TYSABRI® (natalizumab) IV INFUSION GUIDELINES FOR

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TYSABRI® (natalizumab)
IV INFUSION GUIDELINES FOR
RELAPSING MULTIPLE SCLEROSIS (RMS)
These Infusion Guidelines are not intended to replace the infusion center’s general infusion protocol(s).
Nor are these Infusion Guidelines intended to be a substitute for consultation and review of reference
materials and medical literature pertaining to individual clinical circumstances. Healthcare providers
should make all treatment decisions based on the context of the situation and their clinical judgment.
INDICATION
TYSABRI® (natalizumab) is indicated as monotherapy for the treatment of patients with relapsing forms
of multiple sclerosis. TYSABRI increases the risk of PML. When initiating and continuing treatment with
TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
See important information regarding the risk of PML with TYSABRI.
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
TYSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that
usually leads to death or severe disability. Risk factors for the development of PML include duration of
therapy, prior use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be
considered in the context of expected benefit when initiating and continuing treatment with TYSABRI.
Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may
be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom
suggestive of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the
brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.
Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called the TOUCH Prescribing Program.
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
For more information about TYSABRI® (natalizumab),
please call ActiveSource at:
Or visit Biogen Idec Medical Information
(registration required) at:
For further information regarding the guidelines for
IV therapy, visit the IV Nurses Society website at:
For more information about RMS, visit the
National MS Society at:
1-800-456-2255
Monday through Friday, 8:30 am to
8:00 pm (ET)
http://medinfo.biogenidec.com
www.ins1.org
www.nationalmssociety.org
For more information about TYSABRI® (natalizumab),
please visit www.TYSABRIHCP.com
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
2
TABLE OF CONTENTS
Infusion Process........................................................................ 4-12
Infusion and Hypersensitivity Reactions...................................14-16
Special Considerations for Infusion Patients with RMS����������������� 17
TOUCH® Prescribing Program Overview....................................18-19
Important Safety Information..................................................20-23
MS ActiveSource® Support.......................................................... 24
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
INFUSION AND SITE PREPARATION
General guidelines for TYSABRI® (natalizumab) infusion1,2
T he recommended dose of TYSABRI® (natalizumab) is 300-mg IV infusion over 1 hour every 28 days
TYSABRI injection is supplied as 300-mg natalizumab in 15 mL in a sterile, single-use vial free
of preservatives
Storage
— Refrigerate between 36°F and 46°F (2°C to 8°C)
— Protect from light
— Do not shake or freeze
TYSABRI is a colorless, clear to slightly opalescent concentrate. Inspect the TYSABRI vial for particulate
material prior to dilution and administration
Do not use TYSABRI beyond the expiration date printed on the carton or vial
Other medications should not be injected into infusion-set side ports or mixed with TYSABRI
Aseptic technique and observation of standard precautions will reduce risk of complications
from infusion of TYSABRI
Infection control and safety compliance3,4
Use of aseptic technique and observation of standard precautions will reduce the risk of
complications from infusion of TYSABRI. According to the Centers for Disease Control,
strict adherence to handwashing and aseptic technique remains the cornerstone of prevention
of IV catheter–related infections. The following guidelines are recommended:
Wash hands thoroughly before and after procedure
Apply antiseptic cleanser to the skin prior to IV catheter insertion
Use clean or sterile gloves when performing IV catheter insertion and infusion procedure
Dispose of blood-contaminated needles in a nonpermeable, puncture-resistant,
tamper-proof container
Make regulation sharps containers easily accessible
Sterilize nondisposable equipment
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
4
Infusion Process
Site selection and placement3
ite selection influences the risk of complications (e.g., infection and phlebitis). Note that TYSABRI is not
S
in the category of vesicants or irritants
Veins of the upper extremities are preferred
Assess site for vein damage related to previous venipuncture
Consult a doctor prior to IV catheter placement in the arm of a patient who may have contraindications
to peripheral IV catheter placement
Site care and maintenance3
se clean or sterile gloves for all site care
U
Allow access for observation and evaluation of the IV insertion site and surrounding tissue
Apply antiseptic cleanser to the skin prior to IV catheter insertion
Warning
T YSABRI® (natalizumab) increases the risk of PML, an opportunistic viral infection of the brain that usually
leads to death or severe disability. Risk factors for the development of PML include duration of therapy, prior
use of immunosuppressants, and presence of anti-JCV antibodies. These factors should be considered in the
context of expected benefit when initiating and continuing treatment with TYSABRI
Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be
suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive
of PML. For diagnosis, an evaluation including a gadolinium-enhanced MRI scan of the brain and, when
indicated, cerebrospinal fluid analysis for JC viral DNA are recommended
Because of the risk of PML, TYSABRI is available only through a restricted program under a Risk Evaluation
and Mitigation Strategy (REMS) called the TOUCH Prescribing Program
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
PRIOR TO IV INFUSION PREPARATION
Because of the risk of PML, TYSABRI® (natalizumab) is available in the United States only through a 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. Also,
TYSABRI must be administered only to patients who are enrolled in and meet all the conditions of the TOUCH
Prescribing Program
Before you begin each TYSABRI® (natalizumab) infusion,
the following must be completed1
Confirm that the patient is currently authorized to receive TYSABRI at your
infusion center. Check patient’s file to ensure that you have not received
a Notice of Patient Discontinuation. TOUCH authorization alone does not
confirm that the patient’s insurance company has authorized treatment.
