Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha.
Remsima belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases:
• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis (Bechterew’s disease)
• Psoriasis.
• Crohn’s disease
• Ulcerative colitis.
Remsima works by selectively attaching to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
Rheumatoid arthritis Rheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima which you will take with another medicine called methotrexate to:
• reduce the signs and symptoms of your disease,
• slow down the damage in your joints,
• improve your physical function.
Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:
• reduce the signs and symptoms of your disease,
• slow down the damage in your joints,
• improve your physical function.
Ankylosing spondylitis (Bechterew’s disease) Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:
• reduce the signs and symptoms of your disease,
• improve your physical function.
Psoriasis Psoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy. If these medicines or treatments do not work well enough, you will be given Remsima to reduce the signs and symptoms of your disease.
Ulcerative colitis Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to treat your disease.
Crohn’s disease Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:
• treat active Crohn’s disease,
• reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery.
You must not use Remsima if • you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
• you are allergic to proteins that come from mice,
• you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood),
• you have heart failure that is moderate or severe.
Do not use Remsima if any of the above applies to you. If you are not sure, talk to your doctor before you are given Remsima. Warnings and precautions Talk to your doctor before or during treatment with Remsima, if you have:
Had treatment with any medicine containing infliximab before
• Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Remsima treatment again.
• If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Local injection site reactions
• Some patients receiving infliximab via injection under the skin have experienced local injection site reactions. Signs of a local injection site reaction can include redness, pain, itching, swelling, hardness, bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, blisters and scab on the skin of the injection site.
• Most of these reactions are mild to moderate and mostly resolve on their own within a day.
Infections
• Tell your doctor before you are given Remsima if you have an infection even if it is a very minor one.
• Tell your doctor before you are given Remsima if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
• You may get infections more easily when you are being treated with Remsima. If you are 65 years of age or older, you have a greater risk.
• These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening.
Tell your doctor straight away if you get signs of infection during treatment with Remsima. Signs include fever, cough, flu-like signs, feeling unwell, red or hot skin, wounds or dental problems. Your doctor may recommend temporarily stopping Remsima.
Tuberculosis (TB)
• It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
• Your doctor will test you to see if you have TB. Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB. Your doctor will record these tests on your patient reminder card.
• If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Remsima.
Tell your doctor straight away if you get signs of TB during treatment with Remsima. Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Hepatitis B virus
• Tell your doctor before you are using Remsima if you are a carrier of hepatitis B or have ever had it.
• Tell your doctor if you think you might be at risk of contracting hepatitis B.
• Your doctor should test you for hepatitis B virus.
• Treatment with TNF blockers such as Remsima may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
• If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
Heart problems
• Tell your doctor if you have any heart problems, such as mild heart failure.
• Your doctor will want to closely monitor your heart.
Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remsima. Signs include shortness of breath or swelling of your feet.
Cancer and lymphoma
• Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
• Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
• Patients taking Remsima may have an increased risk of developing lymphoma or another cancer.
• Some patients who have received TNF-blockers, including infliximab have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Of these patients, most were teenage boys or young men and most had either Crohn’s disease or ulcerative colitis. This type of cancer has usually resulted in death. Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
• Some patients treated with infliximab have developed certain kinds of skin cancer. If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
• Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer. For women taking Remsima including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Lung disease or heavy smoking
• Tell your doctor before you are given Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
• Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remsima treatment.
Nervous system disease
• Tell your doctor before you are given Remsima if you have or have ever had a problem that affects your nervous system. This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis’.
Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remsima. Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Abnormal skin openings
• Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Remsima.
Vaccinations
• Talk to your doctor if you recently have had or are due to have a vaccine.
• You should receive recommended vaccinations before starting Remsima treatment. You may receive some vaccines during treatment with Remsima but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remsima because they may cause infections.
• If you received Remsima while you were pregnant, your baby may also be at higher risk for getting an infection as a result of receiving a live vaccine during the first year of life. It is important that you tell your baby's doctors and other health care professionals about your Remsima use so they can decide when your baby should receive any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).
