TYSABRI (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC 59075-730-15, 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 Idec at 1-800-456-2255.

TYSABRI single-use vials must be refrigerated between 2 to 8°C (36° 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 to 8°C (36° to 46°F). TYSABRI solution for infusion must be administered within 8 hours of preparation.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).

17.1 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 prescriber’s 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 [see Boxed Warning, Warnings and Precautions (5.1)].
  • Inform all of their physicians that they are receiving TYSABRI.
  • Plan to see their prescriber three months after the first infusion, six months after the first infusion, and at least as frequently as every six months thereafter.

17.2 Progressive Multifocal Leukoencephalopathy

Inform patients that Progressive Multifocal Leukoencephalopathy (PML) has occurred in patients who received TYSABRI. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Instruct the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. Instruct the patient that the progression of deficits usually leads to death or severe disability over weeks or months [see Warnings and Precautions (5.1) ].

17.3 Hypersensitivity Reactions

Instruct patients to report immediately if they experience symptoms consistent with a hypersensitivity reaction (e.g., urticaria with or without associated symptoms) during or following an infusion of TYSABRI [see Warnings and Precautions (5.3) ].

17.4 Immunosuppression/Infections

Inform patients that TYSABRI may lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection [see Warnings and Precautions (5.4) ].

17.5 Hepatotoxicity

Inform patients that TYSABRI may cause liver injury. Instruct the patient to contact their doctor if they develop symptoms of hepatoxicity [see Warnings and Precautions (5.5) ].

I61061-17

TYSABRI (natalizumab)

Manufactured by:
Biogen Idec Inc.
14 Cambridge Center
Cambridge, MA 02142 USA
1-800-456-2255

Distributed by:
Elan Pharmaceuticals, Inc.
South San Francisco, CA 94080

© 2012 Biogen Idec Inc. All rights reserved.

TYSABRI® is a registered trademark of Elan Pharmaceuticals, Inc.
AVONEX® is a registered trademark of Biogen IdecTOUCH® is a registered trademark of Elan Pharmaceuticals, Inc.

U.S. Patent Numbers: 5,840,299; 6,602,503

MEDICATION GUIDE

TYSABRI ® (tie-SA-bree)

(natalizumab)

Read the Medication Guide given to you before you start TYSABRI and before each infusion. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. Ask your doctor or nurse if you have any questions.

What is the most important information I should know about TYSABRI?

  • TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems.
  • No one can predict who will get PML.
  • 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 the 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 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 Tysabri. 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 TYSABRI for a long time, especially longer than 2 years
      • you have received certain medicines that can weaken your immune system before you start receiving TYSABRI

    Your doctor may do a blood test to check if you have been exposed to JCV before you start receiving TYSABRI or during your treatment. There may be other risk factors for getting PML during Tysabri treatment that we do not know about yet.

  • 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 TYSABRI treatment with you before you decide to receive TYSABRI.
  • TYSABRI is available only through a restricted distribution program called the TOUCH® Prescribing Program. In order to receive TYSABRI, you must talk to your doctor and understand the benefits and risks of TYSABRI and agree to all of the instructions in the TOUCH® Prescribing Program.
  • If you take TYSABRI, 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 TYSABRI.

See What are the possible side effects with TYSABRI? for other serious side effects with TYSABRI.

What is TYSABRI?

TYSABRI is a prescription medicine approved for:

  1. Adult patients with relapsing forms of Multiple Sclerosis (MS) to:
    • Slow the worsening of disability that is common in patients with MS and,
    • Decrease the number of flare-ups (relapses)

    Because of the chance of getting PML, TYSABRI is generally recommended for patients that have not been helped enough by, or cannot tolerate another treatment for MS.

  2. Adult patients with moderate to severe Crohn’s disease:
    • To reduce signs and symptoms of Crohn’s disease
    • In patients who have not been helped enough by, or cannot tolerate usual Crohn’s disease medicines and medicines called tumor necrosis factor (TNF) inhibitors.
  • TYSABRI does not cure MS or Crohn’s disease.
  • TYSABRI has not been studied for use longer than 2 years.
  • TYSABRI has not been studied in patients with chronic progressive MS.
  • It is not known if patients older than 65 years have a different response to TYSABRI.
  • TYSABRI is not approved for use in patients under age 18.

TYSABRI 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

Who should not receive TYSABRI?

Do not receive TYSABRI if you:

  • have PML
  • are allergic to TYSABRI

TYSABRI 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.

If you have questions about any of the above, talk to your doctor.

What should I tell my doctor and nurse before receiving each infusion of TYSABRI?

