Tyenne

Pronunciation: tye-en
Generic name: tocilizumab-aazg
Dosage forms: injection for intravenous infusion, prefilled syringe for subcutaneous injection, prefilled autoinjector for subcutaneous injection
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 11, 2024.

What is Tyenne?

Tyenne (tocilizumab-aazg) is an injectable interleukin-6 (IL-6) receptor antagonist that may be used to treat:

• adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
• adults with Giant Cell Arteritis (GCA)
• people aged 2 years and older with Polyarticular Juvenile Idiopathic Arthritis (PJIA)
• people aged 2 years and older with active systemic juvenile idiopathic arthritis (SJIA).

Tyenne works by targeting and binding to a protein that is 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 a variety of 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 is a biosimilar to Actemra (tocilizumab) with both subcutaneous and IV formulations and was FDA-approved on March 5, 2024. 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.

Warnings

Serious and life-threatening hypersensitivity reactions have occurred with tocilizumab products, such as Tyenne, including anaphylaxis. Seek emergency help or tell your doctor immediately if you experience shortness of breath, throat tightness, swelling of the airways and throat, itching, low blood pressure, or hives.

Tyenne affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

Tyenne may also cause a perforation (a hole or tear) in your stomach or intestines. Tell your doctor if you have a fever and stomach pain with a change in your bowel habits.

Tyenne may also cause liver problems. Tell your doctor right away if you have right-sided stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Before you start treatment with Tyenne, your doctor may perform tests to make sure you do not have tuberculosis or other infections. While using Tyenne, 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 or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

Related/similar drugs

prednisone, naproxen, methotrexate, hydroxychloroquine, Humira, Enbrel, adalimumab

Before taking

Do not take Tyenne if you have had an allergic reaction to tocilizumab, or any of the 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.

How is Tyenne administered?

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.

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.

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.

• Follow the instructions from your healthcare provider about how to use the prefilled syringe or autoinjector.
• Your healthcare provider will tell you how much Tyenne to use and when to use it.

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.com.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

What should I avoid while receiving Tyenne?

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.

What are the side effects of Tyenne?

Tyenne can cause serious side effects including:

• 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. Seek medical attention right away if you have any of the following signs of a serious allergic reaction:
• 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.
• 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:
• sweating or chills
• feel very tired
• cough or shortness of breath
• muscle aches
• weight loss
• warm, red, or painful skin
• blood in phlegm
• burning when you urinate or
• sores on your body
• diarrhea or stomach pain
• urinating more often than normal.
• 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:
• feeling tired (fatigue)
• weakness
• lack of appetite for several days or longer
• nausea and vomiting
• yellowing of your skin or the whites of your eyes
• confusion
• abdominal swelling and pain on the right side of your stomach-area
• dark “tea-colored” urine or light-colored stools.
• 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:
• 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.

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 affecting at least 5% of people include:

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

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.

What other drugs will affect Tyenne?

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.

Storage

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 77°F (25°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.

Ingredients

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.

Manufacturer

Fresenius Kabi USA LLC.

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Further information

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