Tyenne 162 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tyenne 162 mg solution for injection in pre-filled syringe

tocilizumab

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

In addition to this leaflet, you will be given a Patient Information Card containing important safety information that you should be aware of before and during treatment with Tyenne.

Contents of this leaflet

1. What Tyenne is and what it is used for
2. What you need to know before using Tyenne
3. How to use Tyenne
4. Possible side effects
5. How to store Tyenne
6. Contents of the pack and other information

1. What Tyenne is and what it is used for

Tyenne contains an active substance called tocilizumab, which is a protein derived from specific immune cells (monoclonal antibody) that blocks the action of a specific type of protein (cytokine) called interleukin-6. This protein is involved in inflammatory processes in the body, and by blocking it, inflammation can be reduced. Tyenne is indicated for the treatment of:

• Adults with moderate to severe active rheumatoid arthritis (RA), which is an autoimmune disease, when previous treatments have not worked well.

• Adults with severe, active and progressive rheumatoid arthritis (RA) who have not previously been treated with methotrexate.

Tyenne helps reduce the symptoms of RA such as pain and swelling in your joints and may also improve your ability to perform daily tasks. Tyenne has been shown to reduce the progression of joint damage to cartilage and bone caused by the disease and to improve your ability to carry out daily activities.

Tyenne is usually used in combination with another medicine for RA called methotrexate. However, Tyenne may be given alone if your doctor determines that methotrexate is not suitable.

• Adults with a blood vessel disease called giant cell arteritis (GCA), caused by inflammation of the larger arteries in the body, especially those supplying blood to the head and neck. Symptoms may include headache, fatigue (tiredness), and jaw pain. Complications may include strokes and blindness.

Tyenne can reduce the pain and swelling of the arteries and veins in the head, neck, and arms.

GCA is often treated with medicines called steroids. These are usually effective but may cause side effects if used at high doses for long periods. Reducing the steroid dose may also lead to a flare-up of GCA. Adding Tyenne to treatment allows for a shorter duration of steroid use while still maintaining control of the disease.

• Children and adolescents, aged 1 year and older, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease causing pain and swelling in one or more joints, as well as fever and skin rash.

Tyenne is used to improve the symptoms of sJIA. It can be given in combination with methotrexate or alone.

• Children and adolescents, aged 2 years and older, with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease causing pain and swelling in one or more joints.

Tyenne is used to improve the symptoms of pJIA. It can be given in combination with methotrexate or alone.

2. What you need to know before using Tyenne

Do not use Tyenne

• If you or the pediatric patient under your care is allergic to tocilizumab or to any of the other ingredients of this medicine (listed in section 6).
• If you or the pediatric patient under your care has a serious active infection.

If any of these apply to you, consult your doctor. Do not use Tyenne.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Tyenne.

• If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling of the lips, tongue, face, or skin rash, hives, or itching during or after the injection, inform your doctor immediately.

• If you have experienced any symptoms of an allergic reaction after administration of Tyenne, do not take the next dose until you have informed your doctor and your doctor has instructed you to take the next dose.

• If you have any kind of infection, whether short-term or long-term, or if you get infections frequently. Inform your doctor immediately if you feel unwell. Tyenne may reduce your body's ability to respond to infections and may worsen an existing infection or increase the likelihood of acquiring a new infection.

• If you have had tuberculosis, inform your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting treatment with Tyenne. Inform your doctor immediately if symptoms of tuberculosis (persistent cough, weight loss, general malaise, low-grade fever), or any other infection, appear during or after treatment.

• If you have had intestinal ulcer or diverticulitis, inform your doctor. Symptoms may include abdominal pain and unexplained changes in bowel habits with fever.

• If you have liver disease, inform your doctor. Before using Tyenne, your doctor will perform a blood test to assess your liver function.

• If any patient has recently been vaccinated, or plans to be vaccinated, inform your doctor. All patients should be up to date with their vaccination schedule before starting treatment with Tyenne. Certain types of vaccines should not be administered while receiving Tyenne.

• If you have cancer, inform your doctor. Your doctor will need to decide whether you can continue receiving Tyenne treatment.

• If you have cardiovascular risk factors, such as high blood pressure or high cholesterol levels, inform your doctor. These factors need to be managed while receiving treatment with Tyenne.

• If you have moderate to severe kidney problems, your doctor will monitor you.

• If you have persistent headaches.

Your doctor will perform blood tests before you receive Tyenne to determine whether you have low levels of white blood cells, low platelet counts, or elevated liver enzymes.

Children and adolescents

The subcutaneous pre-filled syringe injection of Tyenne is not recommended for children under 1 year of age.

