Classifications: biologic response modifier; monoclonal antibody; integrin inhibitor; Therapeutic: immunomodulator; monoclonal antibody
Pregnancy Category: C
300 mg/15 mL injection
Natalizumab is a recombinant immunoglobulin-G4 (IgG4) monoclonal antibody thought to interfere with the migration of lymphocytes
and monocytes into the CNS endothelium of patients with multiple sclerosis, thereby reducing inflammation and demyelination
of CNS white matter.
Inhibition of T-cell infiltration into the brain is thought to impede the demyelinating process of multiple sclerosis. It
reduces relapses and occurrence of brain lesions. Natalizumab is also thought to attenuate T-lymphocytemediated intestinal
inflammation in Crohn's disease and possibly ulcerative colitis.
Treatment of relapsing forms of multiple sclerosis.
Treatment of Crohn's disease.
Safety and efficacy of the drug have not been established for chronic progressive multiple sclerosis. Prior hypersensitivity
to natalizumab; murine protein hypersensitivity; progressive multifocal leukoencephalopathy; active infection; females of
childbearing age; pregnancy (category C); lactation; children <18 y.
Coadministration with other immunosuppressive medication; diabetes mellitus, immunocompromised patients; exposure to infection
Route & Dosage
Adult: IV 300 mg infused over 1 h every 4 wk
PREPARE: IV Infusion: Before and after dilution, solution should be colorless and clear to slightly opaque. Do not use if the solution has visible
particles, flakes, color, or is cloudy. Withdraw 15 mL from the vial and add to an IV bag with 100 mL of NS. Do not use
with any other diluent. Gently invert the bag to mix; do not shake. The IV solution must be used within 8 h.
ADMINISTER: IV Infusion: Flush IV line before/after with NS. Infuse over 1 h. Do not give a bolus dose. Stop infusion immediately if S&S of hypersensitivity
INCOMPATIBILITIES Solution/additive/Y-site: Do not mix or infuse with other drugs.
- Store IV solution for up to 8 h at 2°8° C (36°46° F). Allow solution to warm to room temperature
Adverse Effects (≥1%)Body as a Whole: Anaphylaxis
(rare, usually within 2 h of infusion), infections, fatigue
, rigors. CNS: Depression
, headache, syncope, tremor. CV:
Chest discomfort. GI:
Abdominal discomfort, abnormal liver function tests. Hematologic:
Local bleeding from infusion site. Musculoskeletal:
Arthralgia. Respiratory: Pneumonia
Acute urticaria. Urogenital:
Urinary frequency, irregular menstruation, amenorrhea, dysmenorrhea. Other:
Infusion-related reactions (headache, dizziness, fatigue
, hypersensitivity reactions, urticaria, pruritus, and rigors).
May reduce the effectiveness of vaccines
; may increase risk of infection with immunosuppressants
Assessment & Drug Effects
- During IV infusion and for 12 h after, monitor closely for S&S of hypersensitivity (e.g., urticaria, dizziness, fever,
rash, chills, pruritus, nausea, flushing, hypotension, dyspnea, and chest pain).
- Monitor neurological status frequently. Report promptly any emerging S&S of dysfunction.
- Lab tests: Baseline and periodic CBC with differential.
Patient & Family Education
- Report immediately any of the following during/after IV infusion: difficulty breathing, wheezing or shortness of breath,
swelling or tightness about the neck and throat, chest pain, skin rash or hives.
- Report promptly S&S of infection (e.g., cough, fever, chills, or sore throat).