What is Rituxan (rituximab)?
Rituxan (rituximab) is a B-cell antibody treatment option for patients with pemphigus that is being used as first line therapy by many clinicians.
How does it work? B-cells are responsible for producing antibodies for the body, rituximab works as an immunosuppressant that destroys B-cells of the immune system. 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. Retreatment with rituxan may be required, usually at six months or longer after the initial treatment.
In June of 2018, the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV). Earlier in the year, the FDA had granted Priority Review, Breakthrough Therapy Designation, and Orphan Drug Designation to Rituxan for the treatment of PV.Rituxan is the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years.
In early 2018, an international panel of experts, the International Bullous Disease Consensus Group, provided new recommendations on the diagnosis and management of pemphigus in the Journal of the American Academy of Dermatology.
Based on existing European treatment guidelines, a Delphi survey process was used to help achieve international expert consensus. The consensus includes the recommendation to use an anti-CD20 monoclonal antibody (Rituxan) and corticosteroids as first line therapy options for moderate to severe pemphigus.
What autoimmune diseases does Rituxan treat?
Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.
Pemphigus vulgaris (PV): to treat adults with moderate to severe PV.
It is not known if Rituxan is safe or effective in children.
Rituxan can cause serious side effects that can lead to death, including:
- Infusion Reactions: Infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during an infusion or within 24 hours after an infusion
- Severe Skin and Mouth Reactions: painful sores or ulcers on skin, lips, or in the mouth; blisters, peeling skin, rash, or pustules
- Hepatitis B Virus (HBV) Reactivation: If a patient has had hepatitis B or is a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again
- Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection caused by the JC virus
Before receiving Rituxan, patients should tell their healthcare provider if they:
- have had a severe infusion reaction to Rituxan in the past
- currently have or have a history of other medical conditions, especially heart disease
- have had a severe infection, currently have an infection, or have a weakened immune system
- have had a recent vaccination or are scheduled to receive vaccinations
- have taken Rituxan in the past
- are pregnant or planning to become pregnant. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Rituxan and for 12 months after the last dose of Rituxan
- are breastfeeding or plan to breastfeed. Patients should not breastfeed during treatment and for at least 6 months after the last dose of Rituxan
- are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements
What are the possible side effects of Rituxan?
Rituxan can cause serious and life‐threatening side effects, including:
- Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment or may cause an abnormal heart rhythm
- Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death
- Heart Problems: Rituxan may cause chest pain and irregular heartbeats, which may need treatment, or a patient’s doctor may decide to stop treatment with Rituxan
- Kidney Problems: especially if a patient is receiving Rituxan for non-Hodgkin’s lymphoma (NHL). Doctors should do blood tests to check how well a patient’s kidneys are working
- Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Patients should inform their doctor right away if they have any stomach area pain during treatment with Rituxan
- Low Blood Cell Counts: A doctor may do blood tests during treatment with Rituxan to check a patient’s blood cell counts
What are the most common side effects during treatment with Rituxan?
- Infusion reactions
- Infections (may include fever, chills)
- Body aches
Other side effects include:
- Aching joints during or within hours of receiving an infusion
- More frequent upper respiratory tract infections
These are not all of the possible side effects with Rituxan. For more information, ask a doctor or pharmacist.
Contact a doctor for medical advice about side effects. Report side effects to the FDA at (800) FDA‐1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835‐2555.
We’re Here for You
The IPPF aims to serve as a primary source of information for you regarding this approved treatment and is available to help answer your questions in the upcoming months. If you are considering Rituxan as a potential therapy, please consult your healthcare provider. Inform them of your medical history, and ask about the potential side effects.
Ask A Coach
The IPPF’s Peer Health Coaches (PHC) are pemphigus and pemphigoid patients who help more than 1,200 patients and caregivers each year. These specially trained PHCs reduce patient anxiety and uncertainty while providing unbiased disease and treatment knowledge. You can find our PHCs engaging the community through social media, emails, phone calls, and in-person support. The goal of our PHC program is to ensure we help every person who needs assistance in the shortest amount of time possible.
Genentech Access Solutions
Genentech is the drug company that produces Rituxan (rituximab). Genentech Access Solutions is a resource for people considering Rituxan as a treatment option. It may be worth contacting Access Solutions directly regardless of whether or not you have health insurance.
You can also learn more by downloading this brochure: Genentech Access Solutions Patient Assistance Brochure