Tyenne should not be administered to children with systemic juvenile idiopathic arthritis (sJIA) weighing less than 10 kg.

If a child has a history of macrophage activation syndrome (uncontrolled activation and proliferation of specific blood cells), inform your doctor. Your doctor will need to decide whether Tyenne can still be administered.

Other medicines and Tyenne

Inform your doctor if you are taking any other medicines, or have recently taken any. This is because Tyenne may affect how some medicines work, and a dose adjustment may be needed. Inform your doctor if you have recently used medicines containing any of the following active substances:

• methylprednisolone, dexamethasone, used to reduce inflammation,
• simvastatin or atorvastatin, used to reduce cholesterol levels,
• calcium channel blockers (such as amlodipine), used to treat high blood pressure,
• theophylline, used to treat asthma,
• warfarin or phenprocoumon, used as anticoagulants,
• phenytoin, used to treat seizures,
• cyclosporine, used as an immunosuppressant in organ transplantation,
• benzodiazepines (such as temazepam), used to relieve anxiety.

Regarding vaccines, refer to the warning section above.

Because there is no clinical experience, the use of Tyenne with other biological medicines used to treat RA, sJIA, pJIA, or GCA is not recommended.

Pregnancy and breastfeeding

Tyenne should not be used during pregnancy, unless clearly necessary. Talk to your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.

Women of childbearing potential should use effective contraception during treatment and for at least 3 months after stopping treatment.

Interrupt breastfeeding if you start treatment with Tyenne, and consult your doctor. Breastfeeding should not be resumed until at least 3 months after your last dose of Tyenne. It is unknown whether Tyenne passes into breast milk.

Driving and using machines

This medicine may cause dizziness. If you feel dizzy, do not drive or operate machinery.

Tyenne contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 0.9 ml dose, which is essentially “sodium-free”.

Tyenne contains polysorbate 80

This medicine contains 0.18 mg of polysorbate 80 in each 162 mg/0.9 ml syringe, equivalent to 0.2 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergies.

3. How to use Tyenne

Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Treatment should be initiated by a healthcare professional experienced in the diagnosis and treatment of RA, JIA, pJIA, or GCA.

Adults with RA or GCA

The recommended dose for adults with RA (rheumatoid arthritis) and GCA (giant cell arteritis) is 162 mg (the contents of one pre-filled syringe) administered once weekly.

Children and adolescents with JIA (from 1 year of age onwards)

The usual dose of Tyenne depends on the patient's weight.

• If the patient weighs less than 30 kg: the dose is 162 mg (the contents of 1 pre-filled syringe), once every 2 weeks.
• If the patient weighs 30 kg or more: the dose is 162 mg (the contents of 1 pre-filled syringe), once every week.

Children and adolescents with pJIA (from 2 years of age onwards)

The usual dose of Tyenne depends on the patient's weight.

• If the patient weighs less than 30 kg: the dose is 162 mg (the contents of 1 pre-filled syringe), once every 3 weeks.
• If the patient weighs 30 kg or more: the dose is 162 mg (the contents of 1 pre-filled syringe), once every 2 weeks.

Tyenne is administered by injection under the skin (subcutaneously). At the beginning, your doctor or nurse may administer Tyenne to you. However, your doctor may decide that you can self-inject Tyenne. In this case, you will receive instructions on how to self-inject Tyenne. Parents and caregivers will receive instructions on how to inject Tyenne to patients who cannot self-inject, such as children.

Speak with your doctor if you have any questions about how to self-administer the injection or how to administer it to the child you care for. Detailed “administration instructions” can be found at the end of this leaflet.

If you use more Tyenne than you should

As Tyenne is administered in a pre-filled syringe, it is unlikely that too much will be given. However, if you are concerned, speak with your doctor, pharmacist, or nurse.

If an adult with RA and GCA or a child or adolescent with JIA misses or forgets a dose, it is very important to use Tyenne exactly as prescribed by your doctor. Keep track of your next dose.

• If you miss your weekly dose within 7 days, take your dose on the next scheduled day.
• If you miss your dose every 2 weeks within 7 days, inject a dose as soon as you remember and administer your next dose according to your original schedule.
• If you miss a dose for 7 days or more, or are unsure when to inject Tyenne, contact your doctor or pharmacist.

If a child or adolescent with pJIA misses or forgets a dose

It is very important to use Tyenne exactly as prescribed by the doctor. Keep track of the next dose.

• If you miss a dose within 7 days, inject a dose as soon as you remember and administer the next dose according to your original schedule.
• If you miss a dose for 7 days or more, or are unsure when to inject Tyenne, contact your doctor or pharmacist.

