Before starting

Required

• Baseline
  • Albumin
  • Blood pressure
  • Body weight
  • Chest x-ray or Screening for lung disease · physical examination and lung function may also be necessary on case-by-case basis
  • Full blood count
  • Height
  • Hepatitis B · consider antiviral treatment prior to initiation if chronic viral hepatitis
  • Hepatitis C · consider antiviral treatment prior to initiation if chronic viral hepatitis
  • HIV
  • Liver function tests · consider delayed initiation if results abnormal
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate · avoid in severe renal impairment; reduce dose if moderate

Consider

• Baseline
  • TB screening · if suspected TB; where positive, treat before initiating
  • Varicella Zoster Virus Immunity · if no history of infection; vaccinate if low

Dermatology patients

• Baseline
  • Type III Procollagen Peptide (PIIINP) · if psoriasis

After started or dose changed

Required

• Every 1 - 2 weeks
  • Full blood count
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate

Dermatology patients

• Every 1-2 weeks for first month; repeat until dose stabilised
  • Full blood count
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate

Gastroenterology patients

• At 2, 4, 8, and 12 weeks; then 3 monthly
  • Full blood count
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate

Rheumatology patients

• Every 2 weeks for at least 6 weeks; then every month for 3-12 months
  • Albumin
  • Full blood count
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate

Increasing monitoring frequency

More frequent monitoring is appropriate in patients:

• at higher risk of toxicity
• where methotrexate is combined with leflunomide; 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
  • Full blood count
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate

Dermatology patients

• Every 2 -3 months
  • Full blood count · consider increasing frequency if high risk
  • Liver function tests · consider increasing frequency if high risk
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate
  • Type III Procollagen Peptide (PIIINP) · if psoriasis; seek specialist advice if abnormal

Rheumatology patients

• At least every 12 weeks
  • Full blood count · consider increasing frequency if high risk
  • Liver function tests · consider increasing frequency if high risk
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate · consider increasing frequency if high risk

Gastroenterology patients

• At least every 12 weeks
  • Full blood count
  • Liver function tests
  • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration rate

Abnormal results

Monitor trends

Be aware of trends in results (e.g. gradual decreases in white blood cells or albumin, or increasing liver enzymes). A downward trend of FBC and neutrophil count or an upward trend in liver transaminases could be a sign of toxicity, even if the absolute levels are normal.

Respond to absolute levels

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

Full blood count

• WCC less than 3.5 x 10⁹/L
• Neutrophils less than 1.6 x 10⁹/L
• Unexplained eosinophilia more than 0.5x 10 ⁹/L
• Platelets less than 140 x 10⁹/L
• Unexplained fall in serum albumin less than 30g/L
• MCV greater than 105fL (check B12, folate, thyroid-stimulating hormone levels – if abnormal treat, if normal discuss with specialist team)

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)

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 June 2020)
• Warren R.B., Weatherhead S.C., Smith C.H et al. British Association of Dermatologists’ guidelines for the safe and effective prescribing of methotrexate for skin disease 2016. Br J Dermatol 2016; 175: 23-44. Published August 2016 [cited 30/07/2020]
• Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [cited 30/07/2020]
• Current Problems in Pharmacovigilence Sept 1997, Vol 23, 12
• NICE Clinical Knowledge Summaries (CKS). DMARDs: Summary. Updated Jul 2018 [cited 31/07/2020]
• Smellie W S A, Shaw N, Bowley R, et al. British Medical Journal Journals. Journal of Clinical Pathology. Best practice in primary care pathology: review 10. J Clin Pathol 2007;60:1195–1204 [cited 30/07/2020]
• SPS Accessing resources for patients on high risk medicines Methotrexate Information Book [cited 9/10/2023]
• Lamb CA, Kennedy NA, Raine T et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut 2019; 68:s1-s106 [cited 30/07/2020]
• National Patient Safety Agency. Improving compliance with oral methotrexate guidelines. 2006 [cited 30/07/2020]
• National Institute for Health and Care Excellence (NICE). Psoriasis: assessment and management [CG153]. Oct 2012 [updated Sep 2017; cited 30/07/2020]
• National Institute for Health and Care Excellence (NICE). Hepatitis B and C testing: people at risk of infection [PH43]. Dec 2012 [updated Mar 2013; cited June2020]
• NHS England. Never Events List 2015/16. Mar 2015 [cited 31/07/2020]
• Public Health England. Contraindications and special considerations: the green book, chapter 6. Published 20/03/2013. Last updated 26/10/2017 [cited 10/05/2020]

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