Roactemra 162 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

RoActemra 162 mg, solution for injection in pre-filled pen

tocilizumab

Read the 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 only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions 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 you should know before receiving RoActemra and during treatment with RoActemra.

Contents of the leaflet:

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

1. What is RoActemra and what is it used for?

RoActemra 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. RoActemra 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.

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

RoActemra is usually used in combination with another rheumatoid arthritis medication called methotrexate. However, RoActemra 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 body's large arteries, particularly those supplying blood to the head and neck. Symptoms may include headache, fatigue, and jaw pain. Complications may include strokes and blindness.

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

GCA is often treated with medications called steroids. These are usually effective but may cause side effects if used at high doses over a long period. Reducing steroid doses may also lead to GCA flare-ups. Adding RoActemra to treatment allows for a shorter duration of steroid use while still maintaining control of GCA.

• children and adolescents, aged 12 years 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.

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

• children and adolescents, aged 12 years and older, with active polyarticular juvenile idiopathic arthritis (pJIA). This is an inflammatory disease causing pain and swelling in one or more joints.

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

2. What you need to know before using RoActemra

RoActemra will not be administered to you

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

If either of these applies to you, consult your doctor. Do not use RoActemra.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting RoActemra.

• If you experience allergic reactions such as chest tightness, wheezing, dizziness or severe lightheadedness, swelling of the lips, tongue, or 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 receiving RoActemra, do not take the next dose until you have informed your doctor and your doctor has instructed you to continue.

• If you have any type of infection, whether short- or long-term, or if you frequently get infections, inform your doctor immediately if you feel unwell. RoActemra 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 RoActemra. 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 perforation 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 RoActemra, your doctor will perform a blood test to assess your liver function.

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

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

• If you have cardiovascular risk factors, such as high blood pressure or high cholesterol levels, inform your doctor. These factors need to be monitored while you are receiving RoActemra.

• 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 RoActemra to determine whether you have low white blood cell counts, low platelet counts, or elevated liver enzymes.

Children and adolescents

RoActemra pre-filled pen is not recommended for children under 12 years of age. RoActemra should not be administered to children with juvenile idiopathic arthritis (JIA) weighing less than 10 kg.

If the child has a history of macrophage activation syndrome (uncontrolled activation and proliferation of a specific type of blood cell), inform your doctor. Your doctor will decide whether RoActemra can continue to be administered.

Other medicines and RoActemra

Inform your doctor if you are taking any other medicines or have recently taken any. This is because RoActemra may affect how some medicines work, and a dose adjustment may be needed. Inform your doctor if you have 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 in the treatment of asthma
• warfarin or fenprocoumon, used as anticoagulants
• phenytoin, used to treat seizures
• cyclosporine, used as an immunosuppressant in organ transplantation
• benzodiazepines, such as temazepam, used to relieve anxiety.

Due to lack of clinical experience, the use of RoActemra with other biological medicines used to treat RA, JIA, JIAp, or GCA is not recommended.

Pregnancy, breastfeeding, and fertility

RoActemra should not be used during pregnancy, unless clearly necessary. Speak with your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant.

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

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

Driving and using machines

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

RoActemra contains polysorbate 80 (E433)

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

3. How to use RoActemra

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

Treatment must be prescribed by a healthcare professional experienced in the diagnosis and treatment of RA, pJIA, sjJIA, or GCA.

Recommended dose

The dose for adults with RA or GCA is 162 mg (the content of one pre-filled pen) administered once weekly.

Adolescents with pJIA (12 years of age and older)

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

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

The pre-filled pen must not be used to treat children under 12 years of age.

Adolescents with sjJIA (12 years of age and older)

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

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

The pre-filled pen must not be used to treat children under 12 years of age.

RoActemra is administered by injection under the skin (subcutaneously). Initially, your doctor or nurse may administer RoActemra to you. However, your doctor may decide that you can self-inject RoActemra. In this case, you will receive training on how to self-inject RoActemra. Parents and caregivers will be trained on how to inject RoActemra in patients who cannot self-inject.

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

If you are given more RoActemra than you should

Since RoActemra is administered via a pre-filled pen, it is unlikely that you will receive too much. However, if you are concerned, speak with your doctor, pharmacist, or nurse.

If an adult with RA or GCA or an adolescent with pJIA misses or forgets a dose

It is very important to use RoActemra 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 scheduled every two weeks within 7 days, inject a dose as soon as you remember, and take your next dose according to your regular schedule.
• If you miss your weekly or every-two-weeks dose for more than 7 days, or if you are unsure when to inject RoActemra, contact your doctor or pharmacist.

