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Old 03-26-2008, 11:40 AM #11
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lady_express_44 lady_express_44 is offline
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Location: Vancouver, Canada
Posts: 3,300
15 yr Member
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Barb, I was trying to find the info on whether you need a MRI according to the TOUCH protocol (and didn't find it), but I did run across this information (that I think) you were asking about earlier in the thread:

Do not receive TYSABRI if you:

• have PML
• are allergic to TYSABRI

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.

5.3 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%. These reactions usually occur within two 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 to patients who did not develop antibodies to TYSABRI in both MS and CD studies. Therefore, the possibility of antibodies to TYSABRI should be considered in patients who have hypersensitivity reactions [see Adverse Reactions (6.2)].

Antibody testing: If the presence of persistent antibodies is suspected, antibody testing should be performed. Antibodies may be detected and confirmed with sequential serum antibody tests. Antibodies detected early in the treatment course (e.g., within the first six months) may be transient and disappear with continued dosing. Repeat testing at three months after the initial positive result is recommended in patients in whom antibodies are detected to confirm that antibodies are persistent. Prescribers should consider the overall benefits and risks of TYSABRI in a patient with persistent antibodies.

Experience with monoclonal antibodies, including TYSABRI, suggests that patients who receive therapeutic monoclonal antibodies after an extended period without treatment may be at higher risk of hypersensitivity reactions than patients who received regularly scheduled treatment. Given that patients with persistent antibodies to TYSABRI experience reduced efficacy, and that hypersensitivity reactions are more common in such patients, consideration should be given to testing for the presence of antibodies in patients who wish to recommence therapy following a dose interruption. Following a period of dose interruption, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naïve patients [see Adverse Reactions (6.2)].

http://www.tysabri.com/tysbProject/t...uch/index.html
(found in the Patient Safety tab)

Cherie
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