Natalizumab

>10%

Abdominal discomfort

Arthralgia

Depression

Fatigue

Headache

Lower respiratory infection

UTI

1-10%

Abnnormal LFTs

Allergic reaction

Chest discomfort

Dermatitis

Gastroenteritis

Local bleeding

Menstrual disorder

Pruritus

Rash

Rigors

Syncope

Tonsillitis

Tremor

Urinary urgency/frequency

Vaginitis

Dosage Forms And Strengths

TYSABRI is a concentrated solution that must be diluted prior to intravenous infusion. TYSABRI injection is supplied as 300 mg natalizumab in 15 mL (20 mg/mL) in a sterile, single-use vial free of preservatives.

Storage And Handling

NDC 64406-008-01, TYSABRI injection is supplied as 300 mg natalizumab in 15 mL in a sterile, single-use vial free of preservatives. Each package contains a single-use vial. TYSABRI is a colorless and clear to slightly opalescent solution for dilution prior to intravenous infusion.

TYSABRI is available only through registered infusion centers participating in the TOUCH® Prescribing Program. To locate these infusion centers, contact Biogen at 1-800-456-2255.

TYSABRI single-use vials must be refrigerated between 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the carton and vial label. DO NOT SHAKE OR FREEZE. Protect from light.

If not used immediately, store the diluted TYSABRI solution for infusion at 2°C to 8°C (36°F to 46°F). TYSABRI solution for infusion must be administered within 8 hours of preparation.

Manufactured by: Biogen Inc. Cambridge, MA 02142 USA. Revised: Aug 2017

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Natalizumab is a prescription medication used to treat multiple sclerosis and Crohn's disease. Natalizumab belongs to a group of drugs called immunomodulators. It is thought to work by stopping certain cells of the immune system from reaching the brain and spinal cord or digestive tract and causing damage.

This medication comes in an injectable form to be given once every four weeks through a needle placed in a vein (IV infusion).

Common side effects include headache, tiredness, and joint pain. Because natalizumab can cause serious side effects, this medication is only available through a special program called the Touch program.

Natalizumab increases your chance of getting a rare brain infection that usually causes death or severe disability called progressive multifocal leukoencephalopathy (PML). 

• Your chance of getting PML may be higher if you are also being treated with other medicines that can weaken your immune system, including other treatments for Multiple Sclerosis (MS) and Crohn's disease (CD). You should not take certain medicines that weaken the immune system at the same time you are taking Natalizumab. Even if you use Natalizumab alone to treat your MS or CD, you can still get PML.
• Your chance of getting PML increases if you have been exposed to John Cunningham Virus (JCV). JCV is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems, such as people taking Natalizumab. Most people who are exposed to JCV do not know it or have any symptoms. This exposure usually happens in childhood.
  • If you have been exposed to JCV, your chance of getting PML increases even more if:
    • you have received Natalizumab for a long time, especially longer than 2 years
    • you have received certain medicines that can weaken your immune system before you start receiving Natalizumab
• Your risk of getting PML is greatest if you have all 3 risk factors listed above. Your doctor should discuss the risks and benefits of Natalizumab treatment with you before you decide to receive Natalizumab.
• Your doctor should monitor youfor any new signs or symptoms that may be suggestive of PML for approximately six months after you have stopped using Natalizumab.
• For 6 months after you stop taking Natalizumab, it is important that you call your doctor right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days. Tell all of your doctors that you are getting treatment with Natalizumab.

Other serious side effects with Natalizumab include:

• Infections. Natalizumab may increase your chance of getting an unusual or serious infection because Natalizumab can weaken your immune system.
• Allergic reactions. Symptoms can include:
  • hives
  • itching
  • trouble breathing
  • chest pain
  • dizziness
  • wheezing
  • chills
  • rash
  • nausea
  • flushing of skin
  • low blood pressure

Tell your doctor or nurse right away if you have any symptom of an allergic reaction, even if it happens after you leave the infusion center. You may need treatment if you are having an allergic reaction.

• Liver damage. Natalizumab may cause liver damage. Symptoms can include:
  • yellowing of the skin and eyes (jaundice)
  • nausea
  • vomiting
  • unusual darkening of the urine
  • feeling tired or weak

Call your doctor right away if you have symptoms of liver damage.

Natalizumab is available only through a restricted distribution program called the TOUCH Prescribing Program.