If you stop treatment with Tyenne

You must not stop treatment with Tyenne without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Tyenne may cause adverse effects, although not everyone experiences them. Adverse effects may occur up to at least 3 months after your last dose of Tyenne.

Possible serious adverse effects: consult your doctor immediately.

These are common: may affect up to 1 in 10 people

Allergic reactions during or after injection:

• difficulty breathing, chest tightness, or dizziness,
• skin rash, itching, hives, swelling of the lips, tongue, or face.

If you experience any of these symptoms, speak to your doctor immediately.

Signs of serious infections:

• fever and chills,
• mouth or skin blisters,
• stomach pain.

Signs and symptoms of liver toxicity:

May affect up to 1 in 1,000 people

• fatigue,
• abdominal pain,
• jaundice (yellowing of the skin or eyes).

If you notice any of these symptoms, inform your doctor as soon as possible.

Very common adverse effects:

May affect more than 1 in 10 people

• upper respiratory tract infections, with typical symptoms such as cough, nasal congestion, runny nose, sore throat, and headache,
• high levels of fat in the blood (cholesterol),
• injection site reactions.

Common adverse effects:

May affect up to 1 in 10 people

• lung infection (pneumonia),
• herpes (herpes zoster),
• cold sores (oral herpes simplex), blisters,
• skin infections (cellulitis), sometimes with fever and chills,
• rash and itching, urticaria,
• allergic reactions (hypersensitivity),
• eye infection (conjunctivitis),
• headache, dizziness, hypertension,
• mouth ulcers, stomach pain,
• fluid retention (edema) in the lower legs, weight gain,
• cough, shortness of breath,
• low white blood cell counts in blood tests (neutropenia, leucopenia),
• abnormal liver function tests (elevated transaminases),
• increased bilirubin measured by blood test,
• low levels of fibrinogen in the blood (a protein involved in blood clotting).

Uncommon adverse effects:

May affect up to 1 in 100 people

• diverticulitis (fever, nausea, diarrhea, constipation, stomach pain),
• swollen and red areas in the mouth,
• elevated blood fats (triglycerides),
• stomach ulcers,
• kidney stones,
• hypothyroidism.

Rare adverse effects:

May affect up to 1 in 1,000 people

• Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin),
• life-threatening allergic reactions (anaphylaxis [fatal]),
• liver inflammation (hepatitis), jaundice.

Very rare adverse effects:

May affect up to 1 in 10,000 people

• low counts of white blood cells, red blood cells, and platelets in blood tests,
• liver failure.

Additional adverse effects in children and adolescents with JIA or pJIA

In children and adolescents with JIA or pJIA, adverse effects are generally similar to those in adults. Some adverse effects occur more frequently in children and adolescents: inflammation of the nose and throat, headache, nausea, and decreased white blood cell count.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tyenne

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label of the pre-filled syringe and on the carton after (EXP). The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.

Keep the pre-filled syringes in their outer packaging to protect from light.

The pre-filled syringes may be stored at room temperature (up to 30 °C) for a single period of up to 14 days. The pre-filled syringes must be protected from light and should be discarded if not used within 14 days at room temperature (up to 30 °C) or upon reaching the expiry date, whichever occurs first.

Do not use this medicine if it appears cloudy or contains particles, if it is a different colour than colourless to pale yellow, or if any part of the pre-filled syringe appears damaged.

Do not shake the syringe.

After removing the needle cap, the injection should be started immediately to prevent the medicine from drying and blocking the needle. If the pre-filled syringe is not used immediately after removing the needle cap, it must be discarded in a sharps container and a new pre-filled syringe must be used.

If, after inserting the needle, the plunger of the syringe cannot be pushed, the pre-filled syringe must be discarded in a special sharps container and a new one must be used.

6. Contents of the pack and other information

Composition of Tyenne

• The active substance is tocilizumab.

Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 ml.

• The other components are L-arginine, L-histidine, L-lactic acid, sodium chloride, polysorbate 80 (E 433), hydrochloric acid (E507) and/or sodium hydroxide (E524), water for injections.

Regarding sodium and polysorbate 80, please refer to section 2 "Tyenne contains sodium" and "Tyenne contains polysorbate 80" above.

Appearance of the product and contents of the pack

Tyenne is a solution for injection. The solution is transparent and colourless to pale yellow.

Tyenne is supplied in pre-filled syringes of 0.9 ml containing 162 mg of tocilizumab solution for injection.

