Before starting

Required

• Baseline
  • Blood pressure · required at least twice before starting treatment
  • Serum creatinine (for creatinine clearance) · required at least twice before starting treatment or Calculated glomerular filtration rate
  • Cervical screening · check up-to-date
  • Lipids
  • Liver function tests
  • Serum magnesium
  • Serum potassium · especially in renal dysfunction (risk of hyperkalaemia)
  • Vaccination status

Vaccination status

Consider vaccination against pneumococcus and influenza prior to starting treatment.

Dermatology patients

• Baseline
  • Urate
  • Urinalysis

Rheumatology patients

• Baseline
  • Albumin
  • ALT or AST
  • Blood glucose
  • Blood pressure
  • Calculated glomerular filtration rate
  • Full blood count
  • Height
  • Weight

Consider in patients at risk of infection

• Baseline
  • Hepatitis B
  • Hepatitis C
  • HIV
  • Varicella Zoster Virus Immunity · if no history of chicken pox, shingles or varicella vaccination

After started or dose changed

Required

• Every 2 weeks for first 3 months, then monthly for next 3 months
  • Serum creatinine (for creatinine clearance) or Calculated glomerular filtration rate
• Every 2 weeks until on stable dose for 6 weeks, then monthly for 3 months
  • Albumin
  • ALT or AST
  • Blood pressure
  • Blood glucose
  • Full blood count
• After 1 month
  • Lipids
• Periodically
  • Serum magnesium
  • Serum potassium

Ongoing once stable

Required

• Every 1 - 3 months
  • Albumin
  • ALT or AST
  • Blood pressure
  • Blood glucose
  • Full blood count
  • Serum creatinine (for creatinine clearance) or Calculated glomerular filtration rate

Reducing monitoring frequency after 12 months

The British Society of Rheumatology advises that patients who have been stable for 12 months can be considered for reduced frequency monitoring on an individual patient basis.

Consider

• Periodically
  • Serum potassium
  • Serum magnesium
  • Urate

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 10⁹/L
• Platelets less than 140 x 10⁹/L
• Unexplained fall in serum albumin less than 30g/L
• MCV greater than 105f/L (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/mL

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)

Stop if uncontrolled hypertension

Ciclosporin should be stopped in patients who develop hypertension (140/90 mmHg) which cannot be controlled with antihypertensives.

Investigate if urinary protein

If urinary protein is at 2+ or more, a mid-stream urine sample should be taken, and:

• if there is evidence of infection, this should be treated appropriately
• if the urine sample is sterile (no infection present) and the urinary protein 2+ or more persists on two consecutive measurements, stop ciclosporin and discuss with specialist team.

Notes

Advice to patients

Advise patients to seek urgent medical attention if they develop symptoms such as:

• Skin or mucosal reaction (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

Considering stopping ciclosporin and investigating if these are reported.

Advise patients to use sunscreens, wear protective clothing, and reduce sunlight exposure.

Brand name prescribing

Prescribing and dispensing of ciclosporin should be by brand name to avoid inadvertent switching.

If it is necessary to switch a patient to a different brand, this should be done cautiously under specialist supervision. The patient should be monitored closely for changes in the following:

• Blood-ciclosporin concentration
• Serum creatinine
• BP
• Transplant function (where applicable)

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)
• Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [cited 30/11/2019]
• NICE Clinical Knowledge Summaries (CKS). DMARDs – Scenario: ciclosporin. Updated Jul 2018 [cited 31/07/2020]
• Berth-Jones J, Exton LS, Ladoyanni E et al. British Association of Dermatologists guidelines for the safe and effective prescribing of oral ciclosporin in dermatology 2018. Br J Dermatol. 2019 Jun;180(6):1312-1338 [cited June 2020]
• Novartis Pharmaceuticals. Summary of Product Characteristics – Neoral Soft Gelatin Capsules. Last revised 03/2020 [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]

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