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

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) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.

People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or 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 the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion
  • Severe Skin and Mouth Reactions: 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
  • Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection caused by the JC virus

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
  • Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death
  • Heart Problems: Rituxan may cause chest pain and irregular heartbeats, which may need treatment, or your doctor may decide to stop your treatment with Rituxan
  • Kidney Problems: especially if you are receiving Rituxan for non-Hodgkin's lymphoma (NHL). Your doctor 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 doctor right away if you have any stomach area pain during treatment with Rituxan
  • Low Blood Cell Counts: Your doctor may do blood tests during treatment with Rituxan to check your blood cell counts

What are common side effects during treatment with Rituxan?

  • Infusion reactions
  • Chills
  • Infections
  • Body aches
  • Tiredness
  • Low white blood cell counts

Other side effects include:

  • Aching joints during or within hours of receiving an infusion
  • More frequent upper respiratory tract infections

Tell your doctor 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 doctor or pharmacist.

Call your doctor 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 accompanying full 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.