Natalizumab Brand Name– Tysabri
What is Natalizumab
Natalizumab a humanized monoclonal antibody, is an alpha-4 integrin antagonist in a class of agents known as selective adhesion molecule inhibitors.
Natalizumab was the first FDA-approved alpha-4-integrin inhibitor.
Natalizumab has a different mechanism of action and side-effect profile than other available therapies for multiple sclerosis (MS) and is indicated for adults with relapsing forms of multiple sclerosis.
Natalizumab reduces MS relapse rates, decreases the appearance of brain lesions, and decreases the risk of disability progression; the drug also has been reported to improve quality of life for patients with MS.
The benefit of relapse reduction with natalizumab appears to cease with drug discontinuation; several investigations looking at treatment interruption with natalizumab found an increase in clinical and/or MRI activity.
Natalizumab receipt within 24 to 96 hours of an acute clinical MS relapse does not appear to hasten clinical recovery.
In addition to multiple sclerosis, natalizumab is used for the treatment of moderately to severely active Crohn’s disease (CD) in adults; the drug is indicated to induce and maintain clinical response and remission in patients with evidence of inflammation who have had an inadequate response to or are unable to tolerate conventional CD therapies and TNF blockers.
Natalizumab may cause hypersensitivity reactions and increases the risk for progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal demyelinating disease of the central nervous system.
Due to the risk of PML, natalizumab is only available under a risk-minimization program, called the TOUCH Prescribing Program. The purpose of the program is to attempt to identify cases of PML as early as possible.
The TOUCH program has the following main features:
(1) the drug will only be prescribed, distributed, and infused by prescribers, infusion centers, and pharmacies registered with the program;
(2) the drug will only be administered to patients enrolled in the program;
(3) prior to initiating the therapy, an MRI scan must be obtained for each patient with MS to help differentiate potential, future MS symptoms from PML (a baseline brain MRI may also be helpful in patients with Crohn’s disease, although baseline lesions are uncommon); and
(4) patients are to be evaluated 3 and 6 months after the first infusion and every 6 months thereafter, with their status reported to the manufacturer.
Additional information can be obtained in the U.S. by calling 1-800-456-2255 or visiting the natalizumab (Tysabri) website.
Indications
- Crohn’s disease
- multiple sclerosis
For the monotherapy treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Side Effects
- abdominal pain
- amenorrhea
- anaphylactic shock
- anaphylactoid reactions
- antibody formation
- anxiety
- arthralgia
- ataxia
- back pain
- chest pain (unspecified)
- cholelithiasis
- confusion
- constipation
- cough
- depression
- diarrhea
- dizziness
- drowsiness
- dysmenorrhea
- dyspepsia
- dyspnea
- elevated hepatic enzymes
- fatigue
- fever
- flatulence
- flushing
- GI obstruction
- headache
- hemolytic anemia
- hepatic failure
- hyperbilirubinemia
- hypertension
- hypotension
- increased urinary frequency
- infection
- infertility
- influenza
- infusion-related reactions
- infusion-related reactions
- jaundice
- meningitis
- menstrual irregularity
- muscle cramps
- myalgia
- nausea
- new primary malignancy
- night sweats
- ocular pain
- peripheral edema
- progressive multifocal leukoencephalopathy
- pruritus
- purpura
- rash
- retinopathy
- sinus tachycardia
- sinusitis
- stomatitis
- suicidal ideation
- thrombocytopenia
- tremor
- urinary incontinence
- urinary urgency
- urticaria
- vaginitis
- vertigo
- visual impairment
- vomiting
- weakness
- weight gain
- weight loss
- xerosis
Monitoring Parameters
- anti-JCV antibodies
- LFTs
- serum bilirubin
Contraindications
- acquired immunodeficiency syndrome (AIDS)
- breast-feeding
- children
- corticosteroid therapy
- hepatic disease
- hepatotoxicity
- herpes infection
- human anti-murine antibody (HAMA)
- human immunodeficiency virus (HIV) infection
- immune thrombocytopenic purpura (ITP)
- immunosuppression
- infants
- infection
- jaundice
- leukemia
- lymphoma
- murine protein hypersensitivity
- neonates
- organ transplant
- pregnancy
- progressive multifocal leukoencephalopathy
- serious hypersensitivity reactions or anaphylaxis
- thrombocytopenia
- vaccination
- visual disturbance
Interactions
- Adalimumab
- Alemtuzumab
- Azathioprine
- Azelastine; Fluticasone
- Bacillus Calmette-Guerin Vaccine, BCG
- Basiliximab
- Beclomethasone
- Betamethasone
- Budesonide
- Budesonide; Formoterol
- Certolizumab pegol
- Ciclesonide
- Corticosteroids
- Cortisone
- Cyclophosphamide
- Cyclosporine
- Daclizumab
- Deflazacort
- Dexamethasone
- Etanercept
- Everolimus
- Fludrocortisone
- Flunisolide
- Fluticasone
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- Formoterol; Mometasone
- Golimumab
- Hydrocortisone
- Infliximab
- Influenza Virus Vaccine
- Interferon Beta-1a
- Interferon Beta-1b
- Intranasal Influenza Vaccine
- Live Vaccines
- Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live
- Measles/Mumps/Rubella Vaccines, MMR
- Mercaptopurine, 6-MP
- Methotrexate
- Methylprednisolone
- Mitoxantrone
- Mometasone
- Mycophenolate
- Ocrelizumab
- Ofatumumab
- Ozanimod
- Prednisolone
- Prednisone
- Rituximab
- Rituximab; Hyaluronidase
- Rotavirus Vaccine
- Rubella Virus Vaccine Live
- Sirolimus
- Smallpox and Monkeypox Vaccine, Live, Nonreplicating
- Smallpox Vaccine, Vaccinia Vaccine
- Tacrolimus
- Triamcinolone
- Tumor Necrosis Factor modifiers
- Typhoid Vaccine
- Varicella-Zoster Virus Vaccine, Live
- Vedolizumab
- Yellow Fever Vaccine, Live