Each pack contains 1, 4 or 12 pre-filled syringes. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Fresenius Kabi Deutschland GmbH
Else-Kroener-Strasse 1
61352 Bad Homburg v.d.Hoehe
Germany

Manufacturer

Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria

Date of the most recent revision of this leaflet: February 2024

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

1. Instructions for use

Read these instructions for use carefully before using the Tyenne pre-filled syringe and each time you receive a refill.

Important information

• Read the patient leaflet included with the Tyenne pre-filled syringe to obtain the most important information you need to know before using it.
• Before using the Tyenne pre-filled syringe for the first time, make sure your doctor shows you or your caregiver the correct way to use it. Please note that the syringe comes in an open plastic tray.
• People who are blind or have visual impairments should not use the Tyenne pre-filled syringe without the help of a trained person.
• Speak with your doctor if you have any questions or concerns.

Storage of the Tyenne pre-filled syringe

• Store the pre-filled syringe in its original packaging in a refrigerator at a temperature between 2 °C and 8 °C.
• Keep the pre-filled syringe in its original packaging to protect it from light.
• Keep the pre-filled syringe out of the reach and sight of children.

Do not freeze Tyenne.

Do not use the Tyenne pre-filled syringe if it has been frozen or exposed to direct sunlight, as this could cause harm.

Use of the Tyenne pre-filled syringe

• Always inject Tyenne using the technique taught to you by your doctor.
• The Tyenne pre-filled syringe is for single dose (single use) only.

Do not share the Tyenne pre-filled syringe with another person. You could transmit or acquire an infection.

• The Tyenne pre-filled syringe has a transparent needle shield that covers the needle after the injection is complete.

Do not use the pre-filled syringe if the box is open or damaged.

Do not use the pre-filled syringe if it has fallen onto a hard surface.

The pre-filled syringe may be broken, even if you cannot see the damage.

Do not remove the needle cap from the pre-filled syringe until you are ready to inject.

Do not attempt to reuse the pre-filled syringe, as this could cause an infection.

Travelling with the Tyenne pre-filled syringe

• If necessary, for example when travelling, the Tyenne pre-filled syringe may be stored at room temperature (up to 30 °C) for a maximum of 14 days.
• Dispose of any product that has been stored at room temperature (up to 30 °C) and not used within 14 days.
• When travelling by air, always consult your airline and your doctor about the possibility of carrying injectable medicines. Always carry Tyenne in your hand luggage, as the aircraft hold may be very cold and could cause freezing.

Parts of the Tyenne pre-filled syringe

Do not attempt to activate the transparent needle shield before injecting.

