Tysabri
natalizumab
(na-ta-li-zoo-mab) natalizumab,Tysabri
(trade name)Classification
Therapeutic: anti multiple sclerosis agentsPharmacologic: monoclonal antibodies
Indications
Action
Therapeutic effects
Pharmacokinetics
Time/action profile
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| IV | unknown | unknown | unknown |
Contraindications/Precautions
Adverse Reactions/Side Effects
Central nervous system
- depression
- fatigue
Gastrointestinal
- hepatotoxicity (life-threatening)
- cholelithiasis
Dermatologic
- melanoma
Miscellaneous
- allergic reactions including anaphylaxis
- infections
- PML (life-threatening)
- infusion-related reactions
Interactions
Drug-Drug interaction
↑ risk of infection with immunosupressants (avoid concurrent use).Route/Dosage
NOTE: Because of the risk of PML, natalizumab is available only under a special restricted distribution program, the TOUCH Prescribing Program. Prescribers, pharmacies, and patients must be enrolled in the program to obtain the drug.Multiple Sclerosis
Crohn's Disease
Availability
Nursing implications
Nursing assessment
- Observe patient during infusion and for 1 hr after infusion is completed. Assess for signs of hypersensitivity reactions (urticaria, dizziness, fever, rash, rigors, pruritus, nausea, flushing, hypotension, dyspnea, chest pain, anaphylaxis), especially during first 2 hrs of infusion. If symptoms occur, discontinue natalizumab and treat symptoms.
- Assess for new signs or symptoms suggestive of PML, an opportunistic infection of the brain caused by the JC virus, leading to death or severe disability; withhold dose and notify health care professional promptly. Monitor during therapy and for at least 6 months following discontinuation. PML symptoms may begin gradually but usually worsen rapidly. Symptoms vary depending on which part of the brain is infected (mental function declines rapidly and progressively, causing dementia; speaking becomes increasingly difficult; partial blindness; difficulty walking; rarely, headaches and seizures occur). Diagnosis is usually made via gadolinium-enhanced MRI and CSF analysis. Risk of PML increases with the number of infusions. Withhold natalizumab at first sign of PML.
- Obtain an MRI of the brain prior to initiating therapy to help in differentiating symptoms of MS with those of PML.
- MS: Assess frequency of exacerbations of symptoms of multiple sclerosis periodically during therapy.
- Crohn's disease: Assess abdominal pain and frequency, quantity, and consistency of stools at beginning and during therapy.
- Lab Test Considerations: May cause ↑ lymphocytes, monocytes, eosinophils, basophils, and nucleated RBCs. These ↑ persist during therapy but usually return to baseline within 16 weeks after last dose. Neutrophil ↑ do not usually occur.
- May cause hepatotoxicity. Monitor for ↑ serum hepatic enzymes and total bilirubin may occur within 6 days after the first dose or for the first time after multiple doses. Discontinue if jaundice or other evidence of hepatotoxicity occurs.
- Monitor serum JCV antibodies periodically during therapy. Patients with a negative antibody should be retested periodically during therapy due potential for false-positive results or a new infection.
Potential Nursing Diagnoses
Deficient knowledge, related to medication regimen (Patient/Family Teaching)Implementation
Intravenous Administration
- Intermittent Infusion: Diluent: Dilute 300 mg in 100 mL of 0.9% NaCl. Invert to mix solution; do not shake. Do not mix with other diluents. Solution is colorless and clear to slightly opalescent. Do not administer solutions that are discolored or contain particulate matter. Administer immediately after dilution or refrigerate and use within 8 hrs. Concentration: 2.6 mg/mL.
- Rate: Infuse over 1 hr. Do not use filtration devices. Do not administer as IV push or bolus injection.
Patient/Family Teaching
- Inform patient of purpose of medication. Patients must visit their health care professional/prescriber 3 and 6 months after first infusion and every 6 months thereafter for follow-up exam.
- Instruct patient to read the Medication Guide before starting the infusion. Natalizumab is available only through a special restricted distribution program called the TOUCH™ Prescribing Program, MS-TOUCH for multiple sclerosis and CD-TOUCH for Crohn's Disease, and must be administered only to patients enrolled in this program.
- Instruct patient to report symptoms of PML (progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes), hypersensitivity reactions, hepatotoxicity (yellowing of the skin and eyes, unusual darkening of the urine, nausea, feeling tired or weak, vomiting), or worsening of symptoms (new or sudden change in your thinking, eyesight, balance, or strength or other problems) that persist over several days to health care professional immediately.
- Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Instruct patient to inform all health care professionals about treatment with natalizumab.
- Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Evaluation/Desired Outcomes
- Decrease in frequency of clinical exacerbations in patients with multiple sclerosis.
- Decrease in signs and symptoms of Crohn's disease.
- Patients must be evaluated at 3 mo and 6 mo after first infusion and every 6 mo thereafter to determine effectiveness.