Tyenne: Uses, Side Effects and Dosage

Serious warnings and precautions box

What Tyenne is used for:

Tyenne treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA) and familiar with the Tyenne efficacy and safety profile.

Tyenne (also known as tocilizumab), is a medicine that is used to treat adults with moderate to severe rheumatoid arthritis and adults with giant cell arteritis (GCA). Tyenne is also used to treat active systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA) in patients aged 2 and above. It is also used to treat people who experience severe or life-threatening cytokine release syndrome (CRS) following chimeric antigen receptor (CAR) T-cell treatment, in patient populations specified for authorized CAR T cell products.

Tyenne is used to treat hospitalized adults with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require oxygen support.

The safety and efficacy in patients aged less than 2 years in pJIA and sJIA has not been established. The safety and efficacy in patients aged less than 3 years in CRS has not been established.

The safety and efficacy of Tyenne in children with RA and GCA conditions has not been established.

How Tyenne works:

Tyenne is a medicine that helps keep the immune system from attacking healthy tissues in the body. A normal immune system leaves healthy body tissues alone. In people with rheumatoid arthritis, the immune system attacks normal body tissues causing damage and inflammation, especially in the tissues of your joints. Tyenne interferes with an important step in this attack (blocks a cytokine called IL-6 which is found at high levels in the joints affected by rheumatoid arthritis). By decreasing the immune system’s attack on normal tissues, Tyenne can reduce pain, joint inflammation and tiredness leading to a better quality of life.*

Interleukin-6 (IL-6) is a protein that is made by the immune system and the body uses IL-6 to manage infections. It also plays a major role in the signs and symptoms of rheumatoid arthritis (RA). People with RA have too much IL-6.

The ingredients in Tyenne are:

Medicinal ingredients: tocilizumab

Non-medicinal ingredients:

Intravenous formulation: L-arginine, L-histidine, L-lactic acid, Polysorbate 80, Sodium chloride, Sodium hydroxide, Hydrochloric acid, and water for injection.

Subcutaneous formulation: L-arginine, L-histidine, L-lactic acid, Polysorbate 80, Sodium chloride, Sodium hydroxide, Hydrochloric acid, and water for injection.

Tyenne comes in the following dosage form(s):

Intravenous infusion: available in vials containing 80 mg, 200 mg or 400 mg of tocilizumab.

Subcutaneous injection: supplied in either a single-use pre-filled syringe, or a single-use Autoinjector, each containing 162 mg of Tyenne in a 0.9 mL volume. The prefilled syringe is not made with natural rubber latex.

Do not use Tyenne if:

• you are allergic to tocilizumab or any other non-medicinal ingredient in Tyenne
• you have an active infection or active liver disease.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Tyenne. Talk about any health conditions or problems you may have, including if you:

• have ever had a bad reaction to tocilizumab or any of the non-medicinal ingredients.
• are allergic to other medications, food or dyes.
• are taking any other medications, including but not limited to corticosteroids. You can take other medicines provided your doctor has prescribed them and has told you it is ok to take them while you are taking Tyenne. You should also tell your doctor about any over-the-counter drugs, herbal medicines and vitamin and mineral supplements you are taking.
• have any kind of infection, or if you often get infections. Treatment with Tyenne could cause your infection to get worse. Tell your doctor immediately if symptoms from an infection occur (see warning box above)
• have diabetes, HIV/AIDS or a weaker immune system, which can increase your risk of serious infections.
• live or have lived, or have travelled to certain parts of the world where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use Tyenne.
• are scheduled to have surgery.
• have recently had a vaccination or are planning to have a vaccination. You or your child should be brought up to date (if possible) on all recommended vaccinations, prior to initiation of therapy with Tyenne. Certain vaccines should not be given while receiving Tyenne.
• have tuberculosis (TB), or if you have been in close contact with someone who has had TB. Your doctor should test you for TB before starting treatment with Tyenne.
• have hepatitis or any disease of the liver.
• have had any type of cancer
• have disease of the nerves or nervous system, such as multiple sclerosis
• have a history of macrophage activating syndrome (MAS), a rare but serious immune reaction in patients with systemic juvenile idiopathic arthritis.
• have abdominal pain or have been diagnosed with stomach, pancreas or bowel (intestine) problems, including ulcers, inflammation or infection, including diverticulitis and pancreatitis
• have cardiovascular risk factors such as high blood pressure and raised cholesterol levels.