Natalizumab is only:

• prescribed by doctors who are enrolled in the TOUCH Prescribing Program
• infused at an infusion center that is enrolled in the TOUCH Prescribing Program
• given to patients who are enrolled in the TOUCH Prescribing Program

In order to receive Natalizumab, you must talk to your doctor and understand the benefits and risks of Natalizumab and agree to all of the instructions in the TOUCH Prescribing Program.

• If you take Natalizumab, it is important that you call your doctor right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days. Tell all of your doctors that you are getting treatment with Natalizumab.

Who should not receive Natalizumab?

Do not receive Natalizumab if you:

• have PML
• are allergic to Natalizumab

Natalizumab is not recommended if you:

• have a medical condition that can weaken your immune system such as HIV infection or AIDS, leukemia or lymphoma, or an organ transplant, and others.
• are taking medicines that can weaken your immune system. Talk with your doctor about all of the medicines you take or have taken.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of natalizumab there are no specific foods that you must exclude from your diet when receiving natalizumab.

WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Natalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported in patients taking natalizumab who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving natalizumab as monotherapy.

• Because of the risk of PML, natalizumab is available only through a special restricted distribution program called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, only prescribers, infusion centers, and pharmacies associated with infusion centers registered with the program are able to prescribe, distribute, or infuse the product. In addition, natalizumab must be administered only to patients who are enrolled in and meet all the conditions of the TOUCH Prescribing Program.
• Healthcare professionals should monitor patients on natalizumab for any new sign or symptom that may be suggestive of PML. Natalizumab dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.

Usual Adult Dose for Multiple Sclerosis:

300 mg IV over 1 hour once every 4 weeks

Comments:
-Only prescribers registered in the MS TOUCH (R) Prescribing Program may prescribe this drug for multiple sclerosis.
-Patients should be observed during the infusion and for one hour after the infusion is complete.

Use: Multiple Sclerosis (MS): As monotherapy for the treatment of patients with relapsing forms of multiple sclerosis

Usual Adult Dose for Crohn's Disease -- Maintenance:

300 mg IV over 1 hour once every 4 weeks

Comments:
-Only prescribers registered in the CD TOUCH (R) Prescribing Program may prescribe this drug for Crohn's disease.
-This drug should not be used with concomitant immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or concomitant inhibitors of TNF-alpha.
-Aminosalicylates may be continued during treatment with this drug.
-If the patient has not experienced therapeutic benefit by 12 weeks of induction therapy, this drug should be discontinued.
-For patients who start this drug while on chronic oral corticosteroids, steroid tapering should commence as soon as a therapeutic benefit of this drug has occurred; if the patient cannot be tapered off of oral corticosteroids within 6 months of starting this drug, then this drug should be discontinued.
-Other than the initial 6 month taper, prescribers should consider discontinuing this drug for patients who require additional steroid use that exceeds 3 months in a calendar year to control their Crohn's disease.
-Patients should be observed during the infusion and for one hour after the infusion is complete.

Use: Crohn's Disease (CD): For inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate conventional CD therapies and inhibitors of TNF-alpha

• It is used to treat MS (multiple sclerosis).
• It is used to treat Crohn's disease.

• Tell all of your health care providers that you take natalizumab. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Some people have had side effects within a few hours of the start of the infusion. Tell your doctor if you have any bad effects during this time.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• This medicine is not approved for use in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using natalizumab while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Natalizumab is a monoclonal antibody against the alpha-4 subunit of integrin molecules. These molecules are important to adhesion and migration of cells from the vasculature into inflamed tissue. Natalizumab blocks integrin association with vascular receptors, limiting adhesion and transmigration of leukocytes. Efficacy in specific disorders may be related to reduction in specific inflammatory cell populations in target tissues. In multiple sclerosis, efficacy may be related to blockade of T-lymphocyte migration into the central nervous system; treatment results in a decreased frequency of relapse. In Crohn disease, natalizumab decreases inflammation by binding to alpha-4 integrin, blocking adhesion and migration of leukocytes in the gut.

Distribution

Crohn disease: 2.4 to 8 L; Multiple sclerosis: 3.8 to 7.6 L

Half-Life Elimination

Crohn disease: 3 to 17 days; Multiple sclerosis: 7 to 15 days

Hypersensitivity to natalizumab or any component of the formulation; current or history of progressive multifocal leukoencephalopathy (PML)

Canada labeling: Additional contraindications (not in US labeling): Immunocompromised patients as a result of immunosuppressant or antineoplastic therapy, or immunodeficiencies (eg, HIV, leukemia, lymphoma)

Refer to adult dosing.

LactMed Record Number

716

Last Revision Date

20170905

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.