Natalizumab
Pronouncation: (nay-tal-IZ-oo-mab)Class: Immunologic
Trade Names:
Tysabri
- Injection 20 mg/mL
Pharmacology
 | |||||||||
Feedback for Natalizumab
Compare with other drugs.
| |||||||||
Exact mechanism of action is unknown; however, animal data demonstrate a reduction of leukocyte migration into brain parenchyma and a reduction of plaque formation.
Pharmacokinetics
Absorption
Mean C max is approximately 110 mcg/mL. Steady-state trough concentrations range from 23 to 29 mcg/mL. After 4 wk of dosing, the time to steady state is approximately 24 wk.
Distribution
Vd is 5.7 L.
Elimination
The mean t ½ is about 11 days; Cl is 16 mL/h.
Special Populations
Body weightA less than proportional increase in Cl occurs as body weight increases, such that a 43% increase in body weight produces a 32% increase in Cl.
Indications and Usage
Treatment of relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.
Contraindications
Patients who have progressive multifocal leukoencephalopathy; hypersensitivity to any component of the product.
Dosage and Administration
AdultsIV 300 mg infused over 1 h every 4 wk.
General Advice
- Observe patient during infusion and for 1 h after infusion is complete. Promptly discontinue infusion upon the first signs or symptoms of a hypersensitivity reaction.
- Each vial is intended for single use only.
- Inspect vial for particulate material prior to dilution and administration. If particulates are observed or the liquid is discolored, do not use the vial.
- Upon dilution, gently invert solution to mix completely. Do not shake.
- Visually inspect the final solution for particulate material prior to administration.
- Following dilution, infuse solution immediately or refrigerate at 36° to 46°F and use within 8 h. Do not freeze. Warm solution to room temperature prior to infusion.
- Do not inject other medications into infusion set side ports or mix other medications with natalizumab.
Storage/Stability
Refrigerate between 36° and 46°F. Do not shake or freeze. Protect from light.
Drug Interactions
Antineoplastic, corticosteroid, immunosuppressant, or immunomodulating agentsMay increase the risk of infection.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Headache (38%); fatigue (27%); depression (19%); vertigo (6%); somnolence (2%); progressive multifocal leukoencephalopathy.
Dermatologic
Rash (12%); dermatitis (7%); pruritus (4%); skin laceration (2%); night sweats (1%).
EENT
Tonsillitis (7%).
GI
Abdominal discomfort, gastroenteritis (11%); diarrhea (10%); tooth infections (9%).
Genitourinary
UTI (21%); vaginitis (10%); urinary urgency/frequency (9%); irregular menstruation (5%); urinary incontinence (4%); dysmenorrhea (3%); amenorrhea, ovarian cyst (2%).
Hepatic
Abnormal LFTs (5%).
Metabolic-Nutritional
Weight increase or decrease (2%).
Musculoskeletal
Arthralgia (19%); pain in extremity (16%); muscle cramp (5%); rigors (3%); joint swelling (2%).
Respiratory
Lower respiratory tract infection (17%).
Miscellaneous
Infusion-related reactions (24%); herpes (8%); chest discomfort, other hypersensitivity reactions (5%); acute hypersensitivity reactions (4%); limb injury, seasonal allergy (3%); thermal burn (1%).
Precautions
WarningsNatalizumab therapy increases the risk of progressive multifocal leukoencephalopathy, an opportunistic viral infection of the brain that usually leads to death or severe disability. Natalizumab is available only through a special restricted distribution program, and only prescribers, infusion centers, and pharmacies associated with registered infusion centers are able to prescribe, distribute, or infuse the product. The product must only be administered to patients who are enrolled in and meet the conditions of the prescribing program. |
MonitorEvaluate the patient 3 and 6 mo after the first infusion and every 6 mo thereafter. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Hypersensitivity
Has been associated with hypersensitivity reactions, including serious systemic reactions (eg, anaphylaxis).
Immunosuppression
The immune system effects of natalizumab may increase the risk of infection.
Overdosage
Symptoms
Undetermined.
Patient Information
- Instruct patient to read the Medication Guide before starting therapy and before each infusion.
- Instruct patient to promptly report to health care provider any continuously worsening symptoms that persist over several days.
- Advise patient to inform all health care providers that they are receiving natalizumab.
- Advise patient to see health care provider 3 and 6 mo after the first infusion and at least every 6 mo thereafter.
- Instruct patient to immediately report any symptoms consistent with hypersensitivity during or following an infusion.
 |
Link to Page |  |
Print Page |  |
Email Page |  | Add to List |
More Natalizumab resources:
Natalizumab - Includes detailed dosage instructions.
Multiple Sclerosis, Crohn's Disease -- Maintenance