Other warnings you should know about:

Tyenne should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women who could become pregnant need to use effective birth control methods during Tyenne treatment and for at least 3 months after treatment with Tyenne.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Tyenne:

• Biological medicines: etanercept injection, etanercept for injection, adalimumab injection, infliximab powder for solution, rituximab injection, rituximab for injection, abatacept for injection, abatacept injection, anakinra injection, golimumab injection, golimumab for injection, certolizumab pegol injection. Tyenne has not been studied in combination with these biological medicines. Tyenne is not to be used with biological medicines that are used to treat rheumatoid arthritis.

Before starting treatment, make sure your doctor knows if you are taking or have recently taken any other medicines (including those you have bought for yourself from a pharmacy, supermarket or health store). This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect. Tyenne should not be used with other drugs unless your doctor has told you it is safe to do so.

How to take Tyenne:

Tyenne may be administered as an intravenous infusion or a subcutaneous injection.

Usual dose:

Intravenous formulation:

The recommended starting dose of Tyenne for adult patients with RA is 4 mg per kg of body weight with an increase to 8 mg per kg of body weight, based on how you respond to the drug.

Tyenne will be given to you by a healthcare professional using an intravenous line. This means the medicine will be given to you through a needle placed in a vein in your arm. It will take about 1 hour to give you the full dose of medicine.

Tyenne should be given once every 4 weeks. Your doctor will advise you on how long you will continue to be treated with Tyenne.

The recommended dose for children with sJIA is either 8 or 12 mg per kg of body weight depending on the child’s weight. Children with sJIA receive a dose of Tyenne every 2 weeks.

The recommended dose for children with pJIA is either 8 or 10 mg per kg of body weight depending on the child’s weight. Children with pJIA receive a dose of Tyenne every 4 weeks.

The recommended dose of Tyenne for CRS patients is 8 mg for every kg of body weight if you weigh 30 kg or more or 12 mg for every kg of body weight if you weigh less than 30 kg. Tyenne can be given alone or in combination with corticosteroids.

The recommended dose of Tyenne for treatment of adult patients with COVID-19 is a single 60-minute infusion of 8 mg per kg of body weight. A second dose may be needed.

Subcutaneous formulation:

The recommended starting dose of Tyenne for an adult patient with RA is 162 mg given once every other week followed by an increase to every week depending on clinical response. Patients weighing 100 kg or more should receive treatment weekly.

For adult patients treated for GCA, the Tyenne dose is 162 mg given once every week as a subcutaneous injection. In some cases, your doctor may tell you to take 162 mg of Tyenne once every other week. Your doctor will also ask you to take glucocorticoids with Tyenne. Your doctor may eventually tell you to stop taking glucocorticoids and use Tyenne alone.

The recommended dose for children with pJIA is 162 mg either every two or three weeks depending on the child’s weight.

The recommended dose of Tyenne for patients with sJIA is:

• 162 mg once every two weeks for patients below 30 kg,
• 162 mg once every week for patients ≥30 kg

The pre-filled syringe can be used to treat children of all approved ages. The autoinjector should not be used to treat children <12 years of age.

“Subcutaneous” means that it is given into the fat layer just under the skin. The recommended injection sites are the abdomen, thigh and upper arm. The sites should be rotated and injections should never be given into moles, scars, or areas that are tender, bruised, red, hard or have open sores.

