Rituximab Now Approved in Italy!
Rituximab Risk… FDA Review.
Genentech is the drug company that produces Rituxan(Rituximab).
Rituximab- for refractory skin and musculoskeletal disease.
Rituximab resistance and transformation, February 2010 Newsletter, p. 9-10.
Compromised immunity and maintenance Rituximab, Article 7, p. 28-29.
In hairy cell leukemia, Rituximab is a commonly used monoclonal antibody.
Rituximab is administered at a dose of 375mg/m 2
body surface area weekly for four weeks.
Among them, Rituximab, trastuzumab, bevacizumab is a heavy product
with a sales of $ 7 billion;
She had never prescribed Rituximab before, but was committed to helping me get off of prednisone.
Rheumatoid arthritis protocol- Two doses of Rituximab 1g is administered at an interval of 15 days.
I feel like the information(on maintenance Rituximab) you made so freely available
helped me dodge a bullet!
Research study finds prolonged use of Rituximab heightens risk of suppressed long-term immunity,
October 2011 Newsletter, p. 9-12.
Immunoglobulins and maintenance Rituximab, Article 7,
p. 26-29; September 2012 Newsletter, p. 3-8; November 2011 Newsletter, p. 2-5.
Commentary on maintenance Rituximab from a prominent lymphoma specialist, January 2014 Newsletter,
p. 17-18; September 2012 Newsletter, p. 4-6.
Problems with maintenance Rituximab will likely also apply to Gazyva(obinutuzumab) and so
called“biosimilars” to Rituximab that are now becoming available.
Data: Top sellers TOP10 accounted for 3 seats, Rituximab, trastuzumab, bevacizumab three drug sales totaling
more than 200 billion dollars.
Problems with maintenance Rituximab will likely also apply to Gazyva(obinutuzumab)
and so called“biosimilars” to Rituximab that are now becoming available.
In response to many questions we get regarding maintenance Rituximab, we have prepared a summary of the pros and cons.
If Rituximab were studied in pemphigus or pemphigoid,
it may be eligible for orphan drug designation and all the incentives, including exclusivity.
After much discussion with Dr. Williams, and a lot of reflective thought,
we decided it was time to move ahead with Rituximab.
I embarked on a series of Rituximab infusions ⎯ four over the past eight years ⎯
which have helped to control my symptoms.
A course of Rituximab is administered with the hope that it will destroy
all the B-cells that make antibodies in pemphigus or pemphigoid are removed.
One example of this type of medication is Rituximab, which works specifically on the B cells-
one of the many parts of the immune system.
In recent years, Rituximab has demonstrated to be a generally well-tolerated
and effective treatment that could be beneficial for a high number of pemphigus patients.
Rituximab is currently one of the most popular treatments among P/P patients,
and there is always lively discussion at the patient conference of its use in treatment.
Approval was based on data from the Ritux 3 trial, a randomized, controlled trial conducted in France that used Roche-manufactured, European Union(EU)-
approved Rituximab product as the clinical trial material.
Mr. Baron was diagnosed with Pemphigus Vulgaris in 2005, he
suffered from a severe and refractory case, but was lucky to reach remission after three years of treatment with Rituximab and IVIG.
The FDA approval is based on data from the Ritux 3 trial, a Roche-supported, randomized, controlled trial conducted in France that used Roche-manufactured,
European Union(EU)-approved Rituximab product as the clinical trial material.
To get this treatment accessible to Italy's pemphigus patients, the Italian Pemphigus and Pemphigoid Association(ANPPI), issued a formal requested to the Italian Medicines Agency(AIFA)
to include Rituximab in the list of medicines to administer at public hospitals.