Active ingredient: tocilizumab (rch)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Actemra. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Actemra.

Where to find information in this leaflet:

1. Why am I using Actemra?
2. What should I know before I use Actemra?
3. What if I am taking other medicines?
4. How do I use Actemra?
5. What should I know while using Actemra?
6. Are there any side effects?
7. Product details

1. Why am I using Actemra?

Actemra contains the active ingredient tocilizumab.

Actemra belongs to a group of medicines called monoclonal antibodies.

Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in the body.

Actemra for subcutaneous injection is used to treat active moderate to severe rheumatoid arthritis (RA) and giant cell arteritis (GCA) in adults.

Actemra is also used to treat active moderate to severe polyarticular juvenile idiopathic arthritis (pJIA) in children over 2 years of age and active systemic juvenile idiopathic arthritis (sJIA) in children and adolescents, aged 1 year and over. Some of the signs and symptoms of these conditions are caused by the actions of a protein called interleukin-6 receptor (IL-6R).

Actemra works by binding and blocking IL-6R thereby helping to relieve some of the signs and symptoms of these conditions. For patients with RA, Actemra can also prevent damage occurring to your joints.

There are different types of medicines used to treat RA, GCA, pJIA and sJIA. Your doctor, however, may have prescribed Actemra for another purpose.

Ask your doctor if you have any questions about why Actemra has been prescribed for you.

Actemra is not addictive.

This medicine is available only with a doctor’s prescription.

2. What should I know before I use Actemra?

Warnings

Do not use Actemra if:

Actemra, any of the ingredients listed at the end of this leaflet, or any other recombinant human or humanised antibodies or proteins that are of hamster origin

Always check the ingredients to make sure you can use this medicine.

• Symptoms of an allergic reaction may include:
  – chest tightness, wheezing or difficulty breathing
  – severe dizziness or light-headedness
  – swelling of the face, lips, tongue, throat or other parts of the body with difficulty breathing
  – skin rash, itching or hives (raised red patches of skin that are often very itchy)

or

Actemra can reduce your body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection. This may be important if you have diabetes or diverticulitis (which increase your risk of infection).

Tell your doctor if you think you have an infection or have symptoms of an infection. Signs of an infection, with or without fever include:

• sweating or chills,
• feeling very tired
• cough
• shortness of breath
• muscle aches
• weight loss
• warm, red, or painful skin or sores on your body
• blood in phlegm
• diarrhoea or stomach ache
• persistent headaches
• burning when you urinate or urinating more often than normal.

Check with your doctor if:

• you have any other health problems, especially the following:
  – liver disease such as viral hepatitis or other liver problems
  Your doctor will monitor your liver function closely before and during your treatment with Actemra.
• HIV or AIDs
• tuberculosis
• diverticulitis or ulcers in your intestine
• a low white blood cell count (white blood cells that help the body fight off infections)
• a low platelet count (blood cells that help with blood clotting and stop bleeding)
• diabetes
• cancer
• heart problems
• raised blood pressure
• high cholesterol or triglycerides
• kidney disease
• have a condition which affects your nervous system, such as multiple sclerosis or
• neuropathy
• you are planning to have a vaccination or have recently had a vaccination
  Certain types of vaccines should not be given while using Actemra.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

• Tell your doctor if you are pregnant or intend to become pregnant.
  Women of childbearing potential should be advised to use adequate contraception during and for several months after treatment with Actemra. Actemra should not be used during pregnancy as Actemra may harm your unborn baby. However if there is a need to take Actemra when you are pregnant, your doctor will discuss the benefits and risks to you and the unborn baby.
• Tell your doctor if you are breast-feeding or plan to breast-feed
  It is not known whether Actemra passes into breast milk. It is recommended that you discontinue breast-feeding while you are treated with Actemra.

