Patient leaflet - Tofidence 20 mg/ml concentrate for solution for infusion
1. What Tofidence is and what it is used for
Tofidence 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. Tofidence helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks. Tofidence 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.
Pharmacotherapeutic group: Immunosuppressants, Interleukin inhibitors; ATC code: L04AC07.
- Tofidence is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough. Tofidence is usually given in combination with methotrexate. However, Tofidence can be given alone if your doctor determines that methotrexate is inappropriate.
- Tofidence can also be used to treat adults who have not had previous methotrexate treatment if they have severe, active and progressive rheumatoid arthritis.
- Tofidence is used to treat children with sJIA. Tofidence 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. Tofidence is used to improve the symptoms of sJIA and can be given in combination with methotrexate or alone.
- Tofidence is used to treat children with pJIA. Tofidence 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. Tofidence is used to improve the symptoms of pJIA and can be given in combination with methotrexate or alone.
- Tofidence is used to treat adults with coronavirus disease 2019 (COVID-19), receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.
2. What you need to know before you are given Tofidence
You are not to be given Tofidence
if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in
- 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 you are given Tofidence.
- 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. Tofidence 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 Tofidence. 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 Tofidence, your doctor may do a blood test to measure your liver function.
- If any patient has recently been vaccinated (either adult or child), or is planning a vaccination, tell your doctor. All patients, especially children, should be up-to-date with all their vaccinations before they start treatment with Tofidence, unless urgent treatment initiation is required. Certain types of vaccines should not be used while receiving Tofidence.
If you have cancer tell your doctor. Your doctor will have to decide if you can still be given
Tofidence.
- 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 Tofidence.
- 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 Tofidence, 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
Tofidence 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 Tofidence.
Tofidence contains polysorbate
This medicine contains 0.5 mg of polysorbate 80 (E 433) per 20 mg/mL tocilizumab. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
Other medicines and Tofidence
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. Tofidence 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, Tofidence is not recommended for use with other biological medicines for the treatment of RA, sJIA or pJIA.
Pregnancy, breast-feeding and fertility
Tofidence 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 Tofidence 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 Tofidence 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, cycle, or use machines.
This medicine contains 0.5 mg of polysorbate per 20mg/ml tocilizumab. Polysorbates may cause allergic reactions. Tell your doctor if any known allergies.
3. How Tofidence is given
This medicine is subject to restricted medical prescription by your doctor.
Tofidence 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 Tofidence 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 Tofidence 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 Tofidence 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 Tofidence 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 Tofidence depends on your weight.
- If you weigh less than 30 kg: the dose is 10 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 pJIA will be given Tofidence once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Patients with COVID-19
The usual dose of Tofidence is 8 mg for every kg of body weight. A second dose may be required.
If you are given more Tofidence than you should
Since Tofidence 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 Tofidence
Since Tofidence 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 Tofidence
You should not stop using Tofidence 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, Tofidence can cause side effects, although not everybody gets them. Side effects could occur at least up to 3 months after your last dose of Tofidence.
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:
- 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.
Signs of serious infections
- fever and chills
- mouth or skin blisters
- stomach ache
Signs and symptoms of liver toxicity
These are rare: may affect up to 1 in every 1 000 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.
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
- low fibrinogen levels in the blood (a protein involved in blood clotting).
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.
Rare side effects:
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
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.
- liver failure
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 affects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card Scheme 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 Tofidence
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 carton.
Store vials in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep the vial(s) in the outer carton in order to protect from light.
6. Contents of the pack and other information
What Tofidence 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 (E 473), polysorbate 80 (E 433), L-histidine, L-histidine hydrochloride, arginine hydrochloride, and water for injections.
What Tofidence looks like and contents of the pack
Tofidence is a concentrate for solution for infusion. The concentrate is a clear to opalescent, colourless to light yellow liquid.
Tofidence is supplied in a vial (type I glass) with a stopper (butyl rubber) containing 4 mL, 10 mL or 20 mL concentrate. Pack sizes of 1 and 4 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Internis Pharmaceuticals Limited
Linthwaite Laboratories
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
Manufacturer
Biogen Idec Ltd
5 Foundation Park
Roxborough Way
Maidenhead,
Berkshire SL6 3UD
United Kingdom
This leaflet was last revised in July 2026 The following information is intended for healthcare professionals only:
Instructions for dilution prior to administration
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 Tofidence.
RA and COVID-19 patients
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 Tofidence concentrate required for the patients dose, under aseptic conditions. The required amount of Tofidence 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.
Use in the paediatric population
sJIA and pJIA patients ≥ 30 kg
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 Tofidence concentrate required for the patients dose, under aseptic conditions. The required amount of Tofidence 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.
sJIA patients < 30 kg
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 Tofidence concentrate required for the patients dose, under aseptic conditions. The required amount of Tofidence 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.
pJIA patients < 30 kg
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 Tofidence concentrate required for the patients dose, under aseptic conditions. The required amount of Tofidence 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.
Tofidence is for single-use only.
Any unused product or waste material should be disposed of in accordance with local requirements.