A Selective Adhesion-Molecule Inhibitor.

Indications: Crohn disease: For inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn disease therapies and inhibitors of tumor necrosis factor-alpha (TNF-alpha).

Multiple sclerosis: As monotherapy for the treatment of patients with relapsing forms of multiple sclerosis (MS). Natalizumab increases the risk of PML. When initiating and continuing treatment with natalizumab, consider whether the expected benefit of natalizumab is sufficient to offset this risk.

Canada labeling: Treatment of relapsing forms of multiple

Cautions: Natalizumab is associated with an increased risk of opportunistic infection and progressive multifocal leucoencephalopathy (PML) caused by JC virus

Contra-indications: Hypersensitivity to natalizumab or any component of the formulation.

current or history of progressive multifocal leukoencephalopathy (PML)

Canada labeling: Additional contraindications (not in U.S. labeling): Immunocompromised patients as a result of immunosuppressant or antineoplastic therapy, or immunodeficiencies (eg, HIV, leukemia, lymphoma. Pregnancy: avoid unless essential (toxicity in animal studies).

Breast-feeding: Avoid (present in milk in animal studies

Renal impairment: No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Hepatic impairment: No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Discontinue use with jaundice or signs/symptoms of hepatic injury.

Side Effects: Most common: Central nervous system: Headache, fatigue, depression. Dermatologic: Rash. Gastrointestinal: Nausea, gastroenteritis, abdominal discomfort Genitourinary: Urinary tract infection.

Neuromuscular & skeletal: Arthralgia, extremity pain, back pain Respiratory: Upper respiratory infection, lower respiratory infection. Miscellaneous: Infusion-related reaction, influenza, flu-like syndrome. Less common: Cardiovascular: Peripheral edema, chest discomfort.

Central nervous system: Vertigo, dysesthesia, syncope somnolence. Dermatologic: Dermatitis, pruritus, urticarial, dry skin. Endocrine & metabolic: Dysmenorrhea, menstrual irregularities amenorrhea, ovarian cyst. Gastrointestinal: Diarrhea, dyspepsia, abdominal pain constipation, flatulence, aphthous stomatitis, weight changes cholelithiasis, gingival infection. Genitourinary: Vaginitis/vaginal infections, urinary frequency urinary incontinence. Hematologic: Hematoma. Hepatic: Transaminase increased. Local: Bleeding at injection site. Neuromuscular & skeletal: Muscle cramp, tremor rigors joint swelling. Respiratory: Sinusitis, cough, tonsillitis, pharyngolaryngeal pain epistaxis. Miscellaneous: Antibody formation, tooth infection, herpes infection, viral infection, hypersensitivity reactions, toothache limb injury serious infection, laceration, thermal injury, night sweats. rare (Limited to important or life-threatening): Acne, agitation, anaphylaxis/anaphylactoid reactions, anemia, angina, appendicitis, bilirubin increased, bronchopulmonary aspergillosis, Burkholderia cepacia, Crohn’s disease exacerbation, cryptosporidial gastroenteritis, cytomegalovirus hepatitis, dizziness, dyspnea, erythema. fever, flushing, hemoglobin decreased (mild, transient), hepatic failure, hepatotoxicity, herpes encephalitis, herpes meningitis, hypotension, IRIS, joint stiffness, lethargy, leukocytosis, nasopharyngitis, opportunistic infections (including progressive multifocal leukoencephalopathy [PML], meningitis, and bronchopulmonary infections), muscle spasms, muscle weakness, onychorrhexis, paresis, pericarditis (case report), petechiae, pharyngitis, Pneumocystis jiroveci pneumonia, pneumonia, psychomotor hyperactivity, pulmonary Mycobacterium avium intracellulare, suicidal ideation, tachycardia, thrombocytopenia, thrombophlebitis, varicella pneumonia, vasodilatation Dose: Multiple sclerosis: IV: 300 mg infused over 1 hour every 4 weeks Crohn disease: IV: 300 mg infused over 1 hour every 4 weeks; discontinue if therapeutic benefit is not observed within initial 12 weeks of therapy Concomitant use with corticosteroids: For patients who begin treatment while on chronic oral corticosteroids, begin tapering oral steroids when the onset of natalizumab therapeutic benefit is observed; discontinue use if patient cannot be tapered off of oral corticosteroids within 6 months of therapy initiation. If additional concomitant corticosteroids are required and exceed 3 months/year (in addition to initial corticosteroid taper), consider discontinuing therapy.