Provide the patient with the
Patient Medication Guide.
Patient Medication Guide
www.touchprogram.com
TYSABRI® (natalizumab) is contraindicated in
Patients
who have or have had PML
Patients who have had a hypersensitivity reaction to TYSABRI
Important Safety Information
TYSABRI
increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella
zoster viruses
Clinically significant liver injury, including acute liver failure requiring transplant, has been reported in patients
treated with TYSABRI in the postmarketing setting
Hypersensitivity reactions have occurred in patients receiving TYSABRI, including serious systemic reactions
(e.g., anaphylaxis) which occurred at an incidence of <1%
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
6
Complete the Pre-infusion Patient Checklist.
DETACH HERE
®
TYSABRI
Pre-infusion Patient Checklist
PRESCRIBING PROGRAM
TYSABRI Outreach: Unified Commitment to Health
Phone: 1-800-456-2255
Please submit this form to:
Biogen Idec
www.touchprogram.com
Fax: 1-800-840-1278
Patient name:________________ ___ _____________________________ Patient Enrollment Number: _______________________________________________
First
MI
Last
(Issued by Biogen Idec. Call 1-800-456-2255 or log on to www.touchprogram.com if number is not on file.)
Site name: _______________________________________________________________________________________________Site Authorization Number:______________________________________________
As a condition of your site’s authorization to infuse TYSABRI® (natalizumab), this Pre-infusion Patient Checklist must be completed
for each patient prior to each infusion. This page must be submitted on-line (www.touchprogram.com) OR faxed to Biogen Idec
(1-800-840-1278) within 1 day of the patient’s visit and a copy retained in the patient’s record whether the patient has been
infused or not.
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STEP 1: Ensure that the patient is currently authorized to receive TYSABRI for MS or Crohn’s disease.
You must refer to the patient’s record prior to every infusion.
If the patient did not receive his or her previous infusion, and physician clearance was required, you must confirm
authorization from the prescriber before providing the current infusion
Confirm the patient status is listed as “Authorized” on TOUCH On-Line (www.touchprogram.com) OR
Confirm that there is a current Notice of Patient Authorization on file and that you have not received a Notice of Patient
Discontinuation (paper-based process)
Is the patient currently authorized to receive TYSABRI?
Yes Continue to next question.
No STOP—DO NOT INFUSE. If authorization cannot be verified on-line at www.touchprogram.com OR by calling
1-800-456-2255, the patient must be referred back to the healthcare provider who prescribed TYSABRI.
Yes
No
STEP 2: Confirm that the patient has read and understood the Patient Medication Guide.
The patient must read the Patient Medication Guide prior to every infusion. Has the patient received and read the Patient
Medication Guide, including the section “What should I tell my doctor and nurse before each infusion of TYSABRI?”
Yes Continue to next question.
Yes
No STOP—provide the Patient Medication Guide. Proceed to the next question after the patient has read it.
No
STEP 3: Read aloud and mark “Yes” or “No” for the patient’s answers to the following questions:
1. Over the past month, have you had any new or worsening medical problems (such as a new or sudden change
in your thinking, eyesight, balance, strength, or other problems) that have persisted over several days?
2. Do you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia
or lymphoma, or an organ transplant, that may suggest that your body is not able to fight infections well?
