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Indications Dosing Administration Device Safety Information

Safety Information1

Please refer to the full Prescribing Information for Remsima® to see more information.
Provide the Medication Guide to your patients and encourage discussion.


    Remsima® SC is contraindicated in patients with hypersensitivity to the active substance, to other murine proteins or to any of the following excipients:

    • Sucrose
    • Polysorbate 80
    • Sodium dihydrogen phosphate monohydrate
    • Disodium phosphate dihydrate

    Remsima® SC should not be used in patients with

    • Tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections.
    • Moderate or severe heart failure (NYHA class III/IV).

    Special warnings and precautions for use


    In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.

    Systemic injection reaction/ localised injection site reaction/ hypersensitivity:

    Infliximab has been associated with systemic injection reactions, anaphylactic shock and delayed hypersensitivity reactions. Acute reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following administration of infliximab. For this reason, the initial intravenous administrations should take place where emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway is immediately available. Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects. Localised injection site reactions predominantly of mild to moderate in nature included the following reactions limited to injection site: erythema, pain, pruritus, swelling, induration, haematoma, oedema, bruising, coldness, irritation, paraesthesia, ulcer, urticaria, haemorrhage, rash and scab were reported to be associated with infliximab subcutaneous treatment. Most of these reactions may occur immediately or within 24 hours after subcutaneous injection.
    Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions when administered by intravenous infusion. A low proportion of the infusion reactions was serious allergic reactions. An association between development of antibodies to infliximab and reduced duration of response has also been observed with intravenously administered infliximab. Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and in the case of intravenously administered infliximab, a reduction in the frequency of infusion reactions. The effect of concomitant immunomodulator therapy was more profound in episodically-treated patients than in patients given maintenance therapy. Patients who discontinue immunosuppressants prior to or during infliximab treatment are at greater risk of developing these antibodies.
    Antibodies to infliximab cannot always be detected in serum samples. If serious reactions occur, symptomatic treatment must be given and further infliximab must not be administered.
    Available data suggest an increased risk for delayed hypersensitivity with increasing infliximab free interval. Patients should be advised to seek immediate medical advice if they experience any delayed adverse reaction. If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.


    Patients must be monitored closely for infections including tuberculosis before, during and after treatment with infliximab. Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period. Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis. Caution should be exercised when considering the use of infliximab in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy. Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate. Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses. Experimental data show that TNFα is essential for the clearing of intracellular infections. Clinical experience shows that host defence against infection is compromised in some patients treated with infliximab. It should be noted that suppression of TNFα may mask symptoms of infection such as fever. Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment. Patients taking TNF-blockers are more susceptible to serious infections. Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients treated with infliximab. Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis. Patients, who develop a new infection while undergoing treatment with infliximab, should be monitored closely and undergo a complete diagnostic evaluation. Administration of infliximab should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.


    There have been reports of active tuberculosis in patients receiving infliximab. It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease. Before starting treatment with infliximab, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis. If active tuberculosis is diagnosed, infliximab therapy must not be initiated. If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. In all situations described below, the benefit/risk balance of infliximab therapy should be very carefully considered. If inactive (‘latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of infliximab, and in accordance with local recommendations. In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of infliximab. Use of anti-tuberculosis therapy should also be considered before the initiation of infliximab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis appear during or after infliximab treatment.

    Invasive fungal infections:

    Invasive fungal infections may present as disseminated rather than localised disease, and antigen and antibody testing may be negative in some patients with active infection. Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed taking into account both the risk for severe fungal infection and the risks of antifungal therapy.

    Fistulising Crohn’s disease:

    Patients with fistulising Crohn’s disease with acute suppurative fistulas must not initiate infliximab therapy until a source for possible infection, specifically abscess, has been excluded.

    Hepatitis B (HBV) reactivation:

    Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus. Patients should be tested for HBV infection before initiating treatment with infliximab. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Carriers of HBV who require treatment with infliximab should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, infliximab should be stopped and effective antiviral therapy with appropriate supportive treatment should be initiated.

