Natalizumab Intravenous for Adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

  • Natalizumab has been associated with an increased risk of PML; the risk increases with treatment duration, especially beyond two years
  • Must be initiated and supervised by consultant neurologist
  • Must have access to facilities for managing hypersensitivity reactions including anaphylaxis. See QPulse document: Infusion related Patient reaction in nurse-led setting CLN-NM-0118
  • See section on monitoring requirements
  • Each patient must be given a special alert card (and patient information leaflet) that summarises the key safety information about natalizumab - see Pharmacy Information below
  • In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded

Available preparations

Tysabri 300mg per 15ml vial

Reconstitution

Already in solution

Dilute further prior to administration

Infusion fluids

Sodium chloride 0.9%

Methods of intravenous administration

Intermittent intravenous infusion (administer using an electronically controlled infusion device)

  • Add 300mg (15ml) to 100ml infusion fluid
  • Gently invert solution to mix completely (do not shake)
  • Infuse only if the infusion is FREE FROM particles and discolouration
  • Administer over 60 minutes (rate of infusion is approximately 2ml/minute)

Dose in adults

  • Give 300mg by intravenous infusion, repeated every 4 weeks

Renal or hepatic dysfunction

  • No studies conducted
  • The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment

Monitoring

  • Monitor the patient for signs and symptoms of hypersensitivity reaction during and for at least one hour after the infusion has finished.
  • MRI is recommended annually
  • Regular assessment for neurological dysfunction is recommended (during treatment and for approximately six months after discontinuation), in particular symptoms suggestive of PML e.g. cognitive or psychiatric symptoms.
  • Monitor LFTs
  • Opportunistic infections have been reported in patients receiving natalizumab
  • Acute retinal necrosis has been reported- if decreased visual acuity, redness or painful eye reported, refer for retinal screening

Further information

  • Disease exacerbations or infusion related events may indicate the development of antibodies against natalizumab. In these cases the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, treatment should be discontinued.; See SPC for further information
Pharmacy information
  • A Patient pack (including a patient alert card) is available, contact 1800 812719 or email medinfouki@biogen.com- Ensure patient has been given this pack when treatment is initiated
  • There is a OPD patient prescription sheet available for use in clinic (in-patients: may be prescribed on regular prescription chart)

Storage

  • Store between 2 and 80C
  • Do not freeze

References

SPC 09/2024

Therapeutic classification

Immunomodulatory drug