RoActemra
tocilizumab
tocilizumab
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.
What RoActemra is and what it is used for
What you need to know before you are given RoActemra
How RoActemra is given
Possible side effects
How to store RoActemra
Contents of the pack and other information
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 helps to reduce 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 can also be used to treat adults who have not had previous methotrexate treatment if they have severe, active and progressive rheumatoid arthritis.
RoActemra is used to treat children with sJIA. RoActemra is used for children aged 2 years and over who have 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 and can be given in combination with methotrexate or alone.
RoActemra is used to treat children with pJIA. RoActemra is used for children aged 2 years and over with active polyarticular juvenile idiopathic arthritis (pJIA), an inflammatory disease that causes pain and swelling in one or more joints. RoActemra is used to improve the symptoms of pJIA and can be given in combination with methotrexate or alone.
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 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.
pregnant, may be pregnant, or intend to become pregnant.
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.
This medicine is subject to restricted medical prescription by your doctor.
RoActemra will be given to you as a drip into a vein, by a doctor or a nurse. They will dilute the solution, set up the intravenous infusion and monitor you during and after the treatment.
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.
Children with sJIA (aged 2 and over)
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.
Children with pJIA (aged 2 and over)
The usual dose of RoActemra depends on your weight.
If you weigh less than 30 kg: the dose is 10mg 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.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Like all medicines, RoActemra can cause side effects, although not everybody gets them. Side effects could occur at least up to 3 months after your last dose of RoActemra.
These are common: they may affect up to 1 in every 10 users
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 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.
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).
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.
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
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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
Keep RoActemra out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
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.
Roche Registration GmbH Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen Germany
D-79639 Grenzach-Wyhlen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11
(Voir/siehe Belgique/Belgien)
Рош България ЕООД Тел: +359 2 818 44 44
Roche (Magyarország) Kft. Tel: +36 - 1 279 4500
Roche s. r. o.
Tel: +420 - 2 20382111
Roche a/s
Tlf: +45 - 36 39 99 99
(See Ireland)
Roche Nederland B.V. Tel: +31 (0) 348 438050
Roche Pharma AG
Tel: +49 (0) 7624 140
oder
Chugai Pharma Europe Zweigniederlassung Deutschland
Tel: +49 (0) 69 663000 0
Roche Norge AS
Tlf: +47 - 22 78 90 00
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Roche Austria GmbH
Tel: +43 (0) 1 27739
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
Roche
Tél: +33 (0) 1 47 61 40 00
ou
Chugai Pharma France Tél: +33 (0) 1 56 37 05 20
Roche d.o.o
Tel: +385 1 47 22 333
Roche România S.R.L. Tel: +40 21 206 47 01
Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0700
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00
Roche a/s
c/o Icepharma hf Sími: +354 540 8000
Roche S.p.A.
Tel: +39 - 039 2471
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Γ.Α.Σταμάτης & Σια Λτδ. Τηλ: +357 - 22 76 62 76
Roche AB
Tel: +46 (0) 8 726 1200
Roche Latvija SIA
Tel: +371 - 6 7039831
UAB “Roche Lietuva” Tel: +370 5 2546799
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366000
or
Chugai Pharma UK Ltd. Tel: +44 (0) 208 987 5600
Parenteral medicinal products should be inspected visually for particulate matter or discolouration prior to administration. Only solutions which are clear to opalescent, colourless to pale yellow and free
of visible particles should be diluted. Use a sterile needle and syringe to prepare RoActemra.
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients
dose, under aseptic conditions. The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of
100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection
from a 100 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.4 mL/kg) should be withdrawn from the vial and placed in the 100 mL infusion bag. This should be a final volume of
100 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection
from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.6 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of
50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection
from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions. The required amount of RoActemra concentrate (0.5 mL/kg) should be withdrawn from the vial and placed in the 50 mL infusion bag. This should be a final volume of
50 mL. To mix the solution, gently invert the infusion bag to avoid foaming.
RoActemra is for single-use only.
Any unused product or waste material should be disposed of in accordance with local requirements.