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Infliximab subcutaneous injection

Updated 2 Feb 2023 | Cytokine modulators


Solution for injection of infliximab.

Drugs List

  • infliximab 120mg/1ml solution for injection pre-filled device
  • infliximab 120mg/1ml solution for injection pre-filled syringe
  • REMSIMA 120mg/1ml solution for injection pre-filled pen
  • REMSIMA 120mg/1ml solution for injection pre-filled syringe
  • Therapeutic Indications


    Rheumatoid arthritis when inadequate response to DMARDs incl. methotrexate
    Severe active rheumatoid arthritis

    Adult Rheumatoid arthritis (in combination with methotrexate) Reduction of signs and symptoms as well as the improvement in physical function in patients with: Active disease when the response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate. Severe, active progressive disease not previously treated with methotrexate or other DMARDs.


    Increasing the infliximab free interval may increase the risk for delayed hypersensitivity reactions.


    Rheumatoid arthritis
    Maintenance therapy with subcutaneous infliximab should be initiated 4 weeks after the last administration of two intravenous infusions of infliximab 3mg/kg given 2 weeks apart. The recommended dose for subcutaneous infliximab is 120mg once every 2 weeks.

    Must be given concurrently with methotrexate.

    When switching from the maintenance therapy of intravenous infliximab to subcutaneous infliximab, the subcutaneous formulation may be administered 8 weeks after the last administration of intravenous infliximab 3mg/kg given every 8 weeks. There is insufficient data for switching patients who receive more than 3mg/kg of intravenous infliximab every 8 weeks onto subcutaneous infliximab.

    There is no information available for switching patients from subcutaneous infliximab back onto intravenous infliximab.

    Clinical response is usually seen within 12 weeks of treatment. Carefully reconsider continued treatment if the patient shows no evidence of therapeutic effect within the first 12 weeks of treatment.

    Re-administration for rheumatoid arthritis
    From experience with intravenous infliximab, if signs and symptoms of rheumatoid arthritis recur, infliximab can be re-administered within 16 weeks from the last administration. Delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year. The safety and efficacy of re-administration of infliximab after a 16 week infliximab-free period has not been established.

    Additional Dosage Information

    Missed dose
    If a patient misses a subcutaneous injection of infliximab within 7 days of the missed dose, they should take the missed dose immediately. Then they should remain on their original bi-weekly dosing schedule.

    If the dose is missed by 8 days or more, then the patient should skip the missed dose and wait until their next scheduled dose. Then they remain on their original bi-weekly dosing schedule.


    Infliximab pre-filled device and pre-filled syringe are administered by subcutaneous injection only. Full instructions for use are provided in the patient information leaflet. The prescriber should ensure appropriate follow-up with patients if any systemic or localised injection reactions occur after the initial subcutaneous injection.


    Children under 18 years
    Severe infection
    Hereditary fructose intolerance
    New York Heart Association class III failure

    Precautions and Warnings

    Females of childbearing potential
    History of immunosuppressant treatment
    History of recurrent infection
    Tobacco smoking
    Central nervous system demyelinating disorder
    Hepatic impairment
    Hepatitis B
    History of cancer
    Latent or healed tuberculosis
    Malignant neoplasm
    New York Heart Association class I failure
    Renal impairment

    Administration of live vaccines is not recommended
    Consider anti-TB therapy in patients with latent TB
    Disease reactivation may occur in patients with latent TB
    May mask symptoms or signs of infections
    Advise ability to drive/operate machinery may be affected by side effects
    Before initiating screen at risk patients for hepatitis B infection
    Before starting therapy ensure immunisations are up to date
    Consider pre-medication with antihistamines and/or antipyretics
    Consider premedication with a corticosteroid
    Exclude tubercular infection before treatment
    Treatment to be initiated and supervised by a specialist
    Contains polysorbate
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    For subcutaneous use only
    Record name and batch number of administered product
    Monitor all parameters for at least 6 months post treatment cessation
    Monitor closely any patient who develops new infection while on treatment
    Monitor retreated patients for symptoms of delayed hypersensitivity
    Monitor skin changes
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Advise patient to seek med advice if signs/symptoms of tuberculosis develop
    Anaphylactic reactions may occur within seconds or few hours after infusion
    Antibodies to ingredient may develop and are not always detectable in serum
    Immunosuppressive drugs may increase risk of malignancy
    Monitor for hypersensitivity reactions for 1 hour after administration
    Reactivation of hepatitis B may occur in chronic carriers
    False negative tuberculin test results in immunosupp./severely ill patients
    Consider discontinuation if demyelinating disorders develop or worsen
    Consider discontinuation if severe haematological events occur
    Discontinue and investigate if symptoms of lupus-like syndrome develop
    Discontinue at the first signs of cardiac failure
    Discontinue if ALT level exceeds 5 times the upper limit of normal
    Discontinue if hypersensitivity reactions occur
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if worsening symptoms of cardiac failure develop
    Discontinue treatment if patient develops a serious infection
    Female: Contraception advised during and for 6 months after treatment
    Breastfeeding: Do not breastfeed during & for 6 months after treatment
    Advise patient to seek medical advice if delayed adverse event(s) occurs
    Remind patient of importance of carrying Alert Card with them at all times

    Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer as melanoma and Merkel cell carcinoma have been reported with TNF blocker therapy, including infliximab.

