Golimumab

Registered South African indications:

• Rheumatoid arthritis
• Ankylosing spondylitis
• Psoriatic arthritis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Active tuberculosis 
• Severe infections such as sepsis and opportunistic infections 
• Moderate to severe heart failure 

Cautions

• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Chronic infection or a history of recurrent infections
• Residence or travel to regions where invasive fungal infections are endemic
• Latent tuberculosis
• Carriers of hepatitis B virus
• History of malignancy or when considering continuing treatment in patients who develop a malignancy
• Patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma
• Chronic obstructive pulmonary disease
• Heavy smokers
• Mild heart failure
• Pre-existing or recent onset of demyelinating disorders
• Surgery
• Hypersensitivity to latex 
• Children
• Adolescents
• Coadministration with TNF-antagonists
• Live vaccines
• Fructose intolerance

Forms avail. in SA and covered in this monograph: pfp

South African registered indications and dosages

Rheumatoid arthritis
- In combination with methotrexate (MTX) for the treatment of active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate
- In combination with methotrexate (MTX) for the treatment of active rheumatoid arthritis in patients not previously treated with MTX
Ankylosing spondylitis
- When the response to conventional therapy has been inadequate
Psoriatic arthritis
- Alone or in combination with MTX, for the treatment of active psoriatic arthritis when the response to previous DMARD therapy has been inadequate

• SC: 50mg, once a month

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Should be administered on the same date each month

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Golimumab treatment is to be initiated and supervised by medical practitioners experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

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After proper training in subcutaneous (SC) injection technique, patients may self-inject with golimumab if their physician determines that this is appropriate, with medical follow-up as necessary

Not established for use in children below 18 years

Pregnancy

• Caution; not recommended
• There are no adequate data on the use of golimumab in pregnant women
• 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 use of golimumab in pregnant women is not recommended; golimumab should be given to a pregnant woman only if clearly needed

Breastfeeding

• Caution; not recommended

Renal Impairment

• Caution; no information available 

Hepatic Impairment

• Caution; no information available 

Elderly

• Caution; no dose adjustment recommended 

Central Nervous System Disorders

• Depression
• Insomnia
• Dizziness
• Headache
• Paraesthesia
• Demyelinating disorders
• Dysguesia

Cardiovascular Disorders

• Arrhythmia
• Ischemic coronary artery disorders
• Congestive heart failure
• Hypertension
• Thrombosis
• Flushing
• Raynaud's phenomenon

Respiratory Disorders

• Asthma
• Interstitial lung disease
• Upper respiratory tract infection 
• Lower respiratory tract infection 
• Bronchitis
• Sinusitis

Gastrointestinal Disorders

• Dyspepsia
• Gastrointestinal and abdominal pain
• Nausea
• Gastrointestinal inflammatory disorders 
• Stomatitis
• Constipation
• Gastro-oesophageal reflux disease

Hepatobiliary Disorders

• Increased alanine aminotransferase  
• Increased aspartate aminotransferase
• Cholelithiasis
• Hepatic disorders

Genitourinary Disorders

• Bladder disorders
• Renal disorders
• Breast disorders
• Menstrual disorders

Endocrine and Metabolic Disorders

• Thyroid disorder
• Increased blood glucose
• increased lipids 

Musculoskeletal Disorders

• Burtsitis 
• Bacterial arthritis 
• Lupus-like syndrome
• Fractures

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Rash
• Alopecia
• Dermatitis
• Bullous skin reactions
• Psoriasis
• Urticaria
• Skin exfoliation
• Vasculitis
• Injection site reaction 

Immune, Blood and Lymphatic System Disorders

• Viral infections
• Bacterial infections 
• Superficial fungal infections
• Abscess
• Sepsis including septic shock
• Pyelonephritis
• Tuberculosis
• Opportunistic infections
• Hepatitis B reactivation
• Neoplasms
• Lymphoma
• Leukaemia
• Melanoma
• Merkel cell carcinoma
• Hepatosplenic T-cell lymphoma
• Anaemia
• Leucopaenia
• Thrombocytopaenia
• Pancytopaenia
• Aplastic anaemia
• Allergic reactions 
• Autoantibody positive
• Serious systemic hypersensitivity reactions
• Vasculitis 
• Sarcoidosis
• Pyrexia

Sensory Disorders

• Visual disorders 
• Conjunctivitis
• Eye allergy

• TNF-antagonists
• Anakinra  
• Etanercept
• Abatacept
• Other biological therapeutics
• Live vaccines
• Methotrexate

• Signs and symptoms of infections
• Hepatitis B virus screening

Specific cases may require

• Latent tuberculosis screening
• Cardiac function
• Full blood count

• Traceability : in order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded

Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human tumour necrosis factor (TNF)-alpha, which prevents the binding of TNF-alpha to its receptors.

Injection (per 0.5ml) 50mg

• Simponi pre-filled pen (Janssen) originator