Ruxience

Ruxience is a prescription medicine used to treat adults with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

Ruxience is in a class of medications called monoclonal antibodies. It works by killing cancer cells. In the treatment of GPA and MPA, Ruxience works by blocking the activity of the part of the immune system that may damage the blood vessels.

This medication comes in an injectable form that is given directly into a vein (IV) by a healthcare provider.

Common side effects include infections, chills, body aches, and tiredness.

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.

Serious side effects have been reported with Ruxience. See "Ruxience Precautions" section.

Common side effects of Ruxience include:

• Infusion-related reactions
• Infections (may include fever, chills)
• Body aches
• Tiredness
• Nausea

In patients with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) or Microscopic Polyangiitis (MPA), the most common side effects of Ruxience also include:

• Low 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 infections

This is not a complete list of Ruxience side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or have taken:

• a Tumor Necrosis Factor (TNF) inhibitor medicine
• a Disease Modifying Anti-Rheumatic Drug (DMARD)

If you are not sure if your medicine is one listed above, ask your doctor or pharmacist.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine. Do not take any new medicine without talking with your doctor.

Ruxience can cause serious side effects that can lead to death, including:

• 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
  • Itching
  • Swelling of your lips, tongue, throat, or face
  • Sudden cough
  • Shortness of breath, difficulty breathing, or wheezing
  • Weakness
  • Dizziness or feel faint
  • 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 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 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 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 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, such as blurred vision or loss of vision
• Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:

  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:

  • Kidney failure and the need for dialysis treatment
  • Abnormal heart rhythm
  • Nausea
  • Vomiting
  • Diarrhea
  • 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 of time (longer than 11 months). Some of these patients 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
  • 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 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: Ruxience can cause severe kidney problems that lead to death, especially if you are receiving Ruxience 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: 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 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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ruxience there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Ruxience, tell your doctor if you:

• have had a severe infusion reaction to Ruxience in the past 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)
  • Cytomegalovirus (CMV)
  • Herpes simplex virus (HSV)
  • Parvovirus B19
  • Varicella zoster virus (chickenpox or shingles)
  • West Nile Virus
• have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or after you receive Ruxience. Tell your doctor if anyone in your household is scheduled to receive a vaccination. Some types of vaccines can spread to people with a weakened immune system, and cause serious problems.
• have taken Ruxience for WG or MPA in the past
• have any other medical conditions
• are pregnant or planning to become pregnant. Ruxience may affect the white blood cell counts of your unborn baby. It is not known if Ruxience may harm your unborn baby in other ways. Women who are able to become pregnant should use effective birth-control (contraception) while using Ruxience and for 12 months after you finish treatment. Talk to your doctor about effective birth control.
• are breastfeeding or plan to breastfeed. It is not known if Ruxience passes into your breast milk. You and your doctor should decide the best way to feed your baby if you receive Ruxience.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 

Tell your healthcare provider if you are pregnant or planning to become pregnant. In animal studies, pregnant animals were given another rituximab product and had some babies born with problems. No well-controlled studies have been done in humans.

• 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.

Tell your healthcare provider if you 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.

• 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.

Non-Hodgkin's Lymphoma (NHL)

The recommended dose is 375 mg/m2 as an intravenous (into the vein) infusion according to the following schedules:

• Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: given once weekly for 4 or 8 doses.
• Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL: given once weekly for 4 doses.
• Previously Untreated, Follicular, CD20-Positive, B-Cell NHL: given on Day 1 of each cycle of chemotherapy, for up to 8 doses. With complete or partial response, Ruxience maintenance therapy is 8 weeks following completion of Ruxience in combination with chemotherapy. Ruxience is to be given as a single-agent every 8 weeks for 12 doses.
• Non-progressing, Low-Grade, CD20-Positive, B-cell NHL, after first-line CVP chemotherapy: following completion of 6–8 cycles of chemotherapy, Ruxience is to be given once weekly for 4 doses at 6-month intervals to a maximum of 16 doses.
• Diffuse Large B-Cell NHL: given on Day 1 of each cycle of chemotherapy for up to 8 infusions.

Chronic Lymphocytic Leukemia (CLL)

• The recommended dose is 375 mg/m2 the day prior to the initiation of chemotherapy, then 500 mg/m2 on Day 1 of cycles 2–6 (every 28 days).

In combination with Zevalin (Ibritumomab Tiuxetan)

• The dose of Ruxience is 250 mg/m2.
• Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen.

Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)

• Ruxience 375 mg/m2 intravenous (into the vein) infusion once weekly for 4 weeks.

This medication is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Always let your doctor know what other medications or supplements you may be taking. Talk to your doctor before taking a new medicine. Always keep doctor’s appointments as they may need to check your laboratory tests.

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions

Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions.

Severe Mucocutaneous Reactions

Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products.

Hepatitis B Virus (HBV) Reactivation

HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RUXIENCE. Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation.

Progressive Multifocal Leukoencephalopathy (PML)

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products