Crohn’s disease ONLY
Yes
3. In the past month have you taken, or are
you currently on, any medicines other than
steroid medicines, to treat cancer or
Crohn’s disease or any other medicines that
weaken your immune system? (Review the list
on the next page with the patient.)
No
MS ONLY
3. In the past month, have you taken medicines to
treat cancer or MS or any other medicines that
weaken your immune system? (Review the list
on the next page with the patient.)
Yes
No
Yes
No
Yes
No
STEP 4: Record infusion information.
If the patient answered YES to question 1, 2 or 3, DO NOT INFUSE. Contact the healthcare provider
who prescribed TYSABRI and review the patient’s answers.
After discussing the patient’s answers, did the prescriber authorize the patient to be infused?
Check here if you were unable to contact the prescriber. (See next page for further instructions.)
Date infused (MM/DD/YYYY):________/_________/_________
Not infused
If the next infusion has been scheduled, please enter date (MM/DD/YYYY):________/_________/_________
Name and signature of staff completing checklist:____________________________________________ Date ____________________
STEP 5: Submit the Pre-infusion Patient Checklist to Biogen Idec on-line at www.touchprogram.com
OR fax to 1-800-840-1278.
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
3-3028-xx
IV INFUSION PREPARATION
STEP ONE — TYSABRI® (natalizumab) infusion supply list
The following list includes specifications for all materials required to administer TYSABRI® (natalizumab)2:
Item Description
Quantity
TYSABRI 300-mg vial
1
100-mL bag of 0.9% NaCl (normal saline)
without preservatives
2
Infusion set or peristaltic infusion pump
1
IV catheter
Per routine
IV extension set for post-infusion
1
20-mL syringe
1
Needle for drug preparation (18- to 20-gauge)
Minimum 2
Alcohol wipes for vial and bag preparation
Per routine
Gauze sponge, 2” x 2”, 12-ply, sterile
Per routine
Adhesive tape
1
Tourniquet
1
TYSABRI IV bag label
1
Medications for hypersensitivity reactions (e.g.,
antihistamines, corticosteroids, epinephrine)
Per routine
Clean or sterile gloves
Per routine
Most Common Adverse Reactions
T he most common adverse reactions reported at an incidence of ≥10% with TYSABRI and ≥2% difference with
placebo were headache (38% vs 33%), fatigue (27% vs 21%), infusion reactions (24% vs 18%), urinary tract
infections (21% vs 17%), arthralgia (19% vs 14%), depression (19% vs 16%), pain in extremity (16% vs 14%),
rash (12% vs 9%), gastroenteritis (11% vs 9%), and vaginitis* (10% vs 6%).
*Percentage based on female patients only.
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
8
STEP TWO — Preparation1,2
1
Position the patient comfortably, with elbow
supported, and insert the catheter. Follow
institution’s policy and procedure for IV starts.
2
Clean the port of a 100–mL IV bag of 0.9% NaCI
with alcohol wipe.
3
Inspect TYSABRI® (natalizumab) vial. Do not
use vial if there are particles/discolored liquid.
Remove cap from vial, and clean rubber stopper
with alcohol wipe. Allow vial to warm to room
temperature before infusing.
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
PREPARATION AND DILUTION1,2
STEP THREE — Dilution and mixing
1
Using a 20-mL syringe with 18- to 20-gauge
sterile needle, push approximately 15 mL of air
into the air space of inverted vial. Do not bubble
air through drug solution.
3
Discard the needle. Use a new 18- to 20-gauge
needle, gently inject the TYSABRI concentrate
into IV bag medication port diaphragm. Use only
0.9% NaCI to prepare TYSABRI dosing solution.
2
Do not
administer
TYSABRI as an
IV push or
bolus injection
Withdraw 15 mL of TYSABRI® (natalizumab)
concentrate from vial. Do not administer TYSABRI
as an IV push or bolus injection.
4
Do not shake
IV bag
The diluted drug in the IV bag should be gently
inverted to mix completely. Following dilution,
begin infusion immediately. If TYSABRI is not
infused immediately after the IV bag is prepared, it
should be refrigerated and infused within 8 hours.
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
10
5
Remove and dispose of needle, syringe, and vial
in compliance with facility protocols.
6
Label IV bag with patient’s name, drug, dose,
date, and time of administration.
