Key takeaways
- As with other drugs, Actemra can cause side effects, such as weight gain, headache, and injection site reactions.
- Actemra has a boxed waring about the risk of serious infections. Be sure to talk with your doctor if you have a current infection before starting treatment with Actemra.
- If side effects of Actemra become difficult to tolerate, talk with your doctor or pharmacist.
Actemra (tocilizumab) is a prescription, brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat the following conditions in certain situations:
- rheumatoid arthritis in certain adults
- interstitial lung disease that’s linked to systemic sclerosis (also known as scleroderma that affects the whole body) in adults
- giant cell arteritis in adults
- cytokine release syndrome in certain adults and children ages 2 years and older
- polyarticular juvenile idiopathic arthritis (JIA), which affects five or more joints, in children ages 2 years and older
- systemic JIA, which affects the whole body, in children ages 2 years and older
- COVID-19 in certain hospitalized adults and children ages 2 years and older
Actemra has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warning for Actemra” section.
Actemra can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Actemra in clinical studies:
- upper respiratory tract infection, such as a sinus infection or the common cold
- headache
- hypertension (high blood pressure)
- increases in the levels of certain liver enzymes which, in rare cases, may be a sign of liver damage
- injection site reactions (see “Managing side effects”)
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Mild side effects can occur with Actemra use. This list doesn’t include all the possible mild side effects of the drug. For more information, you can refer to Actemra’s prescribing information.
Mild side effects that have been reported with Actemra include:
- upper respiratory tract infection, such as a sinus infection or the common cold
- headache
- dizziness
- bronchitis (a type of inflammation in the airways)
- skin rash
- mouth ulcers (sore spots in the mouth and on the gums)
- pain in the upper abdomen
- cough
- fluid retention, which may cause swelling in your lower legs, ankles, or feet
- weight gain
- injection site reactions
These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medications safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Actemra and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.
For more information about some of these side effects, see the “Managing side effects” section.
Actemra may cause serious side effects. The list below may not include all the possible serious side effects of the drug. For more information, you can refer to Actemra’s prescribing information.
If you develop serious side effects while using Actemra, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported include:
- liver problems, including increases in the levels of certain liver enzymes, liver damage, and liver failure
- perforations (small holes or tears) or in your stomach or intestines
- blood disorders, including low levels of white blood cells, neutrophils (a type of white blood cell), or platelets
- hypertension (high blood pressure)
- multiple sclerosis
- high cholesterol levels, which don’t cause symptoms in most people.
- increased risk of certain types of cancer (see “Managing side effects”)
- infusion-related side effects (see “Managing side effects”)
- risk of serious infections (see “Boxed warning for Actemra“)
Allergic reactionFor some people, Actemra can cause an allergic reaction. But this side effect was rare in the drug’s clinical studies.
In general, symptoms of allergic reaction can be mild or serious.
Ways to manage
For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.
For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Actemra, your doctor may recommend taking a different medication instead.
Side effects in children who received Actemra in clinical studies were the same as those in adults, with one exception. Diarrhea was a common side effect in children, but adults didn’t report diarrhea as a side effect. Diarrhea was reported by children who received Actemra as an IV infusion to treat systemic juvenile idiopathic arthritis.
In these same studies, children were also more likely than adults to report infusion-related side effects when Actemra was given as an IV infusion. For more information, see “Infusion-related side effects” in the “Managing side effects” section.
Actemra has a boxed warning about the risk of serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
Risk of serious infections
Serious infections, including tuberculosis (TB), have been reported in people using Actemra. In rare cases, these infections have required treatment in a hospital. And in extreme cases, they led to death.
Actemra can increase your risk of infections because the drug works by changing how your immune system works. To be specific, Actemra weakens your immune system. This makes it harder for your body to fight infections.
Other serious infections besides TB that were reported in people who used Actemra include:
- pneumonia
- diverticulitis (a type of inflammation in the large intestine)
- sepsis
- bacterial arthritis (a type of arthritis caused by a bacterial infection in a joint)
Symptoms of a serious infection, such as TB, can include:
What you can do
Your doctor will test you for TB before you start using Actemra. (Note, TB testing is not required for people treated for COVID-19.) If you have TB, they’ll likely treat it before you begin using Actemra. Your doctor will continue to monitor you for TB and other serious infections during treatment with Actemra.
You should tell your doctor right away if you notice symptoms of a serious infection. If you have an infection, they may pause your Actemra doses, especially if it’s a serious infection.
Before beginning treatment with Actemra, be sure to tell your doctor if you have any infections. They’ll likely treat them before prescribing Actemra to you.
While taking Actemra, you may be able to take steps to make side effects easier to manage.
If you have problems with side effects that do not go away or they become worse, talk with your doctor or pharmacist. They can discuss options for managing side effects or other available treatment options.
Infusion-related side effects
If Actemra is given as an IV infusion, related side effects may occur. (With an IV infusion, a drug is injected into a vein over time.)
Infusion-related side effects weren’t common in Actemra’s clinical studies. Children were more likely to have infusion-related side effects than adults. Most cases of these side effects weren’t serious and didn’t require people to stop using the drug.
