Discussion Topic

What are your favorite lines in the new update label?

Posted on 11/08/09, 03:18 am
What are your favorite? I have a ton I highlighted as favorites. I will start typing a few in the replies, I hope you are inclined to do the same.
Showing 9 Replies
  • Reply #1 11/08/09  3:19am
    In Multiple Sclerosis patients, an MRI scan should be obtained prior to initiating therapy wit TTYSABRI. This MRI may be helpful in differentiating subsequent MS symptoms from PML.
  • Reply #2 11/08/09  3:22am
    Typical Symptoms associated with PML are diverse over days to weeks and include progressive weakness on one side of the body or clumsiness of limbs, disturbances of vision and changes in thinking, memory, and orientation leading to confusion and personality changes.
  • Reply #3 11/08/09  3:29am
    For diagnosis of PML, an evaluation including a gadolinium-enhanced MRI scan of the brain, and when indicated, cerebral spinal fluid analysis for JC Viral DNA are recommended. There is no known interventions that can adequately treat PML if it occurs. Three sessions of plasma exchange over 5 to 8 days were shown to accelerate Tysabri clearance in a study of 12 patient with MS who did notr have PML....<another sentance>...Adverse events which may occur during plasma exchange include clearance of other medications and volume shift, which have the potential to lead to hypotension or pulmonary edema
  • Reply #4 11/08/09  3:39am
    Immune Reconstitution Inflammatory Syndrome(IRIS) has been reported in TYSABRI treated 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 an unanticipated clinical decline in patient's condition after return of immune function (and in some cases after apparent clinical improvement) and, in the case of PML, is often follopwed by characteristic changes in the MRI. TYSABRI has not been associated with IRIS in patients discontinuing treatment wit TYSABRI for reasons unrelated to PML. In TYSABRI treated patients with PML, IRIS has been reported within days to several weeks after plasma exchange. Monitoring for development of IRIS and appropriate treatment of the associated inflammation during recovery from PML should be under taken
  • Reply #5 11/08/09  3:42am
    Evaluate the patient 3 months after the first infusion, 6 months after the first infusion and every 6 months thereafter.
    Determine every 6 months whether patient should continue on treatment and if so reathourize treatment ever 6 months.
  • Reply #6 11/08/09  3:53am
    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.

    Ggiven that patients with persistent antibodies to TYSABRI experience reduced efficiency, and that hypersensitivity 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, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naive patients
  • Reply #7 11/08/09  3:57am
    certain types of of infections, including pneumonia and urinary infections(including serious cases), gastroenteritis, vaginal infections, tooth infections, tonsillitis and herpes infection, occured more often in TYSABRI-treated patients trhan in placebo treated patients.

    <<My comment. Makes you think about a pneumonia vaccinmre & the H1N1 vaccine>>>>
  • Reply #8 11/08/09  4:11am
    Cases of PML have been reported in patients taking TYSABRI who recently or concomitantly treated with immunomodulators or immunesuppressants as well as in patients recieving TYSABRI as a monotherapy...

    <<<my comment. Now it is not just immune suppressants like Novatrone of cellcept...its yhe immune modulators that many of us switched from before stating TY. All the DMD drugs except Copaxone are immunmodulators. Copaxone works in the nervous system. RAB--REBIF, AVVONES & BETASERON work in the immune system as immunemodulators. Many of us have switched fropm one of the immunemodulators ! :< Looks like there are alot of us at greater risk for PML>>>
  • Reply #9 11/08/09  4:15am
    TYSABRI dosing should be withheld immediately at the first sig or symptom suggestive of PML. For diagnosis, an evaluation that includes a gangolium-enhanced MRI scan of the brain and, when indicated, cerebrospinal fluid analysis for the JC viral DNA are recommended.

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