Classes
DEA Class; Rx
Common Brand Names; Tysabri
- Multiple Sclerosis Treatments;
- Inflammatory Bowel Disease Agents;
- Monoclonal Antibodies, Integrin Blockers
Description
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)
Indications
Indicated for the monotherapy treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Contraindications
Hypersensitivity
Active/history of progressive multifocal leukoencephalopathy
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
300 mg q4 weeks IV.
300 mg q4 weeks IV.
Safety and efficacy have not been established; data are limited. Maximum dosage not definitively established.
>= 11 years: Safety and efficacy have not been established; data are limited. Maximum dosage not definitively established.
< 11 years: Use not recommended.
How supplied
Natalizumab
injectable solution
300mg/15mL
