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
  • Recent MRI (within 3 months) prior to initiation
  • Each patient must be given a special alert card (and patient information leaflet) that summarises the key safety information about natalizumab
  • In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded
  • See OPD prescription

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, however a dosage reduction MAY not be necessary. There are post-marketing reports of liver injury

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.
  • Consider vigilant monitoring of liver function tests given the recent alert published by the FDA
  • Consider discontinuing the drug after 6 months if no benefit is evident
  • Reassess the risk:benefit before or at 2 years
  • 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

  • Natalizumab is indicated only as single agent disease modifying therapy
  • Natalizumab is indicated only for patients with high disease activity despite adequate treatment with at least one disease modifying therapy OR in patients with rapidly evolving severe relapsing remitting multiple sclerosis
  • Patients may switch directly from beta interferon or glatiramer acetate to natalizumab provided there are no signs of adverse effects such as neutropenia
  • The drug may remain active for approximately 12 weeks after discontinuation, therefore careful consideration should be given before reinstating other therapies within this time period (short courses of steroids used during clinical trials were not associated with increased infections)
  • Natalizumab is not recommended in adults over 65 years
  • 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, as persistent antibodies are associated with a substantial decrease in efficacy of TYSABRI and an increased incidence of hypersensitivity reactions. Since patients who have received an initial short exposure to TYSABRI and then had an extended period without treatment are at a higher risk of developing anti-natalizumab antibodies and/or hypersensitivity upon re-dosing, the presence of antibodies should be evaluated and if these remain positive in a confirmatory test after at least 6 weeks, the patient should not receive further treatment with the drug
Pharmacy information
  • Patient addressograph details are provided and that the patient has been given a special alert card (as indicated on the prescription)
  • Natalizumab should be prescribed on the"Natalizumab Treatment Sheet" only
  • The drug is issued on a named-patient basis
  • A Patient pack (including a patient alert card) is available, contact 1800 812719 or email medinfouki@biogen.com

Storage

  • Concentrate - store between 2 and 80C

References

SPC August 2021

Therapeutic classification

Immunomodulatory drug