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Announcement

ACTEMRA for self-injection is now FDA-approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age or older. To determine these patients' eligibility for the ACTEMRA Co-pay Card Program, please call (855) RA-COPAY (855-722-6729) during the hours of 6 a.m.–5 p.m. PT except for on major holidays.

Please see the full ACTEMRA Prescribing Information for more information.

The information contained in this section of the site is intended for US health care professionals only. Click “OK” if you are a health care professional or specialty pharmacy representative.

The information contained in this section of the site is intended for specialty pharmacy representatives only. Click “OK” if you are a health care professional or specialty pharmacy representative.

The information contained in this section of the site is intended for US health care professionals and specialty pharmacy representatives only. Click “OK” if you are a health care professional or specialty pharmacy representative.

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

What is Rituxan?

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.

Pemphigus Vulgaris (PV): to treat moderate to severe PV.

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

Important Side Effect Information

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 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
  • muscle spasms

Other side effects with Rituxan include:

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

These are not all of the possible side effects with Rituxan.

Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or 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.

What does ACTEMRA treat?

ACTEMRA is a prescription medicine 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
  • Adults with giant cell arteritis (GCA)
  • Patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older
  • Patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

ACTEMRA is not approved for subcutaneous use in people with 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

Serious Infections

ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with ACTEMRA.

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

ACTEMRA can cause other serious side effects. These include:

Tears (perforation) of the Stomach or Intestines
If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking ACTEMRA. Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation).

Changes in Blood Test Results
Your healthcare provider should do blood tests before you start receiving ACTEMRA. You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. These may cause your healthcare provider to stop your ACTEMRA treatment for a time or change your dose.

Cancer
ACTEMRA may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B Infection
If you have or are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use ACTEMRA. Your healthcare provider may do blood tests before you start treatment with ACTEMRA and while you are using ACTEMRA.

Serious Allergic Reactions
Serious allergic reactions, including death, can happen with ACTEMRA. These reactions can happen with any infusion or injection of ACTEMRA, even if they did not occur with an earlier infusion or injection.

Nervous System Problems
While rare, Multiple Sclerosis has been diagnosed in people who take ACTEMRA.

The most common side effects of ACTEMRA include:

  • upper respiratory tract infections (common cold, sinus infections)
  • headache
  • increased blood pressure (hypertension)
  • injection site reactions

ACTEMRA & Pregnancy

Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. If you are pregnant and taking ACTEMRA, join the pregnancy registry. To learn more, call 1-877-311-8972 or talk to your healthcare provider to register.

Tell your healthcare provider if you have any side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information and the Medication Guide, including Serious Side Effects, for more Important Safety Information.

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  • New Year's Day
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  • Good Friday
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  • Columbus Day
  • Thanksgiving Holiday (Thursday and Friday)
  • Christmas Holiday

Questions about this program?

Call (855) RA-COPAY (855-722-6729)
6 a.m.–5 p.m. PT, Monday through Friday (except major holidays)

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