• If you are breast-feeding, it is important that you tell your baby’s doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine. For more information see section on Pregnancy and breast-feeding.
Therapeutic infectious agents
• Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer).
Operations or dental procedures
• Tell your doctor if you are going to have any operations or dental procedures.
• Tell your surgeon or dentist that you are having treatment with Remsima by showing them your patient reminder card.
Liver problems
• Some patients receiving infliximab have developed serious liver problems.
• Tell your doctor straight away if you get symptoms of liver problems during treatment with Remsima. Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Low blood counts
• In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
• Tell your doctor straight away if you get symptoms of low blood counts during treatment with Remsima. Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Immune system disorder
• Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
• Tell your doctor straight away if you develop symptoms of lupus during treatment with Remsima. Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.
Children and adolescents Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.
Other medicines and Remsima Patients who have inflammatory diseases already take medicines to treat their problem. These medicines may cause side effects. Your doctor will advise you what other medicines you must keep using while you are having Remsima.
Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
In particular, tell your doctor if you are using any of the following medicines:
• Medicines that affect your immune system.
• Kineret (which contains anakinra). Remsima and Kineret should not be used together.
• Orencia (which contains abatacept). Remsima and Orencia should not be used together.
While using Remsima you should not receive live vaccines. If you were using Remsima during pregnancy or if you are receiving Remsima while breast-feeding, tell your baby’s doctor and other health care professionals caring for your baby about your Remsima use before the baby receives any vaccines.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Remsima.
Pregnancy, breast-feeding and fertility • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Remsima should only be used during pregnancy or while breast-feeding if your doctor feels it is necessary for you.
• You should avoid getting pregnant when you are being treated with Remsima and for 6 months after you stop being treated with it. Discuss the use of contraception during this time with your doctor.
• Do not breast-feed when you are being treated with Remsima or for 6 months after your last treatment with Remsima.
• If you received Remsima during your pregnancy, your baby may have a higher risk for getting an infection.
• It is important that you tell your baby’s doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine. If you received Remsima while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may result in infection with serious complications, including death. Live vaccines such as the BCG vaccine should not be given to your baby within 12 months after birth, unless your baby’s doctor recommends otherwise. For more information see section on vaccination.
• If you are breast-feeding, it is important that you tell your baby’s doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine. Live vaccines should not be given to your baby while you are breast-feeding unless your baby’s doctor recommends otherwise.
• Severely decreased numbers of white blood cells have been reported in infants born to women treated with infliximab during pregnancy. If your baby has continual fevers or infections, contact your baby’s doctor immediately.
Driving and using machines Remsima is not likely to affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after having Remsima, do not drive or use any tools or machines.
Remsima contains sodium and sorbitol This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’ and 45 mg sorbitol in each 120 mg dose.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Rheumatoid arthritis Your doctor will start your treatment with or without two Remsima intravenous infusion doses of 3 mg Your doctor will start your treatment with or without two infliximab intravenous infusion doses of 3 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). If infliximab intravenous infusion doses are given to start the treatment, they are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection). If Remsima subcutaneous injection doses are given to start the treatment, Remsima 120 mg should be given as a subcutaneous injection followed by additional subcutaneous injections at 1, 2, 3 and 4 weeks after the first injection, then every 2 weeks thereafter.
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.
Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease) and psoriasis Your doctor will start your treatment with two infliximab intravenous infusion doses of 5 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection).
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.
Crohn’s disease and ulcerative colitis Your doctor will start your treatment with two or three infliximab intravenous infusion doses of 5 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are administered 2 weeks apart via intravenous infusion and additional intravenous infusion may be given 4 weeks after the second infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection).
The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.
How Remsima is given • Remsima 120 mg solution for injection is administered by injection under the skin (subcutaneous use) only. It is important to check the product labels to ensure that the correct formulation is being given as prescribed.