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
ADMINISTRATION AND
MONITORING1,2
STEP FOUR — Administration
1
Flush and prime tubing system with diluted drug in
the bag. A few mL of diluted drug may be lost during
priming process. Connect IV catheter to tubing system.
2
Infuse diluted drug in IV over approximately
1 hour (5 mg/min).
STEP FIVE — Flush and monitor
1
Once entire bag of diluted drug is empty, replace
with a 100-mL bag of 0.9% NaCI (normal saline).
Infuse an additional 20 mL of saline to flush IV
line (approximately 2 mL/min).
2
After the infusion is complete, monitor patient
for 1 hour and according to your institution’s policy
for infusion therapy. Dispose of materials properly.
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
12
NOTES
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
INFUSION AND HYPERSENSITIVITY
REACTIONS1,2
The importance of knowing the difference
Because TYSABRI® (natalizumab) is a monoclonal antibody, infusion and hypersensitivity reactions can occur.
Differentiating between infusion and hypersensitivity reactions is important.
Definition
Causes
Symptoms
AFFIRM
results
Infusion reactions
Hypersensitivity reactions
Adverse events that occur during
or shortly after the infusion
procedure
Drug, infusion solution,
equipment, and infusion method
(e.g., infusing the drug too rapidly)
Can cause nonspecific symptoms.
These may include:
Headache
Dizziness
Nausea
Fatigue
Facial flushing
Pruritus
Reactions caused by immune response that can occur
immediately or be delayed. Can be localized or
systemic and may be severe (e.g., anaphylaxis)
Drug, infusion solution, and the equipment used
(e.g., latex tourniquets, packaging, rubber-stopped
vials, injection ports)
Can range from localized hives to a
severe generalized immune response
(e.g., anaphylaxis) that may lead to
cardiopulmonary compromise.
These may include (independently or
in combination):
Urticaria/hives
Angioedema
Dyspnea
Wheezing
Upper-airway edema
Dizziness
Hypotension/shock
Nausea/vomiting
Abdominal cramps
Flushing
In AFFIRM, infusion reactions were
defined as any event that occurred
within 2 hours of the start of the
1-hour infusion
Infusion reactions were observed
in 24% of TYSABRI patients and in
18% of placebo patients
In AFFIRM, hypersensitivity reactions were defined as all
events reported as hypersensitivity, allergic reaction, or
anaphylactic/anaphylactoid by the investigator, as well
as any report of urticaria or hives, based on clinical
judgment or severity
Acute hypersensitivity reactions occurred in 4% of
TYSABRI patients and in <1% of placebo patients
Serious systemic reactions (e.g., anaphylaxis) occurred
in TYSABRI–treated patients at an incidence of <1%
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
14
What steps should be taken when a hypersensitivity reaction is observed?
The following steps are critical in managing hypersensitivity reactions1,2:
With the appearance of any hypersensitivity reaction, administration of
TYSABRI® (natalizumab) should be stopped and an IV line should be maintained
Step 2
Notify HCP immediately and communicate:
Observations of the patient’s reactions
Patient’s reported symptoms
Immediate steps taken to manage the reaction
Step 3
Treatment for hypersensitivity reactions should be directed by the treating HCP and facility
policy per reaction severity. Immediate treatment may include antihistamines
Step 4
Hypersensitivity reactions may occur at any time during or after an infusion, including after
the patient leaves the infusion facility
Step 5
Always give patients instructions on recognizing symptoms of hypersensitivity reactions, and
who to contact if they have a reaction during and after regular office hours
Patients who have a hypersensitivity reaction should not be re-treated with TYSABRI
For additional information on identifying and managing hypersensitivity reactions, a useful
resource is Infusion Nursing Standards of Practice, published by the Infusion Nurses Society 5
Is there a higher risk of hypersensitivity reactions if
TYSABRI® (natalizumab) treatment is interrupted?
Experience with monoclonal antibodies, including TYSABRI,
suggests that patients who receive therapeutic monoclonal
antibodies after an extended period without treatment may
be at a higher risk of hypersensitivity reactions than patients
who received regularly scheduled treatment.
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
Infusion and
Hypersensitivity Reactions
Step 1
ASSAYS ®FOR ANTIBODIES TO
TYSABRI (natalizumab)
In MS studies, hypersensitivity reactions were more frequent in patients with antibodies to TYSABRI®
(natalizumab) compared with patients who did not develop antibodies to TYSABRI. Since patients with
persistent antibodies to TYSABRI experience reduced efficacy and more commonly, hypersensitivity reactions,
consideration should be given to testing for the presence of antibodies in patients who wish to recommence
therapy following a dose interruption.
