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Natalizumab

    Brands

    DEA Class;  Rx

    Common Brand Names; Tysabri

    •  Multiple Sclerosis Treatments; 
    • Inflammatory Bowel Disease Agents; 
    • Monoclonal Antibodies, Integrin Blockers

    Humanized monoclonal antibody against alpha-4 integrin; an alpha-4-integrin inhibitor
    Used in adults for relapsing forms of multiple sclerosis and induces and maintains remission in moderately to severely active Crohn’s Disease
    Only available via the TOUCH Prescribing Program, due to risk of progressive multifocal leukoencephalopathy (PML)

    Indicated for the monotherapy treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    For the treatment of moderately to severely active Crohn’s disease to induce and maintain clinical response and remission in patients who have had an inadequate response to or are unable to tolerate conventional Crohn’s disease therapies and TNF-blockers.

    Hypersensitivity

    Active/history of progressive multifocal leukoencephalopathy

    • Fatigue (10%)
    • Diarrhea (10%)
    • Urinary urgency/frequency (9%)
    • Sinusitis (8%)
    • Vaginal infections (8%)
    • Arthralgia (8%)
    • Cough (3-7%)
    • Viral infection (7%)
    • Dermatitis (7%)
    • Pharyngolaryngeal pain (6%)
    • Peripheral edema (6%)
    • Rash (6%)
    • Dysmenorrhea (2-6%)
    • Vertigo (6%)
    • Dyspepsia (5%)
    • Abnormal liver function test (5%)
    • Irregular menstruation (5%)
    • Urinary incontinence (4%)
    • Toothache (4%)
    • Pruritus (4%)
    • Lower abdominal pain (4%)
    • Constipation (4%)
    • Vaginal infections (4%)
    • Limb injury (3%)
    • Viral infections (3%)
    • Urinary tract infections (3%)
    • Flatulence (3%)
    • Skin laceration (2%)
    • Aphthous stomatitis (2%)
    • Amenorrhea (2%)
    • Ovarian cyst (2%)
    • Somnolence (2%)
    • Acute hypersensitivity reactions (2%)
    • Thermal burn (1%)
    • Dry skin (1%)
    • Tremor (1%)
    • Night sweats (1%)

    Increased risk of PML with prolonged duration of therapy, prior treatment with immunosuppressants, or positive anti-JCV antibody status (see Black Box Warnings)

    Do not use with other immunosuppressives; may increase the risk for certain infections; monitor patients for development of infections

    Possibility of anaphylactic reaction; observe patients during and for 1 hr after infusion to see if symptoms of hypersensitivity-type reactions develop

    There are no adequate data on the developmental risk associated with use in pregnant women

    Natalizumab has been detected in human milk

    No data available on the effects of this exposure on the breastfed infant or the effects of the drug on milk production

    Adults

    300 mg q4 weeks IV.

    Elderly

    300 mg q4 weeks IV.

    Adolescents

    Safety and efficacy have not been established; data are limited. Maximum dosage not definitively established.

    Children

    >= 11 years: Safety and efficacy have not been established; data are limited. Maximum dosage not definitively established.
    < 11 years: Use not recommended.

    Natalizumab

    injectable solution

    • 300mg/15mL