Xaggitin XL (methylphenidate hydrochloride) FDG

For UK healthcare professionals only.

This formulary decision guide was commissioned by Ethypharm and developed from content provided by Ethypharm in a format developed by Guidelines in Practice.

View prescribing and adverse event reporting information

Key points

  • Xaggitin XL is bioequivalent to Concerta® XL1
  • Prescribing branded Xaggitin XL potentially saves the NHS up to 50% compared to Concerta® XL2
  • Xaggitin XL is indicated as part of a comprehensive treatment programme for attention deficit hyperactivity disorder (ADHD) in children aged 6 years and over when remedial measures alone prove insufficient.3

Download a PDF of this formulary decision guide

Product name

Xaggitin® XL prolonged-release tablets

Indication

  • Xaggitin XL is indicated as part of a comprehensive treatment programme for ADHD in children aged 6 years and over when remedial measures alone prove insufficient3
  • Treatment must be under the supervision of a specialist in childhood behavioural disorders3
  • Xaggitin XL treatment is not indicated in all children with ADHD and the decision to use the medicinal product must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age3
  • In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood; however, start of treatment with Xaggitin XL in adults is not appropriate.3

Bioequivalence

  • Xaggitin XL has demonstrated bioequivalence to Concerta® XL for the 18 mg and 54 mg doses under fasting and non-fasting conditions.1

Budgetary implications

  • Xaggitin XL should be prescribed by brand to potentially achieve cost savings of up to 50% for the NHS vs Concerta® XL2
  • For further savings, a PrescQIPP assessed primary care rebate scheme is available set at 20% on branded prescriptions; please see PrescQIPP website or contact Ethypharm UK for details.

Order information

  • Xaggitin XL is available from all mainline wholesalers, including AAH, Alliance, and Phoenix.

Xaggitin XL pack-shots

Undesirable effects3

  • Very common (≥1/10): insomnia, nervousness, headache
  • Common (≥1/100 to <1/10): nasopharyngitis, upper respiratory tract infection, sinusitis, anorexia, decreased appetite, moderately reduced weight and height gain during prolonged use in children, affect lability, aggression, agitation, anxiety, depression, irritability, abnormal behaviour, mood swings, tics, initial insomnia, depressed mood, decreased libido, tension, bruxism, panic attack, dizziness, dyskinesia, psychomotor hyperactivity, somnolence, paraesthesia, tension headache, accommodation disorder, vertigo, arrhythmia, tachycardia, palpitations, hypertension, cough, oropharyngeal pain, upper abdominal pain, diarrhoea, nausea, abdominal discomfort, vomiting, dry mouth, dyspepsia, alopecia, hyperhidrosis, pruritus, rash, urticaria, arthralgia, muscle tightness, muscle spasms, erectile dysfunction, pyrexia, growth retardation during prolonged use in children, fatigue, irritability, feeling jittery, asthenia, thirst, changes in blood pressure and heart rate (usually an increase), weight decreased and alanine aminotransferase increased
  • For a full list of undesirable effects, please refer to the summary of product characteristics.

References

  1. Ethypharm data on file; bioequivalence data. March 2021
  2. British National Formulary: methylphenidate hydrochloride. Available at: https://bnf.nice.org.uk/medicinal-forms/methylphenidate-hydrochloride.html (last accessed May 2021).
  3. Martindale Pharma. Xaggitin XL prolonged-release tablets—summary of product characteristics. Available at: www.medicines.org.uk/emc

Concerta® XL is a registered trademark of Janssen-Cilag Ltd.

 

UK-XAG-19

Date of preparation: July 2021