Testing is available at the following commercial laboratories:
Focus Diagnostics, Inc.
Athena Diagnostics, Inc.
IBT Laboratories
Address:
1785 Corporate Avenue
Cypress, CA 90630
Address:
Address:
11274 Renner Blvd.
Lenexa, KS 66219
Phone:
1-714-220-1900
1-800-445-0185
Phone:
1-913-492-2224
1-800-637-0370
Representatives are
available Monday
through Friday,
7:00 am to 5:00 pm
(PT) and Saturday
and Sunday, 7:00 am
to 3:30 pm (PT)
Fax:
1-714-821-3456
Web:
www.focusdx.com
Phone:
Four Biotech Park
377 Plantation Street
Worcester, MA 01605
1-508-756-2886
1-800-394-4493,
Customer Service, ext. 2
Representatives are
available Monday
through Friday,
8:00 am to
5:30 pm (CT)
Representatives are
available Monday through
Friday, 8:30 am to
6:30 pm (ET)
Fax:
1-913-492-7145
Fax:
1-508-753-5601
Web:
www.ibtreflab.com
Web:
www.athenadiagnostics.com
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
16
SPECIAL CONSIDERATIONS FOR
INFUSION PATIENTS WITH RMS6
Patients with RMS may have symptoms that could complicate the infusion process.
Patient-related Issue
Consequence
Impaired ability to clearly consider treatment options and understand
complex treatment procedures and instructions
Impaired understanding of their disease
Declining physical function
and mobility
L imited mobility may present a barrier to receiving treatment
in an infusion clinic
May require significant transfer assistance at the infusion clinic
Bladder dysfunction
ay result in increased urinary urgency and frequency
M
May require easy accessibility to restroom facilities
Increased risk of urinary tract infections; may delay treatment
Poor hydration, scarring of veins
from overuse, increased motor
tone, and other disease-related
symptoms
Vascular access may be difficult to obtain
Unrealistic expectations
for treatment
L ack of motivation and decreased treatment adherence
(if expectations are not met)
With TYSABRI® (natalizumab), nurses are available 24/7 to discuss adverse events and offer assistance to
infusion specialists and their patients.
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
Patient Considerations
Cognitive changes
THE TOUCH PRESCRIBING
PROGRAM
A commitment to patient safety
TYSABRI® (natalizumab) is available only through a 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
TYSABRI must be administered only to patients who are enrolled in and meet all the conditions
of the TOUCH Prescribing Program
How does the program work?7
Prescriber/Patient
TOUCH Prescribing Program
Infusion Center
Prescriber and patient
complete Enrollment Form
Assigns patients to an
authorized Infusion Center
and changes patient status to
“Authorized” in TOUCH
On-Line and provides Notice
of Patient Authorization
Infusion Center confirms
that patient is currently
authorized to receive TYSABRI
Prescriber completes
Reauthorization Questionnaire
every 6 months
6-month authorization period
begins and Pre-infusion Patient
Checklists are tracked
Patient receives TYSABRI infusion
based on answers to Pre-infusion
Patient Checklist
Pre-infusion Patient Checklist is
submitted via TOUCH On-Line or
faxed by Infusion Center
The TOUCH Prescribing Program Contact Information
Website:www.TOUCHprogram.com
Phone:1-800-456-2255
Monday through Friday, 8:30 am to 8:00 pm (ET)
Fax:1-800-840-1278
Please see complete Important Safety Information on pages 20-23, and Full Prescribing Information,
including Boxed Warning.
18
Get in TOUCH… On-Line
TOUCH On-Line is here to help save valuable time!
All the key features have been designed to make it easier and faster to fulfill
the TOUCH Prescribing Program responsibilities.
