RUXIENCE (RUKSee-ents) (Rituximab-pvvr)
- January 11, 2021
- 0
RUXIENCE
(RUKSee-ents)
(Rituximab-pvvr)
Chemotherapy
RUXIENCE
(RUKSee-ents)
(Rituximab-pvvr)
Chemotherapy
What is RUXIENCE (Rituximab-pvvr)?
RUXIENCE is a prescription medicine used to treat adults with:
- Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
- Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
- Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.
It is not known if RUXIENCE is safe and effective in children.
What is the most important information I should know about RUXIENCE?
RUXIENCE can cause serious side effects. These serious side effects include:
- Infusion-related reactions. Infusion-related reactions are very common side effects of RUXIENCE treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of RUXIENCE. Your healthcare provider should give you medicines before your infusion of RUXIENCE to decrease your chance of having a severe infusion-related reaction. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RUXIENCE:
- Hives (red itchy welts) or rash
- Iitching
- Swelling of your lips, tongue, throat or face
- Sudden cough
- Chest pain
- Shortness of breath, difficulty breathing, or wheezing
- Weakness
- Dizziness or feel faint
- Palpitations (feel like your heart is racing or fluttering)
- 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 RUXIENCE:
- Painful sores or ulcers on your skin, lips or in your mouth
- Blisters
- Peeling skin
- Rash
- Pustules
- Hepatitis B virus (HBV) reactivation. Before you receive your RUXIENCE treatment, your healthcare provider will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving RUXIENCE 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 RUXIENCE 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 RUXIENCE. Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes, during treatment with RUXIENCE.
- Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive RUXIENCE. 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. Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms:
- Confusion
- Dizziness or loss of balance
- Difficulty walking or talking
- Decreased strength or weakness on one side of your body
- Vision problems
- 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
- Abnormal heart rhythm
- Serious infections. Serious infections can happen during and after treatment with RUXIENCE, and can lead to death. RUXIENCE can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RUXIENCE include bacterial, fungal, and viral infections. After receiving RUXIENCE, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. People with serious infections should not receive RUXIENCE. Tell your healthcare provider right away if you have any symptoms of infection:
- Fever
- Cold symptoms, such as runny nose or sore throat that do not go away
- Earache or headache
- Cuts, scrapes or incisions that are red, warm, swollen or painful
- flu symptoms, such as cough, tiredness, and body aches
- Pain during urination
- Cold sores in the mouth or throat
- Heart problems. RUXIENCE may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RUXIENCE if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with RUXIENCE.
- Kidney problems, especially if you are receiving RUXIENCE for NHL. RUXIENCE can cause severe kidney problems that lead to death. 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. Bowel problems, including blockage or tears in the bowel can happen if you receive RUXIENCE with chemotherapy medicines. Tell your healthcare provider right away if you have any severe stomach-area (abdomen) pain or repeated vomiting during treatment with RUXIENCE.
- Your healthcare provider will stop treatment with RUXIENCE if you have severe, serious or life-threatening side effects. The most common side effects of RUXIENCE include:
- Ifusion-related reactions
- Infections (may include fever, chills)
- Body aches
- Tiredness
- Nausea
- In patients with GPA or MPA the most common side effects of RUXIENCE also include:
- Llow white and red blood cells
- Swelling
- Diarrhea
- Muscle spasms
- Other side effects with RUXIENCE include:
- Aching joints during or within hours of receiving an infusion
- More frequent upper respiratory tract infection
How should I take RUXIENCE?
- RUXIENCE is given by infusion through a needle placed in a vein (intravenous infusion), in your arm. Talk to your healthcare provider about how you will receive RUXIENCE.
- Your healthcare provider may prescribe medicines before each infusion of RUXIENCE to reduce infusion side effects such as fever and chills.
- Your healthcare provider should do blood tests regularly to check for side effects to RUXIENCE.
- Before each RUXIENCE treatment, your healthcare provider or nurse will ask you questions about your general health. Tell your healthcare provider or nurse about any new symptoms.
Important Safety Information
- Talk to your healthcare provider about the risks to your unborn baby if you receive RUXIENCE during pregnancy.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with RUXIENCE and for 12 months after the last dose of RUXIENCE. Talk to your healthcare provider about effective birth control.
- It is not known if RUXIENCE passes into your breast milk. Do not breastfeed during treatment and for at least 6 months after your last dose of RUXIENCE.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking RUXIENCE?
Tell your healthcare provider about all of your medical conditions, including if you:
- Have had a severe reaction to RUXIENCE or another rituximab product
- Have a history of heart problems, irregular heart beat or chest pain
- Have lung or kidney problems
- Have an infection or weakened immune system.
- Have or have had any severe infections including:
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Parvovirus B19
- West Nile Virus
- Cytomegalovirus (CMV)
- Herpes simplex virus (HSV)
- Varicella zoster virus (chickenpox or shingles)
- Have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RUXIENCE.
- Are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RUXIENCE during pregnancy.
- Females who are able to become pregnant should use effective birth control (contraception) during treatment with RUXIENCE and for 12 months after the last dose of RUXIENCE. Talk to your healthcare provider about effective birth control.
- Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with RUXIENCE.
- Are breastfeeding or plan to breastfeed. It is not known if RUXIENCE passes into your breast milk. Do not breastfeed during treatment and for at least 6 months after your last dose of RUXIENCE.
-
Especially tell your doctor if you take or have taken:
a Tumor Necrosis Factor (TNF) inhibitor medicine,
a Disease Modifying Anti-Rheumatic Drug (DMARD)
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Available 24/7
Experiencing
symotoms that
concern you
General information about RUXIENCE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about RUXIENCE that is written for healthcare professionals.
What are the ingredients in RUXIENCE?
Active ingredient: Rituximab-pvvr
Inactive ingredient: Edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection, USP.