Your healthcare provider should show you how to prepare and inject properly before you use the Tyenne subcutaneously for the first time. Ask your healthcare provider any questions you may have. Do not attempt to administer an injection until you are sure you understand how to inject using the pre-filled syringe or a single-use autoinjector. Appendix 1 - Instructions for Use explains the use of both the pre-filled syringe and the autoinjector. It is important that you follow the specific instructions for using the kind of Tyenne that your doctor has prescribed.

Overdose:

Because Tyenne is given intravenously by a doctor or nurse, and the subcutaneous injection comes in a single-use pre-filled syringe or autoinjector, it is unlikely that you will be given too much. However, if you are worried then talk to your doctor. If necessary, you will be monitored closely for any signs and symptoms of overdose and be treated for those symptoms as necessary.

Missed dose:

If you have missed your dose of Tyenne, ask your doctor when to schedule your next dose.

Possible side effects from using Tyenne:

These are not all the possible side effects you may have when taking Tyenne. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of Tyenne are upper respiratory tract infections (common cold, sinus infections) headaches, and increase in blood pressure.

In pJIA the most common side effects of Tyenne were upper respiratory tract infections, nausea, headache dizziness, decrease in blood pressure and rash. Patients with pJIA receiving Tyenne subcutaneously also experienced reactions at the injection site.

Possible serious side effects include serious infections, liver injury and allergic reactions.

Patient advice regarding early recognition and treatment to limit risk of a serious infection:

Be alert for the first signs of infection such as:

• body aches, fever, chills
• cough, chest discomfort/tightness, shortness of breath redness, heat, unusual swelling of skin or joint
• abdominal pain/tenderness and/or change in bowel function

Call your doctor and seek medical attention without delay if you think you might be developing an infection.

A severe skin reaction called Stevens-Johnson syndrome (SJS) and serious drug-induced liver injury (DILI), including rapid loss of liver function, inflammation of the liver and jaundice (yellowing of skin and eyes) were reported during treatment with Tyenne.

Stop taking Tyenne and call your doctor or seek medical attention immediately if you notice any of the following:

• Difficulty with breathing or light-headedness.
• Rash, itching, hives, swelling of the lips or other signs of an allergic reaction.
• Chest pain.
• Feeling dizzy or faint.
• Yellowing of the skin and eyes, dark brown coloured urine, pain or swelling in the upper right side of the stomach area, or you feel very tired and confused.

Patient advice regarding hypersensitivity reactions (also known as anaphylaxis, if severe):

If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time following an injection, you should seek emergency care immediately.

Since this medicine can cause dizziness, it is recommended that you do not drive or use machines until it has stopped.

Tell your doctor as soon as possible if you notice any of the following: signs of infection such as fever and chills, mouth or skin blisters, stomach ache or persistent headaches.

The symptoms described above can be signs of the side effects listed in the table below, all of which have been observed with tocilizumab in controlled clinical trials:

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Your Tyenne vials should be stored under refrigeration at 2°C to 8°C and protected from light. Your healthcare professional will prepare the solution for intravenous administration.

Your Tyenne syringe and autoinjector should be stored in a refrigerator at a temperature of 2°C to 8°C. Keep in the outer carton in order to protect from light and moisture.

Protect the syringe and autoinjector from freezing and from light. Keep the syringe and autoinjector dry.

Once removed from the refrigerator, Tyenne syringe and autoinjector can be stored for a single period of up to 2 weeks at or below 30°C. The PFS or autoinjector must always be kept in the carton to protect from light and keep dry. Prior to use, allow the PFS or autoinjector to sit at room temperature outside of the carton for 25-30 minutes (PFS) or 45 minutes (autoinjector).

Keep out of reach and sight of children.

If you want more information about Tyenne:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (Drug Product Database: Access the database); the manufacturer’s website https://www.fresenius-kabi.com/en-ca; or by calling 1-877-821-7724.

