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Gilenya - setting up a service

Gilenya - setting up a service. Pre-screening checklist. Previous immunotherapy treatment. No washout necessary with interferon or copaxone 3 month washout period if previously treated with Natalizumab, Mitoxantrone, Azaithioprine to avoid additional immune effects. Infection.

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Gilenya - setting up a service

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  1. Gilenya - setting up a service

  2. Pre-screening checklist

  3. Previous immunotherapy treatment • No washoutnecessary with interferon or copaxone • 3 month washout periodif previously treated with Natalizumab, Mitoxantrone, Azaithioprine to avoid additional immune effects

  4. Infection • Check patient does not have any active severe infection • Ensure any infection is resolved before commencing Gilenya. Treat with antibiotics • Order full blood count to check baseline reading and rule out patient not neutropenic

  5. Exposure to Chicken Pox • Has patient had chicken pox or been vaccinated against the varicella zoster virus(VZV) • No, then • Test for antibodies to VZV • If antibody negative consider vaccination • Wait for one month before starting Gilenya to allow full effect of vaccination to occur

  6. Diabetic or history of Uveitis Refer for optical coherence tomography Do not use with patients who have macular oedema Regular ophthalmology review required

  7. Liver Disease • Do not use in patients with severe hepatic impairment (Child-Pugh ClassC) • Delay starting Gilenya in patients with active viral hepatitis until resolved due to immunosuppressant effect • Use with caution in patents with mild to moderate hepatic impairment • Measure transaminase/bilirubin levels before commencing treatment

  8. Lung disease • Use Gilenya with caution in patients with: • Severe respiratory disease • Pulmonary fibrosis • COPD • Measure volume of inhaled and exhaled air (spirometry) and diffusing capacity of lungs for carbon monoxide during treatment of patients with known lung disease

  9. Cardiac disease • Advice should be sought from a cardiologist before treating patients with significant cardiovascular disease to rule out any unwanted risk

  10. Irregular heartbeat • Not to be used in patients treated with Class 1a (sodium channel blockers)and Class 3 (potassium channel blockers) drugs for arrhythmias • To be used with caution in patients treated with beta-blockers or other drugs affecting heart rate

  11. Hypertension • Patients with hypertension uncontrolled by medication should be treated with caution and special care • No special requirement with patients with hypertension controlled by medication

  12. Malignancy • Avoid in any current malignancy other than cutaneous basal cell carcinoma

  13. Fertility • Data available does not suggest any increased risk of reduced fertility • If considering a pregnancy once contraception stopped allow at least a 2 month washout period to eliminate Gilenya from body

  14. Pregnancy CARRY OUT PREGNANCY TEST ON WOMEN OF CHILDBEARING AGE PRIOR TO STARTING GILENYA DO NOT USE DURING PREGNANCY

  15. Breastfeeding WOMEN TREATED WITH GILENYA SHOULD NOT BREAST FEED

  16. AGE No safety data available for use In children Use with caution in the elderly

  17. Next steps • Perform baseline EDSS and document any current neurological deficits in notes • ProvideMedical Information Cards & Patient Reminder Cards • Book ophthalmology appointment for 3-4 months following 1st dose • Advise of stopping criteria

  18. Stopping criteria • 2 relapses in 1year • Allergic reaction during observation period • Reduction in Lymphocyte numbers by more than 70% • Macular oedema • Elevation in serum levels of hepatic transaminases  3x ULN (upper limit of normal) • Unresolved Bradyarrhythmia • Pregnancy

  19. WHO PAYS • NICE approved • Notify Patient’s PCT of intention to treat • NICE rejected • Apply to individual funding request teams Liaise with Pharmacist: • prescription design • order 7 day starter pack • send prescription for 1 month supply to home delivery company

  20. Prescription Design

  21. 1st dosing • Venue • ward • Infusion suite • Day ward • Administration • MS Nurse • Infusion Nurse • Ward nurse No interaction with food

  22. 1st dose Observation chart and prescription

  23. 1st dose surveillance • Observe BP and Pulse hourly for 6 hours • Bradyarythmia peaks at about 4 hours • On average drop in mean heart rate of 8bpm • If problematic give atropine; ECG if bradycardia (<60 bpm); • If unproblematic 2nd dose given unsupervised • Any problem bring back for second dosing • If medication is stopped, when restarted needs to be rechallenged • Discharge home when last pulse recording higher than lowest and 80% of starting dose, attenuates over time, normalises after a month. • Send letter to GP advising Gilenya started

  24. Common side effects • Headache • Nausea and vomiting • Tiredness • Flu like symptoms • Diarrhoea • Back pain • Cough

  25. Bradyarrhythmia symptoms • Palpitations • Shortness of breath • Fainting • Chest pain • Hypotension • Dizziness • Weakness • Fatigue Contact Neurology team for clinical management advice

  26. Macular oedema • Painless • Blurred or distorted vision • Develop blindspot in centre of vision • Problems seeing colours or fine details • Occurred in 0.4% trial pts • Caused by swelling or thickening in central retina • Majority of cases noted in 1st 3-4 months of tx • If occurs stop Gilenya • Generally improved or resolved spontaneously

  27. Q&A • ½ life of 8-9 days • Can take 2-3-months to become effective • Unable to have live vaccine whilst on tx, need to be off tx for 2 months, have vaccination then off tx for a further month • Vaccines to avoid: • BCG, Typhoid, cholera, measles, rubella, mumps, polio, yellow fever, varicella • Routine flu vaccination OK; Malaria tablets OK

  28. Q&A • Able to use steroids if relapsing • If severe infection not responding to antibiotics stop Gilenya (2 months wash out period)

  29. Follow-up • Ophthalmology review 3-4 months post start date • Optical Coherence Tomography – test to detect macular oedema. If present patient has no pain unlike ON; will see straight lines as wavy 

  30. Neurology Follow up • Reviewin neurologyOPD • MS Nurse at 1, 3 and 9months . Check BP • Consultant Neurologist at 6 and 12 months • Repeat FBC and LFT at 1, 3, 6 and 12 months • Lymphocytes may drop 1-2 weeks after starting tx up to 70%. If lower than 0.2 stop tx. Return to normal in 1-2 months • Liver enzymes expected to rise and remain high for duration of treatment. If 5x upper limit of normal recheck, if remain high discuss with neurologist. Effects on liver are reversible when therapy stopped and return to baseline. There is no risk of permanent liver damage

  31. Gilenya Care Pathway

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