STEP 1: Prepare your injection
1.1. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area. 1.2. Materials needed (Figure B): 1 alcohol wipe to clean the injection site before injecting 1 sterile cotton ball or gauze pad to use after the injection 1 sharps disposal container (see STEP 7: Dispose of your syringe).
1.3. Remove the Tyenne box from the refrigerator and open it (Figure C).
1.4. Remove the Tyenne plastic tray from the box: Place the plastic tray containing the pre-filled syringe on a clean, flat surface. Clean.
1.5. Allow the pre-filled syringe to remain in its plastic tray at room temperature for at least 30 minutes before use so the medication can reach room temperature (Figure D). Injecting cold medication may cause discomfort and make it difficult to depress the plunger. Do not heat the syringe in any other way, such as in a microwave, hot water, or direct sunlight. Do not remove the needle cap while the Tyenne pre-filled syringe is warming to room temperature.
1.6. Prepare and review your previous injection site records. This will help you select the appropriate injection site for this dose (see STEP 8: Record your injection).
STEP 2: Wash your hands 2.1. Wash your hands thoroughly with soap and water, then dry them well with a clean towel (Figure E).
STEP 3: Check the syringe Remove the Tyenne pre-filled syringe from the plastic tray. Place two fingers on each side, at the center of the transparent needle cap. Pull the pre-filled syringe upward and remove it from the tray (Figure F).
Do not hold the pre-filled syringe by the plunger or the needle cap. Doing so may damage the syringe or activate the transparent needle shield. 3.1. Inspect the pre-filled syringe to ensure: The pre-filled syringe, transparent needle cap, and needle cover are not cracked or damaged (Figure G).
The needle cap is securely attached (Figure H). The cap retraction spring is not extended (Figure I).
Do not use the syringe if it shows any signs of damage. If so, contact your doctor or pharmacist and dispose of the syringe in your sharps disposal container (see STEP 7: Dispose of your syringe).
3.2. Check the liquid through the transparent needle cap to ensure:
The liquid is clear, colorless to pale yellow, and free of particles or flakes (Figure J). Do not use the syringe if the liquid is cloudy, discolored, contains particles or flakes, or shows any signs of deterioration. If the liquid is cloudy, discolored, or contains particles or flakes, contact your doctor or pharmacist immediately and dispose of the syringe in your sharps disposal container (see STEP 7: Dispose of your syringe).
3.3. Check the label to ensure: The name on the pre-filled syringe reads Tyenne (Figure K). The expiration date (EXP:) on the pre-filled syringe has not passed (Figure K). Do not use the syringe if: The name on the pre-filled syringe is not Tyenne The expiration date on the pre-filled syringe has passed If the label does not say Tyenne or the expiration date has passed, contact your doctor or pharmacist immediately and dispose of the pre-filled syringe in the sharps disposal container (see STEP 7: Dispose of your syringe).
STEP 4: Choose the injection site
4.1. Choose an injection site (Figure L): On the front of the thighs, or The stomach area (lower abdomen), except within 5 centimeters around the navel. If injecting someone else, you may use the back of the upper arm (Figure M). Do not attempt to use the upper arm area by yourself. Inject only in the areas indicated.
4.2. Choose a different site (at least 3 cm away from the previous injection site) each time to reduce redness, irritation, or other skin problems. Do not inject into areas that are painful (tender), bruised, red, hard, scarred, or where you have stretch marks, moles, or tattoos. If you have psoriasis, do not inject into any lesions or areas that are red, thickened, raised, or scaly.
STEP 5: Clean the injection site 5.1. Clean the skin at the injection site with an alcohol wipe using circular motions (Figure N). Allow the skin to dry before injecting. Do not blow on or touch the injection site after cleaning.
STEP 6: Administer your injection 6.1. Remove the needle cap Hold the pre-filled syringe by the transparent needle cap with one hand (Figure O) Use your other hand to remove the needle cap by pulling it straight off (Figure O) Do not touch the plunger while removing the needle cap. If you cannot remove the needle cap, ask for help from a caregiver or contact your doctor. Dispose of the needle cap in your sharps disposal container. You may see drops of liquid at the tip of the needle. This is normal and will not affect your dose. Do not touch the needle or let it contact any surface after removing the cap, as you may accidentally prick yourself.
6.2. Pinch the skin With your free hand, gently pinch the skin around the area where you plan to inject (without pressing or touching the cleaned area) and hold it firmly to avoid injecting into muscle (Figure P). Injecting into muscle may cause discomfort. 6.3. Insert the needle Hold the syringe like a pen.
With a quick, short motion, insert the needle fully into the skin at an angle between 45º and 90º (Figure Q). Administer the injection at the angle instructed by your doctor.
It is important to use the correct angle to ensure the medication is delivered under the skin (into the fatty tissue); otherwise, the injection may be painful and the medication may not work properly. 6.4. Inject Use your thumb to gently push the plunger down (Figure R). Continue pressing the plunger until the full dose is delivered and you can no longer push (Figure S). Do not remove the needle from the skin when the plunger is fully depressed.
6.5. Complete the injection Firmly hold the syringe in place without moving it, maintaining the same angle. Slowly release your thumb upward. This will allow the needle to retract. The safety mechanism will withdraw the needle from the skin and cover it (Figure T). Release the pinched skin. Important: Contact your doctor immediately if: The transparent needle shield does not cover the needle after injection. Injecting an incorrect amount of medication could affect your treatment. Do not reuse a syringe, even if not all the medication was injected. Do not attempt to recap the needle, as you may prick yourself.
6.6. After the injection If there is blood or liquid at the injection site, gently press a cotton ball or gauze pad over the skin (Figure U). You may use an adhesive bandage if needed. Do not rub the injection site.
STEP 7: Dispose of your pre-filled syringe 7.1. Immediately after use, dispose of your used syringe in a sharps disposal container (Figure V).
If you do not have a sharps disposal container, you may use a household container that is: Made of heavy-duty plastic; Has a tightly sealed, puncture-resistant lid to prevent sharps from escaping; Upright and stable during use; Leak-resistant; and Clearly labeled to warn of hazardous waste inside. When your sharps disposal container is nearly full, follow local guidelines for proper disposal of the container. Do not throw (dispose of) used syringes in household trash. Do not throw used sharps containers in household trash unless permitted by local regulations. Do not recycle used sharps containers.
Keep Tyenne pre-filled syringes and the sharps disposal container out of reach and out of sight of children.
STEP 8: Record your injection 8.1 To help you remember when and where to administer your next injection, write down the date, time, and specific body area where you injected (Figure W). It may also be helpful to write down any questions or concerns about the injection so you can discuss them with your doctor.
If you have any questions or concerns about the Tyenne pre-filled syringe, contact your doctor who is familiar with Tyenne.