• For patients with rheumatoid arthritis, your doctor may start your Remsima treatment with or without infliximab intravenous infusion doses. For patients with ankylosing spondylitis, psoriatic arthritis or psoriasis, two infliximab intravenous infusion doses will be given to start your Remsima treatment. For patients with Crohn’s disease or ulcerative colitis, two or three infliximab intravenous infusion doses will be given to start your Remsima treatment.
• For rheumatoid arthritis patients, if Remsima treatment is initiated without two infliximab intravenous infusion doses, the table below shows how often you will usually have Remsima 120 mg subcutaneous after your first dose.
2 nd dose 1 week after your 1 st dose
3 rd dose 2 weeks after your 1 st dose
4 th dose 3 weeks after your 1 st dose
5 th dose 4 weeks after your 1 st dose
Further doses 6 weeks after your 1 st dose and every 2 weeks thereafter
• Infliximab intravenous infusion doses will be given 2 weeks apart by your doctor or nurse and additional intravenous infusion may be given 4 weeks after the second infusion for Crohn’s disease and ulcerative colitis under your doctor’s discretion to start your Remsima treatment. The first Remsima subcutaneous injection will be given 4 weeks after the last intravenous infusion followed by Remsima subcutaneous injections given every 2 weeks.
• The first subcutaneous injection of Remsima will be administered under the supervision of your doctor.
• After proper training, if you feel you are well-trained and confident to inject Remsima yourself, your doctor may allow you to inject subsequent doses of Remsima yourself at home.
• Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed “Instructions for Use” at the end of this leaflet.
If you use more Remsima than you should If you have used more Remsima than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor, pharmacist or nurse immediately. Always have the outer carton of the medicine with you, even if it is empty.
If you forget to use Remsima Missed dose for up to 7 days
If you miss a dose of Remsima for up to 7 days, after the original scheduled dose, you should take the missed dose immediately. Take your next dose on the next originally planned date and then follow the original dosing schedule.
Missed dose for 8 days or more
If you miss a dose of Remsima for 8 days or more, after the original scheduled dose, you should not take the missed dose. Take your next dose on the next originally planned date and then follow the original dosing schedule.
If you are not sure when to inject Remsima, call your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However some patients may experience serious side effects and may require treatment. Side effects may also occur after your treatment with Remsima has stopped.
Tell your doctor straight away if you notice any of the following: • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles. Some of these reactions may be serious or life-threatening. An allergic reaction could happen within 2 hours of your injection or later. More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
• Signs of a local injection site reaction such as redness, pain, itching, swelling, hardness, bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, blisters and scab.
• Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
• Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
• Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
• Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest.
• Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
• Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
• Signs of an immune system disorder called lupus such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis).
• Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
• Signs of serious skin problems such as reddish-target-like spots or circular patches often with central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body. These skin reactions can be accompanied by fever.
Tell your doctor straight away if you notice any of the above.
The following side effects have been observed with Remsima:
Very common: may affect more than 1 in 10 people
• Stomach pain, feeling sick
• Viral infections such as herpes or flu
• Upper respiratory infections such as sinusitis
• Headache
• Side effect due to an injection
• Pain.
Common: may affect up to 1 in 10 people
• Changes in how your liver works, increase in liver enzymes (shown in blood tests)
• Lung or chest infections such as bronchitis or pneumonia
• Difficult or painful breathing, chest pain
• Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
• Nettle-type rash (hives), itchy rash or dry skin
• Balance problems or feeling dizzy
• Fever, increased sweating
• Circulation problems such as low or high blood pressure
• Bruising, hot flush or nosebleed, warm, red skin (flushing)
• Feeling tired or weak
• Bacterial infections such as blood poisoning, abscess or infection of the skin (cellulitis)
• Infection of the skin due to a fungus
• Blood problems such as anaemia or low white blood cell count
• Swollen lymph nodes
• Depression, problems sleeping
• Eye problems, including red eyes and infections
• Fast heart beat (tachycardia) or palpitations
• Pain in the joints, muscles or back
• Urinary tract infection
• Psoriasis, skin problems such as eczema and hair loss
• Reactions at the injection site such as pain, swelling, redness or itching
• Chills, a build-up of fluid under the skin causing swelling
• Feeling numb or having a tingling feeling.