*a measurement called HAQ was used to quantify disability (dressing, grooming, eating, walking, hygiene, reach, grip, activities)

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd, Suite 100

Toronto, ON M9W 0C8

Last Revised: 2026-10-09

APPENDIX 1

Instructions for Use

Tyenne

Tocilizumab injection

Solution; 162 mg/0.9 mL

Subcutaneous injection

Autoinjector

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

If you have any questions about using your Tyenne Autoinjector, please call your doctor.

Important Information

• Read the patient information that comes with your autoinjector for important information you need to know before using it.
• Before you use the Autoinjector for the first time, make sure your doctor shows you the right way to use it.
• Do not try to take apart the Tyenne Autoinjector at any time.

Storing Tyenne Autoinjectors

• Store Tyenne in the refrigerator between 2°C to 8°C.
• Store unused Autoinjectors in the original carton to protect from light.
• Do not freeze. If Tyenne freezes, throw it away in a sharp disposal container.
• Keep Tyenne out of exposure to heat or direct sunlight.
• Keep the Autoinjector out of reach and sight of children.
• Tyenne may be stored at temperatures up to 30°C in the carton it comes in for a single period of up to 14 days, but not exceeding the original expiry date
• Throw away (dispose of) Tyenne in a sharp disposal or puncture-resistant container if it has been out of the refrigerator more than 14 days. Once stored at room temperature, do not place back in the refrigerator.

Using the Tyenne Autoinjector

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

Travelling with Tyenne Autoinjector

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

Your Tyenne Autoinjector

Step 1 – Prepare for your injection

1. a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
2. b. Gather the following supplies (not included) (see Figure A):

1. •

   1 alcohol swab to clean the site before injection.

2. • 1 sterile cotton ball or gauze to use after the injection.
3. • A sharps disposal container for safe disposal of Autoinjector (see Step 8 - Throw away your Autoinjector).
4. c. Remove the carton containing the Autoinjector from the refrigerator.

Do not keep your Autoinjector out of the refrigerator for more than 14 days without use.

1. d.

   Check the expiry date on the carton to make sure the date has not passed (see Figure B).

   Do not use the Autoinjector if the expiry date has passed.

2. e. When you open the carton, check for any signs of damage.

Do not use the Autoinjector if the carton looks like it has already been opened or damaged.

1. f. Open the Carton and remove one single-use autoinjector.

Do not hold the autoinjector by the cap (See Figure C)

1. g. Return any remaining autoinjectors in the carton to the refrigerator.
2. h. Let the autoinjector sit on the prepared surface for 45 minutes before use to allow the medicine in the Autoinjector to reach room temperature (see Figure D).

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

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

Do not remove the clear cap of the Autoinjector until you are ready to inject to avoid injury.

Keep Tyenne out of the reach and sight of children.

Step 2 – Check your Autoinjector

1. a.

   Check the Autoinjector to make sure it is not cracked or damaged (see Figure E).

   Do not use if the Autoinjector shows signs of damage or if it has been dropped.

2. b. Check the Autoinjector label to make sure that:

1. • The name on the Autoinjector says Tyenne.
2. •

   The expiry date (EXP) on the Autoinjector has not passed (see Figure F).

   Do not use the Autoinjector if the name on the label is not Tyenne or the expiry date on the label has passed.

1. c.

   Look at the medicine in the viewing window. Make sure it is clear and colorless to pale yellow and does not contain flakes or particles (see Figure G).

   Note: Air bubbles in the medicine are normal.

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

Step 3 – Wash your hands

1. a. Wash your hands well with soap and water, then dry them with a clean towel (see Figure H).

Step 4 – Choose the injection site

1. a.

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

   1. • The front of your upper thigh.

1. • The abdomen, except within 5 cm around the belly button (navel).
2. • If a caregiver is giving the injection, they can use the outer area of the upper arm (see Figure I).

Note: Choose a different site for each injection to reduce redness, irritation or other skin problems. Do not inject into skin that is sore (tender), bruised, red, hard, scaly, or has lesions, moles, scars, or stretch marks or tattoos.