Features
Real-time access to patient data
E asy access to complete details for all patients affiliated with your infusion center or
medical practice, including TOUCH authorization status
TOUCH Prescribing Program records on-line
P aperless records enable users to submit most TOUCH Prescribing Program forms on-line
and save directly to a patient’s electronic file as needed
Data entry prompts
A utomatic prompts for required actions and fields, as well as missing information, are built
into all electronic documents
Benefits
p-to-the-minute data for all your patients and your infusion center are always at your fingertips
U
Streamlined administrative processes with a reduced reliance on paper
Reduced data entry errors with fewer unnecessary calls to and from the TOUCH Prescribing Program
Login information_________________________
Username______________________________
Password_______________________________
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
TOUCH Prescribing Program
TOUCH On-Line
IMPORTANT SAFETY INFORMATION
WARNING
TYSABRI® (natalizumab) increases the risk of PML,
an opportunistic viral infection of the brain that
usually leads to death or severe disability. Risk
factors for the development of PML include duration
of therapy, prior use of immunosuppressants, and
presence of anti-JCV antibodies. These factors
should be considered in the context of expected
benefit when initiating and continuing treatment
with TYSABRI.
Healthcare professionals should monitor patients
on TYSABRI for any new sign or symptom that may
be suggestive of PML. TYSABRI dosing should be
withheld immediately at the first sign or symptom
suggestive of PML. For diagnosis, an evaluation
including a gadolinium-enhanced MRI scan of
the brain and, when indicated, cerebrospinal fluid
analysis for JC viral DNA are recommended.
Because of the risk of PML, TYSABRI is available
only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS) called
the TOUCH Prescribing Program.
Progressive Multifocal
Leukoencephalopathy (PML)
Infection
by the JC Virus (JCV) is required for the
development of PML.
Anti-JCV antibody testing should not be used to
diagnose PML.
There are no known interventions that can reliably
prevent PML or that can adequately treat PML if it
occurs. It is not known whether early detection of
PML and discontinuation of TYSABRI will mitigate
the disease.
PML
has been reported after discontinuation of
TYSABRI in patients who did not have findings
suggestive of PML at the time of discontinuation.
Patients should continue to be monitored for any
new signs or symptoms that may be suggestive of
PML for approximately 6 months after
discontinuation of TYSABRI.
In MS patients, an MRI scan should be obtained
before initiating therapy with TYSABRI. This MRI may
be helpful in differentiating subsequent multiple
sclerosis symptoms from PML.
Three sessions of plasma exchange over the course
of 5 to 8 days were shown to accelerate TYSABRI
clearance in a study of 12 patients with MS who did
not have PML, although in the majority of patients,
alpha-4 integrin receptor binding remained high.
Adverse events that may occur during plasma
exchange include clearance of other medications and
volume shifts, which have the potential to lead to
hypotension or pulmonary edema. Although plasma
exchange has not been studied in TYSABRI-treated
patients with PML, it has been used in such patients
in the postmarketing setting to remove TYSABRI more
quickly from the circulation.
Anti-JCV antibody testing should not be performed
during, or for at least 2 weeks after, plasma
exchange because of the removal of antibodies
from the serum.
Immune reconstitution inflammatory syndrome
(IRIS) has been reported in the majority of TYSABRItreated patients who developed PML and
subsequently discontinued TYSABRI. In almost all
cases, IRIS occurred after plasma exchange was
used to eliminate circulating TYSABRI. It presents as
a clinical decline in the patient’s condition after
TYSABRI removal (and, in some cases, after
Please see Full Prescribing Information, including Boxed Warning.
20
— Review, complete, and sign the Patient-Prescriber
Enrollment Form.
— Evaluate patients 3 months after the first infusion,
6 months after the first infusion, every 6 months
thereafter, and for at least 6 months after
discontinuing TYSABRI.
— Determine every 6 months whether patients
should continue on treatment, and if so, authorize
treatment for another 6 months.
— Submit to Biogen Idec the “TYSABRI Patient
Status Report and Reauthorization Questionnaire”
6 months after initiating treatment and every 6
Contraindications
months thereafter.
TYSABRI is contraindicated in patients who have or
— Complete an “Initial Discontinuation
have had PML.
Questionnaire” when TYSABRI is discontinued,
TYSABRI should not be administered to a patient who
and complete a “6-Month Discontinuation
has had a hypersensitivity reaction to TYSABRI.
Questionnaire” after discontinuation of TYSABRI.
— Report cases of PML, hospitalizations due to
TYSABRI TOUCH Prescribing Program
opportunistic infections, or deaths to Biogen Idec
Because of the risk of PML, TYSABRI is available only
at 1-800-456-2255 and to the Food and Drug
through a restricted program under a REMS called
Administration’s MedWatch Program at 1-800the TOUCH® Prescribing Program.
FDA-1088 as soon as possible.
