Active ingredient
- tocilizumab
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/08/492/006, EU/1/08/492/002, EU/1/08/492/005, EU/1/08/492/004, EU/1/08/492/001, EU/1/08/492/003.
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.
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 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.
2. What you need to know before you are given RoActemra
You are not to be given RoActemra
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 you are given RoActemra.
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 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.
Other medicines and 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:
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.
The data available so far does not suggest any effect on fertility from this treatment.
Driving and using machines
This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.
RoActemra contains sodium
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.
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.
Children with sJIA (aged 2 and over)
The usual dose of RoActemra depends on your 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.
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.
Patients with CRS
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.
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 serious side effects: tell a doctor straight away.
These are common: they may affect up to 1 in every 10 users
Allergic reactions during or after infusion:
If you notice any of these, tell your doctor immediately.
Signs of serious infections
Signs and symptoms of liver toxicity
These may affect up to 1 in every 1000 users
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
Common side effects:
These may affect up to 1 in every 10 users
Uncommon side effects:
These may affect up to 1 in every 100 users
Rare side effects:
These may affect up to 1 in every 1,000 users
Very rare side effects:
These may affect up to 1 in every 10,000 users
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.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Children with sJIA
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.
Children with pJIA
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.
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
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
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
or
This leaflet was last revised April 2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
uk-pil-RoActemra-clean-200430-20mg-inf
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
+44 (0)1707 366 000
+44 (0)800 328 1629
+44 (0)800 731 5711
+44 (0)1707 338 297
+44 (0)1707 384555