What to Know About Actemra (Tocilizumab)

Actemra (tocilizumab) is a biologic therapy used to treat certain inflammatory conditions, including rheumatoid arthritis. This drug reduces inflammation by blocking a specific type of receptor important in the immune system: IL-6 (interleukin-6).

It can be given intravenously or as an injection into the fatty layer beneath the skin.

Uses

Currently, Actemra is FDA approved for several conditions. This medication is used to prevent symptoms. It is used on a schedule, ranging from every week to every four weeks, depending on the indication or other factors that may necessitate an individual modification in the schedule.

Approved indications:

• Adults with rheumatoid arthritis who have tried methotrexate or a similar type of drug but haven’t had a good response.
• Systemic juvenile idiopathic arthritis and polyarticular juvenile idiopathic arthritis in children 2 years of age and older. These are subtypes of juvenile idiopathic arthritis, a childhood condition that usually mostly affects the joints. The systemic version of the disease can affect wider body systems like the internal organs and the eyes.
• Giant-cell arteritis is an inflammatory condition that affects certain blood vessels and can cause headaches, vision symptoms, and even heart attacks and strokes.
• Cytokine storm syndrome is a severe, maladaptive immune response that can cause life-threatening inflammation. Such a response can happen after certain types of immunotherapies, such as chimeric antigen receptor-modified T cells (CART) therapy, designed to treat certain kinds of B cell cancers. Cytokine storm syndrome can also occur as a response to certain types of infections, such as the flu.
• Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) is a rare condition that causes inflammation of the skin, blood vessels, lungs, and other organs as well.
• Adults with COVID-19 who are hospitalized and receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal life support (ECMO).

Emergency Use Authorization for COVID-19

Actemra is used for the treatment of hospitalized pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

It’s thought that some individuals with severe symptoms of COVID-19 may have cytokine storm syndrome. This might be partly caused by high levels of the immune molecule, IL-6. By blocking its receptor, it is thought that Actemra might reduce life-threatening symptoms, such as those coming from severe lung involvement.

Some research about the effects of Actemra on COVID-19:

• One study of 65 patients with COVID-19 found no difference in improvements in patients treated with Actemra compared to those treated with standard care only.
• However, a study of 544 patients with severe symptoms found that treatment with Actemra seemed to reduce the chance that patients would need ventilators while lowering their risk of death.

To definitively see if some people might benefit, we will need to see further results from ongoing studies.

Before Taking

Your clinician will need to give you a thorough medical evaluation before starting Actemra.

This medication is not recommended if you have:

• Signs or symptoms of an ongoing infection
• A condition, like neutropenia or HIV/AIDS that puts you at risk of infections
• A potentially serious infection that could reactivate, like tuberculosis
• A history of liver disease

It’s likely that Actemra will not be the first treatment that you try for your medical condition. In some cases, other treatments are available that should be tried first. For example, children with juvenile idiopathic arthritis usually only start Actemra after they have tried other therapies, like methotrexate.

Precautions and Contraindications

You may need to have liver function tests, a complete blood count, and cholesterol tests before you start taking Actemra. The blood test results might indicate that you shouldn't take Actemra. For example, if you have a low number of certain blood cells or platelets, your practitioner might recommend another therapy instead.

Your pretreatment baseline blood tests can be used to help monitor potential side effects.

Specialized pretreatment tests may include:

• People starting Actemra need to get a test for tuberculosis (a TB test) before treatment. This might involve getting a chest X-ray or a TB skin test. Some people have dormant TB infections that aren’t giving them any symptoms. But because of the way it affects the immune system, starting Actemra might make a TB infection more active. If you do have a TB infection, you’ll need to be treated before you start Actemra.
• Similarly, some people may have an infection with the hepatitis B virus and not know it. In this case, starting Actemra might make that infection more active. Before treatment, your healthcare provider may test to make sure you aren’t infected.

Vaccines

You may not be able to start taking Actemra right away if you’ve recently taken a live vaccine. You also shouldn't take a live vaccine while you are taking Actemra.

Pregnancy

Talk to your healthcare provider if you are pregnant, thinking of becoming pregnant, or breastfeeding. It is not known if Actemra increases the chance of birth defects or death of the fetus. The risks should be weighed with your healthcare provider, and it shouldn’t be used unless clearly necessary.

Other IL-6 Blocking Therapies

Another more recently available biologic therapy blocking the IL-6 receptor is Kevzara (sarilumab). It is approved for similar use only in rheumatoid arthritis.

Other Biologic Therapies

You might be able to try other biologic therapies instead of Actemra. For rheumatoid arthritis, for example, multiple types of biologic therapies are available in several different therapy classes, including TNF blockers like Humira (adalimumab).

In contrast, for giant cell arteritis, Actemra is currently the only FDA-approved biologic therapy available.

Dosage

Actemra can be given through subcutaneous injection or through an intravenous line.

• When given intravenously, therapy is typically given once every four weeks.
• When given as an injection, it is typically administered every week.

Dosage and frequency may vary based on your weight, age, and the illness you are being treated for.

Other Prescriptions

Actemra can be taken as a medication on its own. Some evidence suggests that it may be more effective when taken with methotrexate. In fact, Actemra is often prescribed to be taken in addition to other medications, such as methotrexate or sulfasalazine.

Sometimes Actemra is taken along with glucocorticoids for a time as well. It is not recommended that Actemra be taken along with other biologic-type therapies.

How to Take and Store

When given by injection, your healthcare provider will provide a step-by-step guide on how you can administer the therapy. This injectible form can be taken via a pre-filled syringe or via a kind of injection pen. These are stored in the refrigerator until ready to be used.

If you will have Actemra delivered by intravenous line, you will need to have this done at your practitioner’s office.

Side Effects

Common

Some of the relatively common side effects from Actemra therapy are as follows:

• Upper respiratory tract infection symptoms (like from a cold)
• Elevated cholesterol levels
• Headache
• Elevated blood pressure
• Skin irritation at the injection site

Severe

Actemra can have serious side effects:

• It can cause leukopenia or neutropenia, which are common reasons for discontinuing the drug.
• Less commonly, Actemra carries a risk of gastrointestinal perforation, primarily in people who also have underlying diverticulitis.
• It sometimes causes serious liver damage.
• In some people, it may increase the risk of a serious cardiovascular event, like a heart attack.

Serious and life-threatening allergic reactions are also a risk, as they are for all biologic therapies.

Warnings

Actemra has a couple of risks that warrant warnings.

Risk of Serious Infection

Actemra can also increase your risk of infection, including some infections that might be serious such as pneumonia, cellulitis, and urinary tract infections.

Because of the way Actemra affects your body’s immune system, it’s possible that your body will have a harder time fighting off certain kinds of infections that wouldn’t affect most people. An example might be a serious fungal infection that requires hospitalization for treatment.

Risk of Cancer

To date, no information has indicated that Actemra increases the risk of cancer. But because of the way Actemra affects your immune system, this is a theoretical concern. However, it has been suggested that Actemra poses less of a potential cancer risk than other similar therapies such as TNF-inhibitors, whose cancer risk has been more controversial.

Weighing Risks and Benefits

It’s important to keep these risks in perspective. Actemra seems to have similar risks and safety concerns compared to some other biologic therapies used to treat rheumatoid arthritis, such as Orencia (abatacept), Truxima (rituximab), and Humira (adalimumab).

Though Actemra does carry certain risks, it can be a very helpful therapy for some people. Weigh the risks and benefits in your situation with your healthcare provider.