Uncommon: may affect up to 1 in 100 people
• Shortage of blood supply, swelling of a vein
• Collection of blood outside the blood vessels (haematoma) or bruising
• Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly, and flaky skin
• Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
• Wounds taking longer to heal
• Swelling of the liver (hepatitis) or gall bladder, liver damage
• Feeling forgetful, irritable, confused, nervous
• Eye problems including blurred or reduced vision, puffy eyes or sties
• New or worsening heart failure, slow heart rate
• Fainting
• Convulsions, nerve problems
• A hole in the bowel or blockage of the intestine, stomach pain or cramps
• Swelling of your pancreas (pancreatitis)
• Fungal infections such as yeast infection, or fungal infection of the nails
• Lung problems (such as oedema)
• Fluid around the lungs (pleural effusion)
• Narrowed airway in the lungs, causing difficulty breathing
• Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
• Tuberculosis
• Kidney infections
• Low platelet count, too many white blood cells
• Infections of the vagina
• Blood test result showing ‘antibodies’ against your own body.
• Changes in cholesterol and fat levels in the blood.
• Weight gain (for most patients, the weight gain was small).
Rare: may affect up to 1 in 1,000 people
• A type of blood cancer (lymphoma)
• Your blood not supplying enough oxygen to your body, circulation problems such as narrowing of a blood vessel
• Inflammation of the lining of the brain (meningitis)
• Infections due to a weakened immune system
• Hepatitis B infection when you have had hepatitis B in the past
• Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
• Liver problem that causes yellowing of the skin or eyes (jaundice)
• Abnormal tissue swelling or growth
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening (anaphylactic shock)
• Swelling of small blood vessels (vasculitis)
• Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)
• Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
• Lack of interest or emotion
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
• Other skin problems such as erythema multiforme, blisters and peeling skin, or boils (furunculosis)
• Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
• Inflammation in the eye that may cause changes in the vision, including blindness
• Fluid in the lining of the heart (pericardial effusion)
• Serious lung problems (such as interstitial lung disease)
• Melanoma (a type of skin cancer)
• Cervical cancer
• Low blood counts, including a severely decreased number of white blood cells.
• Small red or purple spots caused by bleeding under the skin
• Abnormal values of a blood protein called ‘complement factor’ which is part of the immune system
• Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Not known: frequency cannot be estimated from the available data
• Cancer
• A rare blood cancer affecting mostly young men (hepatosplenic T-cell lymphoma)
• Liver failure
• Merkel cell carcinoma (a type of skin cancer)
• Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin.
• Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
• Heart attack
• Stroke
• Temporary loss of sight during or within 2 hours of infusion
• Infection due to a live vaccine because of a weakened immune system.
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 via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
• 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 label and the carton after “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 pen in the outer carton in order to protect from light.
• This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to 28 days, but not beyond the original expiry date. In this situation, do not return to refrigerated storage again. Write the new expiry date on the carton including day/month/year. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Remsima contains • The active substance is infliximab. Each 1 ml single dose pre-filled pen contains 120 mg of infliximab.
• The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and water for injections.
What Remsima looks like and contents of the pack Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled pen.
Remsima 120 mg solution for injection in pre-filled pen with 27-gauge staked needle, purple plunger rod is supplied in pack containing 2 pre-filled pens with 2 alcohol pads.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Celltrion Healthcare United Kingdom Limited
The Charter Building, Charter Place
Uxbridge
UB8 1JG
United Kingdom
Manufacturer Biotec Services International Ltd.