If an adolescent with sjJIA misses or forgets a dose

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

• If a dose is missed within 7 days, inject a dose as soon as you remember, and administer the next dose according to the usual schedule.
• If a dose is missed for 7 days or more, or if you are unsure when to inject RoActemra, contact the doctor or pharmacist.

If you interrupt treatment with RoActemra

You must not stop treatment with RoActemra 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, this medicine can cause adverse effects, although not everyone gets them.

Adverse effects may occur up to at least 3 months after your last dose of RoActemra.

Possible serious adverse effects

Contact your doctor immediately if you experience any of the following adverse effects:

These are common: They may affect up to 1 in 10 patients

Allergic reactions during or after injection:

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

Signs of serious infections:

• fever and chills
• blisters in the mouth or on the skin
• stomach pain

Signs and symptoms of liver toxicity

May affect up to 1 in 1,000 patients

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

List of other possible adverse effects

If you notice any of these symptoms, inform your doctor immediately.

Very common adverse effects:

May affect up to 1 in 10 patients

• 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)
• reactions at the injection site

Common adverse effects:

May affect up to 1 in 10 patients

• lung infection (pneumonia)
• shingles (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, high blood pressure
• 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 patients

• 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 patients

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

Very rare adverse effects:

May affect up to 1 in 10,000 patients

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

Adverse effects in children and adolescents with JIA or pJIA

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.

You can 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 RoActemra

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 pen 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 – 8 °C). Do not freeze. Once removed from the refrigerator, the pre-filled pen may be stored for up to 2 weeks at a temperature not exceeding 30 °C.

Keep pre-filled pens in the outer packaging to protect from light and moisture.

Do not use this medicine if it appears cloudy or contains particles, if it is discoloured (other than colourless to slightly yellow), or if any part of the pre-filled pen appears damaged.

Do not shake the pen. After removing the needle cap, the injection should be started within 3 minutes to prevent the medicine from drying and blocking the needle. If the pre-filled pen is not used within 3 minutes after removing the cap, it must be disposed of in a sharps container and a new pre-filled pen must be used.

If, after pressing the dose activation button, the purple indicator does not move, the pre-filled pen must be disposed of in a sharps container. Do not attempt to reuse the pre-filled pen. Do not repeat the injection with another pre-filled pen. If you have any questions or encounter any problems, consult your healthcare professional.

6. Contents of the pack and other information

Composition of RoActemra

• The active substance is tocilizumab.

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

• The other components are L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine/Hydrochloride of L-Arginine, L-Methionine, Polysorbate 80, Water for injections (see section 2 'Roactemra contains polysorbates 80 (E 433)').

Nature and contents of the container

RoActemra is a solution for injection. The solution is colourless to slightly yellowish.

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

Each pack contains 4 pre-filled pens. The multiple pack contains 12 (3 packs of 4) pre-filled pens. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1

79639 Grenzach-Wyhlen

Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium Luxembourg/Luxembourg N.V. Roche S.A. Belgium/Belgium/Belgium Tel/Tel: +32 (0) 2 525 82 11	Latvia Roche Latvija SIA Tel: +371 - 6 7039831
	Lithuania UAB “Roche Lietuva” Tel: +370 5 2546799
Czech Republic Roche s. r. o. Tel: +420 - 2 20382111	Hungary Roche (Magyarország) Kft. Tel: +36 - 1 279 4500
Denmark Roche Pharmaceutical A/S Tlf: +45 - 36 39 99 99	Netherlands Roche Nederland B.V. Tel: +31 (0) 348 438050
Germany Roche Pharma AG Tel: +49 (0) 7624 140	Norway Roche Norge AS Tlf: +47 - 22 78 90 00
Estonia Roche Eesti OÜ Tel: +372 - 6 177 380	Austria Roche Austria GmbH Tel: +43 (0) 1 27739
Greece, Cyprus Roche (Hellas) A.E. Greece Tel: +30 210 61 66 100	Poland Roche Polska Sp. z o.o. Tel: +48 - 22 345 18 88
Spain Roche Farma S.A. Tel: +34 - 91 324 81 00	Portugal Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
France Roche Tél: +33 (0) 1 47 61 40 00	Romania Roche România S.R.L. Tel: +40 21 206 47 01
Croatia Roche d.o.o Tel: +385 1 47 22 333	Slovenia Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Ireland, Malta Roche Products (Ireland) Ltd. Ireland/Ireland Tel: +353 (0) 1 469 0700	Slovakia Roche Slovensko, s.r.o. Tel: +421 - 2 52638201
Iceland Roche Pharmaceutical A/S c/o Icepharma hf Sími: +354 540 8000	Finland/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500
Italy Roche S.p.A. Tel: +39 - 039 2471	Sweden Roche AB Tel: +46 (0) 8 726 1200

Date of the latest review of this leaflet

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

What do I need to know to safely use my pre-filled pen (ACTPen) of RoActemra?

