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 is: PLGB 00031/0897.
RoActemra 162 mg Solution for Injection in Pre-Filled Syringe
Package leaflet: Information for the user
RoActemra 162 mg solution for injection in pre-filled syringe
tocilizumab
Read all of this leaflet carefully before you start using 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 use RoActemra
3. How to use RoActemra
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:
2. What you need to know before you use RoActemra
Do not use RoActemra
If either of these applies to you, tell a doctor. Do not use RoActemra.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using RoActemra.
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.
Children and adolescents
RoActemra subcutaneous injection is not recommended for use in children under 1 year 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.
Other medicines and 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:
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.
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.
Driving and using machines
This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.
3. How to use RoActemra
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure.
The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.
The recommended dose
The dose for RA and GCA adults is 162 mg (the content of 1 pre-filled syringe) given once a week.
Children and adolescents with sJIA (aged 1 year and over)
The usual dose of RoActemra depends on the patient’s weight.
Children and adolescents with pJIA (aged 2 and over)
The usual dose of RoActemra depends on the patient’s weight.
RoActemra is given by injection under the skin (subcutaneously). At the start, your doctor or nurse may inject RoActemra. 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, such as children.
Talk to your doctor if you have any questions about giving yourself or a child patient you look after an injection. You will find detailed “Instructions for administration” at the end of this leaflet.
If you use more RoActemra than you should
Because RoActemra is given in one pre-filled syringe, it is unlikely that you will receive too much. However, if you are worried, talk to your doctor, pharmacist or nurse.
If an adult with RA or GCA or a child or adolescent with sJIA misses or forgets a dose
It is very important to use RoActemra exactly as prescribed by your doctor. Keep track of your next dose.
If a child or adolescent with pJIA misses or forgets a dose
It is very important to use RoActemra exactly as prescribed by the doctor. Keep track of the next dose.
If you stop using 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, pharmacist or nurse.
4. Possible side effects
Like all medicines, RoActemra can cause side effects, although not everybody gets them.
Side effects could occur 3 months or more 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 injection:
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 1 in 10 patients or more
Common side effects:
These may affect up to 1 in 10 patients
Uncommon side effects:
These may affect up to 1 in every 100 patients
Rare side effects:
These may affect up to1in every 1,000 patients
Very rare side effects:
These may affect up to 1 in every 10,000 patients
Side effects in children and adolescents with sJIA or pJIA
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.
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
5. How to store RoActemra
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pre-filled syringe label and carton (EXP). The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.
Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°C.
Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to yellowish, or any part of the pre-filled syringe appears to be damaged.
The syringe should not be shaken. After removing the cap the injection must be started within 5 minutes to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.
If following insertion of the needle, you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.
6. Contents of the pack and other information
What RoActemra contains
What RoActemra looks like and contents of the pack
RoActemra is a solution for injection. The solution is colourless to slightly yellowish.
RoActemra is supplied as a 0.9 mL pre-filled syringe containing 162 mg tocilizumab solution for injection.
Each pack contains 4 pre-filled syringes with multipacks containing 12 (3 packs of 4) pre-filled syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
or
This leaflet was last revised January 2022
What do I need to know to use my RoActemra pre-filled syringe safely?
It is important to read, understand and follow these instructions so that you or your caregiver uses the RoActemra syringe correctly. These instructions do not replace training from your healthcare provider. Your healthcare provider should show you how to prepare and inject properly before you use the RoActemra syringe for the first time. Ask your healthcare provider any questions you may have. Do not attempt to administer an injection until you are sure that you understand how to use the RoActemra syringe.
Please also read the Patient Leaflet that comes with the RoActemra syringe for the most important information you need to know about the medicine. It is important to remain under your healthcare provider's care while using RoActemra.
Important Information:
Storage
Keep the RoActemra syringe and all medicines out of the sight and reach of children. Always store the syringe in a refrigerator at a temperature of 2 - 8°C. Protect the syringe from freezing and from light. Keep the pre-filled syringes in the outer carton to protect it from light and keep them dry.
Pre-filled Syringe parts
You will need the following to give your injection:
Included in the box:
Not included in the box:
A place to prepare your supplies:
Step 1. Visually check the syringe
Dispose of the syringe and do not use if:
Step 2. Allow the syringe to adjust to room temperature
Step 3. Clean your hands
Step 4. Choose and prepare an injection site
Step 5. Remove needle-cap
NOTE: Once the needle-cap is removed, the syringe must be used immediately.
Step 6. Give the injection
It is important to choose the correct angle to ensure the medication is delivered under the skin (into fatty tissue), otherwise the injection could be painful and the medication may not work.
Step 7. Dispose of the syringe
Check with your healthcare provider for instructions about the right way to throw away used syringes. There may be local or state laws about how to throw away used syringes.
Do not throw away used syringes or the puncture resistant container in household trash and do not recycle them.
Patient advice regarding hypersensitivity reactions (also known as anaphylaxis, if severe)
If you develop symptoms such as, but not limited to skin rash, itching, chills, swelling of face, lips, tongue or throat, chest pain, wheezing, difficulty breathing or swallowing or feeling dizzy or faint at any time while not at the clinic during or following an RoACTEMRA injection you should seek emergency care immediately.
Patient advice regarding early recognition and treatment to limit risk of a serious infection
Be alert for the first signs of infection such as:
Call your doctor and seek medical attention without delay if you think you might be developing an infection.
If you have any concerns or questions about your syringe, contact your healthcare provider or pharmacist for assistance.
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