Tyenne

Tyenne is an injectable interleukin-6 (IL-6) receptor antagonist used to treat:

• moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
• Giant Cell Arteritis (GCA) in adults
• Coronavirus Disease 2019 (COVID-19) in hospitalized adults and children aged 2 years and older who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
• Polyarticular juvenile idiopathic arthritis (PJIA) in adults and children aged 2 years and older
• active systemic juvenile idiopathic arthritis (SJIA) in adults and children aged 2 years and older
• Chimeric antigen receptor (CAR) T cell-induced, severe or life-threatening cytokine release syndrome (CRS) in adults and children aged 2 years and older.

Tyenne works by targeting and binding to a protein associated with inflammation called interleukin-6 (IL-6), inhibiting signaling through both soluble and membrane-bound IL-6 receptors. This proinflammatory cytokine is produced by several immune system cells, including T- and B-cells, lymphocytes, monocytes, and fibroblasts. It is also locally produced by synovial and endothelial cells in joints, contributing to inflammatory conditions such as rheumatoid arthritis.

Tyenne (tocilizumab-aazg) gained FDA approval on March 5, 2024, and is a biosimilar to Actemra (tocilizumab) with both subcutaneous and IV formulations.

• A biosimilar is a biological product that is similar to a reference biologic and for which there are no clinically meaningful differences in terms of safety, purity, and potency.

Tyenne is given as an infusion into your vein (intravenously, IV) by a healthcare professional, or it can be given as a subcutaneous (SC) injection just under your skin. It is not approved for subcutaneous use in people with CRS or COVID-19.

• Tell your healthcare provider right away if you have a fever and new-onset stomach-area pain that does not go away, and a change in your bowel habits.

Intravenous (IV) infusion

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 about every 4 weeks.
• For SJIA, you will receive a dose about every 2 weeks.
• For COVID-19, you will receive a single dose, and if needed, one additional dose.

While taking Tyenne, you may continue to use other medicines that help treat your rheumatoid arthritis, PJIA, or SJIA, 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.

Subcutaneous (SC) injection

You can learn how to administer subcutaneous (under the skin) injections yourself at home after adequate training, or they can be given by a healthcare provider. Do not try to inject Tyenne until you have been shown the right way to give the injections by your healthcare provider.

Tyenne is available as a single-dose prefilled syringe or single-dose prefilled autoinjector.

• Let the prefilled syringe sit at room temperature for 30 minutes, or 45 minutes for the autoinjector.
• Follow all the instructions from your healthcare provider about how to use the prefilled syringe or autoinjector.

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.

Do not take Tyenne if you have had an allergic reaction to tocilizumab, Tyenne, or any inactive ingredients in the injection.

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

• have an infection, are being treated for an infection, get a lot of infections, or have infections that keep coming back
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance of infections
• have TB or have been in close contact with someone with TB
• live or have lived or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain 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 or liver problems
• have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
• 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, but can receive non-live vaccines
• plan to have surgery or a medical procedure
• take medications that affect your immune system
• have or have had cancer
• are pregnant or plan to become pregnant or are pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Tyenne may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment.

Breastfeeding

It is not known if Tyenne passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

The most common side effects of Tyenne are:

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

Serious side effects and warnings

Tyenne can cause the following serious side effects:

• Serious allergic reactions that may be fatal. 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. Stop taking Tyenne and seek medical attention right away if you have any of the following signs of a serious allergic reaction:
• Serious Infections. Tyenne affects your immune system and can lower its ability 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 can be life-threatening or fatal. 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:
• Tears (perforation) of the stomach or intestines. The risk is higher in those who take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have a fever and stomach-area pain that does not go away, and a change in your bowel habits
• 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. Tell your healthcare provider right away if you have any of the following symptoms:
• Changes in certain laboratory test results, such as low neutrophils, platelets, or changes in your liver function or cholesterol. Your healthcare provider should do blood tests before you start receiving Tyenne and then regularly thereafter
• Cancer. Tyenne may increase your risk of certain cancers by changing the way your immune system works
• 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 and during treatment. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:

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.

Before you start treatment with Tyenne, your doctor may perform tests to make sure you do not have tuberculosis or other infections (except if you have COVID-19). While using this medication, you may need frequent medical tests to monitor your blood counts, cholesterol, and liver function.

Ensure your vaccinations are up to date before starting treatment with Tyenne. Do not receive a "live" vaccine during treatment because you may develop a serious infection or the vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster ( shingles), and nasal flu (influenza) vaccine.

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Fresenius Kabi USA, LLC at 1-800-551-7176.

See the Tyenne Prescribing Information for dosage information, which depends on the condition being treated and the patient's weight.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine or you could develop a serious infection. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster ( shingles), and nasal flu (influenza) vaccine.

You may still be able to receive a yearly flu shot, or an "inactivated" or other vaccine to prevent diseases such as hepatitis, meningitis, pneumonia, shingles, HPV, or whooping cough. Ask your doctor before getting any vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your healthcare provider about all of the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• any other medicines to treat your RA. You should not take etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi) while you are taking Tyenne because they 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. This list is not complete and many other drugs may interact with tocilizumab. See the Product Information for a complete list of interactions.

Keep Tyenne refrigerated at 36°F to 46°F (2ºC to 8ºC). Do not freeze.

A single prefilled syringe or autoinjector may be stored at room temperature at or below 86°F (30°C) for a single period of up to 14 days.

Protect from light by storing in the original package until the time of use. Keep syringes and autoinjectors dry.

Active ingredient: tocilizumab-aazg.

Inactive ingredients of intravenous and subcutaneous formulations: arginine, histidine, hydrochloric acid, lactic acid, polysorbate 80, sodium chloride, sodium hydroxide, and water for injection.

The IV infusion is available as 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), and 400 mg/20 mL (20 mg/mL) single-dose vials for further dilution before intravenous infusion.

The SC injection is available as a 162 mg/0.9 mL single-dose prefilled syringe or single-dose prefilled autoinjector.

Tyenne is made by Fresenius Kabi USA LLC., located in Lake Zurich, IL 60047, U.S.A.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Tyenne.

Actemra (tocilizumab) - Genentech, Inc.

View Actemra information in detail.

Actemra interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Avtozma (tocilizumab-anoh) - CELLTRION, Inc.

View Avtozma information in detail.

Actemra biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Avtozma (tocilizumab-anoh) - CELLTRION, Inc.

View Avtozma information in detail.

Tofidence (tocilizumab-bavi) - Biogen MA Inc.

View Tofidence information in detail.

Tyenne (tocilizumab-aazg) - Fresenius Kabi USA, LLC