Rituxan Full Prescribing Information  |  Rituxan Important Safety Information |  ACTEMRA Full Prescribing Information  |  ACTEMRA Important Safety Information

Rituxan is a prescription medicine used to treat adults with:

Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.

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

It is not known if Rituxan is safe and effective in children.

What is the most important information I should know about Rituxan?

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

  • Infusion Reactions: Infusion reactions are very common side effects of Rituxan treatment. Serious infusion 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 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

Before receiving Rituxan, patients should tell their healthcare provider if they:

  • have had a severe infusion reaction to Rituxan in the past
  • 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
  • have taken Rituxan in the past
  • 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

What are the possible side effects of Rituxan?

Rituxan can cause serious and life-threatening side effects, including:

  • 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

What are common side effects during treatment with Rituxan?

The most common side effects of Rituxan include:

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

In patients with GPA or MPA, the most common side effects of Rituxan also include:

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

Other side effects with Rituxan include:

  • aching joints during or within hours of receiving an infusion
  • more frequent upper respiratory tract infections

Tell your healthcare provider about any side effect that bothers you or does not go away.

These are not all of the possible side effects with Rituxan. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the Rituxan Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information.

ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist.
ACTEMRA is used to treat:

  • Adults with moderately to severely active rheumatoid arthritis (RA), after at least one other medicine called a Disease Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well.
  • Adults with giant cell arteritis (GCA).
  • People with active polyarticular juvenile idiopathic arthritis (PJIA) ages 2 and above.
  • People with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above.

ACTEMRA is not approved for subcutaneous use in people with PJIA or SJIA.

It is not known if ACTEMRA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

ACTEMRA can cause serious side effects, including serious infections. ACTEMRA changes the way your immune system works, which can make you more likely to get infections or make any current infection worse. Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting ACTEMRA.

ACTEMRA can cause other serious side effects. These include:

  • Tears of the stomach or intestines
  • Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
  • An increased risk of certain cancers by changing the way a patient's immune system works
  • Hepatitis B infection
  • Serious allergic reactions, including death. These may happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
  • Nervous system problems

Do not take ACTEMRA if you are allergic to ACTEMRA or any of the ingredients in ACTEMRA.

Most common side effects in patients treated with ACTEMRA:

  • Upper respiratory tract infections (like common cold and sinus infections)
  • Headache
  • Increased blood pressure (also called hypertension)
  • Injection site reactions

ACTEMRA & pregnancy:

Patients must tell their doctor if they are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. The patient and their doctor should decide if the patient will take ACTEMRA or breast-feed. Patients should not do both. If a patient is pregnant and taking ACTEMRA, they must join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients must tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Call Genentech at 1-888-835-2555.

Please see the accompanying full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information.

Rituxan® and its logo are registered trademarks of Biogen.

ACTEMRA® and its logo are registered trademarks of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.

The Rituxan Immunology Prepaid Mastercard® and the ACTEMRA Prepaid Mastercard® are issued by Comerica Bank pursuant to license by Mastercard International. No cash or ATM access. The card can be used only to purchase prescriptions at participating merchant locations where Debit Mastercard is accepted. Mastercard® is a registered trademark of Mastercard International Incorporated.