Prescribing information For Healthcare Professionals Only

ACTIVE INGREDIENT(S): Golimumab
Excipient with known effect: Sorbitol
Each pre-filled 50 mg/0.5 mL pen contains 20.5 mg sorbitol per 50 mg dose.
Each pre-filled 50 mg/0.5 mL syringe contains 20.5 mg sorbitol per 50 mg dose.
Each pre-filled 100 mg/mL pen contains 41 mg sorbitol per 100 mg dose.
Please refer to Summary of Product Characteristics (SmPC) before prescribing.

INDICATION(S):
Rheumatoid arthritis (RA): Simponi, 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; and the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.
Simponi, 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.
Polyarticular juvenile idiopathic arthritis (pJIA): Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Psoriatic arthritis (PsA): Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi 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.
Ankylosing spondylitis (AS): Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Non radiographic axial spondyloarthritis (nr Axial SpA): Simponi is indicated for the treatment of adults 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 nonsteroidal anti-inflammatory drugs (NSAIDs).
Ulcerative colitis (UC): Simponi 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.

DOSAGE & ADMINISTRATION: Simponi is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Simponi is indicated. Patients treated with Simponi should be given the Patient Reminder Card which is included in the pack.
Adults:
Rheumatoid arthritis:
Simponi 50 mg given once a month, on the same date each month. Simponi should be given concomitantly with MTX.
Psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis: Simponi 50 mg given once a month, on the same date each month.
For all the above indications, available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.

Patients with body weight greater than 100 kg
For all of the above indications, in patients with RA, PsA, AS, or nr Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose. Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.

Ulcerative colitis:
Patients with body weight less than 80 kg
Simponi given as an initial dose of 200 mg, followed by 100 mg at week 2. Patients who have an adequate response should receive 50 mg at week 6 and every 4 weeks thereafter. Patients who have an inadequate response may benefit from continuing with 100 mg at week 6 and every 4 weeks thereafter.

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

During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.

Available data suggest that clinical response is usually achieved within 12-14 weeks of treatment (after 4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Refer to SmPC for missed dose instructions.

Children with juvenile idiopathic arthritis (JIA):
For children with body weight of at least 40 kg, a 50 mg pre-filled pen or pre-filled syringe is available. Dose is Simponi 50 mg administered once a month, on the same day each month.
Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in children who show no evidence of therapeutic benefit within this time period.
Refer to SmPC for missed dose instructions.

Method of administration: Simponi is for subcutaneous use. After proper training in subcutaneous injection technique, patients may self-inject if their physician determines that this is appropriate, with medical follow up as necessary. Patients should be instructed to inject the prescribed amount of Simponi according to the comprehensive instructions for use provided in the pack/package leaflet.
Paediatric population: The safety and efficacy of Simponi in patients aged less than 18 for indications other than pJIA have not been established.
Elderly: No dose adjustment is required in the elderly (≥ 65 years)
Renal impairment: Simponi has not been studied in these patient populations. No dose recommendations can be made.
Hepatic impairment: Simponi has not been studied in these patient populations. No dose recommendations can be made.

CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. of SmPC. Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections. Moderate or severe heart failure (NYHA class III/IV).

SPECIAL WARNINGS & PRECAUTIONS:
Traceability: The name and the batch number of the administered product should be clearly recorded.
Infections: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with golimumab. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. Golimumab should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of golimumab in patients with a chronic infection or a history of recurrent infection. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate.
There have been reports of tuberculosis in patients receiving golimumab. In the majority of these reports, tuberculosis was extrapulmonary presenting as either local or disseminated disease. Reactivation of hepatitis B has occurred in patients receiving a TNF antagonist including golimumab, who are chronic carriers of this virus (i.e. surface antigen positive). Some cases have had fatal outcome.

Malignancies and lymphoproliferative disorders: The potential role of TNF-blocking therapy in the development of malignancies is not known. Based on the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist 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 malignancy. Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting. In the controlled portions of clinical trials of all the TNF-blocking agents including golimumab, more cases of lymphoma have been observed among patients receiving anti TNF-treatment compared with control patients. Cases of leukaemia have been reported in patients treated with golimumab. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long standing, highly active, inflammatory disease. Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. The potential risk with the combination of AZA or 6-MP and golimumab should be carefully considered. A risk for the development of hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded.
Caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with an increased risk of malignancy due to heavy smoking. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including golimumab. Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
It is not known if golimumab treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), 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.
Congestive heart failure (CHF):
Cases of new onset, worsening and fatal CHF have been reported with TNF blockers, including golimumab. In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to CHF have been observed. Golimumab has not been studied in patients with CHF. Golimumab should be used with caution in patients with mild heart failure (NYHA class I/II). Patients should be closely monitored and golimumab must be discontinued in patients who develop new or worsening symptoms of heart failure.
Neurological events:
Use of TNF-blocking agents, including golimumab, has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders. 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 golimumab therapy. Discontinuation of golimumab should be considered if these disorders develop.
Surgery:
There is limited safety experience of golimumab treatment in patients who have undergone surgical procedures, including arthroplasty. The long half-life should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on golimumab should be closely monitored for infections, and appropriate actions should be taken.
Immunosuppression:
The possibility exists for TNF-blocking agents, including golimumab, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Autoimmune processes:
The relative deficiency of TNF-alpha 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 golimumab and is positive for antibodies against double stranded DNA, treatment with golimumab should be discontinued.
Haematologic reactions:
There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anaemia, and thrombocytopenia in patients receiving TNF-blockers, including golimumab. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor). Discontinuation of golimumab therapy should be considered in patients with confirmed significant haematologic abnormalities.
Vaccinations: Patients treated with golimumab may receive concurrent vaccinations, except for live vaccines. In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. If possible, it is recommended that prior to initiating golimumab therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines
Excipients:
Simponi contains sorbitol (E420). In patients with rare hereditary problems of fructose intolerance, the additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

SIDE EFFECTS:
Very common: Upper respiratory tract infections Common: Injection site reaction, Chest discomfort, Bacterial infections, Lower respiratory tract infection, Viral infections, Bronchitis, Sinusitis, Superficial fungal infections, Abscess, Leukopenia (including neutropenia), Anaemia, Allergic reactions (bronchospasm, hypersensitivity, urticaria), Autoantibody positive, depression, Insomnia, Dizziness, Headache, Paraesthesia, Hypertension, Asthma and related symptoms (such as wheezing and bronchial hyperactivity), Dyspepsia, Gastrointestinal and abdominal pain, Nausea, Gastrointestinal inflammatory disorders, Stomatitis, Aminotransferases increased, Pruritus, Rash, Alopecia, Dermatitis, Pyrexia, Asthenia, Bone fractures Uncommon: Sepsis, Pyelonephritis, Neoplasms, Thrombosis, Constipation, Menstrual disorders, Thrombocytopenia, Pancytopenia, Thyroid disorders, Balance disorder, Visual disorders, Arrhythmia, Ischemic coronary artery disorders, Interstitial lung disease, GERD, cholelithiasis, Hepatic disorders, Bullous skin reaction, Psoriasis, Breast disorders

Refer to the SmPC for other side effects.

PREGNANCY: Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.
Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed.
Golimumab crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy.

FERTILITY: No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility.

LACTATION: It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.

INTERACTIONS: No interaction studies have been performed. The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended. Live vaccines and therapeutic infectious agents should not be given concurrently with golimumab. Although concomitant use of MTX results in higher steady state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX.

LEGAL CLASSIFICATION: Prescription Only Medicine

MARKETING AUTHORISATION HOLDER:
Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UK

Prescribing information last revised: October 2024