For prescribers and patients, the TOUCH Prescribing
Patients must be enrolled in the TOUCH Prescribing
Program has two components: MS TOUCH® (for
Program, read the Medication Guide, understand the
patients with multiple sclerosis) and CD TOUCH® (for
risks associated with TYSABRI and complete and sign
patients with Crohn’s disease).
the Patient-Prescriber Enrollment Form.
Prescribers must be certified and must comply with
To dispense or infuse TYSABRI, pharmacies and
the following:
infusion centers must be specially certified.
— Review the TOUCH Prescribing Program prescriber
educational materials, including the Full
Herpes Encephalitis and Meningitis
Prescribing Information.
TYSABRI increases the risk of developing encephalitis
— Educate patients on the benefits and risks of
and meningitis caused by herpes simplex and
treatment with TYSABRI, ensure that patients
varicella zoster viruses.
receive the Medication Guide, and encourage
them to ask questions.
apparent clinical improvement) that may be rapid,
can lead to serious neurological complications or
death, and is often associated with characteristic
changes in the MRI. TYSABRI has not been
associated with IRIS in patients discontinuing
treatment with TYSABRI for reasons unrelated to PML.
In TYSABRI-treated patients with PML, IRIS has been
reported within days to several weeks after plasma
exc hange. Monitoring for development of IRIS and
appropriate treatment of the associated inflammation
should be undertaken.
Important Safety Information
Please see Full Prescribing Information, including Boxed Warning.
IMPORTANT SAFETY INFORMATION
(cont’d)
Serious,
life-threatening, and sometimes fatal cases
have been reported in the postmarketing setting in
multiple sclerosis patients receiving TYSABRI.
The duration of treatment with TYSABRI prior to
onset ranged from a few months to several years.
Monitor patients receiving TYSABRI for signs and
symptoms of meningitis and encephalitis. If herpes
encephalitis or meningitis occurs, TYSABRI should be
discontinued, and appropriate treatment for herpes
encephalitis/meningitis should be administered.
Hepatotoxicity
Clinically
significant liver injury, including acute
liver failure requiring transplant, has been
reported in patients treated with TYSABRI in
the postmarketing setting.
Signs of liver injury, including markedly elevated
serum hepatic enzymes and elevated total bilirubin,
occurred as early as six days after the first dose;
signs of liver injury have also been reported for the
first time after multiple doses.
In some patients, liver injury recurred upon
rechallenge, providing evidence that TYSABRI
caused the injury.
The combination of transaminase elevations and
elevated bilirubin without evidence of obstruction is
generally recognized as an important predictor of
severe liver injury that may lead to death or the
need for a liver transplant in some patients.
TYSABRI should be discontinued in patients with
jaundice or other evidence of significant liver injury
(e.g., laboratory evidence).
Hypersensitivity/Antibody Formation
Hypersensitivity
reactions have occurred in patients
receiving TYSABRI, including serious systemic
reactions (e.g., anaphylaxis) which occurred at an
incidence of <1%.
Reactions
usually occur within 2 hours of the start
of the infusion. Symptoms associated with these
reactions can include urticaria, dizziness, fever, rash,
rigors, pruritus, nausea, flushing, hypotension,
dyspnea, and chest pain. Generally, these reactions
are associated with antibodies to TYSABRI.
If a hypersensitivity reaction occurs, discontinue
administration of TYSABRI and initiate appropriate
therapy. Patients who experience a hypersensitivity
reaction should not be re-treated with TYSABRI.
Hypersensitivity reactions were more frequent in
patients with antibodies to TYSABRI compared with
patients who did not develop antibodies to TYSABRI
in both MS and CD studies.
Patients who receive TYSABRI after an extended
period without treatment may be at higher risk of
hypersensitivity reactions.
Immunosuppression/Infections
immune system effects of TYSABRI may
The
increase the risk for infections.
In Study MS1, certain types of infections—including
pneumonias and urinary tract infections (including
serious cases), gastroenteritis, vaginal infections,
tooth infections, tonsillitis, and herpes infections—
occurred more often in TYSABRI-treated patients
than in placebo-treated patients. One opportunistic
infection, a cryptosporidial gastroenteritis with a
prolonged course, was observed in a patient who
received TYSABRI in Study MS1.
In Studies MS1 and MS2, an increase in infections
was seen in patients concurrently receiving short
courses of corticosteroids. However, the increase in
infections in TYSABRI-treated patients who received
steroids was similar to the increase in placebotreated patients who received steroids.
