Phase III PEMPHIX Study Showed That Genentech?s Rituxan (Rituximab) is Superior to Standard of Care in Achieving Sustained Remission in Patients with Pemphigus Vulgaris
- Rituxan met the primary and secondary endpoints in the Phase III PEMPHIX study
- Rituxan was the first and only biologic therapy approved by the FDA in June 2018 for the treatment of pemphigus vulgaris based on results from the Ritux 3 clinical trial
- Results will be submitted to health authorities around the world, including the U.S. Food and Drug Administration (FDA)
- Infusion-Related Reactions:?Infusion-related reactions are very common side effects of Rituxan treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your healthcare provider should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion-related reaction
- Severe Skin and Mouth Reactions?:?Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with Rituxan: painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash; or pustules
- Hepatitis B Virus (HBV) Reactivation?:?If you have had hepatitis B or are a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. You should not receive Rituxan if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan
- Progressive Multifocal Leukoencephalopathy (PML):?PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML
- have had a severe reaction to Rituxan or a rituximab product
- 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
- 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
- Tumor Lysis Syndrome (TLS):?TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment or may cause an abnormal heart rhythm. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy
- Serious Infections:?Serious infections can happen during and after treatment with Rituxan and can lead to death. Rituxan can increase your risk of getting infections and can lower the ability of your immune system to fight infections. People with serious infections should not receive Rituxan
- Heart Problems:?Rituxan may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with Rituxan if you have symptoms of heart problems or have a history of heart problems
- Kidney Problems:?especially if you are receiving Rituxan for non?Hodgkin?s lymphoma (NHL). Your healthcare provider should do blood tests to check how well your kidneys are working
- Stomach and Serious Bowel Problems That Can Sometimes Lead to Death:?Tell your healthcare provider right away if you have any stomach-area pain during treatment with Rituxan
- infusion-related reactions
- infections (may include fever, chills)
- body aches
- tiredness
- nausea
- low white and red blood cells
- swelling
- diarrhea
- muscle spasms
- aching joints during or within hours of receiving an infusion
- more frequent upper respiratory tract infections