RoActemra 162 mg Solution for Injection in Pre-Filled Syringe

Package leaflet: Information for the user

RoActemra 162 mg solution for injection in pre-filled syringe

Tocilizumab

1. What RoActemra is and what it is used for

RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6.

This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body. RoActemra is used to treat:

• adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
• adults with severe, active and progressive rheumatoid arthritis (RA), who have not had previous treatment with methotrexate.
  RoActemra helps to reduce RA symptoms such as pain and swelling in your joints, and can also improve your performance of daily tasks. RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.
  RoActemra is usually given in combination with another medicine for RA called methotrexate.
  However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.
• adults with a disease of the arteries called giant cell arteritis (GCA), caused by inflammation of the body’s largest arteries, especially those that supply blood to the head and neck. Symptoms include headache, fatigue and jaw pain. Effects can include strokes and blindness.
  RoActemra can reduce pain and swelling in the arteries and veins in your head, neck and arms.
  GCA is often treated with medicines called steroids. They are usually effective, but can have side effects if used at high doses for a long time. Reducing the steroid dose can also lead to a flare-up of the GCA. Adding RoActemra to the treatment means that steroids can be used for a shorter time, while still controlling GCA.
• children and adolescents, aged 1 year and over, with active systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.
  RoActemra 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 over, with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease that causes pain and swelling in one or more joints.
  RoActemra 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 you use RoActemra

3. How to use RoActemra

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure.

The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.

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

4. Possible side effects

Like all medicines, RoActemra can cause side effects, although not everybody gets them.

Side effects could occur 3 months or more after your last dose of RoActemra.

Possible serious side effects: tell a doctor straight away.

These are common: they may affect up to 1 in every 10 users

Allergic reactions during or after injection:

• difficulty with breathing, chest tightness or light-headedness
• rash, itching, hives, swelling of the lips, tongue or face

If you notice any of these, tell your doctor immediately.

Signs of serious infections:

• fever and chills
• mouth or skin blisters
• stomach ache

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

Very common side effects:

These may affect 1 in 10 patients or more

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

Common side effects:

These may affect up to 1 in 10 patients

• lung infection (pneumonia)
• shingles (herpes zoster)
• cold sores (oral herpes simplex), blisters
• skin infection (cellulitis) sometimes with fever and chills
• rash and itching, hives
• allergic (hypersensitivity) reactions
• eye infection (conjunctivitis)
• headache, dizziness, high blood pressure
• mouth ulceration, stomach pain
• fluid retention (oedema) in the lower legs, weight increase
• cough, shortness of breath
• low white blood cell counts shown by blood tests (neutropenia, leucopenia)
• abnormal liver function tests (increased transaminases)
• increased bilirubin shown by blood tests

Uncommon side effects:

These may affect up to 1 in every 100 patients

• diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
• red swollen areas in the mouth
• high blood fat (triglycerides)
• stomach ulcer
• kidney stones
• underactive thyroid.

Very rare side effects:

These may affect up to1in every 10,000 patients

• Stevens-Johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)

5. How to store RoActemra

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

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

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

Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.

Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°C.

Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to yellowish, or any part of the pre-filled syringe appears to be damaged.

The syringe should not be shaken. After removing the cap the injection must be started within 5 minutes to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.

If following insertion of the needle, you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.

6. Contents of the pack and other information

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

or

What do I need to know to use my RoActemra pre-filled syringe safely?

It is important to read, understand and follow these instructions so that you or your caregiver uses the RoActemra syringe correctly. These instructions do not replace training from your healthcare provider. Your healthcare provider should show you how to prepare and inject properly before you use the RoActemra syringe for the first time. Ask your healthcare provider any questions you may have. Do not attempt to administer an injection until you are sure that you understand how to use the RoActemra syringe.

Please also read the Patient Leaflet that comes with the RoActemra syringe for the most important information you need to know about the medicine. It is important to remain under your healthcare provider's care while using RoActemra.

A place to prepare your supplies:

• Find a well-lit, clean, flat surface such as a table

Step 1. Visually check the syringe

• Take the box containing the syringe out of the refrigerator and open the box. Do not touch the trigger fingers on the syringe as this may damage the syringe.
• Remove the syringe from the box and visually examine the syringe, as well as the medicine in the syringe. This is important to ensure that the syringe and medicine are safe to use.
• Check the expiration date on the box and syringe (See Fig. A) to make sure that it has not passed (expired). Do not use the syringe if the expiration date has passed. This is important to ensure that the syringe and medicine are safe to use.