Do not use the Autoinjector through clothing.

Step 5 – Clean the injection site

1. a.

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

   Do not blow on or touch the site after cleaning.

Step 6 – Give your injection

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

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

Note: Use the Autoinjector right away after removing the cap to avoid contamination.

Do not try to recap the needle at any time, even at the end of the injection.

Do not touch the needle cover (the orange part located at the tip of the Autoinjector) because this might cause an accidental needle stick.

1. b. Throw away the clear cap.
2. c. Rotate the Autoinjector so that the orange needle cover points downwards.
3. d. Position your hand on the Autoinjector so that you can see the window.

1. e.

   Place the Autoinjector against your skin at a 90-degree (straight) angle (see Figure L).

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

   Note: You do not need to pinch your skin.

To make sure you inject the full dose, read all of the steps from f to i before you start:

1. f. In a single motion, push the Autoinjector firmly against your skin until you hear a first click. The orange plunger rod will move through the window during the injection (this means the injection has started) (see Figure M).
2. g. WAIT and hold the Autoinjector in place until you hear a second click. This may take up to 10 seconds. Continue to HOLD (see Figure N).
3. h.

   Wait and slowly count to 5 after you hear the second click. Continue to HOLD the Autoinjector in place to make sure you inject a full dose (see Figure O).

   Do not lift the autoinjector until you are sure 5 seconds has passed, and the injection is complete.

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

Note: If the orange plunger rod did not come all the way down or you believe you did not get a full injection, call your doctor. Do not try to repeat the injection with a new Autoinjector.

Step 7 – Remove and check the Autoinjector

1. a.

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

   Note: The needle cover will slide down and cover the needle.

   Do not recap the Autoinjector.

1. b.

   Check the window to make sure the orange plunger rod came all the way down (see Figure R).

   Note: If the orange plunger rod did not come all the way down or you believe you did not get a full injection, call your doctor. Do not try to repeat the injection with a new Autoinjector.

2. c. If you see blood on the injection site, press gauze or a cotton ball against the skin until the bleeding stops (see Figure S).

Do not rub the injection site.

Step 8 – Throw away your Autoinjector

1. a.

   Put your used autoinjector in a sharps disposal container right away after use (see Figure T).

   Do not put the clear cap back on the Autoinjector.

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

   Do not reuse the Autoinjector.

If you do not have a sharps disposal container, you can use a household container that is:

• made of a heavy-duty plastic,
• can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.

Do not throw away (dispose of) your used sharps disposal container in your household trash unless your local guidelines permit this.

Do not recycle your used sharps disposal container.

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

Step 9 – Record your injection

1. a.

   Record your injection date and site (see Figure U).

   Note: This is to help you remember when and where to do your next injection.

Instructions for Use

Tyenne

Tocilizumab injection

Solution; 162 mg/0.9 mL

Subcutaneous injection

Pre-filled syringe

Read and follow the Instructions for Use that come with your Tyenne pre-filled syringe before you start using it and each time you get a prescription refill. This information does not replace talking to your doctor about your medical condition or treatment.

If you have any questions about using your Tyenne pre-filled syringe, please call your doctor.

Important information

• Read the Patient Information that comes with your Tyenne pre-filled syringe for important information you need to know before using it.
• Before you use Tyenne pre-filled syringe for the first time, make sure your doctor shows you or your caregiver the right way to use it.
• People who are blind or have vision problems should not use the Tyenne pre-filled syringe without help from a person trained to use the Tyenne pre-filled syringe.
• Talk to your doctor if you have any questions or concerns.

