Side Effects, Cost, Dosage and More

Like most medicines, Actemra can cause mild to severe side effects. The lists below describe some of the more common side effects Actemra can cause. These lists do not include all possible side effects.

Keep in mind that the side effects of a medicine can depend on:

• your age
• other health problems you have
• other medicines you are taking

Your doctor or pharmacist can tell you more about the potential side effects of Actemra. They can also suggest ways to help reduce side effects.

Mild side effects

Here is a short list of some of the mild side effects that Actemra can cause. For more information about other mild side effects, talk to your doctor or pharmacist, or read the Actemra package leaflet. prescribing information.

Mild side effects of Actemra that have been reported include:

Mild side effects of many medications can disappear within days to weeks. But if they become bothersome, talk to your doctor or pharmacist.

Serious side effects

Serious side effects from Actemra can occur, but they are not common. If you have serious side effects from Actemra, call your doctor right away. But if you think you have a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Actemra that have been reported include:

*For more information on this side effect, see the “Side Effects Focus” section below.

Focus on side effects

Learn more about some of the side effects Actemra can cause.

Framed warning

Actemra has a framed warning for the risk of serious infections. A boxed warning is a serious warning from the Food and Drug Administration (FDA). Actemra’s boxed warning is described below.

Actemra can weaken your immune system. For this reason, the drug may increase your risk of developing an infection. Although most infections are mild, it is possible to develop a serious infection during your treatment with Actemra. In rare cases, infections may require treatment in hospital and may even be life threatening.

In studies, people receiving Actemra who developed a serious infection were usually also taking other medicines that weakened their immune system. Examples of these drugs include methotrexate (Trexall) or steroid medications such as prednisone (Rayos).

The following are examples of infections that can occur:

Symptoms of an infection can vary, but can include:

* Actemra can reactivate tuberculosis (cause symptoms of tuberculosis) if you have had the disease before.

What might help

Before starting treatment with Actemra, your doctor will probably check you for infections. This includes testing for tuberculosis. If you have an infection, your doctor will probably recommend that you treat your infections before starting treatment with Actemra.

During your treatment, it is important that you tell your doctor straight away if you develop any symptoms of infection. Treating an infection as soon as possible can help prevent it from getting worse.

Be sure to tell your doctor if you have had any infections that keep coming back, if you have had tuberculosis, or if you have any other conditions that may increase your risk of infection. Your doctor can determine if Actemra may be a safe treatment option for you.

If you develop an infection during your treatment, your doctor will likely interrupt your treatment until the infection has cleared up.

Side effects of injection or infusion

Actemra can be given by injection under the skin or by intravenous (IV) infusion. (An intravenous infusion is an injection into your vein given over time.) Some people may experience side effects at the injection site. People receiving the drug by IV infusion may have side effects during or shortly after their infusion.

In studies, these side effects were common in people receiving Actemra by subcutaneous injection. In comparison, infusion-related side effects were less common.

The following are examples of injection or infusion side effects that may occur:

• redness or discoloration
• itch
• pain
• swelling

Additionally, side effects of the infusion may also include:

• blood pressure changes
• headache
• dizziness
• nausea
• diarrhea

What might help

If you experience injection side effects while taking Actemra, talk to your doctor or pharmacist. They may be able to recommend over-the-counter medications to manage your symptoms. For example, they may recommend acetaminophen (Tylenol) or diphenhydramine (Benadryl) to help prevent side effects from the injection.

During your Actemra infusion, you will likely be monitored for side effects from the infusion. But keep in mind that side effects can occur up to 24 hours after you finish your infusion. It is important to tell your doctor if you experience any side effects after your infusion.

Weight gain or weight loss

Actemra can cause weight changes in some people. In studiesweight gain has been reported in people receiving Actemra for rheumatoid arthritis (RA), but this was not a common side effect.

In studies, no weight gain was reported in people receiving Actemra for other conditions. It is therefore not known whether weight gain may occur if you use Actemra for a condition other than rheumatoid arthritis.

No weight loss has been reported in studies of people taking Actemra. But weight loss can be a symptom of a serious infection. Actemra can increase your risk of developing serious infections, so tell your doctor straight away if you notice any unexplained weight loss.

What might help

If you notice weight changes during your treatment with Actemra that cause you concern, talk to your doctor. They can determine what may be causing these changes. If you are losing weight, your doctor may check for other symptoms of infection.

Allergic reaction

Some people may have an allergic reaction to Actemra.

Symptoms of a mild allergic reaction may include:

• itchy skin
• itching
• rinsing (temporary warmth, redness or deepening of skin color)

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under the skin, usually on the eyelids, lips, hands or feet. They can also include swelling of the tongue, mouth, or throat, which can lead to difficulty breathing.

Call your doctor right away if you have an allergic reaction to Actemra. But if you think you have a medical emergency, call 911 or your local emergency number.