Use in Children

• Actemra given as a subcutaneous injection to patients below 18 years of age with conditions other than pJIA and sJIA has not been studied.
• Actemra given as a subcutaneous injection in pJIA in children under the age of 2 and sJIA in children under the age of 1 has not been studied.
• Actemra must not be given to children weighing less than 10 kg.
• The pre-filled pen (ACTPen) should not be used to treat children and adolescent patients ˂ 12 years of age as the injection may lead to it being given into the muscle as the fatty tissue layer just under the skin is thinner.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

These medicines increase your risk of side effects with Actemra:

• other biological medicines for RA. e.g. infliximab, adalimumab, etanercept, certolizumab pegol, golimumab anakinra, abatacept, rituximab.
  It is unknown how Actemra interacts with these medicines. You may have an increased risk of infection. You should not use Actemra with other biological medicines for RA.
• vaccines
  Certain types of vaccines should not be given while receiving Actemra. You may have an increased risk of infection.

Actemra may reduce the amount of some medicines that require close monitoring to ensure drug levels are maintained. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you. E.g.:

• warfarin, a medicine used to prevent blood clots
• cyclosporin, a medicine used after organ transplants
• atorvastatin and simvastatin, medicines used to reduce cholesterol levels
• calcium channel blockers, such as amlodipine, which are used to treat raised blood pressure
• theophylline, a medicine used to treat asthma
• phenytoin, a medicine used to treat convulsions
• benzodiazepines, such as diazepam, which are used to treat anxiety

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Actemra.

4. How do I use Actemra?

Follow all instructions given to your doctor or pharmacist carefully. They may differ from the information contained in this leaflet. Use Actemra exactly as your doctor has prescribed.

How much to inject

Adult patients with RA and GCA

The recommended dose of Actemra to treat RA or GCA is 162 mg injected once a week. For GCA, your doctor may prescribe a lower dose of 162 mg every 2 weeks.

Actemra must be used on the same day each week. Choose the day of the week that best fits your schedule.

The pen is designed to deliver 162 mg per injection when used according to the instructions in this leaflet.

Your doctor will test your blood to help guide your treatment. If you experience certain changes in your blood tests, your doctor may decide to reduce the frequency of dosing to 162 mg every 2 weeks.

• For RA, Actemra is usually given in combination with methotrexate (MTX). However you may use Actemra on its own if your doctor determines that initial treatment with MTX is inappropriate or unsuccessful.
• For GCA, Actemra is initially given in combination with a glucocorticoid medicine (such as prednisone). Over the period of treatment, depending on your response to Actemra, your doctor will adjust the dose of the glucocorticoid with the aim to reduce it over time.

Children and adolescents with pJIA or sJIA (aged 12 and over)

The pre-filled pen (ACTPen) should not be used to treat children and adolescent patients ˂ 12 years of age.

The usual dose of Actemra depends on the patient’s weight.

Actemra must not be given to children less than 10 kg.

The increasing body weight of a child initially under 30kg should be checked regularly. This is because there is a risk of underdose for this medicine if the frequency of administration does not increase from every 3 weeks to every 2 weeks for pJIA patients (or every 2 weeks to once every week for sJIA patients) as the child grows from under to over 30 kg body weight.

How to inject Actemra

Actemra is administered by subcutaneous injection. This means it is injected with a short needle into the fatty tissue just under the skin.

Serious allergic reactions can occur with Actemra injections.

At least the first injection of Actemra will be given under the supervision of your healthcare provider in a healthcare facility that can manage these reactions. After your first injection, your doctor may discuss with you whether it would be appropriate for you to inject the next Actemra injection yourself at home, in which case, you or a caregiver would be instructed on how to give the injection and what to do if you experience symptoms of an allergic reaction.

Directions for self-injection

You should read these directions from beginning to end before starting to inject so that you are familiar with each step of the procedure. These instructions must be carefully followed. Consult with your healthcare provider if you require further instructions. These instructions do not replace the instructions from your healthcare provider.

Your healthcare provider should show you how to prepare and inject properly before you inject for the first time. Ask them any questions you may have.

Do not attempt to administer an injection until you are sure that you understand how to self-inject.

It is important to remain under your doctor’s care while using Actemra. It is recommended you have someone else present when you self-inject Actemra in case you experience any symptoms of a serious allergic reaction described under Section 5. What should I know while using Actemra?.

The pen is for single use only and should be safely discarded after use.

How to inject using the pen

The ACTPen components:

Figure A

• Do not remove the pre-filled pen cap until you are ready to inject Actemra.
• Do not try to take apart the pre-filled pen at any time.
• Do not reuse the same pre-filled pen.
• Do not use the pre-filled pen through clothing.
• Do not leave the pre-filled pen unattended.
• Keep out of the reach of children.

