Important Safety Information
Indications

INDICATIONS

  • To treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well

  • To treat adults with giant cell arteritis (GCA)

  • To treat patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older

  • To treat patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

IMPORTANT SAFETY INFORMATION

RISK OF SERIOUS INFECTIONS:

Patients treated with TYENNE® (tocilizumab-aazg) are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TYENNE until the infection is controlled.

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before TYENNE use and during therapy. Treatment for latent infection should be initiated prior to TYENNE use.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with TYENNE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TYENNE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

CONTRAINDICATION

TYENNE is contraindicated in patients with known hypersensitivity to tocilizumab products.

WARNINGS AND PRECAUTIONS

Gastrointestinal Perforations

Events of gastrointestinal (GI) perforation have been reported in clinical trials, primarily as complications of diverticulitis in patients treated with tocilizumab. Use TYENNE with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation.

Hepatotoxicity

Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab products. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation. Most cases presented with marked elevations of transaminases (> 5 times ULN), and some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases.

Treatment with tocilizumab was associated with a higher incidence of transaminase elevations; increased frequency and magnitude of these elevations were observed when tocilizumab was used in combination with potentially hepatotoxic drugs (e.g., methotrexate).

It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN discontinue TYENNE.

Measure liver tests promptly in patients who report symptoms that may indicate liver injury. If the patient is found to have abnormal liver tests, TYENNE treatment should be interrupted. TYENNE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests.

Laboratory Parameters

Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required.

Neutropenia: Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with a low neutrophil count i.e., absolute neutrophil count (ANC) less than 2000 per mm3. In patients who develop an ANC less than 500 per mm3 treatment is not recommended.

Thrombocytopenia: Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate TYENNE in RA, GCA, PJIA, and SJIA patients with a platelet count below 100,000 per mm3. In patients who develop a platelet count less than 50,000 per mm3, treatment is not recommended.

Elevated Liver Enzymes: It is not recommended to initiate TYENNE treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended.

Lipid Abnormalities: Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterols, and/or HDL cholesterol.

Immunosuppression

The impact of treatment with tocilizumab products on the development of malignancies is not known, but malignancies were observed in clinical studies with tocilizumab. TYENNE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. TYENNE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For TYENNE subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of TYENNE immediately and discontinue TYENNE permanently. Do not administer TYENNE to patients with known hypersensitivity to tocilizumab products.

Demyelinating Disorders

The impact of treatment with tocilizumab products on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Monitor patients for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of TYENNE in patients with preexisting or recent-onset demyelinating disorders.

Active Hepatic Disease and Hepatic Impairment

Treatment with TYENNE is not recommended in patients with active hepatic disease or hepatic impairment.

Vaccinations

Avoid use of live vaccines concurrently with TYENNE. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving TYENNE or on the effectiveness of vaccination in patients receiving TYENNE. Patients should be brought up to date on all recommended vaccinations prior to initiation of TYENNE therapy, if possible.

ADVERSE REACTIONS

Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions.

DRUG REACTIONS

In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was observed.

Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates.

Exercise caution when coadministering TYENNE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc.

USE IN PREGNANCY

The limited available data with tocilizumab products in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Fresenius Kabi at (800) 551-7176.

Please see additional Important Safety Information in full Prescribing Information, including BOXED WARNING.

Home For Patients Getting Started

Let’s get started

As you begin your treatment with TYENNE® (tozilizumab), you’re likely to have questions. This page walks you through the injection and infusion processes, explains what support is available to you throughout your treatment journey, and addresses some Frequently Asked Questions (FAQ).

Download Patient Injection Brochure
Download Patient Infusion Brochure

TYENNE injection options are designed for your ease of use

Rather than a separate injection button, the TYENNE pre-filled autoinjector uses a simple “push-on-skin” activation mechanism to administer your dosage—one of the device’s many ergonomic and advanced design features.