Please see Full Prescribing Information, including Boxed Warning.
22
Concurrent
use of antineoplastic, immunosuppressant,
The most frequently reported serious adverse
or immunomodulating agents may further increase
reactions in Study MS1 were infections (3.2% vs
the risk of infections over the risk observed with use
2.6% placebo), including urinary tract infection
of TYSABRI alone. The safety and efficacy of
(0.8% vs 0.3%) and pneumonia (0.6% vs 0%),
TYSABRI in combination with antineoplastic,
acute hypersensitivity reactions (1.1% vs 0.3%,
immunosuppressant, or immunomodulating agents
including anaphylaxis/anaphylactoid reaction
have not been established.
[0.8% vs 0%]), depression (1.0% vs 1.0%,
including suicidal ideation or attempt [0.6% vs
In Studies MS1 and MS2, the rate of any type
0.3%]), and cholelithiasis (1.0% vs 0.3%).
of infection was approximately 1.5 per
Based on animal data, TYSABRI may cause fetal
patient-year in both TYSABRI-treated patients
harm. TYSABRI should be used during pregnancy
and placebo-treated patients.
only if the potential benefit justifies the potential
In
Study MS1, the incidence of serious infections was
risk to the fetus. If a woman becomes pregnant
approximately 3% in TYSABRI-treated patients and in
while taking TYSABRI, consider enrolling her in the
placebo-treated patients. Most patients did not
TYSABRI Pregnancy Exposure Registry, by calling
interrupt treatment with TYSABRI during infections.
1-800-456-2255.
In postmarketing experience, serious herpes
Please see Full Prescribing Information, including
infections have occurred.
Boxed Warning.
Laboratory Test Abnormalities
clinical trials, TYSABRI was observed to induce
In
increases in circulating lymphocytes, monocytes,
eosinophils, basophils, and nucleated red blood
cells. Observed changes persisted during TYSABRI
exposure, but were reversible, returning to baseline
levels usually within 16 weeks after the last dose.
Elevations of neutrophils were not observed.
TYSABRI induces mild decreases in hemoglobin
levels that are frequently transient.
Adverse Reactions
most common adverse reactions reported at an
The
incidence of ≥10% with TYSABRI and ≥2%
difference with placebo were headache (38% vs
33%), fatigue (27% vs 21%), infusion reactions
(24% vs 18%), urinary tract infections (21% vs
17%), arthralgia (19% vs 14%), depression (19%
vs 16%), pain in extremity (16% vs 14%), rash
(12% vs 9%), gastroenteritis (11% vs 9%), and
vaginitis* (10% vs 6%).
*Percentage based on female patients only.
GIVING RMS PATIENTS
THE SUPPORT THEY NEED
As part of Biogen Idec’s commitment to helping RMS patients with their prescribed therapy,
MS ActiveSource has dedicated ActiveSourceTM Coordinators to help patients.
Available to answer patients’ questions with 24/7 phone coaching
Coaching by highly trained RMS Support Specialists
Patients can connect with and hear first-hand from other patients
about living with RMS
RMS patients can call 1-800-456-2255 to learn more
about the support and resources available
References: 1. TYSABRI Prescribing Information. Cambridge, MA: Biogen Idec. 2. O’Leary S, Beavin J, Bishop C, Capolino L, Greinel E, Hudson E. Practical guidelines for
administering natalizumab: a nursing perspective. Int J MS Care. 2007;9:1-8. 3. Centers for Disease Control and Prevention. Guidelines for prevention on intravascular
catheter-related infections. MMWR. 2002:51(RR-10):1-26. 4. Occupational Safety and Health Administration. Protecting yourself when handling contaminated sharps.
https://www.osha.gov/OshDoc/data_BloodborneFacts/bbfact02.pdf. Accessed November 7, 2013. 5. Infusion Nurses Society. Infusion Nursing Standards of Practice.
3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2006. 6. Namey M, Halper J, O’Leary S, Beavin J, Bishop C. Best practices in multiple sclerosis: infusion reactions
versus hypersensitivity associated with biologic therapies. J Infus Nurs. 2010;33(2):98-111. 7. Data on file, Biogen Idec.
Please see complete Important Safety Information on pages 20-23,
and Full Prescribing Information, including Boxed Warning.
© 2014 Biogen Idec
6/14
TYS-1008330

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