Infusion-related side effects of Actemra may happen during or shortly after you receive the treatment. These side effects may include:
- flushing
- skin rash or hives
- itchiness
- headache
- changes in blood pressure
- angioedema (severe swelling of the face, lips, mouth, or throat)
What you can do
Actemra IV infusions are given by a healthcare professional in a medical facility. They’ll monitor you for infusion-related side effects. But you should also tell them right away if you experience a reaction during the infusion.
If you develop symptoms of infusion-related side effects after your infusion, talk with your doctor immediately. But you should call 911 or your local emergency number if you think you’re having a medical emergency or your symptoms feel life threatening.
Weight gain
It’s possible to gain weight with Actemra. This side effect was rare in clinical studies of adults using Actemra to treat rheumatoid arthritis (RA). Adults and children using Actemra to treat conditions other than RA didn’t report weight gain as a side effect.
It’s important to keep in mind that weight gain is common in people with RA. This is because symptoms can make it difficult to exercise on a regular basis.
What you can do
While using Actemra, talk with your doctor if you gain weight without trying to or weight gain bothers you. They can suggest ways to help you maintain a moderate weight.
Injection site reactions
If Actemra is given as a subcutaneous injection, injection site reactions can occur. These are reactions that appear at the site where the medication is injected.
Injection site reactions were common in clinical studies. But in most cases, they were temporary and went away on their own. In nearly every case, the reactions were mild or moderate. No one in the studies stopped using Actemra due to serious injection site reactions.
The reactions can include pain, itching, and reddening or discoloration of the skin.
What you can do
To reduce your risk of injection site reactions, rotate the site where you inject Actemra. This means choosing a different site for each dose. You also should not inject the medication into skin that’s bruised, hard, or tender. In addition, avoid injecting Actemra into skin that’s red, discolored, or cut.
If you have injection site reactions that bother you or don’t go away, talk with your doctor. They may recommend trying a different treatment than Actemra.
Increased risk of certain types of cancer
It’s possible that Actemra could increase the risk of certain types of cancer. This side effect was seen in people using the medication in clinical studies.
Actemra weakens your immune system. A weakened immune system is less able to detect abnormal cells or fight infections that can lead to cancer. (Actemra has a boxed warning about risk of serious infections. See the “Boxed warning for Actemra” section for details.)
Symptoms of cancer vary depending on the type of cancer, but some common symptoms include fatigue and unexplained weight loss.
What you can do
Before you begin treatment with Actemra, tell your doctor if you have cancer or have had it in the past. Talk with them right away if you notice any symptoms of cancer during your Actemra treatment. Your doctor will investigate your symptoms. This may include ordering lab tests.
Actemra may cause several side effects. Here are some frequently asked questions about the drug’s side effects, as well as their answers.
No. People using Actemra in clinical studies didn’t report hair loss.
Other medications used to treat the same conditions that Actemra treats can cause hair loss as a side effect. For example, some biologics and disease-modifying antirheumatic drugs (DMARDs) are used for rheumatoid arthritis (RA) and can cause hair loss.
It’s also important to note that some of the conditions that Actemra is prescribed to treat can cause hair loss. These conditions include RA, polyarticular juvenile idiopathic arthritis (JIA), and systemic JIA.
These are examples of autoimmune diseases, which occur when your immune system attacks your own body by mistake. In some people, hair follicles may be affected, which can lead to hair loss. (Hair follicles are sacs beneath your skin that hold the roots of your hair).
If you’re concerned about hair loss, talk with your doctor. They may be able to suggest ways to help prevent or treat it.
Withdrawal symptoms weren’t reported in clinical studies when people stopped using Actemra.
Keep in mind that if you stop Actemra treatment, symptoms of the condition you’re using the medication for may return. This shouldn’t be confused with withdrawal symptoms.
It’s important that you don’t stop using Actemra unless you first speak with your doctor. They can help find an alternative treatment for your condition, which may help prevent symptoms of your condition from coming back.
The manufacturer of Actemra publishes reviews from people who have used the drug, and you may view these here. It’s important to keep in mind that each person’s body responds differently to medications. Someone else’s experience may not predict how your body will respond to a drug.
Talk with your doctor to help you decide whether Actemra is a good treatment choice for you. They can create a treatment plan that’s based on your unique health history and the current scientific evidence.
Take note of the following important information to consider before taking Actemra.
Actemra has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warning for Actemra” section.
Other precautions
Before taking Actemra, discuss your health history with your doctor. Actemra may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:
- active infection
- tuberculosis (TB)
- hepatitis B
- liver problems
- stomach or intestine ulcers
- multiple sclerosis (MS) and other nervous system conditions
- upcoming vaccinations
- previous allergic reaction to this or a similar drug
- pregnancy
- breastfeeding
- alcohol consumption
Side effects of Actemra can occur, but they’re usually mild. Most mild side effects of the drug go away with time and don’t require medical attention.
Talk with your doctor if you develop symptoms of an infection while using Actemra. You should also talk with them if you become pregnant during your Actemra treatment.
If you’d like to learn more about Actemra, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of the drug.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
