Warnings & Safety Management - National Multiple Sclerosis Society

Skip to navigation Skip to content

Warnings & Safety Management

Share

In this article

Overview

FDA-approved DMTs: Warnings and Safety Management Strategies (Moses & Brandes, 2008; Samkoff, 2011)

Glatiramer acetate (Copaxone)

  • Prescribing Information
  • Warnings:
    • Lipoatrophy and skin necrosis
  • Recommended safety management strategies and recommended monitoring
    • Site rotation is essential
    • Monitoring

Interferon b-1a (Avonex)

  • Prescribing Information
  • Warnings:
    • Hepatic and hematologic abnormalities
    • Depression
    • Iinjection site reactions with SC administration
  • Recommended safety management strategies and recommended monitoring:
    • CBC, LFT q 3 mos during first year, then q 6 mos thereafter
    • Thyroid function tests q 3-6 mos during first year, then yearly thereafter
    • Monitoring for mood changes
    • Education and site rotation with SC IFN

Interferon b-1a (Rebif)

  • Prescribing Information
  • Warnings:
    • Hepatic and hematologic abnormalities
    • Depression
    • Injection site reactions with SC administration
  • Recommended safety management strategies and recommended monitoring:
    • CBC, LFT q 3 mos during first year, then q 6 mos thereafter
    • Thyroid function tests q 3-6 mos during first year, then yearly thereafter
    • Monitoring for mood changes
    • Education and site rotation with SC IFN

Interferon b-1b (Betaseron)

  • Prescribing Information
  • Warnings:
    • Hepatic and hematologic abnormalities
    • Depression
    • Injection site reactions with SC administration
  • Recommended safety management strategies and recommended monitoring:
    • CBC, LFT q 3 mos during first year, then q 6 mos thereafter
    • Thyroid function tests q 3-6 mos during first year, then yearly thereafterMonitoring for mood changes
    • Education and site rotation with SC IFN

Interferon b-1b (Extavia)

  • Prescribing Information
  • Warnings:
    • Hepatic and hematologic abnormalities
    • Depression
    • Injection site reactions with SC administration
  • Recommended safety management strategies and recommended monitoring:
    • CBC, LFT q 3 mos during first year, then q 6 mos thereafter
    • Thyroid function tests q 3-6 mos during first year, then yearly thereafter
    • Monitoring for mood changes
    • Education and site rotation with SC IFN

Pegylated Interferon b-1a (Plegridy)

  • Prescribing Information
  • Warnings:
    • Hepatic injury
    • depression and suicide
    • Seizure
    • Anaphylaxis and other allertic reactions
    • Injection site reactions
    • Congestive heart failure
    • Decreased peripheral blood counts
    • autoimmune disorders
  • Recommended safety management strategies and recommended monitoring:
    • Monitor liver function
    • Encourage reporting of depressive sx/ suicidal ideation
    • Use caution in patients with seizure disorder
    • Teach injection techniques and site rotation
    • Monitor patients with significant cardiac hx 
    • Monitor complete blood counts
    • Consider discontinuation if new autoimmune disorder occurs

Dimethyl fumarate (Tecfidera)

  • Prescribing Information
  • Warnings:
    • Lymphopenia
  • Recommended safety management strategies and recommended monitoring:
    • Recent CBC (< 6 months) before starting treatment, and annually or as clinically indicated.

Fingolimod (Gilenya)

  • Prescribing Information
  • Warnings:
    • Bradycardia and/or atrioventricular conduction after first dose
    • Infection
    • Macular edema
    • Decreased pulmonary function
    • Liver injury
    • Elevated serum hepatic transaminases
    • Hypertension
  • Recommended safety management strategies and recommended monitoring:
    • Recommended screening: white blood cell count, serum transaminase determination, serum bilirubin determination, serum varicella zoster antibody testing (in patients with no history of chicken pox), baseline ECG, and ophthalmologic evaluation
    • Observe for bradycardia for at least 6 hours after first dose with hourly pulse and Bp; obtain ECG prior to dosing nad at end of observation period. If problems occur, continue monitoring overnight and repeat first-dose monitoring; higher risk patients should be monitored overnight
    • Ophthalmologic evaluation after 3 to 4 months of treatment and in the event of new visual symptoms
    • Obtain PFT when clinically indicated
    • Monitor BP during treatment
    • Women of childbearing potential should use contraception during treatment and for two months after stopping treatment

Teriflunomide (Aubagio)

  • Prescribing Information
  • Warnings:
    • Infection
    • Elevated serum hepatic transaminases (“black box” warning)
    • Fetal death and malformations (“black box warning)
    • Skin reactions
    • Blood pressure increase
    • Respiratory effects
  • Recommended safety management strategies and recommended monitoring:
    • Pre-treatment: evaluation for infection, pregnancy, renal failure, peripheral neuropathy, interstitial pulmonary disease and hypertension; White blood cell count, serum transaminase determination and serum bilirubin determination
    • During treatment: blood pressure monitoring; serum transaminase determinations

Alemtuzumab (Lemtrada)

  • Prescribing Information
  • Warnings:
    • Serious, sometimes fatal, autoimmune condition such as immune thrombocytopenia and anti-glomerular basement membrane disease
    • Serious and life-threatening infusion reactions
    • Possible increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders
  • Recommended safety management strategies and recommended monitoring:
    • Lemtrada is available only through the Lemtrada REMS program, requiring patient and healthcare facility enrollment, and prescriber and pharmacy certification
    • Premedicate with corticosteroids prior to to first three infusions of each course.
    • Administer antiviral agents for herpetic prophylaxis starting on first day and continuing for minimum of 2 months after completion of dosing, or until CD4+ lymphocyte count is more than 200 cells per microliter, whichever occurs later.
    • Obtain thyroid function tests prior to initation of treamtne and every 3 months until 48 months after last infusion.
    • Monitor complete blood counts monthly until 48 months after last infusion
    • Consider delaying treatment in patients with active infections until infection is fully resolved
    • Do not administer live viral vaccines following treatment course.

Mitoxantrone (Novantrone)

  • Prescribing Information
  • Warnings:
    • Cardiac toxicity
    • Acute myelogenous leukemia (more likely to occur at cumulative doses >60 mg/m2)
  • Recommended safety management strategies and recommended monitoring:
    • Baseline LVEF and repeat LVEF prior to each dose (with treatment terminated if LVEF <50%)
    • Continued monitoring of cardiac function after completion of treatment

Natalizumab (Tysabri)

  • Prescribing Information
  • Warnings:
    • Progressive multifocal leukoencephalopathy
    • Hypersensitivity reactions
    • Hepatotoxicity includingacute liver failure
    • Encephalitis and meningitis caused by herpes simplex and varicella zoster viruses
  • Recommended safety management strategies and recommended monitoring:

Share

Diagnosis & Management Healthcare Professional App

Download this unique, FREE tool and resource that provides important information about the diagnosis and management of multiple sclerosis for practicing clinicians. The App is a concise compilation of current, easy-to-reference, evidence-based information that you can access at no charge as an Apple, Droid and Windows "App".

App production made possible by Allergan, Bayer HealthCare, Novartis and Questcor Pharmaceuticals, Inc.

Download for iPhone

Download for Android

Download for Windows Phone