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Golimumab parenteral

Updated 2 Feb 2023 | Cytokine modulators


Parenteral formulations of golimumab.

These products have been produced by recombinant technology using murine hybridoma cell lines.

Drugs List

  • golimumab pre-filled pen 100mg injection solution
  • golimumab pre-filled pen 50mg injection solution
  • golimumab pre-filled syringe 50mg injection solution
  • SIMPONI PRE-FILLED PEN 100mg injection solution
  • SIMPONI PRE-FILLED PEN 50mg injection solution
  • SIMPONI PRE-FILLED SYRINGE 50mg injection solution
  • Therapeutic Indications


    Juvenile idiopathic arthritis
    Moderate/severe ulcerative colitis: when other treatment is inappropriate
    Rheumatoid arthritis: Combination treatment
    Severe ankylosing spondylitis in adults if conventional therapy inadequate
    Severe axial spondyloarthritis without radiographic evidence of AS
    Treatment of active & progressive psoriatic arthritis when DMARD inadequate

    Rheumatoid arthritis (RA)
    Golimumab, in combination with methotrexate (MTX), is indicated for:
    -The treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
    -The treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.

    Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

    Juvenile idiopathic arthritis
    Polyarticular juvenile idiopathic arthritis (pJIA)
    Golimumab, in combination with MTX, is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children aged 2 years and older with a body weight of at least 40kg, who have responded inadequately to previous therapy with MTX.

    Psoriatic arthritis (PsA)
    Golimumab, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

    Axial spondyloarthritis
    Ankylosing spondylitis (AS)
    Golimumab is indicated for the treatment of severe, active ankylosing spondylitis in patients who have responded inadequately to conventional therapy.

    Non-radiographic axial spondyloarthritis (nr-Axial SpA)
    Golimumab is indicated for the treatment of patients with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to non steroidal anti-inflammatory drugs (NSAIDs).

    Ulcerative colitis (UC)
    Golimumab is indicated for the treatment of moderately to severely active ulcerative colitis in 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.



    Rheumatoid arthritis
    50mg given once a month, on the same date each month.
    Methotrexate should be given concurrently, according to recommended dosage.

    Psoriatic arthritis
    50mg given once a month, on the same date each month.
    Golimumab can be given alone, or in combination with methotrexate.

    Ankylosing spondylitis
    50mg given once a month, on the same date each month.

    Non-radiographic axial spondyloarthritis (nr-Axial SpA)
    50mg given once a month, on the same date each month.

    Increasing the dose of golimumab to 100mg once a month may be considered for patients weighing more than 100kg who have not achieved adequate clinical response after 3 or 4 doses. Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100mg.

    Ulcerative colitis
    Patients with body weight less than 80kg
    Initial dose of 200mg, followed by 100mg at week 2, if adequate response is achieved then 50mg every 4 weeks, thereafter. If inadequate response is achieved, then 100mg every 4 weeks may be continued.

    Patients with body weight greater than or equal to 80kg
    Initial dose of 200mg, followed by 100mg at week 2, then 100mg every 4 weeks, thereafter.


    Children 2 to 18 years
    Polyarticular juvenile idiopathic arthritis
    50mg given once a month, on the same date each month, for children with a body weight of at least 40kg.

    Additional Dosage Information

    Current data suggests a clinical response is normally achieved within 12 to 14 weeks of initiating treatment (after 3 to 4 doses). Therapy beyond this period should be carefully reconsidered in unresponsive patients.

    If a patient forgets to inject golimumab on the planned date, the forgotten dose should be injected as soon as the patient remembers. Patients should be instructed not to inject a double dose to make up for the forgotten dose.

    A delay of less than two weeks in golimumab administration does not change the original monthly schedule for the patient.

    A delay of more than 2 weeks in golimumab administration requires the establishment of a new once-monthly schedule from the date of the most recent injection.


    For subcutaneous injection only.


    Severe infection
    Hereditary fructose intolerance
    New York Heart Association class III failure

    Precautions and Warnings

    Children under 18 years
    History of recurrent infection
    Patients over 65 years
    Predisposition to demyelinating disorder
    Predisposition to infection
    Tobacco smoking
    Central nervous system demyelinating disorder
    Chronic obstructive pulmonary disease
    Hepatic impairment
    History of cancer
    History of hepatitis B
    Latent or healed tuberculosis
    Malignant neoplasm
    New York Heart Association class I failure
    Severe asthma