Dispose of the syringe and do not use if:

• the medicine is cloudy
• the medicine contains particles
• the medicine is any color besides colorless to yellowish
• any part of the syringe appears to be damaged

Step 2. Allow the syringe to adjust to room temperature

• Do not remove the needle-cap on your syringe until Step 5. Early removal of the needle-cap can cause the medication to dry out and block the needle.
• Place the syringe on a clean flat surface and allow the syringe to come to room temperature (18°C – 28°C) for about 25-30 minutes to warm up. Not allowing the syringe to come to room temperature could result in an uncomfortable injection and it may be difficult to depress the plunger.
• Do not warm up the syringe in any other way.

Step 3. Clean your hands

• Wash your hands with soap and water.

Step 4. Choose and prepare an injection site

• The recommended injection sites are the front and middle of your thighs and the lower part of the abdomen below the navel (belly button) except for the five centimeter area directly around the navel. (See Fig. B)
• If a caregiver is giving the injection, the outer area of the upper arms may also be used. (See Fig. B)

• You should use a different place each time you give yourself an injection, at least three centimeters from the area you used for your previous injection.
• Do not inject into areas that could be bothered by a belt or waistband. Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
• Clean the chosen injection site area using the alcohol pad (See Fig. C), to reduce the risk of infection.

• Let the skin dry for approximately 10 seconds.
• Be sure not to touch the cleaned area prior to the injection. Do not fan or blow on the clean area.

Step 5. Remove needle-cap

• Do not hold the syringe by the plunger while removing the needle-cap.
• Hold the needle-shield of the syringe firmly with one hand and pull off the needle-cap with the other hand. (See Fig. D) If you cannot remove the needle cap you should request the help of a caregiver or contact your healthcare provider.

• Do not touch the needle or let it touch any surface.
• You may see a drop of liquid at the end of the needle. This is normal.
• Throw away the needle-cap in the puncture resistant container or sharps container.

NOTE: Once the needle-cap is removed, the syringe must be used immediately.

• If it is not used within 5 minutes of cap removal, the syringe must be disposed of in the puncture resistant container or sharps container and a new syringe must be used. If the needle cap is removed for more than 5 minutes, it may be more difficult to perform an injection as the medicine can dry out and block the needle.
• Never reattach the needle-cap after removal.

Step 6. Give the injection

• Hold the syringe comfortably in your hand.
• To be sure the needle can be inserted correctly under the skin, pinch a fold of loose skin at the clean injection site with your free hand. Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injection into muscle could result in an uncomfortable injection.
• Do not hold or push on the plunger while inserting the needle into the skin.
• Insert the needle all the way into the pinched skin at an angle between 45° to 90° with a quick, firm action. (See Fig. E).

It is important to choose the correct angle to ensure the medication is delivered under the skin (into fatty tissue), otherwise the injection could be painful and the medication may not work.

• Then keep the syringe in position and let go of the pinch of skin.
• Slowly inject all of the medicine by gently pushing the plunger all the way down. (See Fig. F).
  You must press the plunger all the way down to ensure that you get the full dose of medication and to ensure the trigger fingers are completely pushed to the side. If the plunger is not fully depressed the needle shield will not extend to cover the needle when it is removed. If the needle is not covered proceed carefully, and place the syringe into the puncture resistant container to avoid injury with the needle.

• Once the plunger is pushed all the way down, keep pressing down on the plunger to be sure all of the medicine is injected before taking the needle out of the skin.
• Keep pressing down on the plunger while you take the needle out of the skin at the same angle as inserted. (See Fig. G)
• If following insertion of the needle, you cannot press down the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe (starting again at Step 2). If you still experience difficulty, you should consult your healthcare provider.

• Once the needle is removed completely from the skin, you can release the plunger, allowing the needle-shield to protect the needle. (See Fig. H)

• If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for approximately 10 seconds.
• Do not rub the injection site.

Step 7. Dispose of the syringe

• Do not try to re-cap your syringe.
• Throw away used syringes in a puncture-resistant container or sharps container. Ask your healthcare provider or pharmacist for information about where you can get a "sharps" container or what other types of puncture-resistant containers you can use to safely dispose of your used syringes, if you do not have one. (See Fig. I)

Check with your healthcare provider for instructions about the right way to throw away used syringes.

There may be local or state laws about how to throw away used syringes.

Do not throw away used syringes or the puncture resistant container in household trash and do not recycle them.

• Dispose of the full container as instructed by your healthcare provider or pharmacist.
• Always keep the puncture-resistant container out of the sight and reach of children.

If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance.