Actemra

Actemra (generic name: tocilizumab) is a prescription medication manufactured by Genentech. Doctors prescribe it to treat conditions caused by inflammation and overactive immune systems, including rheumatoid arthritis (RA), giant cell arteritis, systemic juvenile idiopathic arthritis and COVID-19.

Actemra is part of a group of drugs called interleukin-6 (IL-6) receptor antagonists. IL-6 is a substance in the body that causes inflammation, and Actemra works by blocking it.

People take Actemra weekly as an injection or monthly as an IV infusion. Patients on the injection can give themselves shots at home, while those on the IV infusion receive the drug at a medical center.

The most common side effects people may experience when taking Actemra include headaches, upper respiratory infections, increased blood pressure and injection site reactions. Upper respiratory tract infections were the most common of all mild side effects.

These side effects are usually temporary. Tell your doctor if you experience any ongoing side effects or if they cause you discomfort.

Actemra has some serious risks, including severe infections and tears in the stomach or intestines. Severe infections are the most common serious side effects of Actemra.

Serious Infections

Actemra can cause serious or even fatal infections, including tuberculosis (TB) and other infections caused by viruses, bacteria or fungi. Actemra has a black box warning from the U.S. Food and Drug Administration (FDA) — the agency’s most serious warning — for the risk of serious infections. People with compromised immune systems and those with HIV or diabetes are at increased risk.

Before starting treatment with Actemra, make sure you don’t have any active infections. Your doctor can test you to make sure you’re healthy enough to take Actemra. During treatment, your doctor will monitor you for infections, especially if you have COVID-19.

Gastrointestinal Perforation

Some people taking Actemra developed holes or tears in their stomach or intestines, and the drug’s label warns about this side effect. This is more likely to happen in people who suffer from diverticulitis, a condition in which small, inflamed pockets appear in the lining of the intestines.

People who take nonsteroidal anti-inflammatory drugs (NSAIDs) — such as ibuprofen or aspirin — may be more likely to suffer a gastrointestinal perforation. People taking corticosteroid or methotrexate drugs may also have a higher risk.

Tell your doctor right away if you have a fever, persistent stomach pain or changes in bowel habits. These could be signs of a gastrointestinal perforation.

Cancer Risk

Because Actemra changes how your immune system works, it can also increase your risk factors for certain types of cancer.

Heart Attack and Stroke

Some studies have found that people with RA who took Actemra had an increased risk of major cardiovascular events such as heart attack and stroke, while other studies have not.

Actemra doesn’t have a warning on its label for cardiovascular risks. The FDA has received some reports of heart attacks, but the agency doesn’t think an updated Actemra label is necessary.

Researchers shared clinical trial results at the American College of Rheumatology‘s 2016 Annual Meeting that compared serious side effects in people who took Actemra and Enbrel. Enbrel is a TNF inhibitor in the same drug class as Humira — it treats RA and several other forms of arthritis.

Among people with severe, active RA and elevated, preexisting cardiovascular risk factors who took Actemra, scientists found a 5% increased risk of major cardiovascular events compared to Enbrel.

This 2016 study also found a 53% increased risk of non-fatal stroke and a 50% increase in hospitalizations for heart failure in those who took Actemra compared to Enbrel.

However, a later study published the following year in Arthritis & Rheumatology didn’t find an increased cardiovascular risk in RA patients who switched from other biologic drugs to Actemra.

Lung Complications

There have been some rare reports of interstitial lung disease (ILD) — which causes inflammation and scarring in the lungs — in people who took Actemra, but there’s no warning on the label. In fact, Actemra is approved to treat a type of ILD called systemic sclerosis-associated interstitial lung disease (SSc-ILD).

People with RA may develop ILD, and the main symptom is shortness of breath. Some people may have a dry cough. But certain drugs may increase the risk for ILD or make it worse. It typically starts in the first 20 weeks of using a drug, and older adults have an increased risk.

If you experience shortness of breath while taking Actemra, talk to your doctor. Drug-induced ILD might be misdiagnosed as another condition.

Does Actemra Increase the Risk of Death?

Studies haven’t found that Actemra can increase the risk of death on its own. However, it can increase the risk of serious infections, which can be fatal.

A 2017 report by STAT — a subsidiary of Boston Globe Media — found the FDA received 1,128 reports of deaths linked to Actemra, but the FDA was unable to determine whether those deaths were related to the drug.

Neither Actemra’s manufacturer, Genentech, nor the FDA has ever recalled the drug, but it does have a black box warning for the risk of serious infections. People on Actemra have been hospitalized for infections, and some have died from them.

Most people who suffered serious infections while taking Actemra were also taking other drugs that suppress the immune system, like methotrexate or corticosteroids.

Your health care provider should monitor you for infections during treatment with Actemra. Before you take this drug, make sure to talk about the risks and benefits with your doctor.

People who are most at risk for Actemra complications and side effects include older people, those with preexisting medical conditions and people with weak immune systems.

Patients who are elderly or regularly take NSAIDs or other drugs that suppress the immune system are also at high risk. Make sure to discuss your medical history with your health care provider before taking Actemra.

If you have increased risk factors, tell your doctor right away about any adverse effects you experience while taking Actemra.

If you are taking Actemra and experience side effects, immediately inform your doctor. Mild side effects typically go away on their own and don’t require medical intervention, but serious side effects may require hospitalization or immediate treatment.

You and your doctor can report any side effects you experience to the FDA’s MedWatch program.

Actemra injuries led to lawyers investigating Actemra lawsuits, claiming that Genentech failed to properly warn of injuries such as heart attacks, lung disease, stroke and others. These lawsuits were based on reports suggesting that Actemra had a similar or higher risk of these health problems than other similar drugs on the market.

Drugwatch’s legal partners aren’t currently accepting Actemra lawsuits, but other firms may still be accepting cases.