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Tyenne Injection 162 mg/0.9 mL: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
162 mg/0.9 mL
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Active ingredient:

Patient information: uses, side effects, how to take - Tyenne Injection 162 mg/0.9 mL

What is the most important information I should know about TYENNE?

TYENNE can cause serious side effects including:

  1. 1. Serious Infections. TYENNE is a medicine that affects your immune system. TYENNE can lower the ability of your immune system to fight infections. Some people have serious infections while taking TYENNE, 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 assess you for TB before starting TYENNE (except if you have COVID-19).

If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with TYENNE.

Your healthcare provider should monitor you closely for signs and symptoms of TB during and after treatment with

TYENNE.

  • You should not start taking TYENNE if you have any kind of infection unless your healthcare provider says it is okay.

Before starting TYENNE, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection, with or without a fever, such as:
  • sweating or chills
  • shortness of breath
  • warm, red, or painful skin or sores on your body
  • feel very tired
  • muscle aches
  • blood in phlegm
  • diarrhea or stomach pain
  • cough
  • weight loss
  • burning when you urinate or urinating more often than normal
  • 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 for 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 for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use TYENNE. 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 B.

After starting TYENNE, call your healthcare provider right away if you have any symptoms of an infection. TYENNE can make you more likely to get infections or make worse any infection that you have.

  1. 2.

    Tears (perforation) of the stomach or intestines.

    1. • Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking TYENNE get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
    2. • Tell your healthcare provider right away if you have fever and new onset stomach-area pain that does not go away, and a change in your bowel habits.
  2. 3. Liver problems (Hepatotoxicity): Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your healthcare provider may tell you to stop taking TYENNE if you develop new or worse liver problems during treatment with TYENNE. Tell your healthcare provider right away if you have any of the following symptoms:
  • feeling tired (fatigue)
  • lack of appetite for several days or longer (anorexia)
  • yellowing of your skin or the whites of your eyes (jaundice)
  • abdominal swelling and pain on the right side of your stomach-area
  • light colored stools
  • weakness
  • nausea and vomiting
  • confusion
  • dark “tea-colored” urine
  1. 4.

    Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start receiving TYENNE. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA) your healthcare provider should do blood tests every 4 to 8 weeks after you start receiving TYENNE for the first 6 months and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of TYENNE:

    1. • low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
    2. • low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
    3. • increase in certain liver function tests.
    4. • increase in blood cholesterol levels. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving TYENNE.

Your healthcare provider will determine how often you will have follow-up blood tests. Make sure you get all your follow-up blood tests done as ordered by your healthcare provider.

You should not receive TYENNE if your neutrophil or platelet counts are too low, or your liver function tests are too high.

Your healthcare provider may stop your TYENNE treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results.

  1. 5. Cancer. TYENNE 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.

See “What are the possible side effects with TYENNE?” for more information about side effects.

What is TYENNE?

TYENNE is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. TYENNE is used:

  • To treat adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease-Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well.
  • To treat adults with giant cell arteritis (GCA).
  • To treat people with active PJIA ages 2 and above.
  • To treat people with active SJIA ages 2 and above.
  • To treat people age 2 years and above who experience severe or life-threatening Cytokine Release Syndrome (CRS) following chimeric antigen receptor (CAR) T cell treatment.
  • To treat hospitalized people ages 2 years and above with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.
  • TYENNE is not approved for subcutaneous use in people with CRS or COVID-19.

It is not known if TYENNE is safe and effective in children with PJIA, SJIA, CRS or COVID-19 under 2 years of age or in children with conditions other than PJIA, SJIA, CRS or COVID-19.

Do not take TYENNE: if you are allergic to tocilizumab products, or any of the ingredients in TYENNE. See the end of this Medication Guide for a complete list of ingredients in TYENNE.

Before you receive TYENNE, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection. See “What is the most important information I should know about TYENNE?”
  • have liver problems.
  • have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.
  • have had a reaction to tocilizumab products or any of the ingredients in TYENNE before.
  • have or had a condition that affects your nervous system, such as multiple sclerosis.
  • have recently received or are scheduled to receive a vaccine:

    • All vaccines should be brought up-to-date before starting TYENNE, unless urgent treatment initiation is required.
    • People who take TYENNE should not receive live vaccines.
    • People taking TYENNE can receive non-live vaccines.
  • plan to have surgery or a medical procedure.
  • are pregnant or plan to become pregnant. TYENNE may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with TYENNE.