Storing Tyenne pre-filled syringe

• Store the pre-filled syringe in the refrigerator between 2°C and 8°C.
• Keep the pre-filled syringe in the original carton to protect from light.
• Do not freeze Tyenne.
• Do not use Tyenne pre-filled syringe that has been frozen or left in direct sunlight because it could lead to illness.
• Keep the pre-filled syringe out of the reach and sight of children.
• If needed, for example when traveling, Tyenne pre-filled syringe can be stored at temperatures up to 30°C for up to 14 days but not exceeding the original expiry date.
• Throw away (dispose of) Tyenne if it has been out of the refrigerator more than 14 days. Once stored at room temperature, do not place back in the refrigerator

Using Tyenne pre-filled syringe

• Always inject Tyenne using the technique your doctor taught you.
• Tyenne pre-filled syringe is for single-dose (one-time) use only.
• Do not share your Tyenne pre-filled syringe with another person. You may give another person an infection or get an infection from them.
• Tyenne pre-filled syringe has a clear needle guard that covers the needle after the injection is complete.
• Do not use the pre-filled syringe if the carton is open or damaged.
• Do not use the pre-filled syringe if it has been dropped on a hard surface. The pre-filled syringe may be broken even if you cannot see the break.
• Do not remove the needle cap from the pre-filled syringe until you are ready to inject.
• Do not try to reuse the pre-filled syringe because it could lead to an infection.

Travelling with Tyenne pre-filled syringe

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

Your Tyenne pre-filled syringe

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.

Step 1 – Prepare for your injection

1. a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.
2. b. Supplies needed (Figure B):

1. • 1 alcohol swab to clean the site before injection.
2. • 1 sterile cotton ball or gauze to use after the injection.
3. • 1 sharps disposal container for safe disposal of needle cap and used syringe (see Step 7 - Throw away your syringe).

1. c. Take the Tyenne carton out of the refrigerator and open it (Figure C).
2. d.

   Remove one single-use Tyenne pre-filled syringe from the carton:

   1. • Place two fingers on either side, in the middle of the clear needle guard.

1. • Pull the pre-filled syringe straight up and out of the tray (Figure D)
2. • 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.
3. e. Return the carton with any remaining pre-filled syringes to the refrigerator.

1. f. Let the pre-filled syringe sit at room temperature for at least 30 minutes before use to allow the medicine to reach room temperature (Figure E). Injecting cold medicine can 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, or direct sunlight.

Do not remove the needle cap while allowing your Tyenne pre-filled syringe to reach room temperature.

1. g. Prepare and check your records of previous injection sites. This will help you choose the appropriate injection site for this injection (see Step 8 - Record your injection).

Step 2 – Wash your hands

1. a. Wash your hands well with soap and water and dry them with a clean towel (Figure F).

Step 3 – Check the syringe

1. a.

   Check the pre-filled syringe to make sure that:

   1. • The pre-filled syringe, the clear needle guard, and the needle cap are not cracked or damaged (Figure G).

1. • The needle cap is securely attached (Figure H).
2. • The needle guard spring is not extended (Figure I).

Do not use the syringe if it shows any sign of damage. If damaged, call your doctor or pharmacist right away and throw away the syringe in your sharps disposal container (see Step 7 - Throw away your syringe).

1. b.

   Check the liquid through the clear window of the syringe to make sure that:

   1. • The liquid is clear and colorless to pale yellow, and free of particles and flakes (Figure J).

Do not use the pre-filled syringe if the liquid is cloudy, discolored, contains particles or flakes, or shows any sign of damage. If the liquid is cloudy, discolored, contains particles or flakes, call your doctor or pharmacist right away and throw away the syringe in your sharps disposal container (see Step 7 - Throw away your syringe).

1. c.

   Check the label on the pre-filled syringe to make sure that:

   1. • The name on the pre-filled syringe says Tyenne (Figure K).
   2. • The expiry date (EXP:) on the prefilled syringe has not passed (Figure K).

Do not use the pre-filled syringe if:

• The name on the pre-filled syringe is not Tyenne.
• The expiry date on the pre-filled syringe has passed.

