- Tocilizumab (RoActemra™) is a type of drug called a biological therapy. In some conditions too much of a protein called IL-6 is produced in the body, leading to tiredness, anaemia, inflammation and damage to bones, cartilage and other tissues. Tocilizumab blocks the action of IL-6, reducing these effects.
- Tocilizumab isn't a painkiller, but can modify the disease over a longer period. It may be 2–12 weeks before you notice an improvement.
- Tocilizumab can be prescribed by a rheumatologist for rheumatoid arthritis or juvenile idiopathic arthritis (JIA).
What is it used for?
- Moderate to severe rheumatoid arthritis.
- Tocilizumab is used for rheumatoid arthritis that has not responded adequately to treatment with DMARDs, eg sulfasalazine, methotrexate. It can be used in combination with methotrexate, or on its own for people who cannot take methotrexate.
How does it work?
- RoActemra infusion contains the active ingredient tocilizumab, which is a type of medicine called a human monoclonal antibody. It works by suppressing part of the immune system and modifying the process of inflammation.
- Tocilizumab works in a similar way to the natural antibodies produced by our immune system. Our natural antibodies recognise foreign invaders and bind to them, helping our immune systems to attack them and protect us from infections.
Use with caution in
- Liver disease or decreased liver function.
- Carriers of hepatitis virus.
- Moderate to severely decreased kidney function.
- People with low levels of white blood cells or platelets in their blood.
- People with currently inactive tuberculosis infection.
- People with a history of recurrent or long-term infections.
- People with conditions that increase the risk of getting infections, such as diabetes.
- People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
- People with increased risk factors for cardiovascular diseases, such as high blood pressure or high cholesterol.
- People with inflammation in the gut or abdomen or a history of this (eg diverticulitis, stomach ulcers, colitis associated with chemotherapy).
- History of or current cancer.
- Heavy smokers.
Not to be used in
- Active tuberculosis.
- People with severe active infections, eg abscesses, sepsis, opportunistic infections.
- This medicine is not recommended for children and adolescents under 18 years of age.
- This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- There is no information about the safety of this medicine during pregnancy, and it is not recommended for use during pregnancy unless considered essential by your doctor. Women who could get pregnant should use effective contraception to avoid pregnancy during treatment, and for at least three months after their last treatment.
- It is not known whether this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for three months after their last dose.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Very common
- Upper respiratory tract infections such as cough and cold.
- Inflammation of the nose and throat (nasopharyngitis).
- Raised cholesterol levels.
Common
- High blood pressure.
- Headache.
- Dizziness.
- Infection in the tissues under the skin (cellulitis).
- Pneumonia.
- Cold sores.
- Shingles.
- Inflammation of the stomach (gastritis).
- Abdominal pain.
- Mouth ulcers.
- Conjunctivitis.
- Decrease in the number of white blood cells in the blood.
- Fluid retention causing swollen ankles or feet (peripheral oedema).
- Rash.
- Itching.
- Hypersensitivity reactions.
Uncommon
- Diverticulitis.
- Stomach ulcer.
- Inflammation of the lining of the mouth (stomatitis).
- Increased levels of fats called triglycerides in the blood.
- Kidney stones.
- Underactive thyroid gland (hypothyroidism).
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while being treated this one, to ensure that the combination is safe.
Tocilizumab may decrease the blood levels of the following medicines:
- atorvastatin
- benzodiazepines, such as temazepam, diazepam
- calcium channel blockers, such as verapamil, nifedipine
- ciclosporin
- phenytoin
- theophylline
- warfarin.
This medicine may decrease the body's immune response. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine.
References:
https://www.medicines.org.uk/emc/product/5357/smpc
https://www.hpra.ie/docs/default-source/3rd-party-documents/educational-materials/roactemra_patient_ra-patient-brochure_v1-07-15.pdf?sfvrsn=2
https://www.ema.europa.eu/en/medicines/human/EPAR/roactemra
https://www.netdoctor.co.uk/medicines/aches-pains/a8739/roactemra-tocilizumab/
https://www.nras.org.uk/what-is-roactemra-tocilizumab-
https://www.roche.com/products/product-details.htm?productId=42bf9d08-8573-491a-944a-fdbc030ec44b
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