark icon

    Change the injection site each time you inject

    do not icon

    Do not inject into skin that is tender, damaged, or has bruises or scars

    checkmark icon

    Wash your hands

    checkmark icon

    Clean the skin at the injection site with an alcohol wipe and let it air dry before injecting

    do not icon

    Do not touch the injection site again before injection

Step B: Give the injection

(Complete Step B after completing all steps in Step A)

    pull off needle cap

    checkmark icon

    Hold the syringe in the middle of the syringe body with the needle pointing away from you

    checkmark icon

    Keep your hand away from the plunger

    do not icon

    Do not get rid of any air bubbles in the syringe

    do not icon

    Do not pull off the needle cap until you are ready to inject

    do not icon

    Do not put the needle cap back on

    pinch skin

    checkmark icon

    Use your thumb and first (index) finger to pinch a fold of skin at the cleaned injection site

    insert needle at 45-degree angle
    push plunger down

    checkmark icon

    Slowly push the plunger down as far as it will go until the syringe is empty

    empty syringe before removal

    checkmark icon

    Pull the needle out at the same angle as inserted

    checkmark icon

    If you see any blood at the injection site, press a cotton ball or gauze on the site

    do not icon

    Do not rub the injection site

    throw away syringe in sharps disposal container

    do not icon

    The KEVZARA syringe should not be reused

    checkmark icon

    Put the used syringe into your FDA-cleared sharps disposal container or a puncture-resistant container

    do not icon

    Do not put the needle cap back on

    How should I dispose of (throw away) KEVZARA pre-filled syringes?

    checkmark icon

    Put the used syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the syringe in your household trash

    checkmark icon

    If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.

    do not icon

    Do not reuse the syringe.

    do not icon

    Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

waste icon

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

Important: Always keep the sharps disposal container out of the reach of children.

cool temperature icon

Keep KEVZARA cool

When you fill your prescription for KEVZARA, it’s important to keep it in your refrigerator. But once it reaches room temperature, you’ll have to use the syringe within 14 days or throw it away.

IMPORTANT SAFETY INFORMATION

KEVZARA® (sarilumab
) can cause serious side effects including:

  • SERIOUS INFECTIONS: KEVZARA is a medicine that affects your immune system. KEVZARA can lower the ability of your immune system to fight infections. Some people have had 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 KEVZARA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with KEVZARA.
  • Before starting KEVZARA, tell your healthcare provider if you
    • think you have an infection or have signs or symptoms of an infection, with or without a fever such as sweats or chills, muscle aches, a 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, if you feel very tired, or if you are being treated for an infection, get a lot of infections or have repeated infections.
    • have diabetes, HIV, or a weakened immune system.
    • 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).
    • 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 and after starting KEVZARA to check for low neutrophil (white blood cells that help the body fight off bacterial infections) counts, low platelet (blood cells that help with blood clotting and stop bleeding) counts, and an increase in certain liver function tests. Changes in test results are common with KEVZARA and can be severe. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests 4 to 8 weeks after starting KEVZARA and then every 6 months during treatment to check for an increase in blood cholesterol 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 anti-inflammatory 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.
  • SERIOUS ALLERGIC REACTIONS: Serious allergic reactions can happen with KEVZARA. Get medical attention right away if you have any of the following signs: shortness of breath or trouble breathing; feeling dizzy or faint; swelling of your lips, tongue, or face; moderate or severe stomach (abdominal) pain or vomiting; or chest pain.
  • Do not use KEVZARA if you are allergic to sarilumab or any of the ingredients of KEVZARA.
  • Before using KEVZARA, tell your healthcare provider if you
    • have an infection.
    • have liver problems.
    • have had stomach (abdominal) pain or a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines.
    • recently received or are scheduled to receive a vaccine. People who take KEVZARA should not receive live vaccines.
      • All vaccines should be brought up-to-date before starting KEVZARA, unless urgent treatment initiation is required.
    • plan to have surgery or a medical procedure.
    • are pregnant or plan to become pregnant. It is not known if KEVZARA will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you use KEVZARA. It is not known if KEVZARA passes into your breast milk.
    • take prescription or nonprescription medicines, vitamins, or herbal supplements. It is especially important to tell your healthcare provider if you use:
      • any other medicines to treat your PMR. Using KEVZARA with these medicines may increase your risk of infection.
      • medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
  • The most common side effects include:
    • injection site redness
    • injection site itching
    • upper respiratory tract infection
    • urinary tract infection
    • nasal congestion, sore throat, and runny nose

These are not all the possible side effects of KEVZARA. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

To learn more, talk about KEVZARA with your healthcare provider or pharmacist. The FDA-approved Medication Guide and Prescribing Information can be found at www.KEVZARA.com or by calling 1-844-KEVZARA.

