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Medical Forum / Diseases and Disorders / Arthritis / December 2005

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Rituxan  (LONG)

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Donald Whitely - 20 Dec 2005 00:34 GMT
HI EVERYONE,

Today I had my first appt with the new RD. He is a super Doc,  answered
all of our questions in detail in language and terms that non Docs can
understand. He felt that I had not gotten the right direction as far as
Pain meds were concerned. He is a believer in the approach that the
patient should be able to be the judge as to dosage as long as you are
not the type who would abuse that latitude.  So he has increased the
number of Oxcodone 40 mg  ER pills I get in each prescription so that I
would be able to take three a day when my pain level is high.  He also
has no problem of my increasing my doses of Pred. when I feel it is
necessary as long as I don't forget to back it back down properly.

He  was pleased to know,  that he knows the RD I had seen for over 20
years at the Cleveland Clinic, said that they had attended many of the
same seminars and meetings.

He recently attended a meeting at which many RD from across the nation
met to hear about the plans to approve Rituxan for patients with severe RA.
He said the approval would be very soon.

Below is info on Rituxan for those who may not be familiar with it,
Rituxan was the "R" in my RCHOP chemo treatment for my Nonhodgkins
Lymphoma  The patient would get an infusion in an outpatient setting
every  six months.  My Cancer Doc had discussed the possibility of
Rituxan infusions very six month once my Lymphoma was in remission.

 Rituxan (Rituxan)
Immunology Description Rituxan is a therapeutic antibody which binds to
the CD20 antigen on the surface of normal and malignant B cells. From
there, it recruits the body's natural defenses to attack and kill the
marked B cells. Stem cells (B-cell progenitors) in bone marrow lack the
CD20 antigen, allowing healthy B cells to regenerate after treatment and
return to normal levels within several months.

Development Status A supplemental Biologics License Application (sBLA)
was submitted in August 2005 with the U.S. Food and Drug Administration
for Rituxan in patients with active rheumatoid arthritis (RA) who
inadequately respond to an anti-TNF therapy. Rituxan is also being
evaluated in the following immunological studies: Phase II/III clinical
trials for primary progressive multiple sclerosis, ANCA-associated
vasculitis, systemic lupus erythematosus; and a Phase II clinical trial
in relapsed remitting multiple sclerosis. We are preparing for a Phase
III clinical trial for DMARD (disease-modifying anti-rheumatic drug)
refractory moderate-to-severe rheumatoid arthritis and a Phase III
clinical trial in lupus nephritis. This product is being developed in
collaboration with F. Hoffmann-La Roche and Biogen Idec Inc.

Approved Uses Rituxan received U.S. Food and Drug Administration
approval in November 1997 for the treatment of patients with relapsed or
refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's
lymphoma (NHL). In April 2001, a supplemental Biologics License
Application was approved for Rituxan for these additional uses:
retreatment of patients with Rituxan who have relapsed following initial
Rituxan therapy, use of eight weekly doses (compared to original four)
per course of treatment, treatment of patients with bulky disease
(lesions > 10 cm).

Read more about Rituxan's approved uses.

October 2005

Don Whitely
Harvey R. Stone - 20 Dec 2005 02:02 GMT
Thanks for the update, Don.    A good start with a new RD issss GREAT news.
I hope you build the faith in you with the doc about taking Oxcodone and a
good start with that too.
Harv

> HI EVERYONE,
>
[quoted text clipped - 59 lines]
>
> Don Whitely
blades49456 - 20 Dec 2005 03:15 GMT
For what it's worth:  I believe any physician can prescribe any FDA
approved drug for conditions other than it was approved for.  The
physician has only to have a reasons to think the med is likely to be
effective and reasonably safe, and for conventional therapies to have
failed or the crisis so immanent that drastic measures are required.

As Rituxan is an FDA approved medication, it can and has been used
effectively and safely to treat some autoimmune diseases other than RA.
--
Bruce (WG '97)
Nann Bell - 20 Dec 2005 04:15 GMT
> For what it's worth:  I believe any physician can prescribe any FDA
> approved drug for conditions other than it was approved for.  The
[quoted text clipped - 6 lines]
> --
> Bruce (WG '97)

yeah, but the problem is paying for it for "non-approved" purposes.  In the
US, most insurance companies will deny drug coverage for any medication
prescribed for a condition the FDA has not approved it for.  And at the
prices of these drugs, that really matters!

That's why more than a few folk with PA are officially called RA patients by
their doctors.  All the new meds are approved for RA several years before
they are approved for PA.

Signature

Nann
remove the Gator cheer to email me
Simply the thing I am shall make me live --- William Shakespeare

Smokie Darling (Annie) - 20 Dec 2005 16:28 GMT
> > For what it's worth:  I believe any physician can prescribe any FDA
> > approved drug for conditions other than it was approved for.  The
[quoted text clipped - 11 lines]
> prescribed for a condition the FDA has not approved it for.  And at the
> prices of these drugs, that really matters!

Exactly, my Rituxan treatments (which didn't work, but I digress) ended
up being $14,000 for two.  Medicare does not cover it (as it was an out
patient/hospital thing) for use with RA, it went to my primary
insurance (who paid some), then on to Tri-Care (which I don't know what
they've paid).

> That's why more than a few folk with PA are officially called RA patients by
> their doctors.  All the new meds are approved for RA several years before
[quoted text clipped - 4 lines]
> remove the Gator cheer to email me
> Simply the thing I am shall make me live --- William Shakespeare
 
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