Gather what you will need:

Step 1. Preparing for a Actemra Injection

• Find a comfortable space with a clean, flat, working surface. Take the box containing the pre-filled pen out of the refrigerator.
• If you are opening the box for the first time, check to make sure that it is properly sealed. Do not use the pre-filled pen if the box looks like it has already been opened.
• Check that the pre-filled pen box is not damaged. Do not use pre-filled pen if the box looks damaged.
• Check the expiration date on the pre-filled pen box.
• Do not use the pre-filled pen if the expiration date has passed because it may not be safe to use.
• Open the box, and remove 1 single-use pre-filled pen from the box.
• Return any remaining pre-filled pens in the box to the refrigerator.
• Check the expiration date on the pre-filled pen (See Figure A).
• Do not use it if the expiration date has passed because it may not be safe to use. If the expiration date has passed, safely dispose of the pre-filled pen in a sharps container and get a new one.
• Check the pre-filled pen to make sure it is not damaged.
• Do not use the pre-filled pen if it appears to be damaged or if you have accidentally dropped the pre-filled pen.
• Place the pre-filled pen on a clean, flat surface and let the pre-filled pen warm up for 45 minutes to allow it to reach room temperature. If the pre-filled pen does not reach room temperature, this could cause your injection to feel uncomfortable and it could take longer to inject.
• Do not speed up the warming process in any way, such as using the microwave or placing the pre-filled pen in warm water.
• Do not leave the pre-filled pen to warm up in direct sunlight.
• Do not remove the green cap while allowing your Actemra pre-filled pen to reach room temperature.
• Hold your pre-filled pen with the green cap pointing down (See Figure C).

Figure C

• Look in the clear Window area. Check the liquid in the pre-filled pen (See Figure C). It should be clear and colourless to pale yellow.
• Do not inject Actemra if the liquid is cloudy, discoloured, or has lumps or particles in it because it may not be safe to use.
• Safely dispose of the pre-filled pen in a sharps container and get a new one.
• Wash your hands well with soap and water.

Step 2. Choose and Prepare an Injection Site

Choose an Injection Site

• The front of your thigh or your abdomen except for the 2-inch (5 cm) area around your navel are the recommended injection sites (See Figure D).
• The outer area of the upper arms may also be used only if the injection is being given by a caregiver. Do not attempt to use the upper arm area by yourself (See Figure D).

Rotate Injection Site

• Choose a different injection site for each new injection at least 1 inch (2.5 cm) from the last area you injected.
• Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.

Figure D

Prepare the Injection Site

• Wipe the injection site with an alcohol pad in a circular motion and let it air dry to reduce the chance of getting an infection. Do not touch the injection site again before giving the injection.
• Do not fan or blow on the clean area.

Step 3. Inject Actemra

Hold the Actemra pre-filled pen firmly with one hand. Twist and pull off the green cap with the other hand (See Figure E). The green cap contains a loose fitting metal tube.

If you cannot remove the green cap you should ask a caregiver for help or contact your healthcare provider.

Figure E

• Do not touch the needle shield which is located at the tip of the Autoinjector below the Window area (see Figure A), to avoid accidental needle stick injury.
• Throw away the green cap in a sharps container.
• After you remove the green cap, the pre-filled pen is ready for use. If the pre-filled pen is not used within 3 minutes of the cap removal, the pre-filled pen should be disposed of in the sharps container and a new pre-filled pen should be used.
• Never reattach the green cap after removal.
• Hold the pre-filled pen comfortably in 1 hand by the upper part, so that you can see the Window area of the pre-filled pen (See Figure F).

Figure F

Use your other hand to gently pinch the area of skin you cleaned, to prepare a firm injection site (See Figure G). The pre-filled pen requires a firm injection site to properly activate.

Pinching the skin is important to make sure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). Injection into muscle could cause the injection to feel uncomfortable.

Figure G

• Do not press the green activation button yet.
• Place the needle-shield of the pre-filled pen against your pinched skin at a 90° angle (See Figure H).
• 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.