TYENNE subcutaneous pre-filled autoinjector

The steps below summarize use of the Tyenne pre-filled autoinjector device. Read the Medication Guide and Instructions for Use for full administration instructions.

Icon illustration of hand washing Icon illustration of a packaged pre-filled autoinjector

Prepare

Wash your hands and examine your device for damage or expiration.

Icon illustration of a pre-filled autoinjector application

Inject

Choose the injection site (stomach or front of upper thighs) and make sure the area is clean.

Watch the video for complete injection instructions:

Icon illustration of a safe needle disposal bin Icon illustration of a journal and pen

Dispose and document

Properly dispose of the device and supplies, document your injection site, and date of therapy.

How to inject TYENNE

Watch the injection video and read the Instructions for Use that come in each package. Watching this video is not a substitute for reading the Medication Guide and Instructions for Use. Still have questions? Talk to your doctor.

How to administer TYENNE

Instructions for use

FVO: This quick guide video has been designed to support you with administering a TYENNE autoinjector. The video provides only supplementary information for the administration of TYENNE using the autoinjector. It does NOT substitute the reading of the FDA-approved instructions for use. The instructions for use should be read before administering TYENNE.

Read the medication guide that comes with your TYENNE autoinjector for important information you need to know before using it.

This video demonstrates the administration of TYENNE with the active ingredient tocilizumab-aazg using an autoinjector.

You’ve been prescribed TYENNE, which is available as an autoinjector as well as a syringe with a dosage of 162 milligrams/0.9 mililiters.

In this video, we will demonstrate the correct way to inject using your TYENNE autoinjector.

Before we go over the steps to self-administer using an autoinjector, there are a few things to consider.

FVO: It is important to follow instructions so that you inject TYENNE correctly.

Don’t reuse your TYENNE autoinjector. The autoinjector is for single dose (1-time) use only.

Don’t share your autoinjector with another person.

Don’t remove the autoinjector cap until you are ready to inject.

Don’t use the autoinjector if it shows signs of damage or has been dropped.

FVO: Do talk to your healthcare provider to be sure you understand TYENNE dosing instructions or if you or your caregiver have any questions about the right way to inject TYENNE.

FVO: Let’s take a moment to talk about storing your TYENNE autoinjector.

Keep it in the original carton to protect from light and store it in a refrigerator set between 36 and 46 degrees Fahrenheit or 2 and 8 degrees Celsius.

Do not freeze TYENNE.

Do not use TYENNE if frozen. Throw away the TYENNE autoinjector 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 77°F (25°C) in the original carton for up to 14 days.

Throw away 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.

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.

FVO: Before use, the autoinjector consists of a cap that covers the needle, an orange needle cover, and the body of the autoinjector with a window through which you can see the medicine.

After use, the needle cover is extended, and the plunger rod is visible through the window in its final position. Do not use the device if the autoinjector is like this before use.

FVO: Step 1: Prepare for your injection

FVO: Remove the carton containing the autoinjector from the refrigerator. Check the expiration date and make sure the date has not passed.

Remove the sealed tray from the carton and check for any signs of damage and make sure that the expiration date has not passed. Do not use if the tray is damaged or expired.

Before use, let the sealed tray sit for 45 minutes on a clean flat surface to allow the medicine to warm up to reach room temperature. Injecting cold medicine can feel uncomfortable and may take longer to inject.

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

FVO: Once the medicine has reached room temperature, peel the seal off the tray and turn upside down to remove the single-dose autoinjector. To avoid injury, do not remove the clear cap until you are ready to inject.

FVO: Step 2: Checking your autoinjector

Check the autoinjector to make sure it is not cracked or damaged. Do not use if the autoinjector shows signs of damage or if it has been dropped.

Check the autoinjector label to make sure that the name on the autoinjector says TYENNE and the expiration date has not passed.

