Warnings

Safety Management Strategies and Recommended Monitoring

Interferon b-1a [Avonex]

Hepatic and hematologic abnormalities; depression; injection site reactions with SC administration

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]

Interferon b-1b

[Betaseron]

Interferon b-1b [Extavia]

Glatiramer acetate [Copaxone]

Lipoatrophy and skin necrosis 

Site rotation is essential; monitoring

Fingolimod                 [Gilenya]

Infection; macular edema; dose-dependent decreased pulmonary function; elevated serum hepatic transaminases; hypertension

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]

Infection; elevated serum hepatic transaminases (“black box” warning); fetal death and malformations (“black box warning); skin reactions; blood pressure increase; respiratory effects

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 fumerate

[Tecfidera]

Natalizumab      [Tysabri]

Progressive multifocal leukoencephalopathy; hypersensitivity reactions; hepatotoxicity; infections resulting from immunosuppression

TOUCH Safety Monitoring Program; risk factors for PML: antibody-positive for JC virus; prior treatment with immunosuppressant; > 2 yrs on Tysabri. Antibody testing should be repeated every six months.

Mitoxantrone [Novantrone]

Cardiac toxicity; acute myelogenous leukemia (more likely to occur at cumulative doses >60 mg/m²)

Baseline LVEF and repeat LVEF prior to each dose (with treatment terminated if LVEF <50%); continued monitoring of cardiac function after completion of treatment