Before starting

Required

• Baseline
  • ALT or AST
  • Albumin
  • Blood pressure
  • Full blood count
  • Height
  • Liver function tests
  • Platelet count
  • Serum creatinine (for creatinine clearance) or Calculated glomerular filtration rate
  • Vaccination status
  • Weight
  • White blood cell differential

Vaccination status

Consider vaccination against pneumococcus and influenza prior to starting treatment.

Consider in patients at risk of infection

• Baseline
  • Hepatitis B
  • Hepatitis C
  • HIV

Consider

• Baseline
  • Lung disease screening

After started or dose changed

Required

• Every 2 weeks until on stable dose for 6 weeks, then monthly for 3 months
  • Blood pressure
  • Full blood count
  • Liver function tests · including AST or ALT and albumin
  • Platelet count
  • Serum creatinine (for creatinine clearance) or Calculated glomerular filtration rate
  • Weight
  • White blood cell differential

Increasing monitoring frequency

More frequent monitoring is appropriate in patients:

• at higher risk of toxicity
• where leflunomide is combined with methotrexate; for these patients, continue monthly monitoring until stable for 12 months, then consider reduced frequency monitoring on an individual basis

Ongoing once stable

Required

• Every 2 - 3 months
  • Blood pressure
  • Full blood count
  • Liver function tests · including ALT or AST and albumin
  • Platelet count
  • Serum creatinine (for creatinine clearance) or Calculated glomerular filtration rate
  • Weight
  • White blood cell differential

Increasing monitoring frequency

More frequent monitoring is appropriate in patients at higher risk of toxicity.

Abnormal results

Monitor trends

Be aware of trends in results and respond accordingly.

Respond to absolute levels

Consider stopping treatment and contacting a specialist if any of the following develop:

Full blood count

• Albumin less than 30g/L
• WCC less than 3.5 x 10⁹/L
• Neutrophils less than 1.6 x 10⁹/L
• Eosinophilia more than 0.5 x 10⁹/L
• Platelets less than 140 x 10⁹/L
• MCV greater than 105fL

Liver function

• AST and/or ALT greater than 100units/L

Renal function

• Creatinine increase greater than 30% above baseline over 12 months
• Calculated GFR less than 60ml/min/1.73m² (repeat in 1 week, if still more than 30% from baseline, withhold and discuss with specialist team)

Notes

Advice to patients

Advise patients to seek urgent medical attention if they develop any of the following:

• Skin or mucosal reaction; for example rash, pruritus, mouth or throat ulceration
• Sore throat
• Fever
• Unexplained bruising or bleeding
• Nausea, vomiting, diarrhoea or weight loss
• Diffuse alopecia
• Breathlessness, infection or cough
• Peripheral neuropathy

Bibliography

• Ledingham J, Gullick N, Irving K et al. BSR and BHPR Standards, Guidelines and Audit Working Group, BSR and BHPR guideline for the prescription and monitoring of non-biologic disease-modifying anti-rheumatic drugs, Rheumatology, Volume 56, Issue 6, June 2017, Pages 865–868 [cited 21/02/2020)
• Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [cited 21/02/2020]
• NICE Clinical Knowledge Summaries (CKS). DMARDs: Summary. Updated Jul 2018 [cited 31/07/2020]

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