RoActemra 162 mg Solution for Injection in Pre-Filled Pen

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it onto others. It may harm them even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In addition to this leaflet, you will be given a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with RoActemra.

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

• if you or a child patient you look after are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6).
• if you or a child patient you look after have an active, severe infection.

If either of these applies to you, tell a doctor. Do not use RoActemra.

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

• If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.
• Do not take the next dose until you have informed your doctor AND your doctor has told you to take the next dose if you have experienced any allergic reaction symptoms after RoActemra administration.
• If you have any kind of infection, short- or long-term, or if you often get infections. Tell your doctor immediately if you feel unwell. RoActemra 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.
• If you have had tuberculosis, tell your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.
• If you have had intestinal ulcers or diverticulitis, tell your doctor. Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.
• If you have liver disease, tell your doctor. Before you use RoActemra, your doctor may do a blood test to measure your liver function.
• If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor. All patients should be up-to-date with all their vaccinations before they start treatment with RoActemra. Certain types of vaccines should not be given while receiving RoActemra.
• If you have cancer, tell your doctor. Your doctor will have to decide if you can still be given RoActemra.
• If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor. These factors need to be monitored while receiving RoActemra.
• If you have moderate to severe kidney function problems, your doctor will monitor you.
• If you have persistent headaches.

Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.

RoActemra pre-filled pen (ACTPen^®) is not recommended for use in children under 12 years of age. RoActemra must not be given to children with sJIA weighing less than 10 kg.

If a child has a history of macrophage activation syndrome (activation and uncontrolled proliferation of specific blood cells), tell your doctor. Your doctor will have to decide if they can still be given RoActemra.

Tell your doctor if you are taking any other medicines, or have recently taken any. RoActemra can affect the way some medicines work, and the dose of these may require adjustment. If you are using medicines containing any of the following active substances, tell your doctor:

• methylprednisolone, dexamethasone, used to reduce inflammation
• simvastatin or atorvastatin, used to reduce cholesterol levels
• calcium channel blockers (e.g. amlodipine), used to treat raised blood pressure
• theophylline, used to treat asthma
• warfarin or phenprocoumon, used as a blood thinning agents
• phenytoin, used to treat convulsions
• ciclosporin, used to suppress your immune system during organ transplants
• benzodiazepines (e.g. temazepam), used to relieve anxiety

Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA, sJIA, pJIA, or GCA.

RoActemra is not to be used in pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.

Women of childbearing potential must use effective contraception during and up to 3 months after treatment.

Stop breast-feeding if you are to be given RoActemra, and talk to your doctor. Leave a gap of at least 3 months after your last treatment before you start breast-feeding. It is not known whether RoActemra is passed into breast milk.

This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.

The dose with RA or GCA for all adults is 162 mg (the content of 1 pre-filled pen) given once a week.

Adolescents with sJIA (aged 12 years and over)

The usual dose of RoActemra depends on the patient’s 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 should not be used to treat children less than 12 years of age.

Adolescents with pJIA (aged 12 years and over)

The usual dose of RoActemra depends on the patient’s 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 should not be used to treat children less than 12 years of age.

RoActemra is given by injection under the skin (subcutaneously). At the start, your doctor or nurse may inject RoActemra (ACTPen^®). However, your doctor may decide that you may inject RoActemra yourself. In this case you will get training on how to inject RoActemra yourself. Parents and carers will get training on how to inject RoActemra for patients who cannot inject themselves.

Talk to your doctor if you have any questions about giving yourself or an adolescent patient you look after an injection. You will find detailed “Instructions for administration” at the end of this leaflet.

Because RoActemra is given in one pre-filled pen, it is unlikely that you will receive too much. However, if you are worried, talk to your doctor, pharmacist or nurse.

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 once every other week dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time.
• If you miss your weekly or once every other week dose by more than 7 days or you are not sure when to inject RoActemra, call your doctor or pharmacist.

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 give the next dose at the regular scheduled time.
• If a dose is missed by more than 7 days, or you are not sure when to inject RoActemra, call the doctor or pharmacist.

You should not stop using RoActemra without discussing with your doctor first.

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.

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

These may affect up to 1 in every 1000 users

• tiredness,
• abdominal pain,
• jaundice (yellow discolouration of skin or eyes)

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
• low fibrinogen levels in the blood (a protein involved in blood clotting).

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.

Rare side effects:

These may affect up to 1 in every 1,000 patients

• Stevens-Johnson Syndrome (skin rash, which may lead to severe blistering and peeling of the skin)
• Fatal Allergic Reactions (Anaphylaxis [fatal])
• inflammation of the liver (hepatitis), jaundice.

Very rare side effects:

These may affect up to 1 in every 10,000 patients

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

Side effects in children and adolescents with sJIA or pJIA 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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• The active substance is tocilizumab.
  Each pre-filled pen contains 162 mg tocilizumab in 0.9 mL.
• The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine hydrochloride, L-Methionine, Polysorbate 80 and Water for injections. May contain L-Arginine.

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

RoActemra is supplied as a 0.9 mL pre-filled pen containing 162 mg tocilizumab solution for injection.

Each pack contains 4 pre-filled pens with multipacks containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.

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 RoActemra 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 RoACTEMRA pre-filled pen from the box.
• Return any remaining pre-filled pens in the box to the refrigerator.
• Check the expiration date on the RoACTEMRA 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 RoACTEMRA pre-filled pen to reach room temperature.

• Hold your RoACTEMRA pre-filled pen with the green cap pointing down (See Figure C).

• Look in the clear Window area. Check the liquid in the RoACTEMRA pre-filled pen (See Figure C). It should be clear and colourless to pale yellow. Do not inject RoACTEMRA 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.

Choose an Injection Site

• The front of your thigh or your abdomen except for the 2-inch (5cm) 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 (2.5cm) 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.

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.

• Hold the RoACTEMRA 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.

Important: Do not touch the needle shield which is located at the tip of the pre-filled pen 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).

• 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.

• 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.

• 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).

• 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.

• 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.

• The injection may take up to 10 seconds.
• You may hear a second “click” during the injection but you should continue to hold the pre-filled 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).

• 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 pre-filled 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 RoACTEMRA. 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.

• The RoACTEMRA pre-filled pen should not be reused.
• Put the used pre-filled pen into your sharps container (see “How do I dispose of used pre-filled 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 RoACTEMRA 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.

• 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 RoACTEMRA 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.