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Actemra

Actemra is an immunosuppressive biologic drug used for treating autoimmune conditions like rheumatoid arthritis (RA). The FDA also approved the medication for giant cell arteritis treatment and for patients who developed cytokine release syndrome after CAR T cell therapy. It is available in an infusion or injection. Its dosing varies. Many patients and doctors believed Actemra was a safer alternative to rheumatoid arthritis medications like Humira and Enbrel. This is because Actemra’s label does not warn of certain serious side effects. But the drug has led to patient injuries and deaths.

Actemra medication
Actemra Facts
  1. Uses Rheumatoid arthritis, giant cell arteritis, polyarticular and systemic juvenile idiopathic arthritis, cytokine release syndrome
  2. Side Effects Serious infections, certain cancers, gastrointestinal perforations, serious allergic reactions, heart failure, heart attack, stroke, pancreatitis, lung disease
  3. Manufacturer Genentech/Roche
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Actemra is a biologic drug that changes the way the immune system works. The active ingredient in Actemra is tocilizumab.

Acemtra is used to treat rheumatoid arthritis (RA). It can also treat other autoimmune conditions caused by inflammation. It comes in an injection or infusion.

The U.S. Food and Drug Administration first approved Actemra in 2010. Genentech makes Actemra. The company is a subsidiary of Roche.

What Is Acetmra?
Actemra is an immunosuppressive biologic therapy. It reduces the overall activity or effectiveness of the immune system.
Source: U.S. Food and Drug Administration

What Is Actemra Used For?

Actemra is mostly used to treat rheumatoid arthritis. RA is an autoimmune disease. It causes the body’s immune system to attack the joints.

But the U.S. Food and Drug Administration also approved Actemra for other uses. This includes giant cell arteritis treatment. The FDA also approved Actemra to treat cytokine release syndrome associated with CAR T cell therapy in patients 2 years of age and older.

Timeline of FDA-Approved Actemra Uses
  • January 2010
    Rheumatoid Arthritis – autoimmune disease in which the body’s immune system attacks the joints
  • April 2011
    Systemic Juvenile Idiopathic Arthritis – chronic inflammatory joint disease that affects children under age 16
  • April 2013
    Polyarticular Juvenile Idiopathic Arthritis – affects five or more joints in children under age 16
  • May 2017
    Giant Cell Arteritis Treatment – an inflammatory disease of blood vessels
  • August 2017
    CAR T Cell Induced Cytokine Release Syndrome – immunotherapy designed for the treatment of certain cancers causes a large, rapid release of cytokines into the blood

How Does Actemra Work?

Actemra works by blocking the action of a certain protein in the body called interleukin 6 (IL-6).

IL-6 acts as both a pro-inflammatory and anti-inflammatory. It’s said to have a role in rheumatoid arthritis and its effects.

IL-6 connects to the body’s cells. It communicates a message to the cells, triggering them to activate. This activation may cause various signs and symptoms of RA.

Actemra is the first RA drug to block IL-6 from connecting to cells.

How Actemra Works Illustration
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Source: Actemra.com

How Is Actemra Administered?

Patients can receive Actemra via two different methods. The first method is by subcutaneous (SC) injection. The second method is by intravenous (IV) infusion.

Actemra Injection

Actemra comes in a syringe or a shot for injection under the skin. You can administer it yourself at home, or a caregiver or health care professional can administer it for you.

Actemra Infusion

Patients receive Actemra in IV form at a health care provider’s office or other medical center. A medical professional administers the liquid solution into the vein with a needle. This type of infusion lasts about one hour.

Actemra Dosing

Dosing for Actemra depends on a person’s weight, how the drug is given and the condition it’s treating.

Other factors can also influence the recommended dosage. These include any pre-existing health conditions and whether the patient takes other medications.

Rheumatoid Arthritis (RA)
IV infusion: 4 mg per kg given once every four weeks; the dose may be gradually increased to 8 mg per kg once every four weeks, depending on the patient’s tolerance; dosing should not exceed 800 mg per IV infusion

Subcutaneous injection: 162 mg once every other week in patients who weigh less than 220 pounds and 162 mg once every week in patients who weigh over 220 pounds

Giant Cell Arteritis
IV infusion: Not approved for GCA

Subcutaneous injection: 162 mg every week

Polyarticular Juvenile Idiopathic Arthritis
IV infusion: 8 mg per kg (patients at or above 30 kg) to 10 mg per kg (patients less than 30 kg) every four weeks as a 60-minute single intravenous (IV) drip infusion

Subcutaneous injection: 162 mg every three weeks in patients less than 30 kg and 162 mg every two weeks in patients at or above 30 kg

Systemic Juvenile Idiopathic Arthritis
IV Infusion: 8 mg per kg (patients at or above 30 kg) to 12 mg per kg (patients less than 30 kg) every two weeks as a 60-minute single intravenous (IV) drip infusion

Subcutaneous injection: Not approved for SJIA

Cytokine Release Syndrome (CRS)
IV Infusion: 8 mg per kg (patients at or above 30 kg) to 12 mg per kg (patients less than 30 kg) as a 60-minute single intravenous (IV) drip infusion; up to 3 additional doses can be given with an interval of at least eight hours between consecutive doses

Subcutaneous injection: Not approved for CRS

Actemra Side Effects

Actemra side effects can be mild or severe.

Common side effects include upper respiratory tract infections, headache, increased blood pressure and reactions at the injection site.

Serious or deadly side effects can include heart failure, heart attack, stroke and pancreatitis.