  • are breastfeeding or plan to breastfeed. It is not known if TYENNE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take TYENNE.

Tell your healthcare provider about all of the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. TYENNE and other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

  • any other medicines to treat your RA. Taking TYENNE 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.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How will I receive TYENNE?

Into a vein (IV or intravenous infusion) for Rheumatoid Arthritis, Giant Cell Arteritis, PJIA, SJIA, CRS, or COVID-19:

  • If your healthcare provider prescribes TYENNE as an IV infusion, you will receive TYENNE from a healthcare provider through a needle placed in a vein in your arm. The infusion will take about 1 hour to give you the full dose of medicine.
  • For rheumatoid arthritis, giant cell arteritis or PJIA you will receive a dose of TYENNE about every 4 weeks.
  • For SJIA you will receive a dose of TYENNE about every 2 weeks.
  • For CRS you will receive a single dose of TYENNE, and if needed, additional doses.
  • For COVID-19, you will receive a single dose of TYENNE, and if needed one additional dose.
  • While taking TYENNE, you may continue to use other medicines that help treat your rheumatoid arthritis, PJIA, SJIA, or COVID-19 such as methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as instructed by your healthcare provider.
  • Keep all of your follow-up appointments and get your blood tests as ordered by your healthcare provider.

Under the skin (SC or subcutaneous injection) for Rheumatoid Arthritis, Giant Cell Arteritis, PJIA or SJIA:

  • See the Instructions for Use at the end of this Medication Guide for instructions about the right way to prepare and give your TYENNE injections at home.
  • TYENNE is available as a single-dose prefilled syringe or single-dose prefilled autoinjector.
  • You may also receive TYENNE as an injection under your skin (subcutaneous). If your healthcare provider decides that you or a caregiver can give your injections of TYENNE at home, you or your caregiver should receive training on the right way to prepare and inject TYENNE. Do not try to inject TYENNE until you have been shown the right way to give the injections by your healthcare provider.
  • For PJIA or SJIA, you may self-inject with the prefilled syringe or prefilled autoinjector, or your caregiver can give you TYENNE, if both your healthcare provider and parent/legal guardian find it appropriate.
  • Your healthcare provider will tell you how much TYENNE to use and when to use it.

What are the possible side effects with TYENNE?

TYENNE can cause serious side effects, including:

  • See “What is the most important information I should know about TYENNE?”
  • Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use TYENNE. Your healthcare provider may do blood tests before you start treatment with TYENNE and while you are using TYENNE. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
  • feel very tired
  • vomiting
  • chills
  • dark urine
  • skin or eyes look yellow
  • clay-colored bowel movements
  • stomach discomfort
  • skin rash
  • little or no appetite
  • fevers
  • muscle aches
  • Serious Allergic Reactions. Serious allergic reactions, including death, can happen with TYENNE. These reactions can happen with any infusion or injection of TYENNE, even if they did not occur with an earlier infusion or injection. Stop taking TYENNE, contact your healthcare provider, and get emergency help right away if you have any of the following signs of a serious allergic reaction:

    • swelling of your face, lips, mouth, or tongue
    • trouble breathing
    • wheezing
    • severe itching
    • skin rash, hives, redness, or swelling outside of the injection site area
    • dizziness or fainting
    • fast heartbeat or pounding in your chest (tachycardia)
    • sweating
  • Nervous system problems. While rare, Multiple Sclerosis has been diagnosed in people who take TYENNE. It is not known what effect TYENNE may have on some nervous system disorders.

The most common side effects of TYENNE include:

  • upper respiratory tract infections (common cold, sinus infections)
  • headache
  • increased blood pressure (hypertension)
  • injection site reactions

Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of TYENNE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Fresenius Kabi USA, LLC at 1-800-551-7176.

General information about the safe and effective use of TYENNE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not give TYENNE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TYENNE that is written for health professionals.

For more information go to www.TYENNE.com or you can enroll in a patient support program by calling 1-833-522-4227 or visiting the patient support program website: www.kabicare.us.

What are the ingredients in TYENNE?

