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

*Eligible commercially insured patients can receive up to $10,000 per 12-month period. They pay $5 per drug co-pay until the $10,000 limit is reached.

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, 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 Rituxan 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 antirheumatic drug (DMARD) has been used and did not work well
  • Patients with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

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

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. Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results (including low neutrophil count, low platelet count, increase in certain liver function tests, and increase in blood cholesterol levels), hepatitis B infection becoming an active infection again, and nervous system problems.

ACTEMRA affects the immune system and may increase your risk of certain cancers.

Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion or injection of ACTEMRA, even if they did not occur with an earlier infusion or injection. If a patient had hives, a rash, or experienced flushing after injecting, he or she should tell a doctor or nurse before his or her next injection. Patients must also tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients.

Common side effects with ACTEMRA in patients with RA include upper respiratory tract infections (common cold, sinus infections), headache, increased blood pressure (hypertension), and injection site reactions.

Common side effects with ACTEMRA in patients with PJIA or SJIA include upper respiratory tract infections (sinus infections), headache, nasopharyngitis (common cold), and diarrhea.

In general, the types of adverse drug reactions in patients with PJIA were consistent with those seen in SJIA patients.

Patients must tell their health care provider if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their health care provider.

Patients must call their health care provider for medical advice about any side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see 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 Prepaid MasterCard® and the ACTEMRA Prepaid MasterCard® are issued by The Bancorp Bank pursuant to license by MasterCard International Incorporated. The Bancorp Bank; Member FDIC. These cards may not be used everywhere Debit MasterCard® is accepted. No cash or ATM access. MasterCard® is a registered trademark of MasterCard International Incorporated.