Snapshot of Tysabri® (natalizumab)
| Tysabri®: Descriptives1 |
|
Method of administration |
Intravenous infusion |
| Indication |
For use as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of exacerbations. The safety and efficacy of Tysabri® beyond 2 years are unknown.
Tysabri® is generally recommended for patients who have had inadequate response to,
or are unable to tolerate, alternate MS therapies |
| Needle size |
N/A |
|
Delivery information |
Every 4 weeks by IV infusion. Available only through a restricted distribution
program |
|
Injection aid(s) |
N/A–must be administered at a medical facility |
|
Pregnancy category |
Category C1 (when administered to pregnant animals, there was some harm to the fetus)2 |
| Black box warning |
Yes* |
*Summary of black box warning3:
Tysabri® increases the risk of progressive multifocal
leukoencephalopathy (PML), an opportunistic viral infection
of the brain that usually leads to death or severe disability.
Although the cases of PML were limited to patients with
recent or concomitant exposure to immunomodulators or
immunosuppressants, there were too few cases to rule out the
possibility that PML may occur with Tysabri® monotherapy.
- Because of the risk of PML, Tysabri® 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, Tysabri® 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
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 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
| Tysabri®: Common side effects/reactions1 |
| Clinically significant difference in flu-like symptoms when compared to placebo (an inactive substance) |
No |
| Fatigue/Malaise (bodily discomfort) increased while on therapy |
Yes |
| Warning for use in people with depression |
No |
| Warning for use in people with suicidal thoughts |
No |
| Warning or precaution for liver impairment |
No |
| Recommended monitoring of liver function or complete blood count |
No |
| Associated with localized site reactions |
No |
| Associated with neutralizing antibodies (proteins produced by the body that may decrease the effectiveness of therapy) |
Yes |
Additional important information about Tysabri®4
- 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). PML 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 MS treatments
- Even if you use Tysabri® alone to treat your MS, it is not
known if your chance of getting PML will be lower. It is
also not known if treatment for a long period of time
with Tysabri® can increase your chance of getting PML
- 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®
Allergic reactions
- 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 |
- 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
symptoms 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
Infections
- Tysabri® may increase your chance of getting an unusual
or serious infection because Tysabri® can affect your
immune system
Other side effects with Tysabri® include:
| —headache |
—feeling tired |
| —urinary tract infection |
—joint pain |
| —lung infection |
—depression |
| —pain in your arms and legs |
—diarrhea |
| —vaginitis |
—rash |
| —stomach area pain |
References:
- Tysabri® prescribing information, 6/06. Elan Pharmacuticals.
- FDA Web site. Available at: http://www.fda.gov/cder/handbook/categc.htm. Accessed August 1, 2006.
- Tysabri® Web site. Available at: http://www.tysabri.com/. Accessed August 10, 2006.
- Getting Started with Tysabri®. Biogen Idec. 06/06.
Tysabri® is a registered trademark of Elan Pharmacuticals.