Active ingredient: tocilizumab-aazg.

Inactive ingredients of Intravenous and Subcutaneous TYENNE: arginine, histidine, hydrochloric acid, lactic acid, polysorbate 80, sodium chloride, sodium hydroxide and Water for Injection.

TYENNE is a registered trademark of Fresenius Kabi

Manufactured by: Fresenius Kabi USA LLC, Lake Zurich, IL 60047, U.S.A

U.S License Number 2146

Read and follow the Instructions for Use that come with your TYENNE autoinjector before you start using it and each time you get a refill. There may be new information. This information does not replace talking to your healthcare provider about your medical condition or treatment.

If you have any questions about using your TYENNE autoinjector, please call your healthcare provider or Company at 1-833-522-4227.

Important information

  • Read the Medication Guide that comes with your autoinjector for important information you need to know before using it.
  • Before you use the autoinjector for the first time, make sure your healthcare provider shows you the right way to use it.
  • Do not try to take apart the TYENNE autoinjector at any time.
  • Always inject TYENNE the way your healthcare provider taught you to.

Using the TYENNE autoinjector

  • The autoinjector is for self-injection or administration with the help of a caregiver.
  • The autoinjector is for use at home.
  • When injecting TYENNE, children may self-inject if both the healthcare provider and caregiver find it appropriate.
  • Do not reuse the autoinjector. The autoinjector is for single-dose (1-time) use only.
  • Do not share your autoinjector with another person. You may give another person an infection or get an infection from them.
  • Do not remove the autoinjector clear cap until you are ready to inject.
  • Do not use the autoinjector if it shows any signs of damage or if it has been dropped.

Storing TYENNE autoinjectors

  • Store TYENNE in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Store unused autoinjectors in the original carton to protect from light.
  • Do not freeze TYENNE. Do not use TYENNE if frozen. Throw away (dispose of) in a sharps disposal container.
  • Do not expose TYENNE to heat or direct sunlight.
  • Keep the autoinjector out of the reach of children.
  • TYENNE may be stored at room temperature at or below 86°F (30°C) in the original carton for up to 14 days. Throw away (dispose of) TYENNE in a sharp disposal container if it has been out of the refrigerator more than 14 days. After being stored at room temperature, do not place it back in the refrigerator.

    See the Medication Guide for more information.

Traveling with TYENNE autoinjector

  • When travelling on an airplane, always check with your airline and your healthcare provider about bringing injectable medicine with you. Always carry TYENNE in your carry-on luggage because the airplane luggage area can be very cold and TYENNE could freeze.

Your TYENNE autoinjector

Before Use

After Use

1.1. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.

1.2. Gather the following supplies (not included) (see Figure A):

  • A sterile cotton ball or gauze
  • An alcohol pad
  • An FDA-cleared sharps disposal container (see Step 8, “Throw away your autoinjector”).

1.3. Remove the carton containing the autoinjector from the refrigerator.

1.4. Check the expiration date on the carton to make sure the date has not passed (see Figure B). Do not use the autoinjector if the expiration date has passed.

1.5. Check to make sure that the carton is properly sealed and is not damaged. Do not use the Autoinjector if the carton looks like it has already been opened or damaged.

1.6. Remove the tray from the carton.

1.7. Let the tray with the autoinjector sit on the prepared surface for 45 minutes before use to allow the medicine in the autoinjector to reach room temperature (see Figure C).

Note: Not doing so could cause your injection to feel uncomfortable and it could take longer to inject.

Do not warm in any other way, such as in a microwave, hot water, or direct sunlight.

1.8. Turn the tray upside down to remove the single-dose autoinjector (see Figure D).
Do not remove the clear cap of the autoinjector until you are ready to inject to avoid injury.
2.1 Check the autoinjector to make sure it is not cracked or damaged (see Figure E).
Do not use if the autoinjector shows signs of damage or if it has been dropped.

2.2 Check the autoinjector label to make sure that:

  • The name on the autoinjector says TYENNE
  • The expiration date (EXP) on the autoinjector has not passed (see Figure F)
Do not use the autoinjector if the name on the label is not TYENNE or the expiration date on the label has passed.

2.3 Look at the medicine in the viewing window.

Make sure it is clear and colorless to pale yellow and does not contain flakes or particles (see Figure G).