    Hepatobiliary events:

    Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of infliximab. Isolated cases of liver failure resulting in liver transplantation or death have occurred. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or ALT elevations≥5 times the upper limit of normal develop(s), infliximab should be discontinued, and a thorough investigation of the abnormality should be undertaken.

    Concurrent administration of TNF-alpha inhibitor and anakinra:

    Serious infections and neutropenia were seen in clinical studies with concurrent use of anakinra and another TNF-blocking agent, etanercept, with no added clinical benefit compared to etanercept alone. Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα-blocking agents. Therefore, the combination of infliximab and anakinra is not recommended.

    Concurrent administration of TNF-alpha inhibitor and abatacept:

    In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit. The combination of infliximab and abatacept is not recommended.

    Concurrent administration with other biological therapeutics:

    The concomitant use of infliximab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions.

    Switching between biological DMARDs:

    Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse reactions, including infection.


    It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remsima® therapy. Patients on infliximab may receive concurrent vaccinations, except for live vaccines.

    Live vaccines/therapeutic infectious agents:

    Use of live vaccines can result in clinical infections, including disseminated infections. The concurrent administration of live vaccines with infliximab is not recommended. In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (BCG) infection has been reported following administration of BCG vaccine after birth. At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab. It is recommended that therapeutic infectious agents not be given concurrently with infliximab.

    Autoimmune processes:

    The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with infliximab and is positive for antibodies against double-stranded DNA, further treatment with infliximab must not be given.

    Neurological events:

    In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of anti-TNF treatment should be carefully considered before initiation of infliximab therapy. Discontinuation of infliximab should be considered if these disorders develop.

    Malignancies and lymphoproliferative disorders:

    In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation. With the current knowledge, a risk for the development of lymphomas or other malignancies in patients treated with a TNF-blocking agent cannot be excluded. Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents including infliximab. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Almost all patients had received treatment with AZA or 6-MP concomitantly with or immediately prior to a TNF-blocker. The vast majority of infliximab cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were reported in adolescent or young adult males. The potential risk with the combination of AZA or 6-MP and infliximab should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with infliximab cannot be excluded. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma, or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course. This evaluation should include colonoscopy and biopsies per local recommendations. Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer. Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.

    Heart failure:

    Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II). Patients should be closely monitored and infliximab must not be continued in patients who develop new or worsening symptoms of heart failure.

    Haematologic reactions:

    All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias. Discontinuation of infliximab therapy should be considered in patients with confirmed significant haematologic abnormalities.


    There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty. The long half-life of infliximab should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on infliximab should be closely monitored for infections, and appropriate actions should be taken.
    Failure to respond to treatment for Crohn’s disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment. There is no evidence to suggest that infliximab worsens or causes fibrotic strictures.

    For more information, please see full Prescribing Information for Remsima®. Provide the Medication Guide to your patients and encourage discussion.

    For a full list of reported side effects please see the Summary of Product Characteristics and/or the Prescribing Information.

    Side Effects

    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
    • Signs of a heart problem
    • Signs of infection (including TB)
    • Possible signs of cancer
    • Signs of a lung problem
    • Signs of a nervous system problem (including eye problems)
    • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past)
    • Signs of an immune system disorder called lupus
    • Signs of low blood counts
    • Signs of serious skin problems

    The following side effects have been observed with Remsima®:

    Very Common (1 in 10 people or more)
    • Stomach pain, feeling sick
    • Viral infections such as herpes or flu
    • Upper respiratory infections such as sinusitis
    • Headache
    • Side effect due to an infusion
    • Pain
    Common (1 in 10 people or less)
    • 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 (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
    Rare (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)


1. Remsima® Summary of Product Characteristics. Available at:®-epar-product-information_en.pdf Accessed 4 Sep 2020.


SC, subcutaneous