Ruxience

Ruxience is a biosimilar of Rituxan approved to treat:

• Non-Hodgkin's lymphoma in adults alone or with other chemotherapy medicines
• Chronic lymphocytic leukemia in adults, in combination with the chemotherapy medicines fludarabine and cyclophosphamide
• Rheumatoid arthritis (RA) in adults, in combination with methotrexate, to reduce signs and symptoms of moderate to severely active RA after an inadequate response to treatment with a Tumor Necrosis Factor (TNF) antagonist
• Pemphigus vulgaris (moderate to severe) in adults
• Granulomatosis with Polyangiitis (GPA, Wegener's granulomatosis) and Microscopic Polyangiitis (MPA) in adults and children 2 years of age and older, in combination with glucocorticoids.

Ruxience (rituximab-pvvr) gained FDA approval on July 23, 2019, and was the second biosimilar of Rituxan to be approved.

• Ruxience is not approved for use in children, except for children 2 years of age and older with GPA or MPA.

Before you receive Ruxience, tell your healthcare provider about all of your medical conditions, including if you:

• have had a severe reaction to Ruxience or a rituximab product
• have a history of heart problems, irregular heartbeat, or chest pain
• have lung, liver, or kidney problems
• have an infection or a weakened immune system
• have or have had any severe infections, including: Hepatitis B virus (HBV) Parvovirus B19 Hepatitis C virus (HCV) Varicella zoster virus (chickenpox or shingles) Cytomegalovirus (CMV) West Nile Virus Herpes simplex virus (HSV).
• have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with Ruxience. You should be up-to-date on any needed immunizations before starting treatment with Ruxience.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Ruxience may harm an unborn baby. Talk to your healthcare provider about the risks to an unborn baby if you or someone you are caring for receives Ruxience during pregnancy. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test to check for pregnancy before starting Ruxience.

Effective birth control (contraception) should be used during treatment with Ruxience and for 12 months after the last dose. Talk to your healthcare provider about effective birth control.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Ruxience.

Breastfeeding

Ruxience may pass into your breast milk. It is not safe to breastfeed a baby while you are using this medicine. Do not breastfeed during treatment and for 6 months after your last dose of Ruxience.

The most common side effects of Ruxience are:

• infusion-related reactions
• infections (may include fever, chills)
• body aches
• tiredness
• nausea.

In adults and children with GPA or MPA, the most common side effects of Ruxience also include:

• swelling
• diarrhea
• muscle spasms
• low white and red blood cells

These are not all of the possible side effects of Ruxience. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects and warnings

Ruxience carries a Boxed Warning for fatal infusion-related reactions, severe skin reactions, hepatitis B virus reactivation, and a rare brain condition called progressive multifocal leukoencephalopathy (PML).

Ruxience can cause the following serious side effects:

• Infusion-related reactions. These are very common side effects of Ruxience treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after. Your healthcare provider should give you medicines before your Ruxience infusion to decrease the 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: hives (red itchy welts) or rash shortness of breath, difficulty breathing, or wheezing itching weakness swelling of your lips, tongue, throat, or face dizziness or feeling faint sudden cough palpitations (feel like your heart is racing or fluttering) chest pain.
• 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 Ruxience treatment, your healthcare provider will do blood tests to check for HBV infection. If you have had hepatitis B or is a carrier of the 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 immediately if you get worsening tiredness or yellowing of your skin or white part of your eyes, during treatment.
• 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 decreased strength or weakness on one side of your body difficulty walking or talking 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 need dialysis treatment an abnormal heart rhythm.

TLS can happen within 12 to 24 hours after an infusion of Ruxience. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:

• nausea diarrhea vomiting lack of energy.
• 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 (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 a runny nose or sore throat, that do not go away flu symptoms, such as cough, tiredness, and body aches earache or headache pain during urination cold sores in the mouth or throat cuts, scrapes, or incisions that are red, warm, swollen, or painful.
• Heart problems. Ruxience may cause chest pain, irregular heartbeats, and a heart attack. Your healthcare provider may monitor your heart during and after treatment with Ruxience if you have symptoms or 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 can 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.

Get emergency medical help if you have signs of an allergic reaction to Ruxience, such as hives, difficulty breathing, swelling in your face or throat, or a severe skin reaction (symptoms may include fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

These are not all of the possible side effects of Ruxience. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Ruxience.

Ruxience is given as an infusion through your central catheter or into a vein. A healthcare provider will give you this injection.

Ruxience is not given daily. Your schedule will depend on the condition being treated. Follow your doctor's dosing instructions very carefully.

Before each injection, you may be given other medications to prevent certain side effects of rituximab.

You will need frequent medical tests.

If you've ever had hepatitis B, using Ruxience can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

If you need surgery, tell the surgeon ahead of time that you are using Ruxience.

Call your doctor if you miss an appointment for your Ruxience.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Do not receive a "live" vaccine while using Ruxience. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Tell your doctor about all your other medicines, especially:

• medicines to treat conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, or psoriasis--adalimumab, certolizumab, etanercept, golimumab, infliximab, leflunomide, methotrexate, sulfasalazine, tocilizumab, tofacitinib, and others.

This list is not complete. Other drugs may affect Ruxience, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: rituximab-pvvr

Inactive ingredients: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection.

Ruxience is manufactured by Pfizer Ireland Pharmaceuticals, Cork, Ireland.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Ruxience.

Rituxan (rituximab) - Genentech, Inc.

View Rituxan information in detail.

Rituxan interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Truxima (rituximab-abbs) - CELLTRION, Inc.

View Truxima information in detail.

Rituxan biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Riabni (rituximab-arrx) - Amgen Inc.

View Riabni information in detail.

Ruxience (rituximab-pvvr) - Pfizer Ireland Pharmaceuticals Unlimited Company

Zimrixby (rituximab-cdxx) - Dr. Reddy's Laboratories SA

Zimrixby