Note: Air bubbles in the medicine are normal.
Do not inject if the liquid is cloudy, discolored, or has lumps or particles in it because it may not be safe to use.
3.1 Wash your hands well with soap and water, then dry them with a clean towel (see Figure H).

4.1 If you are giving yourself the injection, you can use:

  • The front of your upper thigh
  • The belly (abdomen), except within 2 in (5 cm) around the belly button (navel)

If a caregiver is giving the injection, they can use the outer area of the upper arm (see Figure I).
Note: Choose a different site for each injection to reduce redness, irritation, or other skin problems.

Do not inject into skin that is sore (tender), bruised, red, hard, scaly, or has lesions, moles, scars, or stretch marks or tattoos.

Do not use the autoinjector through clothing.

5.1 Wipe the skin where you want to inject with an alcohol pad to clean it (see Figure J). Let the skin dry.

Do not blow on or touch the site after cleaning.

6.1 When you are ready to inject, hold the autoinjector in one hand with the clear cap on top, pointing straight up.

Using your other hand, firmly pull the clear cap straight off without twisting (see Figure K).

Note: Use the autoinjector within 3 minutes after removing the cap to avoid contamination.
Do not try to recap the needle at any time, even at the end of the injection.
Do not touch the needle cover (the orange part located at the tip of the autoinjector) because this might cause an accidental needle stick.

6.2 Throw away the clear cap in a sharps disposal container.

6.3 Rotate the autoinjector so that the orange needle cover points downwards.

6.4 Position your hand on the autoinjector so that you can see the window.

6.5 Place the needle cover flat against your skin at a 90-degree angle (see Figure L).

Note: To make sure you inject under the skin (into fatty tissue), do not hold the autoinjector at an angle.

Do not pinch your skin.
To make sure you inject the full dose, read all of the steps from 6.6 to 6.9 before you start:

6.6 In a single motion, push and hold the autoinjector firmly against your skin until you hear a first click. This means the injection has started (see Figure M).

The orange plunger rod will move through the window during the injection.

6.7 Hold the autoinjector in place until you hear a second click. This may take up to 10 seconds. (see Figure N).

6.8 Wait and slowly count to 5 after you hear the second click. Continue to hold the autoinjector in place to make sure you inject a full dose (see Figure O). Do not lift the autoinjector until you are sure 5 seconds has passed, and the injection is complete.

6.9 While holding the autoinjector in place, check the window to make sure the orange plunger rod has fully appeared in the viewing window, and has stopped moving (see Figure P).

7.1 When the injection is complete, lift the autoinjector straight away from your skin (see Figure Q).

Note: The needle cover will slide down and cover the needle.
Do not recap the autoinjector.
7.2 Check the window to make sure the orange plunger rod came all the way down (see Figure R).

Note: If the orange plunger rod did not come all the way down or you believe you did not get a full injection, call your healthcare provider.

Do not try to repeat the injection with a new autoinjector.

7.3 If you see blood on the injection site, press gauze or a cotton ball against on the skin until the bleeding stops (see Figure S).
Do not rub the injection site.
8.1 Put your used autoinjector in an FDA-cleared sharps disposal container right away after use (see Figure T).

Do not throw away (dispose of) your autoinjector in your household trash.

If you do not have a FDA-cleared sharps disposal container, you can 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.

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

Do not throw away (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.

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

9.1 Write the date, time, and specific part of your body where you injected yourself (see Figure U).

It may also be helpful to write any questions or concerns about the injection, so you can ask your healthcare provider.

Manufactured by:

Fresenius Kabi USA, LLC

Lake Zurich, Illinois 60047

U.S. License No. 2146

This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 09/2025

Read and follow the Instructions for Use that come with your TYENNE prefilled syringe before you start using it and each time you get a refill. There may be new information. This does not replace talking to your healthcare provider about your medical condition or treatment.

If you have any questions about using your TYENNE prefilled syringe, please call your healthcare provider or Company at 1-833-522-4227.

Important Information

  • Read the Medication Guide that comes with your TYENNE prefilled syringe for important information you need to know before using it.
  • Before you use the prefilled syringe for the first time, make sure your healthcare provider shows you the right way to use it.
  • Do not remove the needle cap until you are ready to inject TYENNE.
  • Do not try to take apart the prefilled syringe at any time.
  • Always inject TYENNE the way your healthcare provider taught you.

