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Kom i gang - LIS anbefaling UC (for voksne)2

 

I Norge er det anbudskonkurranse på de betennelsesdempende legemidlene (biologiske, JAK- og S1P-hemmere) som er innført til behandling av alvorlig Ulcerøs kolitt (UC). Anbudet forvaltes av Sykehusinnkjøp HF, divisjon legemidler (LIS). I anbefalingene står det blant annet:

  • Dersom pasienten av medisinske årsaker ikke kan bruke den rimeligste behandlingen, skal dette spesifiseres og dokumenteres i pasientens journal.
  • Når doseøkning vurderes på grunn av utilstrekkelig effekt, skal økte kostnader veies opp mot kostnader og forventet helsegevinst ved skifte av preparat.
Tabellen under er tilpasset av Pfizer, der de to legemidlene fra Pfizer (Velsipity og Xeljanz) er uthevet2

 

* Gjeldende for Helse Nord og Sør-Øst RHF / Helse Vest og Midt RHF
** Velsipity (etrasimod) er indisert for ungdom og voksne > 16 år. 

Enkel behandling med en tablett, én gang om dagen1

With VELSIPITY, you can offer patients 16 years of age and older1:

 One pill, once a day

2 mg orally once daily, taken with food for the first 3 days, then with or without food thereafter

 The same dose right from the start—no titration required

The initiation dose is the maintenance dose

 Recommended monitoring for certain safety signals, but no unique required scheduled monitoring† No required scheduled monitoring outside of standard clinical assessments. Safety signals should be monitored during treatment and managed appropriately, as recommended in the Summary of Product Characteristics for VELSIPITY (etrasimod).Getting started with VELSIPITY

Test to determine if VELSIPITY is appropriate for patients before starting treatment1
  • Exclude patients who1:
    • Had certain cardiovascular conditions,* including stroke, in the last 6 months
    • Are or who plan to become pregnant
  • Please see Summary of Product Characteristics for all contraindications and special warnings and precautions for use
  • Obtain a recent (ie, within the last 6 months or after discontinuation of prior UC therapy) complete blood count with differential and liver function tests—including lymphocyte count, transaminase levels, and bilirubin levels
  • Electrocardiogram (ECG or EKG)
  • Pregnancy test
A reminder of other standard assessments
  • Vaccinations (recommended to update immunizations in agreement with current guidelines—no herpes zoster vaccine is required)
  • Obtain an eye exam of the fundus, including the macula, near or following the start of treatment to screen for any preexisting eye conditions. Patients with a history of diabetes mellitus, uveitis, or an underlying/coexsisting retinal disease are recommended to undergo an eye exam before the start of treatment and regularly during treatment1

AFTER THE LAST DOSE1:

  • Women of childbearing potential should use effective contraception for at least 14 days
  • Vigilance for infection should be continued for up to 2 weeks
  • Use of live attenuated vaccine should be avoided for up to 2 weeks due to risk of infection
 Patients in the last 6 months who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischaemic attack (TIA), decompensated heart failure requiring hospitalization, or New York Heart Association (NYHA) class III or class IV heart failure. Patients with history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block, unless patient has a functioning pacemaker.1Due to the risk of transient decreases in heart rate with the initiation of VELSIPITY, 4-hour monitoring for signs and symptoms of symptomatic bradycardia after the first dose is recommended in patients with resting heart rate <50 bpm, second-degree AV block (Mobitz type I), or a history of myocardial infarction or heart failure.1 Resources for your patients

See the different resources available to help your patients start and stay on VELSIPITY.

RessurserLoadingReferences:VELSIPITY (etrasimod) Summary of Product Characteristics. Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.
PP-V1A-NOR-0028 | Utarbeidet 11.2024

Pfizer AS, Org.nr 915 213 596

Postadresse: Postboks 3, 1324 Lysaker
Besøksadresse: Drammensveien 288, 0283 Oslo

Tlf.: +47 67 52 61 00


PP-BCP-NOR-0001 juni 2023

Copyright © 2023 Pfizer AS. Innholdet er rettighetsbeskyttet.

 




 
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