Rituximab

---

Rituximab

Side effects are always a possibility with any treatment.

Your doctor is the best one to advise you.

Rituximab is pronounced rye-TUX-im-ab.

In the USA it is made by Genentech and is known as Rituxan® www.rituxan.com

In England it is made by Roche and is known as Mabthera® www.mabthera.com

There may be other sources for rituximab.

Rituximab is the name given to a monoclonal antibody that has been available since 1997.

Rituximab was found to be effective in treating patients with Non-Hodgkins Lymphoma, its main use, however, it is now also being used in the treatment of Cold Agglutinin Disease. It is not the only method available for treating CAD (see Treatment Options) but rituximab has shown the most promise, thus far. It is not always successful and there can be serious side effects.

Manufacturers information

This link displays Genentech’s Rituxan fact-sheet:

http://www.gene.com/gene/products/information/immunological/rituxan/factsheet.html

Further information is available from:

http://www.gene.com/gene/products/information/oncology/rituxan/

Rituximab is an anti-CD20 monoclonal antibody that depletes B cells and thereby interferes with the production of Cold Agglutinins. Since using rituximab, the reduction in the numbers of cold antibodies has caused a significant improvement in our hemoglobin levels of several people listed on our web site. These monoclonal antibodies, a new breed of drugs, are being used to treat previously hard to deal with diseases, as they have the ability to target a specific site. Because of their nature, these monoclonal antibodies are difficult and expensive to produce.

We suggest you try searching the web and our Links Page for articles regarding Rituximab and CAD

Additionally the following three articles should be read, as one provides hope while the others urge caution.

Severe Cold Hemagglutunin Disease (CHD same as CAD) Successfully Treated With Rituximab

www.bloodjournal.org/cgi/content/full/100/5/1922 September 1, 2002

FDA Warns of Safety Concern Regarding Rituxan in New Patient Population

The Food and Drug Administration (FDA) is alerting health care professionals and patients treated with Rituxan (rituximab), to reports of an emerging risk of a serious side effect on patients who were treated with Rituxan for systemic lupus erythematosus (SLE).

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01532.html

September 25, 2013–US FDA Issues Black Boxed Warning of Hepatitis B Virus Reactivation risk for those starting Rituxan and Ofatumumab

The FDA recommends screening for HBV prior to treatment to prevent a possible reactivation for those who have previously had the Hepatitis B Virus.

For those who have had the Hepatitis B virus and are considering being treated with Rituxan, have your medical professional do a Hepatitis B DNA Test prior to treatment.

http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm369846.htm

HAMA Test — Human Anti-Murine (Mouse) Antibody Test

For those who have had an infusion reaction to Rituximab or other monoclonal antibodies given by infusion, this test can help determine whether one has developed antibodies against the murine (mouse) antibodies and is able to continue to receive additional infusions without incident.

Discuss with your medical professional.

Should Rituximab be warmed prior to infusion

We have been asked repeatedly whether the Rituximab solution should be heated prior to infusion as is recommended for blood and other medical infusions for us CADdys.

We called Genentech, one of the manufacturers, and were advised that since Rituxan is a protein and heating degrades proteins, we should not warm the solution. Their literature regarding Rituxan says that once diluted for infusion, the product can be kept refrigerated for 24 hours and an additional 24 hours at room temperature (68-77 degrees). There should be no freezing nor shaking!

We also posed the question to Dr. Sigbjorn Berentsen , the highly respected Cold Agglutinin researcher from Norway who said the following:

“For drug safety reasons, we do not recommend prewarming of rituximab before infusion. The infusion solution should, however, definitely have room temperature and not be taken from the fridge. Even though this implies minor variations of the temperature between facilities and the infusion rate is often “rapid” (which means 500 mL / 90 min.) from infusion #2 onwards, we do not think that this will cause sufficient cooling of the blood to induce significant hemolysis.”

SUGGESTION: When you are planning to undergo Rituxan / Mabthera treatment, you should arrange, beforehand, with your medical professionals to infuse you with a Rituxan / Mabthera solution which is at room temperature, and is not straight out of the refrigerator.