Using TYENNE prefilled syringe

  • The prefilled syringe is for self-injection or administration with the help of a caregiver.
  • Do not use the prefilled syringe if the carton is open or damaged.
  • Do not use the prefilled syringe if it has been dropped on a hard surface.

    The prefilled syringe may be broken even if you cannot see the break.

Storing TYENNE prefilled syringes

  • Store TYENNE in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Store unused prefilled syringes in the original carton to protect from light.
  • Keep the prefilled syringes out of the reach of children.
  • Do not freeze TYENNE. Do not use TYENNE if frozen. Throw away (dispose of) in a sharps disposal container.
  • Do not expose TYENNE to heat or direct sunlight.
  • If needed, for example when traveling, TYENNE may be stored at room temperature at or below 86°F (30°C) in the original carton for up to 14 days. Throw away (dispose of) TYENNE in a sharps disposal container if it has been out of the refrigerator for more than 14 days. After being stored at room temperature, do not place it back in the refrigerator.

See the Medication Guide for more information.

Your TYENNE prefilled syringe (see Figure A)

Do not try to activate the clear needle guard before injecting.

Do not insert your fingers into the opening of the clear needle guard because the needle could injure you.

1.1 Find a comfortable space with a clean, flat working surface.

1.2 Supplies needed for your TYENNE prefilled syringe injection (see Figure B):

  • TYENNE prefilled syringe
  • An alcohol pad
  • A sterile cotton ball or gauze
  • Puncture-resistant container or sharps container for safe disposal of used syringe (see Step 7 “Throw away used prefilled syringe”)

1.3 Take the box containing the syringe out of the refrigerator and open the box (see Figure C).

1.4 Remove the plastic tray out of the box and let it warm up for 30 minutes to reach room temperature (see Figure D). If the syringe does not reach room temperature, this could cause your injection to feel uncomfortable and make it difficult to push the plunger in.

  • Do not speed up the warming process in any way, such as in a microwave or placing the syringe in hot water.
  • Prepare and check your records of previous injection sites. This will help you choose the appropriate injection site for this injection (see Step 8 “Record your injection”).

Remove TYENNE prefilled syringe from the plastic tray

  • Place two fingers on either side, in the middle of the clear needle guard.
  • Pull the prefilled syringe straight up and out of the tray (see Figure E).
  • Do not pick up the prefilled syringe by the plunger or the needle cap. Doing so could damage the prefilled syringe or activate the clear needle guard.

2.1 Check the expiration date on the TYENNE prefilled syringe (see Figure F).

Do not use it if the expiration date has passed because it may not be safe to use. If the expiration date has passed, safely dispose of the syringe in a sharps container and get a new one.

2.2 Check the name on the prefilled syringe says TYENNE (see Figure F).

2.3 Check the liquid in the TYENNE prefilled syringe. It should be clear and colorless to pale yellow (see Figure G).

Do not inject TYENNE if the liquid is cloudy, discolored or has lumps or particles in it because it may not be safe to use. Safely dispose of the syringe in a sharps container and get a new one.

2.4 Check the prefilled syringe to make sure that:

  • The prefilled syringe, the clear needle guard, and the needle cap are not cracked or damaged (see Figure H).
  • The needle cap is securely attached (see Figure I).
  • The needle guard spring is not extended (see Figure J).
  • Do not use the syringe if it shows any sign of damage. If damaged, call your healthcare provider or pharmacist right away and throw away the syringe in your sharps disposal container (see Step 7 “Throw away used prefilled syringe”).

Wash your hands well with soap and water (see Figure K).

4.1 Choose an injection site

  • The front of the thighs and your belly (abdomen) except for 2-inch area around your navel are the recommended injection sites (see Figure L).
  • The outer area of the upper arms may also be used only if the injection is being given by a caregiver. Do not attempt to use the upper arm area by yourself (see Figure M).

4.2 Rotate injection site

  • Choose a different injection site for each new injection.
  • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.

5.1 Clean the injection site

  • Wipe the injection site with an alcohol pad in a circular motion and let it air dry to reduce the chance of getting an infection. Do not touch the injection site again before giving the injection.
  • Do not fan or blow on the clean area.