Biotec House, Central Park, Western Avenue
Bridgend Industrial Estate
Bridgend
CF31 3RT
United Kingdom
Biotec Services International Ltd.
Units 2100, 2110, 2010, 2120, 2130 and 2500
Phase 18, Central Park
Bridgend Industrial Estate
Bridgend
CF31 3TY
United Kingdom
Millmount Healthcare Ltd.
Block 7
City North Business Campus
Stamullen
Co. Meath
K32 YD60
Ireland
Nuvisan GmbH
Wegenerstraße 13
89231 Neu Ulm
Germany
Nuvisan France SARL
2400, Route des Colles
06410, Biot
France
Midas Pharma GmbH
Rheinstraße 49
55218 Ingelheim am Rhein
Germany
For any information about this medicine, please contact the Marketing Authorisation Holder:
United Kingdom Celltrion Healthcare United Kingdom Limited
Tel: +44 (0) 1753 983 500 This leaflet was last revised in 06/2026.
Remsima 120 mg/1 ml Solution for injection pre-filled pen (purple) comes as solution containing 120 mg/1. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Remsima 120 mg/1 ml Solution for injection pre-filled pen (purple) is infliximab.
Medicines with the same active substance include: Flixabi 100 mg powder for concentrate for solution for infusion, Inflectra 100 mg powder for concentrate for solution for infusion, Remicade 100mg powder for concentrate for solution for infusion, Remsima 100 mg powder for concentrate for solution for infusion, Remsima 120 mg solution for injection in pre-filled pen. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Remsima 120 mg/1 ml Solution for injection pre-filled pen (purple), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Rheumatoid arthritis
Remsima, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
• adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X‑ray, has been demonstrated (see section 5.1).
Crohn's disease
Remsima is indicated for:
• treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
• treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Ulcerative colitis
Remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Ankylosing spondylitis
Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Remsima should be administered
• in combination with methotrexate
• or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.
Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).
Psoriasis
Remsima is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated. Patients treated with Remsima should be given the package leaflet and the patient reminder card. Instruction for use is provided in the package leaflet.
For subsequent injections and after proper training in subcutaneous injection technique, patients may self-inject with Remsima if their physician determines that it is appropriate and with medical follow-up as necessary. Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose. Patients should seek immediate medical attention if developing symptoms of serious allergic reactions (see section 4.4).
During Remsima treatment, other concomitant therapies, e.g., corticosteroids and immunosuppressants should be optimised.
It is important to check the product labels to ensure that the correct formulation (intravenous or subcutaneous) is being administered to the patient, as prescribed. Remsima subcutaneous formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
Posology
Adults (≥18 years)
Rheumatoid arthritis
Treatment with Remsima subcutaneous formulation should be initiated with loading doses of infliximab which may be intravenous or subcutaneous. When subcutaneous loading is used, Remsima 120 mg should be given as a subcutaneous injection followed by additional subcutaneous injections at 1, 2, 3 and 4 weeks after the first injection, then every 2 weeks thereafter. If intravenous loading doses of infliximab are given to initiate treatment, 2 intravenous infusions of infliximab 3 mg/kg should be given 2 weeks apart. The first treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the second intravenous administration. The recommended maintenance dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.
Remsima must be given concomitantly with methotrexate.
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment (see section 5.1).
Moderately to severely active Crohn's disease
The first treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of intravenous infusions. Before initiating treatment with Remsima subcutaneous formulation, 2 intravenous infusions of infliximab 5 mg/kg should be given at 2 weeks apart, and an additional intravenous infusion of infliximab 5 mg/kg may be given 4 weeks after the second infusion. The recommended maintenance dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond after loading doses of intravenous infliximab, no additional treatment with infliximab should be given. Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.