Do not use the autoinjector if the name on the label is not TYENNE or the expiration date on the label has passed

Look at the medicine in the viewing window. Make sure the solution is clear and colorless to pale yellow and does not contain flakes or particles.

Do not inject if the liquid is cloudy, discolored, or has lumps or particles in it because it may not be safe to use.

Air bubbles in the medicine are normal.

FVO: Step 3: Wash your hands

When you are ready to inject your TYENNE, wash your hands thoroughly with soap and water then dry them with a clean towel.

FVO: Step 4: Choose the injection site

If you are giving yourself the injection, you can use the front of the upper thigh or the belly (abdomen), except within 2 inches (5 cm) around the belly button (navel).

If a caregiver is giving the injection, they can also use the outer area of the upper arm.

Each time you inject, choose a different site to reduce redness, irritation, or other skin problems.

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

FVO: Step 5: Clean the injection site

Wipe the skin where you want to inject with an alcohol pad to clean it. Let the skin dry.

Do not blow on or touch the site after cleaning.

FVO: Step 6: Give your injection

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

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 because this might cause an accidental needle stick

Throw away the clear cap in a sharps disposal container.

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

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

Place the needle cover flat against your skin at a 90-degree angle. Do not hold the autoinjector at an angle. Do not pinch your skin

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

Hold the autoinjector in place until you hear a second click. This may take up to 10 seconds.

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

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

FVO: Step 7: remove and check the autoinjector

When the injection is complete, lift the autoinjector straight up from your skin. Do not recap the autoinjector

As you lift the autoinjector away from your skin, the needle cover will slide down into place to protect you from the needle. Check the window to make sure the orange plunger rod came all the way down. If it did not come all the way down, or you do not believe you got the full injection, call your healthcare provider.

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

If there is blood or liquid on the injection site, gently press a cotton ball or gauze on the skin. Do not rub the injection site.

FVO: Step 8: Throw away your autoinjector

Throw away your used autoinjector in a sharps disposal container right after use. Do not throw away your autoinjector in your household trash.

If you do not have a sharps disposal bin, use a household container that is made of heavy-duty plastic, puncture-resistant with a tight fitting lid, upright and stable during use, leak resistant, and labelled with a hazardous waste warning.

Always keep the sharps disposal container out of reach of children

FVO: Step 9: Record date of administration and injection site

It’s helpful to record the date and time of your injection, and your injection site to help you remember when and where to do your next injection.

FVO: Thank you for watching this quick guide video on TYENNE. If you have any further questions, please contact your healthcare provider.

Frequently asked questions

It depends on what you’re being treated for, how much you weigh, and the progression of your treatment. At most, you may need an injection once a week; it may be every other week. Your health care provider will walk you through the frequency and dosage of your injections.

Before you start TYENNE injections, your doctor or nurse should review the TYENNE Medication Guide and Instructions for Use with you. This should help you to better understand the risks and benefits of your treatment. After reviewing the Important Side Effect Information for TYENNE, you should be properly trained on using your injection device.

It’s important to pay close attention to how you’re feeling before, during, and after an injection. TYENNE may lead to serious allergic reactions, including death. Allergic reactions may happen during and after any injection, even if they have not happened before. In case of emergency or if you experience an allergic reaction, contact 911 immediately, as well as your health care provider or nurse.

Also, TYENNE is a medicine that affects your immune system. It can lower your immune system’s ability to fight infections, make you more likely to get infections, or make worse any infection you may have. After starting TYENNE, contact your health care provider right away if you have any symptoms of an infection.

Talk to your doctor if you have any questions about your medicine, the device, the preparation, or the details of your injection.

TYENNE injection options are designed for your ease of use

The TYENNE pre-filled syringe offers an ergonomic design to a classic device. It features extended finger flanges for stability and a safety needle guard to protect patients and caregivers.

TYENNE subcutaneous injection syringe

The steps below summarize use of the Tyenne pre-filled syringe device. Read the Medication Guide and Instructions for Use for full administration instructions.