6.1 Remove the needle cap.

  1. Hold the TYENNE prefilled syringe by the clear needle guard with 1 hand and pull the needle cap straight off with your other hand (see Figure N).
  2. • Do not hold the plunger while you remove the needle cap. If you cannot remove the needle cap, you should ask a caregiver for help or contact your healthcare provider.
  3. • Throw away the needle cap in your sharps container.
  4. • There may be a small air bubble in the TYENNE prefilled syringe. You do not need to remove it.
  5. • You may see drops of liquid at the end of the needle. This is normal and will not affect your dose.
  6. • Do not touch the needle or let it touch any surfaces.
  7. • Do not use the prefilled syringe if it is dropped.
  8. • If it is not used within 5 minutes of needle cap removal, the syringe should be disposed of in the puncture resistant container or sharps container and a new syringe should be used.
  9. • Never reattach the needle cap after removal.

6.2 Pinch the skin

  • Hold the TYENNE prefilled syringe in 1 hand between the thumb and index finger (see Figure O).
  • Do not pull back on the plunger of the syringe.
  • Use your other hand and gently pinch the area of skin firmly (see Figure P). Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injection into muscle could cause the injection to feel uncomfortable.

6.3 Insert the needle

  • Use a quick, dart-like motion to insert the needle all the way into the pinched skin at an angle between 45° to 90° (see Figure Q). It is important to use the correct angle to make sure the medicine is delivered under the skin (into fatty tissue), or the injection could be painful, and the medicine may not work.
  • Keep the syringe in position.
  • Do not hold or push on the plunger while inserting the needle into the skin.

6.4 Inject

  • Slowly inject all of the medicine by gently pushing the plunger all the way down (see Figure R).
  • You must press the plunger all the way down to get the full dose of medicine until you cannot press any more (see Figure S).
  • Do not pull the needle out of the skin when the plunger is pushed all the way down.

6.5 Finish Injection

  • After the plunger is pushed all the way down, hold the syringe firmly without moving it, at the same angle as inserted.
  • Slowly release your thumb off the plunger. The plunger will move up. The safety system will remove the needle from the skin and cover the needle (see Figure T).
  • Release the pinched skin

Important: Call your healthcare provider right away if you did not inject the full dose. Injecting an incorrect amount of medicine could affect your treatment.

Do not reuse a syringe even if all of the medicine was not injected.

Do not try to recap the needle as it could lead to needle stick injury.

6.6 After the injection

  • There may be a little bleeding at the injection site. You can press a cotton ball or gauze on the injection site.
  • Do not rub the injection site.
  • If needed, you may cover the injection site with a small bandage.
  • The TYENNE prefilled syringe should not be reused.
  • Do not put the needle cap back on the needle
  • If your injection is given by another person, this person must also be careful when removing the syringe and disposing of the syringe to prevent accidental needle stick injury and passing injection.

How do I throw away used syringes?

Put your used syringe in an FDA-cleared sharps disposal container right away after use (see Figure U). Do not throw away (dispose of) loose needles and syringes in your household trash.

  • 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.

      • 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 syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
      • Do not throw away (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.

Keep TYENNE prefilled syringes and disposal container out of the reach of children.

Write the date, time, and specific part of your body where you injected yourself (see Figure V).

It may also be helpful to write any questions or concerns about the injection, so you can ask your healthcare provider.

Manufactured by:

Fresenius Kabi USA, LLC

Lake Zurich, Illinois 60047

U.S. License No. 2146

This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 09/2025

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761449 · View the label on DailyMed

Revision date stated in the text: September 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Tyenne Injection 162 mg/0.9 mL

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Interleukin-6 Receptor Antagonist
Active ingredient Tocilizumab 162 mg/0.9 mL
Dosage form Injection, solution
Route Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) FRESENIUS KABI USA
FDA approval BLA 761449Biologics License Application (BLA) Approved March 14, 2025
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
162 mg/0.9 mL – 0.9 ml in 1 syringe, glass / 1 in 1 carton NDC 65219-598-10
162 mg/0.9 mL – 0.9 ml in 1 syringe, glass / 1 in 1 carton NDC 65219-596-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.