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Actemra

Generic Name: tocilizumab (TOE si LIZ oo mab)
Brand Names: Actemra

Medically reviewed on May 15, 2018

What is Actemra?

See also: Orencia

Actemra (tocilizumab) reduces the effects of a substance in the body that can cause inflammation.

Actemra is used to treat moderate to severe rheumatoid arthritis in adults. It is sometimes given together with other arthritis medicines.

Actemra is used to treat systemic juvenile idiopathic arthritis (or "Still disease") in children who are at least 2 years old. It is sometimes given together with methotrexate (Rheumatrex, Trexall).

Actemra is also used in adults to treat giant cell arteritis, or inflammation of the lining of your arteries (blood vessels that carry blood from your heart to other parts of your body).

Actemra is also used to treat severe or life-threatening cytokine release syndrome (CRS) caused by an overactive immune response to certain types of blood cell treatments for cancer. It is used for CRS in adults and children ages 2 and older.

Tocilizumab is usually given after other medications have been tried without successful treatment of symptoms.

Important Information

Actemra affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

Actemra may also cause a perforation (a hole or tear) in your stomach or intestines. Tell your doctor if you have a fever and stomach pain with a change in your bowel habits.

Before you start treatment with Actemra, your doctor may perform tests to make sure you do not have tuberculosis or other infections. While using Actemra, you may need frequent medical tests.

Before taking this medicine

You should not use Actemra if you are allergic to tocilizumab.

Tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common (Ohio River Valley, Mississippi River Valley, and the Southwest).

Tell your doctor if you have ever had:

Actemra may cause certain types of cancer. Ask your doctor about this risk.

It is not known whether Actemra will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tocilizumab on the baby.

You should not breast-feed while using Actemra.

How is Actemra given?

Actemra is given as an infusion into a vein. A healthcare provider will give you this type of injection.

Actemra is sometimes injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Actemra.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Actemra if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Actemra is usually given every 1 to 4 weeks. Follow your doctor's instructions.

Use all your medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

Actemra affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

If you've ever had hepatitis B, using tocilizumab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

Store the Actemra prefilled syringes in their original container in a refrigerator. Protect from moisture and light. Do not freeze. Throw away any prefilled syringes not used before the expiration date on the medicine label.

Each Actemra single-use prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Actemra can have long-lasting effects on your body. You may need certain medical tests every 6 months after you stop using this medication.

Actemra dosing information

Usual Adult Dose of Actemra for Rheumatoid Arthritis:

This drug may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs as an IV infusion or as a subcutaneous injection.

RECOMMENDED IV DOSAGE REGIMEN: 4 mg/kg IV given once every 4 weeks as a 60 minute single drip infusion, followed by an increase to 8 mg/kg IV given once every 4 weeks as a 60 minute single drip infusion based on clinical response
Maximum dose: 800 mg per infusion in RA patients

RECOMMENDED SUBCUTANEOUS DOSAGE REGIMEN:
-Patients less than 100 kg: 162 mg subcutaneously every other week, followed by an increase to every week based on clinical response
-Patients 100 kg or greater: 162 mg subcutaneously every week

Comments:
-This drug should not be administered as an IV push or bolus.
-When transitioning from IV to subcutaneous therapy, give the first subcutaneous dose instead of the next scheduled IV dose.
-This drug should not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).

Use: For adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Usual Pediatric Dose of Actemra for Juvenile Idiopathic Arthritis:

This drug may be used as monotherapy or concomitantly with methotrexate:
POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS:
2 years or older:
-Weight less than 30 kg: 10 mg/kg IV given once every 4 weeks as a 60 minute single drip infusion
-Weight 30 kg or more: 8 mg/kg given once every 4 weeks as a 60 minute single drip infusion

This drug may be used as monotherapy or concomitantly with methotrexate:
SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS:
2 years or older:
-Weight less than 30 kg: 12 mg/kg IV given once every 2 weeks as a 60 minute single drip infusion
-Weight 30 kg or more: 8 mg/kg IV given once every 2 weeks as a 60 minute single drip infusion

Comments:
-The weight of the patient may fluctuate; therefore, a dose adjustment should not be based on a single visit body weight measurement.
-This drug may be used as monotherapy or in combination with methotrexate.
-Not recommended for use in children less than 2 years of age.
-This drug should not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).

Uses:
-Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA)
-Patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Actemra?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using tocilizumab. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Actemra side effects

Get emergency medical help if you have signs of an allergic reaction to Actemra: hives; chest pain, difficulty breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach cramps, bloating, diarrhea or constipation;

  • unusual bleeding - nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems - loss of appetite, stomach pain, vomiting, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • signs of infection - fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, burning when you urinate; or

  • signs of perforation (a hole or tear) in your stomach or intestines - fever, ongoing stomach pain, change in bowel habits.

Common Actemra side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Actemra?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

This list is not complete and many other drugs may interact with tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Actemra only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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