Limited data in patients who initially responded to induction regimen with infliximab but who lost response indicate that some patients may regain response with dose escalation (see section 5.1). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
Fistulising, active Crohn's disease
The first treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of intravenous infusions. Before initiating treatment with Remsima subcutaneous formulation, 2 intravenous infusions of infliximab 5 mg/kg should be given at 2 weeks apart, and an additional intravenous infusion of infliximab 5 mg/kg may be given 4 weeks after the second infusion. The recommended maintenance dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond after loading doses of intravenous infliximab, no additional treatment with infliximab should be given. Available data do not support further infliximab treatment, in patients not responding within 14 weeks of the initial infusion.
Limited data in patients who initially responded to induction regimen with infliximab but who lost response indicate that some patients may regain response with dose escalation (see section 5.1). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
In Crohn's disease, experience with re‑administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Ulcerative colitis
The first treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of intravenous infusions. Before initiating treatment with Remsima subcutaneous formulation, 2 intravenous infusions of infliximab 5 mg/kg should be given at 2 weeks apart, and an additional intravenous infusion of infliximab 5 mg/kg may be given 4 weeks after the second infusion. The recommended maintenance dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.
Available data suggest that the clinical response is usually achieved within 14 weeks of treatment (see section 5.1). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Ankylosing spondylitis
Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient does not respond by 6 weeks (i.e. after 2 intravenous infusions), no additional treatment with infliximab should be given.
Psoriatic arthritis
Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.
Psoriasis
Treatment with Remsima administered subcutaneously should be initiated as maintenance therapy 4 weeks after the last administration of two intravenous infusions of infliximab 5 mg/kg given 2 weeks apart. The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks. If a patient shows no response after 14 weeks (i.e. 2 intravenous infusions and 5 subcutaneous injections), no additional treatment with infliximab should be given.
Re‑administration for Crohn's disease and rheumatoid arthritis
From experience with intravenous infliximab, if the signs and symptoms of disease recur, infliximab can be re‑administered within 16 weeks following the last administration. In clinical studies with intravenous infliximab, delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year (see sections 4.4 and 4.8). The safety and efficacy of re‑administration after an infliximab-free interval of more than 16 weeks has not been established. This applies to both Crohn's disease patients and rheumatoid arthritis patients.
Re‑administration for ulcerative colitis
From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Re-administration for ankylosing spondylitis
From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Re-administration for psoriatic arthritis
From experience with intravenous infliximab, the safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Re-administration for psoriasis
Limited experience from re-treatment with one single intravenous infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Limited experience from re-treatment of intravenous infliximab following disease flare by a re‑induction regimen suggests a higher incidence of infusion reactions, including serious ones, when compared to 8-weekly maintenance treatment of intravenous infliximab (see section 4.8).
Re‑administration across indications
In case maintenance therapy is interrupted, and there is a need to restart treatment, use of a re‑induction regimen of intravenous infliximab is not recommended (see section 4.8). In this situation, infliximab should be re‑initiated as a single dose of intravenous infliximab followed by the maintenance dose recommendations of subcutaneous infliximab described above given 4 weeks after the last administration of intravenous infliximab.
Switching to and from Remsima subcutaneous formulation across indications
When switching from the maintenance therapy of infliximab intravenous formulation to the subcutaneous formulation of Remsima, the subcutaneous formulation may be administered at the time of next planned administration of the intravenous infusions of infliximab.
There is insufficient information regarding the switching of patients who received the intravenous infusions of infliximab higher than 3 mg/kg for rheumatoid arthritis or 5 mg/kg for Crohn's disease every 8 weeks to the subcutaneous formulation of Remsima.
Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available.
Missed dose
If patients miss an injection of Remsima subcutaneous formulation, they should be instructed to take the missed dose immediately in case this happens within 7 days from the missed dose, and then remain on their original dosing schedule. If the dose is delayed by 8 days or more, the patients should be instructed to skip the missed dose, wait until their next scheduled dose, and then remain on their original dosing schedule.