    Administration of live vaccines is not recommended
    Before starting therapy ensure immunisations are up to date in children
    Consider prophylactic anti-tuberculosis therapy if appropriate
    Not all available products are licensed for all age groups
    Not all available strengths are licensed for all indications
    Prior to starting therapy rule out active tuberculosis
    Prior to starting therapy screen for latent tuberculosis
    Treat and control infections prior to commencing therapy
    Treatment to be initiated and supervised by a specialist
    Contains polysorbate
    Needle cover contains a derivative of latex
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Record name and batch number of administered product
    May cause activation / exacerbation of latent / intercurrent infections
    Monitor closely any patient who develops new infection while on treatment
    Monitor for active hepatitis B during therapy and for several months after
    Monitor for dysplasia in patients at increased risk of colon cancer
    Monitor for infection for 5 months after treatment
    Monitor for melanoma regularly
    Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
    Monitor skin changes
    Review if an adequate response not obtained within 3 months
    Advise patient to seek med advice if signs/symptoms of tuberculosis develop
    Advise patient to seek urgent medical advice if blood dyscrasias suspected
    Discontinue if a serious infection develops
    Discontinue if hepatitis develops
    Reactivation of hepatitis B may occur in chronic carriers
    Risk of developing opportunistic infections
    False negative tuberculin test results in immunosupp./severely ill patients
    Discontinue and investigate if symptoms of lupus-like syndrome develop
    Discontinue if haematological abnormalities develop
    Discontinue if serious allergic or anaphylactic reaction occurs
    Discontinue or review if symptoms of congestive heart failure occur
    Female: Contraception advised during and for 6 months after treatment
    Breastfeeding: Do not breastfeed during & for 6 months after treatment
    Remind patient of importance of carrying Alert Card with them at all times

    Bacterial, mycobacterial, invasive fungal and opportunistic infections, including fatalities, have been reported in patients treated with golimumab. Some of these infections have occurred in patients on concomitant immunosuppressant therapy. For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of treatment should be carefully considered.

    When switching from one biologic DMARD to another monitor for signs of infection.

    Patients with active tuberculosis should receive a standard anti-tuberculosis treatment for at least 2 months prior to starting golimumab. After receiving adequate treatment for tuberculosis patients using golimumab should be monitored every 3 months for possible recurrence.

    Anti-tuberculosis therapy should be considered before the initiation of golimumab in patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis. Anti-tuberculosis therapy should also be considered before the initiation of golimumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.

    Advise patients to seek medical attention if signs of tuberculosis infection or other opportunistic infections occur during or after treatment. Signs may include persistent cough, wasting/weight loss or low grade fever.

    The safety of performing surgical procedures (including arthroplasty) in patients treated with golimumab has not been established. If a surgical procedure is planned, the long half life of golimumab should be considered. Patients who require surgery during treatment should be closely monitored for infections.

    Pregnancy and Lactation


    Use golimumab with caution during pregnancy.

    Manufacturer does not recommend golimumab during pregnancy and states that it should be given only if clearly needed.

    Golimumab crosses the placenta and has been detected for up to 6 months in the serum of the infant which may increase the risk of infection in the infant. Infants exposed to golimumab in utero should not be given live vaccines for 6 months following the mother's last golimumab injection during pregnancy.

    Animal studies indicate no increased risk of teratogenic or developmental effects.


    Golimumab is contraindicated during breastfeeding.

    Use of golimumab when breastfeeding is contraindicated by the manufacturer.

    The manufacturer recommends avoiding breast-feeding for 6 months after the last golimumab treatment.

    Animal studies showed the presence of golimumab in breast milk.

    Side Effects

    Abdominal pain
    Alanine aminotransferase increased
    Allergic reaction
    Aplastic anaemia
    Aspartate aminotransferase increased
    Bacterial infection
    Bladder dysfunction
    Breast changes
    Chest discomfort
    Congestive cardiac failure
    Coronary artery disorder
    Cutaneous vasculitis
    Demyelinating disorders
    Eye irritation
    Eye pruritus
    Fungal infection
    Gastro-intestinal pain
    Gastroesophageal reflux disease
    Gastrointestinal disorder
    Hepatic disorders
    Hypersensitivity reactions
    Impaired healing
    Injection site reactions
    Interstitial lung disease
    Kaposi's Sarcoma
    Lichenoid rash
    Loss of balance
    Lower respiratory tract infection
    Lupus erythematosus-like syndrome
    Menstrual disturbances
    Opportunistic infections
    Raynaud's phenomenon
    Reactivation of hepatitis B
    Renal disorders
    Septic shock
    Skin exfoliation
    Thyroid abnormalities
    Upper respiratory tract infection
    Viral infection
    Visual disturbances
    Worsening of symptoms of dermatomyositis


    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: November 2021

    Reference Sources

    NICE Evidence Services
    Available at:
    Last accessed: 22 November 2021

    Summary of Product Characteristics: Simponi 50mg solution for injection. Merck Sharp & Dohme Ltd. Revised January 2021.

    Summary of Product Characteristics: Simponi 100mg solution for injection. Merck Sharp & Dohme Ltd. Revised January 2021.

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