Figure H

• To use the pre-filled pen, you first have to unlock the green Activation button.
• To unlock it, press the pre-filled pen firmly against your pinched skin until the needle-shield is completely pushed in (See Figure I).

Figure I

• Continue to keep the needle-shield pushed in.
• If you don’t keep the needle-shield completely pushed against the skin, the green Activation button will not work.
• Continue to pinch the skin while you keep the pre-filled pen in place.
• Press the green Activation button to start the injection. A “click” sound indicates the start of the injection. Keep the green button pressed in and continue holding the pre-filled pen pressed firmly against your skin (See Figure J). If you cannot start the injection you should ask for help from a caregiver or contact your healthcare provider.

Figure J

The purple indicator will move along the Window area during the injection (See Figure K).

Watch the purple indicator until it stops moving to be sure the full dose of medication is injected.

Figure K

The injection may take up to 10 seconds.

You may hear a second “click” during the injection but you should continue to hold the prefilled pen firmly against your skin until the purple indicator stops moving.

When the purple indicator has stopped moving, release the green button. Lift the pre-filled pen straight off of the injection site at a 90° angle to remove the needle from the skin. The needle shield will then move out and lock into place covering the needle (See Figure L).

Figure L

Check the Window area to see that it is filled with the purple indicator (See Figure L).

If the Window area is not filled by the purple indicator then:

• The needle-shield may not have locked. Do not touch the needle-shield of the prefilled pen, because you may stick yourself with the needle. If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid any injury with the needle.
• You may not have received your full dose of Actemra. Do not try to re-use the pre-filled pen. Do not repeat the injection with another pre-filled pen. Call your healthcare provider for help.

After the Injection

There may be a little bleeding at the injection site. You can 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

The Actemra pre-filled pen should not be reused.

Put the used pre-filled pen into your sharps container (see “How do I dispose of used prefilled pens?”). Do not put the cap back on the pre-filled pen.

If your injection is given by another person, this person must also be careful when removing the pre-filled pen and disposing of it to prevent accidental needle stick injury and passing infection.

How do I dispose of used pre-filled pens?

Put your used Actemra pre-filled pen and green cap in a sharps disposal container right away after use (See Figure M).

Do not throw away (dispose of) the pre-filled pen and the green cap in your household trash and do not recycle them.

Figure M

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.

Keep the Actemra pre-filled pen and disposal container out of the reach of children.

Record your Injection

Write the date, time, and specific part of your body where you injected yourself. It may also be helpful to write any questions or concerns about the injection so you can ask your healthcare provider.

If you have any questions or concerns about your Actemra Autoinjector, talk to your healthcare provider familiar with Actemra.

When to use Actemra

The duration of treatment depends on how you are responding to the medicine. Your doctor will discuss this with you.

Continue to use Actemra until your doctor tells you to stop.

If an adult with RA/GCA or a child or adolescent with pJIA or sJIA forgets to use Actemra

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

Do not give yourself two injections to make up for the injection that you missed.

If it has been more than 7 days since your missed dose, contact your doctor for advice.

If you are not sure when to inject your next dose, contact your doctor for advice.

If you are given too much Actemra

If you think that you or anyone else have had too much Actemra, you may need urgent medical care. You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Actemra?

Things you must do

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if:

you experience symptoms of a serious allergic reaction during or after receiving Actemra such as;

• chest tightness, wheezing or difficulty breathing
• severe dizziness or light-headedness
• swelling of the face, lips, tongue, throat or other parts of the body with difficulty breathing
• skin rash, itching or hives (raised red patches of skin that are often very itchy).

The reaction can occur even after multiple doses of Actemra. If you have experienced any allergic reaction symptoms after using Actemra, do not take the next dose until you have informed your doctor AND your doctor has told you it is safe to take the next dose.

Tell your doctor immediately if:

• sweating or chills,
• feeling very tired
• cough
• shortness of breath
• muscle aches
• weight loss
• warm, red, or painful skin or sores on your body
• blood in phlegm
• diarrhoea or stomach ache
• persistent headaches
• burning when you urinate or urinating more often than normal.

