Golimumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of golimumab.
These products have been produced by recombinant technology using murine hybridoma cell lines.
Drugs List
Therapeutic Indications
Uses
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.
Dosage
Adults
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
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.
Administration
For subcutaneous injection only.
Contraindications
Severe infection
Breastfeeding
Hereditary fructose intolerance
New York Heart Association class III failure
Tuberculosis
Precautions and Warnings
Children under 18 years
History of recurrent infection
Patients over 65 years
Predisposition to demyelinating disorder
Predisposition to infection
Surgery
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
Pregnancy
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
Pregnancy
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.
Lactation
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
Abscess
Agranulocytosis
Alanine aminotransferase increased
Allergic reaction
Alopecia
Anaemia
Aplastic anaemia
Arrhythmias
Aspartate aminotransferase increased
Asthenia
Asthma
Bacterial infection
Bladder dysfunction
Breast changes
Bronchitis
Bronchospasm
Bursitis
Chest discomfort
Cholelithiasis
Colitis
Congestive cardiac failure
Conjunctivitis
Constipation
Coronary artery disorder
Cutaneous vasculitis
Demyelinating disorders
Depression
Dermatitis
Dizziness
Dysgeusia
Dyspepsia
Eye irritation
Eye pruritus
Flushing
Fractures
Fungal infection
Gastritis
Gastro-intestinal pain
Gastroesophageal reflux disease
Gastrointestinal disorder
Headache
Hepatic disorders
Hepatitis
Hyperglycaemia
Hyperlipidaemia
Hypersensitivity reactions
Hypertension
Impaired healing
Injection site reactions
Insomnia
Interstitial lung disease
Jaundice
Kaposi's Sarcoma
Leucopenia
Leukaemia
Lichenoid rash
Loss of balance
Lower respiratory tract infection
Lupus erythematosus-like syndrome
Lymphoma
Menstrual disturbances
Nausea
Neoplasms
Neutropenia
Opportunistic infections
Pancytopenia
Paraesthesia
Pruritus
Psoriasis
Pyelonephritis
Pyrexia
Rash
Raynaud's phenomenon
Reactivation of hepatitis B
Renal disorders
Sarcoidosis
Sepsis
Septic shock
Sinusitis
Skin exfoliation
Stomatitis
Thrombocytopenia
Thrombosis
Thyroid abnormalities
Tuberculosis
Upper respiratory tract infection
Urticaria
Vasculitis
Viral infection
Visual disturbances
Worsening of symptoms of dermatomyositis
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2021
Reference Sources
NICE Evidence Services
Available at: www.nice.org.uk
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.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.