Icon illustration of hand washing Icon illustration of a packaged syringe

Prepare

Wash your hands and examine your device for damage or expiration.

Icon illustration of a syringe injection

Inject

Choose the injection site (stomach or front of upper thighs) and make sure the area is clean.

Watch the video for complete injection instructions:

Icon illustration of a safe needle disposal bin Icon illustration of a journal and pen

Dispose and document

Properly dispose of the device and supplies, document your injection site, and date of therapy.

How to inject TYENNE

Watch the injection video and read the Instructions for Use that come in each package. Watching this video is not a substitute for reading the Medication Guide and Instructions for Use. Still have questions? Talk to your doctor.

How to administer TYENNE

Instructions for use

FVO: This quick guide video has been designed to support you with administering a TYENNE pre-filled syringe. The video provides only supplementary information for the administration of TYENNE pre-filled syringe. It does NOT substitute the reading of the FDA-approved instructions for use. The instructions for use should be read before administering TYENNE.

Read the medication guide that comes with your TYENNE pre-filled syringe for important information you need to know before using it. This video demonstrates…

…The administration of TYENNE with the active ingredient tocilizumab-aazg using a pre-filled syringe.

You’ve been prescribed TYENNE, which is available as an autoinjector as well as a pre-filled syringe with a dosage of 162 milligrams /0.9 millileters to be injected.

In this video we’ll demonstrate the correct way to inject using a pre-filled syringe

Before we go over the steps to self-administer using a pre-filled syringe, there are a few things to consider.

FVO: It is important to follow instructions so that you inject TYENNE correctly.

Don’t remove the needle cap until you are ready to inject TYENNE.

Don’t try to take apart the pre-filled syringe at any time.

Don’t use a pre-filled syringe if the new carton is open or damaged

Don’t use a pre-filled syringe that has been dropped on a hard surface. The pre-filled syringe may be broken even if you cannot see the break.

FVO: Do talk to your healthcare provider to be sure you understand TYENNE instructions for use or if you or your caregiver have any questions about the right way to inject TYENNE.

FVO: Let’s take a moment to talk about storing your TYENNE pre-filled syringe.

Keep it in the original carton to protect from light and store it in a refrigerator set between 36 and 46 degrees Fahrenheit or 2 and 8 degrees Celsius.

Do not freeze TYENNE.

Do not use TYENNE if it has been frozen or left in the heat or direct sunlight.

If needed, such as travelling, a TYENNE pre-filled syringe can be stored in its original carton at room temperature for up to 14 days. After being stored at room temperature, do not place it back in the refrigerator

FVO: Before use, you can see the pre-filled syringe consists of a cap that covers the needle, a clear needle guard through which you can see the liquid-filled syringe barrel, and a finger flange and plunger for administering the dose.

After use, the needle guard spring is visible. Do not use the device if the syringe is like this before use.

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.

FVO: Step 1: Prepare for your injection

FVO: Now that you are familiar with the pre-filled syringe, let’s go over the first step: preparing for injection.

Remove the box containing the syringe out of the refrigerator and open the box. Remove the sealed plastic tray from the box.

Let the tray warm up for 30 minutes to reach room temperature. 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.

FVO: Step 2: Check your syringe.

Once the medicine has reached room temperature and you are ready to inject your TYENNE syringe, peel the seal off the tray and place two fingers on either side in the middle of the clear needle guard. Pull the pre-filled syringe straight up and out of the tray.

Do not pick up the pre-filled syringe by the plunger or the needle cap. Doing so could damage the pre-filled syringe or activate the clear needle guard

Check the expiration date on the TYENNE pre-filled syringe. 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.

Check the name on the pre-filled syringe says TYENNE

Check the liquid in the TYENNE pre-filled syringe. It should be clear and colorless to pale yellow

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.