    Injection reactions and hypersensitivity
    Antibodies directed towards infliximab may develop and have been associated with increased frequency of infusion reactions when administered by intravenous infusion and reduced duration of response. Concomitant administration of immunomodulators has been associated with lower incidence of antibodies and a reduction in infusion reactions. The effect of immunomodulators was greater in patients treated episodically rather than those on maintenance treatment. If serious reactions occur, symptomatic treatment must be given and further infliximab must not be administered.

    Before starting treatment, all patients must be evaluated for both active and inactive (latent) tuberculosis (TB). Appropriate screening tests, i.e. tuberculin skin test, interferon gamma release assay and chest X-ray, should be performed in all patients (local recommendations may apply). It is recommended that the conduct of these tests should be recorded in the patient's alert card.

    If latent tuberculosis is diagnosed, anti-tuberculosis therapy must be started before initiation of infliximab therapy in accordance with local recommendations. Consideration of treatment with anti-tuberculosis therapy should be given to patients with several or significant risk factors for TB (but have a negative test for latent TB) and in patients with a history of TB in whom an adequate course of treatment cannot be confirmed. Patients should be advised to seek medical advice if signs/symptoms suggestive of infection occur.

    Chronic carriers of hepatitis B should be evaluated and monitored prior to, during and for several months after treatment has finished. In patients who develop hepatitis B reactivation, infliximab should be stopped and an effective anti-viral with supportive treatment should be initiated.

    It is recommended that all patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating therapy. Administration of live vaccines to infants exposed to infliximab in utero is not recommended for at least 6 months after birth.

    Live vaccines or therapeutic infectious products should not be given during treatment with infliximab.

    Pregnancy and Lactation


    Use infliximab with caution during pregnancy.

    The manufacturer recommends that infliximab should only be used during pregnancy if clearly needed.

    Post marketing reports from approximately 1100 pregnancies exposed to infliximab during the first trimester do not indicate an increased rate of malformation in the newborn.

    Due to its inhibition of TNF alpha, infliximab administered during pregnancy could affect normal immune responses in the newborn. In an animal study inhibiting TNF alpha activity, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.

    Infliximab crosses the placenta and has been detected for up to 6 months in the serum of infants born to women exposed to infliximab during pregnancy. These infants may be at an increased risk of infection.

    Schaefer (2015) recommends that infliximab does not need to be stopped when planning a pregnancy. Treatment in the second/third trimester should be reserved for justifiable indications. Discontinuation of therapy is recommended by gestational week 30. A detailed foetal ultrasound may be offered to confirm normal foetal development. Infliximab in the second half of pregnancy should also result in the close monitoring of the pregnant woman and the foetus sonographically monitored.


    Use infliximab with caution during breastfeeding.

    The manufacturer states that it is not known if infliximab is excreted in human milk or absorbed systemically after ingestion. They recommend that mothers must not breastfeed for at least 6 months after treatment.

    Lactmed (2020) states the despite the manufacturer recommendations, other sources state that the drug is a low risk to the nursing infant and breastfeeding can continue during infliximab use.

    Side Effects

    Anaphylactic reaction
    Antibody formation
    Cardiac disorders
    Cardiac failure
    Cerebrovascular accident
    Chest pain
    Circulatory failure
    Complement factor abnormality
    Delayed hypersensitivity reactions
    Demyelinating disorders
    Gastro-intestinal haemorrhage
    Gastro-intestinal perforation
    Gastro-intestinal symptoms
    Granulomatous lesions
    Haematological reactions
    Haemolytic anaemia
    Hepatic failure
    Hepatic impairment
    Hypersensitivity reactions
    Idiopathic thrombocytopenic purpura (ITP)
    Impaired healing
    Injection site reactions
    Interstitial lung disease
    Linear IgA bullous dermatosis
    Lupus erythematosus-like syndrome
    Myocardial infarction
    Myocardial ischaemia
    Pericardial effusion
    Peripheral ischaemia
    Pleural effusion
    Pulmonary oedema
    Reactivation of hepatitis B
    Serum sickness-like reactions
    Skin reactions
    Stevens-Johnson syndrome
    Thrombotic thrombocytopenic purpura
    Toxic epidermal necrolysis
    Transverse myelitis
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2020

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Remsima 120mg solution for injection. Celltrion Healthcare UK Limited. Revised February 2020.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Infliximab Last revised: 30 January 2020
    Last accessed: 07 April 2020

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