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RoActemra 20mg/ml Concentrate for Solution for Infusion

Last Updated on eMC 10-Sep-2014 View changes  | Roche Products Limited Contact details

Risk Management

This product has additional materials to minimise the risk during use.   Please register or log in to view the materials.

The following materials are available for healthcare professionals:

RoActemra (tocilizumab) Step by Step Dosing & Administration Guide for HCPs - IV & SC for RA

This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan. Please register or log in to view the materials.

RoActemra (tocilizumab) Important Efficacy and Safety Information for HCPs - IV and SC for RA

This material is provided by Roche Products Ltd as a licence requirement for this medicine and forms part of the Risk Management Plan. Please register or log in to view the materials.

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Please click on the link to the left to view the PIL in PDF format.

Text only version for the visually impaired
Below is a text only representation of the Patient Information leaflet. The original may contain images or tables and can be viewed in PDF format using the link to the left. This PIL may be available from the RNIB in large print, Braille or audio CD. For further information please call the RNIB Medicine Leaflet line on 0800 198 5000. The product code(s) for this leaflet is/are: EU/1/08/492/005, EU/1/08/492/006, EU/1/08/492/003, EU/1/08/492/004, EU/1/08/492/001, EU/1/08/492/002.



RoActemra 20mg/ml Concentrate for Solution for Infusion

Package Leaflet: Information for the user

RoActemra 20 mg/ml concentrate for solution for infusion

Tocilizumab

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • 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 is in this leaflet:

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

1. What RoActemra is and what it is used for

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 is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough. RoActemra can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. 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 is usually given in combination with methotrexate. However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.
  • RoActemra is also used to treat children (aged 2 years and over) with 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 also used to treat patients 2 years of age and older 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.

2. What you need to know before you are given RoActemra

You are not to be given RoActemra

  • 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.

Warnings and precautions

Talk to your doctor or nurse before using 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 been recently vaccinated, or are planning a vaccination (either adult or child), tell your doctor. All patients, especially children, should be up to date with all their vaccinations before they start treatment with RoActemra. 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.

Children and adolescents

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

If you have a history of macrophage activation syndrome, which is the activation and uncontrolled proliferation of specific blood cells, tell your doctor. Your doctor will have to decide if you can still be given RoActemra.

Other medicines and RoActemra

Tell your doctor if you are taking (or your child is, if they are the patient), have recently taken or might take any other medicines. RoActemra can affect the way some medicines work, and the dose of these may require adjustment. You and parents/guardians of sJIA or pJIA patients should tell your doctor if you are using medicines containing any of the following active substances:

  • 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 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.

Pregnancy, breast-feeding and fertility

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.

Available non-clinical data does not suggest an effect on fertility under tocilizumab treatment

Driving and using machines

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

RoActemra contains sodium

This medicine contains 26.55 mg sodium per maximum dose of 1200 mg. To be taken 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.

3. How RoActemra is given

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.

Adult patients with RA

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.

Use in children and adolescents

Children 2 years of age and above with sJIA

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 2 years of age and above with pJIA

The usual dose of RoActemra depends on your weight.

  • If you weigh less than 30kg: the dose is 10mg per kg
  • If you weigh 30kg or more: the dose is 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 your vein (intravenous infusion) over one hour.

If you are given more RoActemra than you should

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.

If you miss a dose of RoActemra

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.

If you stop being given RoActemra

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.

4. Possible side effects

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.

Possible common serious side effects: tell a doctor.

Infections:

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

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.

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.

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.
  • stevens-johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin).

sJIA Patients

In general, the side effects in sJIA patients were similar in type to those seen in RA patients as stated above with the exception of nasopharyngitis, lower white blood cells, hepatic transaminases increased and diarrhoea which were reported more frequently.

pJIA Patients

In general, the side effects in pJIA patients were similar in type to those seen in RA patients as stated above with the exception of nasopharyngitis, headache, nausea and lower white blood cells, which were reported more frequently.

Reporting of side effects

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.

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel:+353 1 6764971
Fax:+353 1 6762517
Website:www.hpra.ie
email:medsafety@hpra.ie

Malta

ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3
Rue D'Argens
GŻR-1368 Gżira
Website:www.medicinesauthority.gov.mt
e-mail:postlicensing.medicinesauthority@gov.mt

United Kingdom

Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

5. How to store RoActemra

Keep RoActemra out of the sight and reach of children.

Store in a refrigerator (2°C–8°C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton.

6. Contents of the pack and other information

What RoActemra contains

  • 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.

What RoActemra looks like and contents of the pack

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.

Marketing Authorisation Holder

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Roche Products Ltd.
Tel:+44 (0) 1707 366000
or
Chugai Pharma UK Ltd.
Tel:+44 (0) 208 987 5600

This leaflet was last revised in September 2014

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments.

RoActemra-uk-ie-mt-pil-clean-140-98-20mg-inf

Company contact details

Roche Products Limited

Company image
Address

Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW

Fax

+44 (0)1707 338 297

Medical Information e-mail
Medical Information Fax

+44 (0)1707 384555

Telephone

+44 (0)1707 366 000

Medical Information Direct Line

+44 (0)800 328 1629

Customer Care direct line

+44 (0)800 731 5711

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

tocilizumab

Legal categories

POM - Prescription Only Medicine

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