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TYSABRI- natalizumab injection


  1. Patient Information
  2. Counsel Patients To Understand The Risks And Benefits Of Tysabri Before An Initial Prescription Is Written. The Patient May Be Educated By Either The Enrolled Prescriber Or A Healthcare Provider Under That Prescribers Direction. Instruct Patients Using Tysabri To:
  3. Your Risk Of Getting Pml Is Higher If You:
  4. Your Risk Of Getting Pml Is Greatest If You Have All 3 Risk Factors Listed Above. There May Be Other Risk Factors For Getting Pml During Tysabri Treatment That We Do Not Know About Yet. Your Doctor Should Discuss The Risks And Benefits Of Tysabri Treatment With You Before You Decide To Receive Tysabri. Tysabri Is A Prescription Medicine Used To Treat Adults With:relapsing Forms Of Multiple Sclerosis (ms), To Include Clinically Isolated Syndrome, Relapsing-remitting Disease And Active Secondary Progressive Disease. Tysabri Increases The Risk Of Pml. When Starting And Continuing Treatment With Tysabri, It Is Important That You Discuss With Your Doctor Whether The Expected Benefit Of Tysabri Is Enough To Outweigh This Risk. Do Not Receive Tysabri If You:
  5. Have Medical Conditions That Can Weaken Your Immune System, Including:
  6. Have Any New Or Worsening Medical Problems That Have Lasted Several Days. These May Be New Or Sudden And Include Problems With:
  7. How Should I Receive Tysabri?
  8. Tysabri May Cause Serious Side Effects, Including:
  9. Attention Pharmacist:
  10. Revised: 8/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

General Counseling Information

Counsel Patients To Understand The Risks And Benefits Of Tysabri Before An Initial Prescription Is Written. The Patient May Be Educated By Either The Enrolled Prescriber Or A Healthcare Provider Under That Prescribers Direction. Instruct Patients Using Tysabri To: 

  • Read the Medication Guide before starting TYSABRI and before each TYSABRI infusion.
  • Promptly report any new or continuously worsening symptoms that persist over several days to their prescriber [

    • TYSABRI increases your chance (risk) of getting a rare brain infection that usually leads to death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems.
      • There is no known treatment, prevention, or cure for 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 your immune system at the same time you are taking TYSABRI. Even if you use TYSABRI alone to treat your MS or CD, you can still get PML.

Your Risk Of Getting Pml Is Higher If You: 

  • have received TYSABRI for a long time, especially longer than 2 years
  • have received certain medicines that can weaken your immune system before you start receiving TYSABRI
  • have been infected by the 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 TYSABRI. Most people who are infected by JCV do not know it or do not have any symptoms. This infection usually happens in childhood. Before you start receiving TYSABRI or during your treatment, your doctor may do a blood test to check if you have been infected by JCV.

Your Risk Of Getting Pml Is Greatest If You Have All 3 Risk Factors Listed Above. There May Be Other Risk Factors For Getting Pml During Tysabri Treatment That We Do Not Know About Yet. Your Doctor Should Discuss The Risks And Benefits Of Tysabri Treatment With You Before You Decide To Receive Tysabri. Tysabri Is A Prescription Medicine Used To Treat Adults With:relapsing Forms Of Multiple Sclerosis (ms), To Include Clinically Isolated Syndrome, Relapsing-remitting Disease And Active Secondary Progressive Disease. Tysabri Increases The Risk Of Pml. When Starting And Continuing Treatment With Tysabri, It Is Important That You Discuss With Your Doctor Whether The Expected Benefit Of Tysabri Is Enough To Outweigh This Risk. Do Not Receive Tysabri If You: 


  • have PML

Have Medical Conditions That Can Weaken Your Immune System, Including: 

  • HIV infection or AIDS
  • leukemia or lymphoma
  • an organ transplant
  • other medical conditions that can weaken your immune system

Have Any New Or Worsening Medical Problems That Have Lasted Several Days. These May Be New Or Sudden And Include Problems With: 

  • thinking
  • strength
  • eyesight
  • weakness on 1 side of your body
  • balance
  • using your arms and legs
  • have had hives, itching or trouble breathing during or after receiving a dose of TYSABRI
  • have a fever or infection (including shingles or any unusually long lasting infection)
  • are pregnant or plan to become pregnant. It is not known if TYSABRI can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. TYSABRI can pass into your breast milk. It is not known if the TYSABRI that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive TYSABRI.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take medicines that can weaken your immune system. Ask your doctor if you are not sure.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How Should I Receive Tysabri? 


  • TYSABRI is given 1 time every 4 weeks through a needle placed in your vein (IV infusion).
  • Before each TYSABRI dose you will be asked questions to make sure TYSABRI is still right for you.

Tysabri May Cause Serious Side Effects, Including: 



  • Active ingredient: natalizumab
    Inactive Ingredients: sodium chloride, sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; polysorbate 80, and water for injection
    Manufactured by: Biogen Inc.; Cambridge, MA 02142 USA

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Vial Label

    NDC 64406-008-01

    TYSABRI

    (natalizumab)

    300 mg/ 15 mL

    (20 mg/mL)

    For Intravenous

    Infusion Only. Must be diluted prior to use.

    Usual Dosage: See prescribing information.

    Manufactured by:

    Biogen Inc.

    Cambridge, MA 02142 USA

    US License # 1697

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Vial Label

    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Carton Label

    NDC 64406-008-01

    TYSABRI

    (natalizumab)

    300 mg/ 15 mL (20 mg/mL)

    For Intravenous Infusion Only

    Must be diluted prior to use

Attention Pharmacist: 

Each patient is required to receive

the enclosed Medication Guide.

Rx Only

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Carton Label
TYSABRI
natalizumab injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64406-008
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
natalizumab(UNII: 3JB47N2Q2P) (natalizumab - UNII:3JB47N2Q2P)natalizumab300 mg in 15 mL
Inactive Ingredients
Ingredient NameStrength
sodium chloride(UNII: 451W47IQ8X)
sodium phosphate, monobasic, monohydrate(UNII: 593YOG76RN)
sodium phosphate, dibasic, heptahydrate(UNII: 70WT22SF4B)
polysorbate 80(UNII: 6OZP39ZG8H)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64406-008-011 in 1 CARTON11/23/2004
115 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12510411/23/2004
Labeler -Biogen Inc. (121376230)

Revised: 8/2019document Id: 

3fdc6d09-d79f-4439-9020-90f7e076088fSet id: c5fdde91-1989-4dd2-9129-4f3323ea2962Version: 34Effective Time: 20190812Biogen Inc.



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