Actemra (shot)

Tocilizumab

For Rheumatoid Arthritis

Drug available as

shotShots (Prefilled Syringe)

ivIntravenous infusion (IV)

Track record

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Limited (approved in 2013)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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Rheumatoid Arthritis

What is Rheumatoid Arthritis?

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Sometimes, for unclear reasons, the immune system turns against the body and attacks it. This process is called autoimmunity. Rheumatoid arthritis is one of many different autoimmune diseases.

Other treatments for Rheumatoid Arthritis

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

Bottom Line

What is Actemra?

Actemra is called a “biologic.” It is used for people with moderately-to-severely active rheumatoid arthritis (RA) who have not responded enough to traditional “Disease Modifying Anti-Rheumatic Drugs" (DMARDs) such as Methotrexate, Sulfasalazine or Plaquenil.

RA is caused when the body’s own immune system mistakenly attacks the joints. This leads to inflammation that causes RA symptoms and joint damage.

Actemra treats RA by making it harder for a chemical in the body called interleukin to signal the immune system to attack the joints. This reduces the inflammation that causes symptoms and joint damage.

Where does Actemra fit with other rheumatoid arthritis drugs?

The sooner RA is under control, the lower the chance of permanent joint damage and disability. That is why doctors sometimes use powerful medicines, adjusting the dose or adding new ones until patients have no or minimal symptoms.

Actemra is generally not the first-choice drug for people with moderately-to-severely active RA. Instead, most major U.S. and European medical organizations recommend using Methotrexate first because it has a long track record.

Good evidence shows that starting with Methotrexate alone - and only adding more medicines if symptoms do not improve substantially over 3 to 6 months - is safer and works as well as starting multiple drugs right away. If additional medicines are needed, most doctors add traditional DMARDs (such as Sulfasalazine or Plaquenil). Others may add a biologic like Actemra. Studies show patients do as well with either strategy.

Although Actemra can be used alone, it is usually given with Methotrexate because the combination works better.

Benefit

FDA approved Actemra to reduce joint pain and swelling, improve physical function and reduce worsening of joint damage.

Actemra can take a few weeks to start working. It can be used as long as it continues to work, either alone or with traditional DMARDs, steroids, or drugs called NSAIDs (such as Aspirin, Ibuprofen or Naproxen), but not with other biologics (such as Enbrel or Humira).

Side Effects

Actemra can cause serious and possibly fatal problems. The FDA considers these possible side effects so serious that it put a black box warning, its highest safety alert, on this medication. These serious side effects, which are generally uncommon, are:

  • weakening of the immune system, which can lead to possibly fatal infections from tuberculosis (TB), other bacteria, viruses and fungi
  • reactivation of the herpes or hepatitis B virus if present in the body

Other serious side effects include:

  • may increase the chance of certain cancers
  • tears (perforations) in the stomach or intestines
  • nervous system problems (including multiple sclerosis)
  • low white cell and platelet blood counts
  • serious allergic reactions
  • high liver inflammation blood tests
  • higher cholesterol

More common side effects include colds and sinus infections, stuffy nose and sore throat, headache, high blood pressure and nausea.

Lifestyle changes

Actemra is given as an infusion in the hospital or clinical every month. Infusions take about 1 hour.

People who are taking Actemra need blood tests done regularly and TB skin tests, can't take live vaccines, and have to be careful about also taking other medicines.

The FDA does not caution people to avoid alcohol with Actemra alone. So, moderate alcohol consumption (up to 1 drink a day for women, 2 a day for men) may be ok. However, if you use Actemra with other medicines, ask your doctor.

FDA-approved use

To treat moderately-to-severely active rheumatoid arthritis alone or in combination with methotrexate or a non-biologic medicine

Actemra (a biologic) is used when rheumatoid arthritis does not respond enough to other Disease Modifying Anti-Rheumatic Drugs (DMARDs). According to the FDA, Actemra shots can reduce joint pain and swelling, improve physical function and reduce worsening of joint damage. Actemra should not be taken with other biologic medicines.
Other FDA-approved uses: Juvenile rheumatoid arhritis (polyarticular or systemic).

Who might consider taking it?

Adults with moderately-to-severely active rheumatoid arthritis despite other DMARDs

Moderately-to-severely active means at least 5 inflamed joints, high inflammation blood tests and possibly inflammation or bone damage on x-ray

What is not known

Not tested in people with moderate to severe kidney disease

Not known what affect Actemra may have on some nervous system disorders (such as Multiple Sclerosis)

Track record

Limited track record for this form of the drug means that new‚ unexpected side effects are possible

Actemra in intravenous (IV) form was approved by FDA in 2010 but the injection form of Actemra was only approved in 2013. Important side effects may emerge when a drug is given in a new form.

Open questions

FDA-required studies at approval to answer questions about harms

The drug company was required to create a pregnancy registry to learn more about safety during pregnancy and to conduct additional studies about possible side effects‚ including heart attacks and strokes, side effects from long-term use, and the effect of Actemra on vaccines.

Do not take if you...

Are allergic to Actemra or its ingredients

Take other rheumatoid arthritis drugs in the family called "biologic DMARDs"

Including etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), rituximab (Rituxan), abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), or golimumab (Simponi)

Safe if pregnant or breastfeeding?

Pregnant

Only take if potential benefits outweigh potential harm to baby (FDA Category C)

Breastfeeding

Do not breastfeed while taking Actemra - either stop breastfeeding or stop Actemra

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