RoActemra 20mg/ml Concentrate for Solution for Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only.
• If you get any side effects, talk to your doctor 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 are given RoActemra
3. How RoActemra is given
4. Possible side effects
5. How to store RoActemra
6. Contents of the pack and other information

• if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in Section 6).
• if you have an active, severe infection.

If any of these applies to you, tell the doctor or nurse giving you the infusion.

Talk to your doctor or nurse before you are given RoActemra.

• If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
• 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 (either adult or child), or is planning a vaccination, tell your doctor. All patients, especially children, should be up-to-date with all their vaccinations before they start treatment with RoActemra, unless urgent treatment initiation is required. Certain types of vaccines should not be used 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 blood tests before you are given RoActemra, and during your treatment, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.

RoActemra is not recommended for use in children under 2 years of age.

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 your child is, if they are the patient), or have recently taken any. This includes medicines obtained without a prescription. 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 or pJIA.

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.

The data available so far does not suggest any effect on fertility from this treatment.

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

This medicine contains 26.55 mg sodium per maximum dose of 1200 mg. Take this into account if you are on a low-sodium diet. However, doses below 1025 mg of this medicine contain less than 23 mg sodium, so they are virtually sodium free.

The usual dose of RoActemra is 8 mg per kg of body weight. Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.

Adults will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.

The usual dose of RoActemra depends on your weight.

• If you weigh less than 30 kg: the dose is 12 mg for every kilogram of body weight
• If you weigh 30 kg or more, the dose is 8 mg for every kilogram of body weight

The dose is calculated based on your body weight at each administration.

Children with sJIA will be given RoActemra once every 2 weeks through a drip in the vein (intravenous infusion) over one hour.

The usual dose of RoActemra depends on your weight.

• If you weigh less than 30 kg: the dose is 10 mg for every kilogram of body weight
• If you weigh 30 kg or more: the dose is 8 mg for every kilogram of body weight

The dose is calculated based on your body weight at each administration.

Children with pJIA will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.

The usual dose of RoActemra is 8 mg for every kg of body weight if you weigh 30 kg or more.

The dose is 12 mg for every kg of body weight if you weigh less than 30 kg.

RoActemra can be given alone or in combination with corticosteroids.

The usual dose of RoActemra is 8 mg for every kg of body weight. A second dose may be required.

Since RoActemra is given by a doctor or nurse, it is unlikely that you will be given too much. However, if you are worried, talk to your doctor.

Since RoActemra is given by a doctor or nurse, it is unlikely that you will miss a dose. However, if you are worried, talk to your doctor or nurse.

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

• 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 more than 1 in every 10 users

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

Common side effects:

These may affect up to 1 in every 10 users

• 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 ulcers, 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 users

• 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 users

• 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 users

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

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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In general, side effects in sJIA patients were of a similar type to those in adults with RA. Some side effects were seen more often: inflamed nose and throat, diarrhoea, lower white blood cell counts and higher liver enzymes.

In general, side effects in pJIA patients were of a similar type to those in adults with RA. Some side effects were seen more often: inflamed nose and throat, headache, feeling sick (nausea) and lower white blood cell counts.

• The active substance is tocilizumab.
  Each 4 mL vial contains 80 mg tocilizumab (20 mg/mL).
  Each 10 mL vial contains 200 mg tocilizumab (20 mg/mL).
  Each 20 mL vial contains 400 mg tocilizumab (20 mg/mL).
• The other ingredients are sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate and water for injections.

RoActemra is a concentrate for solution for infusion. The concentrate is a clear to opalescent, colourless to pale yellow liquid.

RoActemra is supplied as vials containing 4 mL, 10 mL and 20 mL concentrate for solution for infusion. Pack size of 1 and 4 vials. Not all pack sizes may be marketed.