Special populations
Elderly
Specific studies of infliximab in elderly patients have not been conducted. No major age-related differences in clearance or volume of distribution were observed in clinical studies with infliximab intravenous formulations and the same is expected for subcutaneous formulation. No dose adjustment is required (see section 5.2). For more information about the safety of infliximab in elderly patients (see sections 4.4 and 4.8).
Renal and/or hepatic impairment
Infliximab has not been studied in these patient populations. No dose recommendations can be made (see section 5.2).
Paediatric population
The safety and efficacy of Remsima subcutaneous therapy in children aged below 18 years of age have not yet been established. No data are available. Therefore, subcutaneous use of Remsima is recommended for use only in adults.
Method of administration
Remsima 120 mg solution for injection in pre-filled pen is administered by subcutaneous injection only. Full instructions for use are provided in the package leaflet. For the two initial intravenous infusions, patients may be pre‑treated with, e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion‑related reactions especially if infusion-related reactions have occurred previously (see section 4.4). The physician should ensure appropriate follow-up of patients for any systemic injection reaction and localised injection site reaction after the initial subcutaneous injection is administered.
Hypersensitivity to the active substance, to other murine proteins or to any of the excipients listed in section 6.1.
Patients with tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections (see section 4.4).
Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
No interaction studies have been performed.
In rheumatoid arthritis, psoriatic arthritis and Crohn's disease patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab. However, the results are uncertain due to limitations in the methods used for serum analyses of infliximab and antibodies against infliximab.
Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
The combination of infliximab with other biological therapeutics used to treat the same conditions as infliximab, including anakinra and abatacept, is not recommended (see section 4.4).
It is recommended that live vaccines not be given concurrently with Remsima. It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for 12 months following birth. If infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier timepoint if there is a clear clinical benefit for the individual infant (see section 4.4).
Administration of a live vaccine to a breastfed infant while the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable (see sections 4.4 and 4.6).
It is recommended that therapeutic infectious agents not be given concurrently with infliximab (see section 4.4).
Women of childbearing potential
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last infliximab treatment.
Pregnancy
The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1,100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p‑value) for C-section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies). The potential contribution of exposure to infliximab and/or the severity of the underlying disease in these outcomes remains unclear.
Due to its inhibition of TNFα, infliximab administered during pregnancy could affect normal immune responses in the newborn. In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity (see section 5.3).
The available clinical experience is limited. Infliximab should only be used during pregnancy if clearly needed.
Infliximab crosses the placenta and has been detected in the serum of infants up to 12 months following birth. After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal. Administration of live vaccines (e.g. BCG vaccine) to infants exposed to infliximab in utero is not recommended for 12 months after birth (see sections 4.4 and 4.5). If infant infliximab serum levels are undetectable or infliximab administration was limited to the first trimester of pregnancy, administration of a live vaccine might be considered at an earlier timepoint if there is a clear clinical benefit for the individual infant. Cases of agranulocytosis have also been reported (see section 4.8).
Breast-feeding
Limited data from published literature indicate infliximab has been detected at low levels in human milk at concentrations up to 5% of the maternal serum level. Infliximab has also been detected in infant serum after exposure to infliximab via breast milk. While systemic exposure in a breastfed infant is expected to be low because infliximab is largely degraded in the gastrointestinal tract, the administration of live vaccines to a breastfed infant when the mother is receiving infliximab is not recommended unless infant infliximab serum levels are undetectable. Infliximab could be considered for use during breast-feeding.
Fertility
There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3).
Remsima may have a minor influence on the ability to drive and use machines. Dizziness may occur following administration of infliximab (see section 4.8).
Single intravenous doses up to 20 mg/kg have been administered without toxic effects and repeated doses of Remsima subcutaneous formulation up to 240 mg have been administered without toxic effects. There is no specific treatment for Remsima overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
Ask anything about Remsima 120 mg/1 ml Solution for injection pre-filled pen (purple). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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