Skin cancer monitoring:

if you are at increased risk for skin cancer:

• Regular skin examination is recommended if you are at increased risk for skin cancer.
• Exposure to sunlight and UV light should be limited by wearing protective clothing and using sunscreen with a high protection factor.
• Immunosuppressive medication (a medicine that reduces the activity of your immune system), such as Actemra, have an increased risk of developing skin cancer (melanoma and non-melanoma).

Tell all doctors, dentists and pharmacists who are treating you that you are receiving Actemra.

Tell your doctor if you become pregnant while taking Actemra.

Tell your doctor if you are breast-feeding while being treated with Actemra.

Tell your doctor if you feel Actemra is not helping your condition.

Be sure to keep all of your appointments and get follow-up blood tests done as ordered by your doctor so that your progress can be checked.

Blood tests/monitoring:

• Liver enzymes:
  – If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA), your doctor should do blood tests every 4 to 8 weeks for the first 6 months of treatment followed by every 12 weeks. Your doctor will then decide on the frequency.
  – If you have polyarticular juvenile idiopathic arthritis (pJIA) or systemic juvenile idiopathic arthritis (sJIA), your doctor should do blood test at the time of second administration and every 4 to 8 weeks for pJIA and 2 to 4 weeks for sJIA.
• Blood count:
  – If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA), your doctor should do blood tests every 4 to 8 weeks after the start of therapy. Your doctor will then decide on the frequency.
  – If you have polyarticular juvenile idiopathic arthritis (pJIA) or systemic juvenile idiopathic arthritis (sJIA), your doctor should do blood tests at the time of second administration and every 4 to 8 weeks for pJIA and 2 to 4 weeks for sJIA.
  – Your doctor should do blood test levels according to the current clinical guidelines.
• Cholesterol:
  – If you have RA and sJIA, your doctor will decide on the frequency of testing.
  – If you have pJIA, your cholesterol levels should be tested every 3 months while on Actemra.

Remind any doctor, dentist or pharmacist you visit that you are using Actemra.

Driving or using machines

Be careful driving or operating machinery until you know how Actemra affects you.

Actemra has not been shown to impair the ability to drive or operate machinery. However if you experience dizziness, a reported side effect, then you should not drive or operate machinery until it has resolved.

Looking after your medicine

Before injection

• Store in a refrigerator (2°C to 8°C). Do not freeze.
• Store the pens in the carton to protect them from light and to keep them dry.
• Once removed from the refrigerator, the pre-filled pen can be stored up to 2 weeks (14 days) at or below 30°C. The unopened pre-filled pen may be removed and returned to the refrigerator multiple times as long as the total length of time at or below 30°C is not more than 14 days. The pre-filled pen must always be kept in the carton to protect from light and keep dry.
• Do not use Actemra if the package is torn or shows signs of tampering.
• Do not use Actemra after the expiry date which is stated on the carton and pen labels after ‘EXP’. The expiry date refers to the last day of that month.

After injection

• The pen is intended for single use only and must be discarded after the injection.
• Dispose of the pens in a sharps container as instructed by your doctor, nurse or pharmacist.
• Do not put the used pens in your normal household rubbish.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date or if your doctor tells you to stop using Actemra, take it to any pharmacy for safe disposal. Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Side effects in children and adolescents with pJIA and sJIA

Side effects in children and adolescents with pJIA and sJIA are generally similar to those in adults. Some side effects are seen more often in children and adolescents: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Actemra contains

Do not take this medicine if you are allergic to any of these ingredients.

What Actemra looks like

Actemra is a clear to opalescent, colourless to pale yellow solution.

Australian Registration Numbers:

• Actemra® 162mg/0.9mL pre-filled pens (ACTPen) AUST R 296808
• Actemra® SC 162mg/0.9mL pre-filled pens (ACTPen) AUST R 370314

Actemra is available as a pre-filled syringe (162mg/0.9mL) in packs of 1 and 4 syringes, with the tradenames Actemra® and Actemra® SC.

Actemra is also available as a concentrated solution for intravenous infusion.

Who distributes Actemra

Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney NSW Australia

How to contact us

You can contact us at www.medinfo.roche.com/australia or by scanning the below code:

You can also call us on 1800 233 950.

This leaflet is for people in Australia only. If you are not in Australia, you can contact Roche/Genentech in your country at www.medinfo.roche.com.

This leaflet was prepared in November 2022.

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