It is important to read and follow the instructions for use provided with the RoActemra pre-filled pen before you use the pen and each time your doctor prescribes this medication again. Your healthcare professional will show you how to properly use the RoActemra pre-filled pen before your first use.

Important information: Store unused pre-filled pens in their original packaging in the refrigerator at a temperature between 2 °C and 8 °C. Do not freeze.

Once removed from the refrigerator, the pre-filled pen may be stored for up to a total of 2 weeks at a temperature not exceeding 30°C, but must not exceed the original expiry date (EXP). Mark the corresponding date on the carton. Always keep pre-filled pens in their outer packaging to protect them from light and moisture.

• Do not remove the cap from the pre-filled pen until you are ready to inject RoActemra.
• Do not attempt to disassemble the pen at any time.
• Do not reuse the same pre-filled pen.
• Do not inject the pre-filled pen through clothing covering your skin.
• Do not leave the pre-filled pen unattended.
• Keep the pen out of the reach of children.

Parts of the RoActemra pre-filled pen (see Figure A).

Supplies needed to prepare the injection with your RoActemra pre-filled pen (see Figure B):

• 1 RoActemra pre-filled pen
• 1 alcohol wipe
• 1 sterile cotton ball or gauze
• 1 sharps container or puncture-resistant container for the safe disposal of the pen cap and used pre-filled pen (see Step 4 “Disposal of the pre-filled pen” )

Step 1. Preparation for a RoActemra injection

Find a comfortable place with a clean, flat surface.

• Remove the pen’s carton from the refrigerator.
• If opening the carton for the first time, ensure it is properly sealed. Do not use the pre-filled pen if the carton appears to have been opened.
• Check that the pre-filled pen carton is undamaged. Do not use the RoActemra pre-filled pen if the carton appears damaged.
• Check the expiry date on the pre-filled pen carton. Do not use the pre-filled pen if it has passed the expiry date, as it may not be safe.
• Open the carton and remove one single-use RoActemra pre-filled pen.
• Return any unused pre-filled pens to the refrigerator.
• Check the expiry date on the RoActemra pre-filled pen (see Figure A).
• Do not use the pre-filled pen if it has passed the expiry date, as its use may not be safe. If the expiry date has passed, dispose of the pen safely in a sharps container and use a new one.
• Check that the pre-filled pen is not damaged. Do not use the pre-filled pen if it appears damaged or if it has been accidentally dropped.
• Place the pre-filled pen on a clean, flat surface and allow it to warm to room temperature for 45 minutes. If the pen is not at room temperature, the injection may be uncomfortable and the injection time may be prolonged.

o Do not accelerate the warming process in any way, such as using a microwave or placing the pre-filled pen in hot water.

o Do not leave the pre-filled pen in direct sunlight to warm.

Do not remove the green cap while the RoActemra pre-filled pen is warming to room temperature.

• Keep the RoActemra pre-filled pen with the green cap pointing downward (see Figure C).

• Inspect the visibility window of the pen. Check the liquid in the RoActemra pre-filled pen (see Figure C). The liquid should be clear and colourless to slightly yellowish. Do not inject RoActemra if the liquid is cloudy, discoloured, or contains flakes or particles, as it may not be safe. Dispose of the pre-filled pen safely in a sharps container and obtain a new one.
• Wash your hands with soap and water.

Step 2. Choose and prepare the injection site

Choose an injection site

• Recommended injection sites are the front of the thighs or the abdomen, except for the area within five centimetres immediately surrounding the navel (see Figure D).
• If a caregiver administers the injection, the outer surface of the upper arms may also be used. Do not attempt to self-inject into the upper arm (see Figure D).

Rotate the injection site

• Choose a different injection site for each new injection, at least 2.5 cm away from the previous injection site.
• Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or not intact.

