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Natalizumab

Class
Targeted therapy
Subclass
Anti-VLA-4 monocolonal antibodies
Generic name
Natalizumab
Brand names
Tysabri®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Crohn's disease • Moderate-to-severe, inadequate response to conventional therapies and TNF-α inhibitors, unable to tolerate conventional therapies and TNF-α inhibitors
•
300 mg IV q4 weeks, administered over 1 hour
Multiple sclerosis • Relapsing forms
•
300 mg IV q4 weeks, administered over 1 hour
Indications for use
Labeled indications
Adults
•
Treatment of Crohn's disease (moderate-to-severe, inadequate response to conventional therapies and TNF-α inhibitors, unable to tolerate conventional therapies and TNF-α inhibitors)
•
Treatment of multiple sclerosis (relapsing forms)
Safety risks
Boxed warnings
Exacerbation of progressive multifocal leukoencephalopathy
Progressive multifocal leukoencephalopathy
•
Use extreme caution in patients who are immunocompromised, or have presence of anti-JCV antibodies or are on longer treatment duration, especially beyond 2 years or have had prior treatment with an immunosuppressant.
Contraindications
Hypersensitivity to natalizumab or any of its components
Warnings and precautions
Acute retinal necrosis
•
Maintain a high level of suspicion, as treatment with natalizumab has been associated with a higher risk of acute retinal necrosis.
Drug-induced liver injury
•
Use caution in patients with jaundice or other evidence of significant liver injury.
Opportunistic infections
•
Use caution in patients receiving concurrent immunosuppressants.
Thrombocytopenia
•
Use caution in newborns with in utero exposure to natalizumab.
Viral encephalitis, meningitis
•
Maintain a high level of suspicion as, natalizumab increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available. Monitor serum aminotransferases. Monitor for toxicity.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Consider safer alternatives. Evidence of fetal harm in humans. Monoclonal antibodies cross the placenta, particularly during the third trimester, and may affect the immune response of the fetus. Cases of neonatal thrombocytopenia, sometimes associated with anemia, were reported.
Breastfeeding
Acceptable for use during breastfeeding.
Low excretion in breastmilk (5-25%).
Undetectable levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
Gastroenteritis, influenza virus infection, infusion-related reactions, lower respiratory tract infections, abdominal discomfort, arthralgia, back pain, depression, fatigue, headache, limb pain, nausea, skin rash, urinary tract infections, upper respiratory tract infections
Common 1-10%
•
Dermatitis, hypotension, peripheral edema, chest discomfort, chest pain, cough, diarrhea, dizziness, dysmenorrhea, dyspnea, fever, generalized pruritus, indigestion, menstrual irregularity, muscle cramps, skin rash, throat pain, urinary urgency, vertigo, sinusitis, tonsillitis, tooth abnormalities, urticaria, vaginitis, viral infections
Uncommon < 1%
•
Acute appendicitis, anaphylaxis, cholelithiasis, peritoneal adhesions, pneumonia, progressive multifocal leukoencephalopathy, suicidal ideation
Unknown frequency
•
Autoimmune hepatitis, acute retinal necrosis, anemia, bowel obstruction, drug-induced liver injury, herpes simplex virus infection, hemolytic anemia, immune reconstitution inflammatory syndrome, immune thrombocytopenia, ↑ WBC count, ↑ liver enzymes, ↑ serum TBIL, melanoma, melanoma, progressive outer retinal necrosis, psoriasis, serum sickness
Interactions
Drug(s)
Check Interactions
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