Check the pre-filled syringe to make sure the syringe, the clear needle guard, and the needle cap are not cracked or damaged, that the needle cap is securely attached, and the needle guard spring is not extended.

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

FVO: Step 3: Wash your hands

When you are ready to inject your TYENNE, wash your hands thoroughly with soap and water

FVO: Step 4: Choose your injection site

If you are giving yourself the injection, you can use the front of the upper thigh or the belly (abdomen), except for 2-inch area around your navel.

If a caregiver is giving the injection, they can also use the outer area of the upper arm. Do not attempt to use the upper arm area by yourself.

Each time you inject, choose a different site.

Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.

FVO: Step 5: 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.

FVO: Step 6: Give your injection

Hold the pre-filled syringe by the clear needle guard with 1 hand and pull the needle cap straight off with your other hand. Do not hold the plunger while you remove the needle cap. Throw away the needle cap in your sharps container.

There may be a small air bubble in the TYENNE pre-filled syringe. You do not need to remove it. You may see drops of liquid at the needle tip. This is normal and will not affect your dose.

Do not touch the needle or let it touch any surfaces. Do not use the pre-filled syringe if it is dropped.

Hold the TYENNE pre-filled syringe in 1 hand between the thumb and index finger. Do not pull back on the plunger of the syringe

Use your other hand and gently pinch the area of skin firmly.

With a quick dart-like motion, insert the needle all the way into the pinched skin at an angle between 45˚ and 90˚. Do not hold or push on the plunger while inserting the needle into the skin.

Use your thumb to slowly inject all of the medicine by gently pushing the plunger all the way down and the full dose has been injected. Do not pull the needle out of the skin when the plunger is pushed all the way down.

Hold the syringe 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 the needle guard will cover the needle. Release the pinched skin.

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.

FVO: Step 7: Throw away used pre-filled syringe

The TYENNE pre-filled syringe should not be reused nor should you put the needle cap back on the needle.

Put your used syringe in a sharps disposal bin immediately after use. If you do not have a sharps disposal bin, use a household container that is made of heavy-duty plastic, puncture-resistant with a tight fitting lid, upright and stable during use, leak resistant, and labeled with a hazardous waste warning.

Do not dispose of your pre-filled syringe in your household trash or recycling. Keep your sharps disposal container out of the reach of children.

FVO: Step 8: Record your injection

To help you remember when and where to do your next injection, write the date, time, and specific part of your body where you injected yourself.

FVO: Thank you for watching this quick guide video on TYENNE pre-filled syringe. If you have any further questions, please contact your healthcare provider.

Frequently asked questions

It depends on what you’re being treated for, how much you weigh, and the progression of your treatment. At most, you may need an injection once a week; it may be every other week. Your health care provider will walk you through the frequency and dosage of your injections.

Before you start TYENNE injections, your doctor or nurse should review the TYENNE Medication Guide and Instructions for Use with you. This should help you to better understand the risks and benefits of your treatment. After reviewing the Important Side Effect Information for TYENNE, you should be properly trained on using your injection device.

It’s important to pay close attention to how you’re feeling before, during, and after an injection. TYENNE may lead to serious allergic reactions, including death. Allergic reactions may happen during and after any injection, even if they have not happened before. In case of emergency or if you experience an allergic reaction, contact 911 immediately, as well as your health care provider or nurse.

Also, TYENNE is a medicine that affects your immune system. It can lower your immune system’s ability to fight infections, make you more likely to get infections, or make worse any infection you may have. After starting TYENNE, contact your health care provider right away if you have any symptoms of an infection.

Talk to your doctor if you have any questions about your medicine, the device, the preparation, or the details of your injection.

Icon illustration of an IV Bag

What is an infusion?

TYENNE is administered using an infusion. Also called IV therapy or infusion therapy , an infusion delivers medicine directly into the bloodstream. For you, that means medication flows from a sterile bag through plastic tubing into a small needle inserted into your arm.