Prepare the injection site

• Clean the injection site with an alcohol wipe using circular motions and allow it to air dry to reduce the risk of infection. Do not touch the cleaned area again before the injection.
• Do not fan or blow on the cleaned area.

Step 3. Injecting RoActemra

• Hold the RoActemra pre-filled pen firmly in one hand. Twist and remove the green cap with the other hand (see Figure E). The green cap contains a loose metal tube.
• If you cannot remove the green cap, ask your caregiver for help or contact your healthcare professional.

Important information: Do not touch the needle shield located at the end of the pre-filled pen below the visibility window (see Figure A), to avoid accidental needlestick injury.

• Dispose of the green cap in the sharps container.
• After removing the green cap, the pre-filled pen is ready for use. If the pre-filled pen is not used within 3 minutes after removing the cap, it must be discarded in the sharps container and a new pre-filled pen must be used.
• Never reattach the green cap after removal.
• Hold the pre-filled pen comfortably by the top with one hand so that you can see the visibility window area of the pen (see Figure F).

• Use your other hand to gently pinch the area of cleaned skin to create a firm site for injection (see Figure G). The pre-filled pen requires a firm injection site to activate properly.
• Pinching the skin is important to ensure that you inject under your skin (into the fatty tissue) and not deeper (into the muscle). Injection into the muscle may cause discomfort.

• Do not press the green activation button yet.
• Position the needle shield of the pre-filled pen at a 90° angle to the skin fold (see Figure H).
• It is important to choose the correct angle to ensure that the medicine is delivered under the skin (into the fatty tissue); otherwise, the injection may be painful and the medicine may not work properly.

• To use the pre-filled pen, you must first unlock the green activation button.
• To unlock it, press the pre-filled pen firmly against the skin fold until the needle shield is fully depressed (see Figure I).

• Continue pressing the needle shield fully.
• The green activation button will not work unless the needle shield is fully depressed against the skin.
• Continue pinching the skin while holding the pre-filled pen in place.
• Press the green activation button to start the injection. A "click" indicates the start of the injection. Keep the green button pressed and continue holding the pre-filled pen firmly against your skin (see Figure J). If you cannot start the injection, ask a caregiver for help or contact your healthcare professional.

• The purple indicator will move across the visibility window during the injection (see Figure K).
• Watch the purple indicator until it stops moving to ensure the full dose of medicine is injected.

• The injection should last about 10 seconds.
• You may hear a second "click" during the injection, but continue holding the pre-filled pen firmly against your skin until the purple indicator stops moving.
• When the purple indicator has stopped, release the green button. Lift the pre-filled pen straight off the injection site at a 90° angle to remove the needle from the skin. The needle shield will move and return to its original position, covering the needle (see Figure L).

• Check the visibility window with the purple indicator to see if it is fully filled (see Figure L).

• If the visibility window is not filled by the purple indicator, then:

• The needle shield may not have been unlocked. Do not touch the needle shield of the pre-filled pen, as you may get a needlestick injury. If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid injury.

• You may not have received your full dose of RoActemra. Do not attempt to reuse the pre-filled pen. Do not repeat the injection with another pre-filled pen. Contact your healthcare professional for assistance.

After the injection

• There may be slight bleeding at the injection site. You may press a cotton ball or gauze over the injection site.
• Do not rub the injection site.
• If needed, you may cover the injection site with a small bandage.

Step 4. Dispose of the pre-filled pen

• Do not reuse the RoActemra pre-filled pen.
• Place the used pre-filled pen immediately into your sharps container (see "How should you dispose of used pre-filled pens?" ).
• Do not replace the cap on the pre-filled pen.
• If someone else administers the injection, that person must also be careful when removing and disposing of the pen to avoid accidental needlestick injuries and infections.

How should you dispose of used pre-filled pens?

• Immediately after use, place your used RoActemra pre-filled pen and the green cap into a sharps container (see Figure M).
• Do not dispose of (throw away) the pre-filled pen and green cap in household waste and do not recycle them.

• Dispose of the full container as instructed by your doctor or pharmacist.
• Always keep the sharps container out of sight and out of reach of children.

Keep the RoActemra pre-filled pen and the sharps container out of sight and out of reach of children.

Record your injection

• Write down the date, time, and specific body location where you self-injected. It may also be helpful to note any questions or concerns about the injection so you can discuss them with your healthcare professional.

If you have any questions or concerns about your RoActemra pre-filled pen, consult your healthcare professional familiar with RoActemra.

These pictograms appear on the left side of the printed leaflet.