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Ruxience is the brand name for rituximab-pvvr and is available as an IV infusion.

Ruxience is available as a 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL) solution for an IV infusion.

Ruxience is a monoclonal antibody that is used for the following:

Blood cancers

• Certain types of CD20-positive non-Hodgkin’s lymphoma (NHL) in adults and children ages 6 months and older
• CD20-positive chronic lymphocytic leukemia (CLL) in adults

Autoimmune conditions

• Moderate to severe rheumatoid arthritis (RA) in adults
  Granulomatosis with polyangitis (GPA) and microscopic polyangitis (MPA) in adults and children ages 2 years and older
• Moderate to severe pemphigus vulgaris in adults

Ruxience is a monoclonal antibody. It targets specific immune cells called B cells that can be involved in a range of different health conditions. For example, B cells sometimes turn into cancer cells. Other times, they become overly active and cause autoimmune conditions.

Ruxience is dosed as follows: Your provider will determine your dose of Ruxience based on your body surface area (BSA) in m². This medication is typically given by a healthcare provider in a hospital or infusion clinic setting. Your provider might also give you other anticancer medications along with Ruxience.

Non-Hodgkin’s lymphoma

• Adults: The typical dose is 375 mg/m² given as an intravenous infusion. How often you’ll receive a dose usually ranges from weekly to every 8 weeks, depending on the type of NHL you have and where you are in the treatment process.

Children: Talk with your child’s provider.

• Chronic Lymphocytic Leukemia (CLL)
• Adults: The typical dose is to receive one 375 mg/m² intravenous infusion before the start of chemotherapy. Then, your provider will raise your dose to 500 mg/m² infused on Day 1 of a 28-day chemotherapy cycle, for 2 to 6 cycles.

Autoimmune conditions

• Your provider might also give you other medications along with Ruxience to treat your condition.

RA

• Adults: The typical starting dose is 1,000 mg infused IV for 2 doses, given 2 weeks apart. The typical maintenance dose is 1,000 mg infused once every 4 to 6 months, depending on your condition.

GPA and MPA

• Adults: Your provider will determine your dose of Ruxience based on your body surface area (BSA) in m². The typical starting dose is 375 mg/m² given as an intravenous infusion weekly for 4 weeks. The typical maintenance dose is 250 mg/m², usually infused once every 6 months.

Children: Ask your child’s provider.

• PV
• Adults: The typical starting dose is 1,000 mg infused IV for 2 doses, given 2 weeks apart. The typical maintenance dose is 500 mg infused a year after the starting dose, then once every 6 months.

Ruxience is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Ruxience:

• Fever
• Lower white blood cell counts
• Chills
• Infection
• Weakness
• Nausea
• Headache
• Night sweats
• Rash

Serious side effects are rare with Ruxience. Contact your healthcare provider immediately if you experience any of the following.

• Infusion-related reaction: swelling, trouble breathing, chest pain, low blood pressure, red skin
• Serious skin reaction: painful blisters, skin wounds, peeling skin, fever, sore throat, body aches
• Tears in the gut: sudden and severe stomach pain, fever, chills, and nausea or vomiting that won’t go away
• Infection: fever, chills, cough, muscle aches, very fast heartbeat, severe tiredness
• Tumor lysis syndrome: seizures, hallucinations, nausea, tiredness, no appetite, dark-colored urine, muscle
• cramps, numbness
  Serious heart problems: tiredness, weakness, dizziness, feeling faint, trouble breathing, pressure on the chest, pounding heart, irregular heart beat, sweating, feeling anxious, nausea

The following medications may interact with Ruxience:

• Renal toxicity when used in combination with cisplatin

Pfizer

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:

• Your healthcare provider should do a pregnancy test to see if you are pregnant before starting Ruxience
• You should use effective birth control (contraception) during treatment with Ruxience and for 12 months after your 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

• Rituximab-PVVR