Let’s walk though the sequence.

Looking for an infusion center?

Infusion centers can be found throughout the US. The National Infusion Center Association maintains an online infusion center locator that can provide a list of options close to you.

Find a center

Infusion basics

Most patients prescribed TYENNE need an hour-long infusion every four weeks.a

If you are prescribed TYENNE, you’ll probably need an infusion about once a month. The infusion will take place at an infusion center. Although the procedure typically lasts about an hour, you may need to arrive early. Between infusions, your doctor may order blood tests.

aDosage and frequency may depend on indication and patient weight.

Icon illustration of a calendar
Icon illustration of paperwork

Before you start

Have questions about your infusion? Bring those questions with you, as well as a list of any modifications to your medical situation, including planned surgeries, recent illnesses, changes in medicines, etc. Give this list to your infusion nurse.

Always review your medication guide.

Download medication guide
Icon illustration of a glass of water and a pitcher

The day before your infusion, drink plenty of water.

Icon illustration of a book

On the day of your infusion, be sure to pack things you might need: your phone, laptop, or maybe a favorite book of puzzles.

Icon illustration of a long-sleeved shirt

Dress in layers so you can be comfortable.

Icon illustration of an IV Bag and a treatment chair

During the infusion

Relax! There’s nothing you need to do.

Your doctor or nurse will guide you through the process. Feel free to ask them questions; they’re there to support you. During the infusion, you can read, work, or even nap. You may be given medication to address any potential infusion reactions. You’ll also be told if you need any follow-up tests before your next infusion.

After you’re done

When the infusion is complete, your nurse will monitor you for few minutes.

Afterwards, if you’re not feeling any symptoms, you’ll be free to go. Be sure to schedule your next infusion—it’s important to stick to your treatment plan. Your doctor may order more blood tests between infusions.

Icon illustration of a car leaving a hospital

Frequently asked questions

Infusion

A standard medical procedure that delivers medication into your bloodstream directly through the veins in your arm.

It depends on what you’re being treated for. For rheumatoid arthritis (RA), giant cell arteritis (GCA), or polyarticular juvenile idiopathic arthritis (PJIA), you'll receive a dose of TYENNE about every 4 weeks. Patients being treated for systemic juvenile idiopathic arthritis (SJIA) will receive a dose of TYENNE about every 2 weeks.

It can vary, but generally about an hour.

Drink plenty of water and pack smartly. See our suggestions above.

Infusion reactions may occur. A health care provider or nurse will be there to monitor you.

Also, TYENNE is a medicine that affects your immune system. It can lower your immune system’s ability to fight infections, make you more likely to get infections, or make worse any infection you may have. After starting TYENNE, contact your health care provider right away if you have any symptoms of an infection.

TYENNE infusions are available at infusion centers across the US. This useful Infusion Center Locator can help find the one that’s best for you.

KabiCare Patient support from Fresenius Kabi

Support is available for your new medicine

Through KabiCare, its patient support program, Fresenius Kabi offers comprehensive resources to supplement your experience with TYENNE. Your health care provider can enroll you in KabiCare at no cost.

Once enrolled, you’ll have access to a wide range of materials, including:

  • Insurance Support: help navigating your insurance to obtain coverage and to review your patient benefits
  • Financial support: as little as $0 copay for commercially insured patients prescribed TYENNE® (tocilizumab-aazg)a
  • Fresenius Kabi Patient Assistance Program (PAP): patients may be eligible for assistance through PAPb or through an independent nonprofit PAPc
  • Therapy Support: help from nurse educators,d who can answer medical-related questions, educational resources to teach you about your medication, and additional benefits that may be offered by your insurancec
Explore KabiCare

aEligibility criteria apply. Patients are not eligible for commercial copay assistance or Bridge to Therapy program if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program.

bGovernment insurance or uninsured/underinsured patients may be eligible. Underinsured means that your health insurance plan does not cover TYENNE®.

cEligibility for resources provided by independent nonprofit patient assistance programs is based on the nonprofits’ criteria. Fresenius Kabi has no control over these programs.

dNurse support provided by KabiCare is not meant to replace discussions with a health care provider regarding a patient’s care and treatment.

INDICATIONS

  • To treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well

  • To treat adults with giant cell arteritis (GCA)

  • To treat patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older

  • To treat patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

IMPORTANT SAFETY INFORMATION

TYENNE can cause serious side effects

Serious Infections

TYENNE changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. 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 and during treatment with TYENNE.

Before starting TYENNE, tell your healthcare provider if you have:

  • an infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Symptoms of an infection, with or without a fever, include sweating or chills; shortness of breath; warm, red or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more than normal
  • any of the following conditions that may give you a higher chance of getting infections: diabetes, HIV, or a weak immune system
  • tuberculosis (TB), or have been in close contact with someone with TB
  • live or have lived, or have traveled to certain parts of the United States where there is an increased chance of getting fungal infections. These parts include the Ohio and Mississippi River valleys and the Southwest
  • hepatitis B or have had hepatitis B

Who should not take TYENNE?

Do not take TYENNE if you are allergic to tocilizumab products, or any of the ingredients in TYENNE.

Be sure to talk to your healthcare provider if you see any signs of these serious side effects:

Tears (perforation) of the Stomach or Intestines

If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking TYENNE. Some people taking TYENNE may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you see any of these side effects: fever, stomach- area pain that does not go away, or if you see a change in your bowel habits.

Liver problems (Hepatotoxicity)

Some people have experienced serious life-threatening liver problems, which required liver transplant or led to death. Your healthcare provider may tell you to stop taking TYENNE if you develop new or worsening 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 the stomach-area
  • light colored stools
  • weakness
  • nausea and vomiting
  • confusion
  • dark “tea-colored” urine

Changes in Blood 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 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:

  • Low neutrophil count: neutrophils are white blood cells that help the body fight infection
  • Low platelet count: platelets are blood cells that help with clotting, which stops bleeding
  • Increase in liver function test levels
  • Increase in blood cholesterol levels: your cholesterol levels should be checked 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 and platelet counts are too low or your liver function test levels are too high. Changes in blood test results may cause your healthcare provider to stop your TYENNE treatment for a time or change your dose.

Cancer

TYENNE may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B Infection

If you have or 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 signs of these symptoms:

  • feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • muscle aches
  • dark urine
  • skin rash

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. Tell your healthcare provider before your next dose if you had hives, rash or flushing after your injection.

Contact 911 immediately, as well as your healthcare provider, if you experience any of these reactions:

  • shortness of breath or trouble breathing
  • swelling of the lips, tongue, or face
  • chest pain
  • feeling dizzy or faint
  • moderate or severe abdominal pain or vomiting

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.

What should I tell my healthcare provider before receiving TYENNE?

TYENNE may not be right for you. Before receiving TYENNE, tell your healthcare provider if you:

  • have an infection
  • 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
  • plan to have surgery or a medical procedure
  • have any other medical conditions
  • plan to become pregnant or are pregnant. It is not known if TYENNE will harm your unborn baby.
  • plan to breast-feed or are breast-feeding. You and your healthcare provider should decide if you will take TYENNE or breast-feed. You should not do both.
  • are taking any medications, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The most common side effects of TYENNE include:

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

TYENNE & Pregnancy

Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your healthcare provider should decide if you will take TYENNE or breast-feed. You should not do both.

Tell your healthcare provider if you have any side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Fresenius Kabi at 1-800-551-7176.

Please see full Prescribing Information and the Medication Guide, including Serious Side Effects, for more Important Safety Information.

INDICATIONS

What does TYENNE treat?

TYENNE® (tocilizumab-aazg) 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 antirheumatic drug (DMARD) has been used and did not work well
  • To treat adults with giant cell arteritis (GCA)
  • To treat patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older
  • To treat patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

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

Important Safety Information
Indications

INDICATIONS

  • To treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well

  • To treat adults with giant cell arteritis (GCA)

  • To treat patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older

  • To treat patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

IMPORTANT SAFETY INFORMATION

TYENNE can cause serious side effects

Serious Infections

TYENNE changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. 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 and during treatment with TYENNE.

Before starting TYENNE, tell your healthcare provider if you have:

  • an infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Symptoms of an infection, with or without a fever, include sweating or chills; shortness of breath; warm, red or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more than normal
  • any of the following conditions that may give you a higher chance of getting infections: diabetes, HIV, or a weak immune system
  • tuberculosis (TB), or have been in close contact with someone with TB
  • live or have lived, or have traveled to certain parts of the United States where there is an increased chance of getting fungal infections. These parts include the Ohio and Mississippi River valleys and the Southwest
  • hepatitis B or have had hepatitis B

Who should not take TYENNE?

Do not take TYENNE if you are allergic to tocilizumab products, or any of the ingredients in TYENNE.

Be sure to talk to your healthcare provider if you see any signs of these serious side effects:

Tears (perforation) of the Stomach or Intestines

If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking TYENNE. Some people taking TYENNE may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you see any of these side effects: fever, stomach- area pain that does not go away, or if you see a change in your bowel habits.

Liver problems (Hepatotoxicity)

Some people have experienced serious life-threatening liver problems, which required liver transplant or led to death. Your healthcare provider may tell you to stop taking TYENNE if you develop new or worsening 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 the stomach-area
  • light colored stools
  • weakness
  • nausea and vomiting
  • confusion
  • dark “tea-colored” urine

Changes in Blood 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 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:

  • Low neutrophil count: neutrophils are white blood cells that help the body fight infection
  • Low platelet count: platelets are blood cells that help with clotting, which stops bleeding
  • Increase in liver function test levels
  • Increase in blood cholesterol levels: your cholesterol levels should be checked 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 and platelet counts are too low or your liver function test levels are too high. Changes in blood test results may cause your healthcare provider to stop your TYENNE treatment for a time or change your dose.

Cancer

TYENNE may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B Infection

If you have or 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 signs of these symptoms:

  • feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • muscle aches
  • dark urine
  • skin rash

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. Tell your healthcare provider before your next dose if you had hives, rash or flushing after your injection.

Contact 911 immediately, as well as your healthcare provider, if you experience any of these reactions:

  • shortness of breath or trouble breathing
  • swelling of the lips, tongue, or face
  • chest pain
  • feeling dizzy or faint
  • moderate or severe abdominal pain or vomiting

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.

What should I tell my healthcare provider before receiving TYENNE?

TYENNE may not be right for you. Before receiving TYENNE, tell your healthcare provider if you:

  • have an infection
  • 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
  • plan to have surgery or a medical procedure
  • have any other medical conditions
  • plan to become pregnant or are pregnant. It is not known if TYENNE will harm your unborn baby.
  • plan to breast-feed or are breast-feeding. You and your healthcare provider should decide if you will take TYENNE or breast-feed. You should not do both.
  • are taking any medications, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The most common side effects of TYENNE include:

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

TYENNE & Pregnancy

Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your healthcare provider should decide if you will take TYENNE or breast-feed. You should not do both.

Tell your healthcare provider if you have any side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Fresenius Kabi at 1-800-551-7176.

Please see full Prescribing Information and the Medication Guide, including Serious Side Effects, for more Important Safety Information.

INDICATIONS

What does TYENNE treat?

TYENNE® (tocilizumab-aazg) 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 antirheumatic drug (DMARD) has been used and did not work well
  • To treat adults with giant cell arteritis (GCA)
  • To treat patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older
  • To treat patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

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