Patients injured by Actemra have filed Actemra lawsuits against Genentech and Roche. Families of patients who died after using Actemra are also suing for compensation.

Competing Rheumatoid Arthritis Medications

Other FDA-approved rheumatoid arthritis medications include Humira, Enbrel and Remicade.

Unlike with Actemra, these medications’ labels warn of many serious side effects. This led many patients and doctors to believe that Actemra was safer than the other drugs.

But studies and reports to the FDA reveal similar risks with Actemra. In fact, a 2017 STAT investigation showed the risk of certain side effects is as high or higher with Actemra compared with other rheumatoid arthritis medications.

All the drugs are similarly effective in treating rheumatoid arthritis. They are all used to treat other conditions as well.

Comparing RA Drugs: Actemra, Humira, Enbrel & Remicade
Category Actemra Humira Enbrel Remicade
Manufacturer Genentech AbbVie Amgen Janssen
FDA Approval Date 2010 2006 2002 1999
Average Cost $1,300 to $6,300 per three vials of 4ml, 10ml or 30ml of 20mg $5,500 per two 40mg syringes or pens $5,000 per carton of four 50 mg cartridges, sureclicks or syringes $5,000 to $16,000 per infusion/ $1,100 to $1,300 per vial
Dose for RA IV: 4 mg per kg of weight every four weeks; subcutaneous injection: 162 mg weekly or every other week depending on weight 40 mg every other week 50 mg weekly; pediatric doses range from 0.8 mg to 50 mg weekly 3 mg given at 0, 2 and six weeks followed by 3 mg every eight weeks
Common Side Effects Runny or stuffy nose, sinus pain, sore throat, headache, dizziness, itching, stomach cramps, or UTI – urinary tract infection Injection site reactions, headache, stuffy nose, sinus pain, stomach pain Nausea, vomiting, diarrhea, stomach pain, headache, injection site reactions, heartburn, weight changes, cold symptoms, weakness Headache, stomach pain, nausea, stuffy nose, sinus pain, skin rash, flushing

Actemra Interactions

Using Actemra with other drugs or substances can change the way Actemra works. Drug interactions can increase or decrease Actemra’s effectiveness. They can also result in the increase or decrease of the effects of the other drugs or substances.

Before starting Actemra, patients should speak with their doctor about all other substances they are using. This includes medications, supplements and alcohol.

CYP450 Substrates

Patients taking Actemra with CYP450 substrates may have an increased metabolism of the CYP450 enzyme medications. The effect of Actemra on the activity of the CYP450 enzyme can last for several weeks after stopping Actemra.

Also, patients taking CYP3A4 substrates with Actemra should use caution. Actemra may decrease the effectiveness of these drugs.

Alcohol

You should limit the amount of alcohol you drink while taking Actemra. This can help prevent further injury to the liver.

Tocilizumab is the active ingredient in Actemra. It is linked to elevated liver enzymes and liver toxicity. Doctors should assess patients for liver injury before starting them on Actemra.

Live Vaccines

Patients taking Actemra should avoid live vaccines. Researchers haven’t evaluated how safe and effective live vaccines are in Actemra users.

You should make sure you are up-to-date on vaccines before starting Actemra.

Who Should Not Take Actemra?

Actemra may not be the right treatment for everyone.

Patients who have signs of an infection or have ever had tuberculosis should speak with their doctor before using Actemra.

This is also true for anyone scheduled to receive live vaccines. These include the shingles vaccine, the chickenpox vaccine and the MMR vaccine. Others live vaccines protect against polio, rotavirus, typhoid or yellow fever.

Tell your doctor if you are pregnant or breastfeeding before starting Actemra.

Talk to your doctor before using Actemra if you have:
  • Active or chronic infection
  • Liver disease
  • Diverticulitis
  • Stomach ulcer
  • Stomach or intestinal bleeding
  • Diabetes
  • HIV or a weak immune system
  • Hepatitis B
  • Cancer
  • Nerve muscle disorders like multiple sclerosis

Please seek the advice of a medical professional before making health care decisions.

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8 Cited Research Articles

  1. Genentech. (n.d.). How Actmera Is Believed To Work. Retrieved from https://www.actemra.com/ra/consider-actemra/actemra-works-differently.html
  2. Genentech. (n.d.). Treatment Method Options. Retrieved from https://www.actemra.com/ra/taking-actemra/taking-actemra-treatment-options.html
  3. Daily Med. (2018, May 25). Label: Actemra – tocilizumab injection, solution, concentrate; Actemra – tocilizumab injection, solution. U.S. National Library of Medicine. NIH. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2e5365ff-cb2a-4b16-b2c7-e35c6bf2de13
  4. Mahamid, M., et al. (2011, October 4). Hepatotoxicity of tocilizumab and anakinra in rheumatoid arthritis: management decisions. Clinical Pharmacology: Advances and Applications. NIH. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3262392/
  5. Arthritis Foundation. (n.d.). What is Rheumatoid Arthritis? Retrieved from https://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php
  6. Medline Plus. (2017, July 14). Rheumatoid arthritis. U.S. National Library of Medicine. NIH. Retrieved from https://medlineplus.gov/ency/article/000431.htm
  7. Piller, C. (2017, June 5). Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients. STAT. Retrieved from https://www.statnews.com/2017/06/05/actemra-rheumatoid-arthritis-fda/
  8. Monson, PharmD, K. and Schoenstadt, MD, A. (2017, January 1). Actemra Dosage. eMedTV. Retrieved from http://arthritis.emedtv.com/actemra/actemra-dosage.html
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