If the label does not have Tyenne on it or the expiry date has passed contact your doctor or pharmacist right away and throw away the pre-filled syringe in your sharps disposal container (see Step 7 - Throw away your syringe).

Step 4 – Choose the injection site

1. a. Choose an injection site (Figure L):

1. • The front of the thighs, or
2. • Stomach area (lower abdomen), except for 5 cm around the navel (belly button).
3. • If you are injecting someone else, you may use the back of the arm (Figure M).

Do not attempt to use the upper arm area by yourself. Only inject into the sites shown.

1. b.

   Choose a different injection site (at least 3 cm from the last area you injected) for each new injection to reduce redness, irritation or other skin problems.

   Do not inject into an area that is sore (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 red, thick, raised or scaly patches.

Step 5 – Clean the injection site

1. a. Wipe the skin of your injection site with an alcohol swab in a circular motion to clean it (Figure N). Let the skin dry before injecting.

Do not blow or touch the injection site after cleaning.

Step 6 – Give your injection

1. a.

   Remove the needle cap.

   1. • Hold the pre-filled syringe by the clear needle guard in one hand (Figure O).
   2. • Use your other hand to remove the needle cap by pulling the cap straight off (Figure O).

Do not hold the plunger while you remove the needle cap.

If you cannot remove the needle cap, you should ask a caregiver for help or contact your doctor.

• Throw away the needle cap in your sharps container.

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 surface after removing the needle cap, because this might cause an accidental needle stick.

There may be a small air bubble in the Tyenne pre-filled syringe, You do not need to remove it.

1. b. Pinch the skin.

1. • With your free hand, gently pinch around the area where you plan to inject (without squeezing or touching the cleaned area) and hold it firmly to avoid injecting into muscle (Figure P). Injection into muscle could cause the injection to feel uncomfortable.

1. c.

   Insert the needle. Hold the pre-filled syringe like a pencil.

   1. • With a quick, short motion, insert the needle all the way into the pinched skin at an angle between 45° to 90° (Figure Q). Give the injection at the angle your doctor instructed you to use.

It is important to use the correct angle to make sure the medicine is delivered under the skin (into fatty tissue), or the injection could be painful, and the medicine may not work.

1. d.

   Inject.

   1. • Use your thumb to gently push the plunger all the way down (Figure R).
   2. • Keep pressing down on the plunger to deliver the full dose until you cannot press any more (Figure S).

Do not pull the needle out of the skin when the plunger is pushed all the way down.

1. e. Finish Injection.

1. • Hold the syringe firmly without moving it, at the same angle as inserted.
2. • Slowly release your thumb off the plunger. The plunger will move up.

The safety system will remove the needle from the skin and cover the needle (Figure T).

• Release the pinched skin.

Important: Call your doctor right away if:

• The clear needle guard does not cover the needle after injecting.

Injecting an incorrect amount of medicine could affect your treatment.

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

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

1. f. After Injection.

If there is blood or liquid on the injection site, gently press a cotton ball or gauze on the skin (Figure U). You may use an adhesive bandage if needed.

Do not rub the injection site.

Step 7 – Throw away used pre-filled syringe

1. a. Put your used syringe in a sharps disposal container right away after use (Figure V).

If you do not have a sharps disposal container, you may use a household container that is:

• Made of a heavy-duty plastic;
• Can be closed with a tight-fitting, puncture-resistant lid; that will keep sharps from coming out,
• Upright and stable during use,
• Leak-resistant and
• Properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your local guidelines to dispose of your sharps disposal container.

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

Do not dispose of your used sharps disposal container in your household trash unless your local guidelines permit this.

Do not recycle your used sharps disposal container.

Keep Tyenne pre-filled syringes and disposal container out of the reach and sight of children.

Step 8 – Record your injection

1. a. To help you remember when and where to give your next injection, write the date, time, and specific part of your body where you injected yourself. (Figure W).

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

If you have questions or concerns about your Tyenne pre-filled syringe, please contact your doctor familiar with Tyenne.