Actemra ACTPen is used in adults to treat:

• moderate to severe rheumatoid arthritis after at least one other medicine has been used and did not work;

• giant cell arteritis, (inflammation in the lining of the blood vessels that carry blood from your heart to other parts of your body);

• to slow the decline in lung function caused by scleroderma with interstitial lung disease; and

• coronavirus disease 2019 (COVID-19) in hospitalized people who receive steroid medicine and require supplemental oxygen, a ventilator, or ECMO (a heart-lung machine that helps increase oxygen in the blood).

Actemra ACTPen is used in adults and children 2 years and older to treat:

• polyarticular or systemic juvenile idiopathic arthritis ("Still disease"); and

• severe cytokine release syndrome (CRS, an overactive immune response to certain blood cell treatments for cancer).

The US Food and Drug Administration (FDA) has authorized emergency use of tocilizumab with steroid medicine to treat children at least 2 years old who are hospitalized with COVID-19 and using supplemental oxygen, a ventilator, or ECMO (a heart-lung machine that helps increase oxygen in the blood).

Actemra ACTPen may also be used for purposes not listed in this medication guide.

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

Actemra ACTPen 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.

Actemra ACTPen may also cause liver problems. Tell your doctor right away if you have right-sided stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Before you use Actemra ACTPen, your doctor may test you for tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Actemra ACTPen is injected under the skin or into a vein. Actemra ACTPen is usually given every 1 to 4 weeks for most conditions. For CRS, only one dose is usually given.

When injected into a vein, this medicine is given slowly for about 1 hour.

Read and carefully follow any Instructions for Use provided with the medicine. Ask your doctor or pharmacist if you don't understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Your healthcare provider will show you where to inject Actemra ACTPen. Do not inject into the same place two times in a row.

Do not reuse a needle, syringe, or autoinjector. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

If you've had hepatitis B, it may come back or get worse. You may need liver function tests while using this medicine and for several months after you stop.

Tell your doctor if you have a planned surgery.

Use all your medications as directed. Do not change your dose or stop using a medicine without your doctor's advice.

Store this medicine in the original carton 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.

After removed from the refrigerator, the prefilled syringe and autoinjector can be stored up to 2 weeks at or below 86 F (30 C). Throw away the prefilled syringe or autoinjector after one use, even if there is still medicine left inside.

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

You should not use Actemra ACTPen if you are allergic to it.

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've had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

• an active or chronic infection;

• liver disease;

• diverticulitis, ulcers in your stomach or intestines;

• a nerve-muscle disease such as multiple sclerosis;

• diabetes;

• HIV, or a weak immune system;

• hepatitis B (or if you are a carrier of the virus);

• cancer; or

• if you have received or are scheduled to receive any vaccines.

Using Actemra ACTPen may increase your risk of developing other cancers. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

Tell your baby's doctor if you used Actemra ACTPen during pregnancy. It could affect your baby's vaccination schedule during the first months of life. Your name may be listed on a pregnancy registry to track the effects of tocilizumab on the baby.

Call your doctor for instructions if you miss a dose.

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

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

You may still be able to receive a yearly flu shot, or an "inactivated" or other vaccine to prevent diseases such as hepatitis, meningitis, pneumonia, shingles, HPV, or whooping cough. Ask your doctor before getting any vaccine.

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

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

Actemra ACTPen may cause serious side effects. 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, right-sided stomach pain, vomiting, confusion, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of infection--fever, chills, aches, skin sores, diarrhea, burning when you urinate;

• signs of tuberculosis: cough, shortness of breath, night sweats, loss of appetite, weight loss, and feeling very tired; or

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

Common side effects of Actemra ACTPen may include:

• runny or stuffy nose, sinus pain, sore throat;

• headache;

• increased blood pressure;

• abnormal liver function tests; or

• pain, swelling, burning, or irritation where an injection was given.

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.

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 other medicines to treat rheumatoid arthritis, such as:

• abatacept, etanercept;

• anakinra; or

• adalimumab, certolizumab, golimumab, infliximab, or rituximab.

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