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Warnings & Safety Management

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Overview

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

Interferon b-1a (Avonex)

  • 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-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

Glatiramer acetate (Copaxone)

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

Fingolimod (Gilenya)

  • Prescribing Information
  • Warnings:
    • Infection
    • Macular edema
    • Dose-dependent decreased pulmonary function
    • Elevated serum hepatic transaminases
    • Hypertension
  • Recommended safety management strategies and recommended monitoring:
    • 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
    • Baseline pulse/blood pressure prior to first dose and observation of all patients for 6 hours after the first dose for signs and symptoms of bradycardia
    • Ophthalmologic evaluation after 3 to 4 months of treatment and in the event of new visual symptoms

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

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.

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:

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

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