Class: Biologic Therapy

Generic Name: tocilizumab

Trade Name: Actemra®

How is this drug used? Actemra is approved for adults with moderate to severe rheumatoid arthritis (RA) when one or more other Disease Modifying Anti-Rheumatic Drugs (DMARDs) have not worked, and for patients with polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA).

What is the mechanism of action? Actemra is an antibody that works by blocking the inflammatory effects of a protein called tumor necrosis factor alpha (TNFα) in RA and other conditions associated with inflammation. The body produces TNFα when there is inflammation.

How is Actemra given (administered)? Actemra is administered either by IV infusion or subcutaneous injection. IV infusion is administered approximately every four weeks by your doctor, which usually takes about an hour. If Actemra is administered by subcutaneous injection at home either by you or a caregiver, your healthcare provider will prescribe you dosage and scheduling regimens.

How are patients monitored? Patients should have complete blood counts (CBC), including platelet counts, before treatment with Actemra, then four to eight weeks after starting treatment, then every three months thereafter. Also, patients will be monitored for signs and symptoms of tuberculosis (TB) before and during treatment.

What are the most common side effects of treatment with Actemra?

• Injection site reactions
• Upper respiratory tract infections
• Headache
• Increased blood pressure

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

Are there any special precautions patients should be aware of before starting treatment?

• Do not use Actemra if you are allergic to tocilizumab or any of the ingredients in Actemra.
• Actemra may lower your ability to fight infections. It is not known if treatment with medicines that cause immunosuppression, like Actemra, affect your risk of getting cancer.
• Tears (perforations) may occur in the stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
• Actemra may cause you to have a lower number of certain white blood cells that help fight infection. Death has occurred in certain cases from these infections. Be sure to keep scheduled appointments for blood tests.

What should patients tell their healthcare provider before using Actemra?

Before using Actemra, tell your healthcare provider if you:

• Have an infection, a history of infections that keep coming back, or other problems that can increase your risk of infections.
• Have diabetes, HIV, or a weak immune system.
• Have TB, or have been in close contact with someone who has TB.
• Have liver problems.
• Have lived in certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of developing certain types of fungal infections.
• Have had any stomach-area pain or have been diagnosed with diverticulitis or ulcers in your stomach or intestines.
• Have had any type of cancer.
• Have had a reaction to tocilizumab or any of the ingredients of Actemra before.
• Have had a condition that affects your nervous system such as Multiple Sclerosis (MS).
• Plan to have surgery or a medical procedure.
• Are scheduled to receive any vaccines. People using Actemra should not receive live vaccines.
• Are pregnant or plan to become pregnant. It is not known if Actemra will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if Actemra passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines and all herbal supplements as Actemra and other medicines may affect each other and cause serious side effects. Especially tell your doctor if you:

• Take any other medicines to treat your RA. Taking these medicines may increase your risk for infection.

When should patients notify their physician?

Contact your healthcare professional immediately if you have signs of any of the following:

• Serious infection: Fever, chills; unusual tiredness; warm, red, or painful skin; or open sores on your body.
• Allergic reaction: Swelling of face, lips, mouth or tongue; trouble breathing; wheezing; severe itching; dizziness or fainting; hives or rash; fast heartbeat or pounding in your chest; sweating.
• Tears (perforations) of the stomach or intestines: Stomach pain, abdominal pain, fever, change in bowel habits.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 01/17.

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