Please click here to see full Prescribing Information, including risk of SERIOUS SIDE EFFECTS, and Medication Guide.

What is KEVZARA?

KEVZARA is an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker. KEVZARA is used to treat adult patients with polymyalgia rheumatica (PMR) after corticosteroids have been used and did not work well or when a slow decrease in the dose of corticosteroids (taper) cannot be tolerated.

The health information contained herein is provided for general educational purposes only. Your healthcare provider is the single best source of information regarding your health. Please consult your healthcare provider if you have any questions about your health or treatment.

IMPORTANT SAFETY INFORMATION

KEVZARA® (sarilumab
) can cause serious side effects including:

  • SERIOUS INFECTIONS: KEVZARA is a medicine that affects your immune system. KEVZARA can lower the ability of your immune system to fight infections. Some people have had 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 KEVZARA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with KEVZARA.
  • Before starting KEVZARA, tell your healthcare provider if you
    • think you have an infection or have signs or symptoms of an infection, with or without a fever such as sweats or chills, muscle aches, a 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, if you feel very tired, or if you are being treated for an infection, get a lot of infections or have repeated infections.
    • have diabetes, HIV, or a weakened immune system.
    • 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).
    • 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 and after starting KEVZARA to check for low neutrophil (white blood cells that help the body fight off bacterial infections) counts, low platelet (blood cells that help with blood clotting and stop bleeding) counts, and an increase in certain liver function tests. Changes in test results are common with KEVZARA and can be severe. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests 4 to 8 weeks after starting KEVZARA and then every 6 months during treatment to check for an increase in blood cholesterol 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 anti-inflammatory 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.
  • SERIOUS ALLERGIC REACTIONS: Serious allergic reactions can happen with KEVZARA. Get medical attention right away if you have any of the following signs: shortness of breath or trouble breathing; feeling dizzy or faint; swelling of your lips, tongue, or face; moderate or severe stomach (abdominal) pain or vomiting; or chest pain.
  • Do not use KEVZARA if you are allergic to sarilumab or any of the ingredients of KEVZARA.
  • Before using KEVZARA, tell your healthcare provider if you
    • have an infection.
    • have liver problems.
    • have had stomach (abdominal) pain or a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines.
    • recently received or are scheduled to receive a vaccine. People who take KEVZARA should not receive live vaccines.
      • All vaccines should be brought up-to-date before starting KEVZARA, unless urgent treatment initiation is required.
    • plan to have surgery or a medical procedure.
    • are pregnant or plan to become pregnant. It is not known if KEVZARA will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you use KEVZARA. It is not known if KEVZARA passes into your breast milk.
    • take prescription or nonprescription medicines, vitamins, or herbal supplements. It is especially important to tell your healthcare provider if you use:
      • any other medicines to treat your PMR. Using KEVZARA with these medicines may increase your risk of infection.
      • medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
  • The most common side effects include:
    • injection site redness
    • injection site itching
    • upper respiratory tract infection
    • urinary tract infection
    • nasal congestion, sore throat, and runny nose

These are not all the possible side effects of KEVZARA. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

To learn more, talk about KEVZARA with your healthcare provider or pharmacist. The FDA-approved Medication Guide and Prescribing Information can be found at www.KEVZARA.com or by calling 1-844-KEVZARA.

Please click here to see full Prescribing Information, including risk of SERIOUS SIDE EFFECTS, and Medication Guide.

What is KEVZARA?

KEVZARA is an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker. KEVZARA is used to treat adult patients with polymyalgia rheumatica (PMR) after corticosteroids have been used and did not work well or when a slow decrease in the dose of corticosteroids (taper) cannot be tolerated.

The health information contained herein is provided for general educational purposes only. Your healthcare provider is the single best source of information regarding your health. Please consult your healthcare provider if you have any questions about your health or treatment.