Etanercept

Registered South African indications:

• Rheumatoid arthritis
• Juvenile idiopathic arthritis
• Psoriatic arthritis
• Plaque psoriasis
• Ankylosing spondylitis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Sepsis or risk of sepsis
• Patients with active infections, including chronic or localised infections

Cautions

• Breastfeeding
• Chronic infection or a history of recurrent infections
• Underlying conditions that may predispose patients to infections
• Diabetes mellitus
• Increased risk for tuberculosis
• Carriers of hepatitis B virus  
• History of hepatitis C
• Hypersensitivity to latex 
• Risk factors for skin cancer
• Psoriasis
• Patients with immunosuppression
• History of malignancy 
• Children
• Adolescents
• Previous history of blood dyscrasias
• Pre-existing, recent, or increased risk of developing demyelinating disease
• Congestive heart failure 
• Moderate to severe alcoholic hepatitis

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

Moderate to severe rheumatoid arthritis where there is an inadequate response to disease-modifying antirheumatic agents
Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate
Active and progressive psoriatic arthritis where there is an inadequate response to disease-modifying antirheumatic agents
Severe active ankylosing spondylitis with inadequate response to conventional therapy
Severe non-radiographic axial spondyloarthritis with an inadequate response to nonsteroidal anti-inflammatory drugs

• SC: 25mg, twice weekly OR 50mg, once weekly

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Twice weekly doses should be given 3 to 4 days apart

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Treatment should be initiated and supervised by a specialist experienced in treating these conditions

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Clinical response is usually achieved within 12 weeks of treatment

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Moderate to severe plaque psoriasis who failed to respond to systemic therapy

• SC: 25mg, twice weekly; Treatment duration: Until remission is achieved for up to 24 weeks
  OR 
• SC: 50mg, once weekly; Treatment duration: Until remission is achieved for up to 24 weeks
  OR 
• SC: 50mg, twice weekly, for up to 12 weeks followed by 25mg, twice weekly; Treatment duration: Until remission is achieved for up to 24 weeks
  OR
• SC: 50mg, once weekly; Treatment duration: Until remission is achieved for up to 24 weeks

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Treatment should be discontinued in patients who show no response after 12 weeks

If re-treatment is indicated, the same guidance on treatment duration should be followed

Paed. forms avail. in SA and covered in this monograph: inj

Chronic severe plaque psoriasis inadequately controlled on systemic therapy or phototherapy

Younger than 4 years

• Not established for use

Older than 4 years

• SC: 0.8mg/kg (Max 50mg/dose), once weekly; Treatment duration: Up to 24 weeks

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Treatment should be discontinued in patients who show no response after 12 weeks

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Polyarthritis and extended oligoarthritis with inadequate response to methotrexate

Younger than 4 years

• Not established for use  

Between 4-18 years

• SC: 0.4mg/kg (Max 25mg/dose), twice weekly
  OR 
• SC: 0.8mg/kg (Max 50mg/dose), once weekly

Juvenile idiopathic arthritis

Younger than 4 years

• Not established for use

Between 4-18 years

• SC: 0.4mg/kg (Max 25mg/dose), twice weekly
  OR 
• SC: 0.8mg/kg (Max 50mg/dose), once weekly

---

Discontinue if no response within 4 months

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Weekly dosing is recommended to improve patient compliance

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Psoriatic arthritis with an inadequate response to methotrexate
Enthesitis-related arthritis with an inadequate response to methotrexate

Younger than 12 years

• Not established for use

Older than 12 years

• SC: 0.4mg/kg (Max 25mg/dose), twice weekly
  OR
• SC: 0.8mg/kg (Max 50mg/dose), once weekly

---

Weekly dosing is recommended to improve patient compliance

Pregnancy

• FDA Pregnancy Category B

Breastfeeding

• Caution; not recommended

Renal Impairment

• No dose adjustment recommended 

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended 

Central Nervous System Disorders

• Seizures
• Demyelinating events 
• Localised demyelinating conditions 
• Peripheral demyelinating events
• Chronic inflammatory demyelinating polyneuropathy
• Demyelinating polyneuropathy
• Multifocal motor neuropathy 
• Fever

Cardiovascular Disorders

• Congestive heart failure 

Respiratory Disorders

• Interstitial lung disease 

Hepatobiliary Disorders

• Elevated liver enzymes
• Autoimmune hepatitis

Musculoskeletal Disorders

• Subacute cutaneous lupus erythematosus
• Discoid lupus erythematosus
• Lupus-like syndrome

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Angioedema
• Urticaria
• Rash
• Psoriasiform rash
• Psoriasis
• Cutaneous vasculitis 
• Stevens-Johnson syndrome
• Erythema multiforme
• Toxic epidermal necrolysis
• Injection site reactions

Immune, Blood and Lymphatic System Disorders

• Infections 
• Tuberculosis
• Opportunistic infections 
• Listeria
• Hepatitis B reactivation
• Non-melanoma skin cancers
• Lymphoma
• Melanoma 
• Leukaemia
• Merkel cell carcinoma
• Thrombocytopenia
• Anaemia
• Leukopenia
• Neutropenia
• Pancytopenia
• Aplastic anaemia
• Allergic reactions 
• Autoantibody formation
• Systemic vasculitis 
• Serious anaphylactic reactions 
• Sarcoidosis
• Macrophage activation syndrome
• Worsening of symptoms of dermatomyositis

Sensory Disorders

• Uveitis
• Scleritis

• Anakinra
• Abatacept
• Sulfasalazine
• Live vaccines 

• Signs and symptoms of infections
• Symptoms of lupus-like syndromes
• Signs and symptoms of malignancy
• Tuberculosis screening
• Hepatitis B virus screening
• Full blood count
• Differential count

Specific cases may require

• Cardiac function

Etanercept is a competitive inhibitor of tumor necrosis factor (TNF) and blocks its binding to cell surface receptors; thereby preventing TNF-mediated cellular activity. Etanercept may also modulate biologic responses controlled by additional downstream molecules that are induced or regulated by TNF.

Injection (per vial) 25mg

• Enbrel (Pfizer) originator

Injection (per syringe) 25mg

• Enbrel 25mg PS pre-filled syringe (Pfizer) originator
• Erelzi 25mg (Sandoz SA)

Injection (per syringe) 50mg

• Enbrel 50mg PS pre-filled syringe (Pfizer) originator
• Erelzi 50mg (Sandoz SA)