Tell your doctor and nurse about all of your medical conditions. Tell them if you:

  • have 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 several days
  • have had hives, itching or trouble breathing during or after an infusion of TYSABRI
  • have a fever or infection (including shingles or any unusually long lasting infection)
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. TYSABRI can pass into your milk. It is not known if the TYSABRI that passes into breast milk can harm your baby.
  • Tell your doctor and nurse about all of the medicines you are taking, including prescription and non-prescription medicines, vitamins and herbal supplements.
  • Know the medicines you take. Keep a list of them with you to show your doctor and nurse. The nurse may ask to see this list before every TYSABRI infusion.

How do I receive TYSABRI?

  • TYSABRI is given once every four weeks through a needle placed in a vein (IV infusion).
  • You must follow all the instructions of the TOUCH® Prescribing Program. Before you can begin to receive TYSABRI, your doctor or nurse will:
    • explain the TOUCH® Prescribing Program to you
    • have you sign the TOUCH® Prescriber/Patient Enrollment Form
  • Before every TYSABRI infusion you will be asked a series of questions to confirm that TYSABRI is still right for you.
  • Call your doctor who prescribes TYSABRI right away to report any medical problems that keep getting worse and last several days.

What are the possible side effects of TYSABRI?

TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems. (see What is the most important information I should know about TYSABRI?)

Other serious side effects with TYSABRI include:

  • Infections. TYSABRI may increase your chance of getting an unusual or serious infection because TYSABRI can weaken your immune system.
  • Allergic reactions including serious allergic reactions. Symptoms can include:
    • hives
    • chills
    • itching
    • rash
    • trouble breathing
    • nausea
    • chest pain
    • flushing of skin
    • dizziness
    • low blood pressure
    • wheezing
  • Serious allergic reactions usually happen within 2 hours of the start of the infusion, but they can happen at any time after receiving TYSABRI.
  • 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. TYSABRI may cause liver damage. Symptoms can include:
    • yellowing of the skin and eyes (jaundice)
    • unusual darkening of the urine
    • nausea
    • feeling tired or weak
    • vomiting

Blood tests can be done to check for liver damage. Call your doctor right away if you have symptoms of liver damage.

Other side effects with TYSABRI include:

  • headache
  • feeling tired
  • urinary tract infection
  • joint pain
  • lung infection
  • depression
  • pain in your arm and legs
  • diarrhea
  • vaginitis
  • rash
  • nose and throat infections
  • stomach area pain

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with TYSABRI. Ask your doctor for more information.

General information about the safe and effective use of TYSABRI

This Medication Guide provides a summary of the most important information about TYSABRI. If you would like more information or have any questions, talk with your doctor or nurse. You can ask your doctor or nurse for information about TYSABRI that is written for healthcare professionals. You can also call 1-800-456-2255 or visit www.TYSABRI.com.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in TYSABRI?

Active ingredient: natalizumab

Inactive Ingredients: sodium chloride, sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; polysorbate 80, and water for injection.

Manufactured by Biogen Idec Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

I61061-17
Revised 12/2012

Manufactured by: Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142 USADistributed by: Elan Pharmaceuticals, Inc., South San Francisco, CA 94080

TYSABRI® is a registered trademark of Elan Pharmaceuticals, Inc.

TOUCH® is a registered trademark of Elan Pharmaceuticals, Inc.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 59075-730-15

TYSABRI ® biogen idec®

(natalizumab)

300 mg/ 15 mL

(20 mg/mL)

Concentrated Solution For Intravenous

Infusion Only. Must be diluted prior to use.

Manufacture by:

Biogen Idec Inc.

Cambridge, MA 02142 USA

US License # 1697

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Carton Label

NDC 59075-730-15

TYSABRI ®

(natalizumab)

300 mg/ 15 mL (20 mg/mL)

Concentrated Solution

For Intravenous Infusion Only.

Must be diluted prior to use.

ATTENTION PHARMACIST:

Each patient is required to receive

the endorsed Medication Guide.

Rx Only

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Carton Label
(click image for full-size original)
TYSABRI natalizumab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59075-730
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
natalizumab (natalizumab) natalizumab 300 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
sodium phosphate, monobasic, monohydrate
sodium phosphate, dibasic, heptahydrate
polysorbate 80
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59075-730-15 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 1 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (59075-730-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125104 11/23/2004
Labeler — Elan Pharmaceuticals, Inc. (025477170)
Registrant — Biogen Idec Inc. (121376230)

Revised: 12/2012 Elan Pharmaceuticals, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.