Actemra

Actemra is a prescription medication used to treat rheumatoid arthritis (RA) in adults. It is used to treat systemic juvenile idiopathic arthritis (SJIA) or polyarticular juvenile idiopathic arthritis (PJIA) in children 2 years or older. This medication is also used to treat giant cell arteritis, inflammation of the lining of the arteries. In addition, Actemra is used to treat chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS). 

Actemra is referred to as an interleukin-6, or IL-6, receptor inhibitor. IL-6 is a molecule produced by the body that binds to the IL-6 receptor and causes inflammation. Patients with arthritis have increased levels of IL-6 in their body. By blocking the IL-6 receptor, Actemra can decrease the symptoms of arthritis.

Actemra comes in an injectable form to be given directly into a vein (IV) or under the skin by a healthcare provider, depending on the condition being treated. 

It is usually given once every 4 weeks for RA and PJIA, every 2 weeks for SJIA and once every week for giant cell arteritis. For CRS, Actemra is given as one dose and can be repeated up to 3 additional doses 8 hours apart. 

Common side effects of Actemra are cold-like symptoms, increased blood pressure, and headache. 

Actemra is a prescription medicine used to treat: 

• Adults with moderate to severe rheumatoid arthritis (RA) after at least one other medicine called Disease Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well.
• People with active polyarticular juvenile idiopathic arthritis (PJIA) ages 2 and above.
• People with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above.
• Adults with giant cell arteritis. 
• Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genentech, Inc.

Actemra can cause serious side effects. See "Drug Precautions" for some serious side effects of Actemra.

• feel very tired
• chills
• skin or eyes look yellow
• stomach discomfort
• little or no appetite
• muscle aches
• vomiting
• dark urine
• clay-colored bowel movements
• skin rash 
• fevers

Tell your doctor about all of the medicines you take, including prescription and non­-prescription medicines, vitamins and herbal supplements. Actemra and other medicines may affect each other causing side effects. Especially tell your doctor if you take:

• any other medicines to treat Rheumatoid Arthritis 
• etanercept (Enbrei)
• adalimumab (Humira) 
• infliximab (Remicade) 
• rituximab (Rituxan)
• abatacept (Orencia) 
• anakinra (Kineret)
• certolizumab (Cimzia)
• golimumab (Simponi)

Taking Actemra with these medicines may increase your risk of infection.

This is not a complete list of Actemra drug interactions. Ask your doctor or pharmacist for more information.

Actemra can cause serious infections by lowering the ability of your immune system to fight infections including tuberculosis (TB), as well as others. These are serious infections that may cause death. 

• Your doctor should test you for TB before starting Actemra as well as monitor you closely for signs and symptoms of TB during treatment with Actemra.

• fever, sweating, or chills
• warm, red, or painful skin or sores
• muscle aches on your body
• cough
• diarrhea or stomach pain
• shortness of  breath
• burning when you urinate or urinating more often than normal
• blood in phlegm
• weight loss
• feel very tired

Before starting Actemra, tell your doctor if you:

• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance of infections.
• have TB, or have been in close contact with someone with TB
• live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance of getting certain kinds of fungal infections (histoplasmosis, coccidiomycosis, or blastomycosis). These infections may happen or become more severe if you use Actemra. Ask your doctor, if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B.

• Before taking Actemra, tell your doctor if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking Actemra get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
• Tell your doctor right away if you have a fever and stomach-area pain that does not go away, and a change in your bowel habits. 

• low neutrophil count. Neutrophils are white blood cells that help the body fight off bacterial infections.
• low platelet count. Platelets are blood cells that help with blood clotting and stop bleeding.
• increase in certain liver function tests.

You should not receive Actemra if your neutrophil or platelet counts are too low or your liver function tests are too high. Your doctor may stop your Actemra treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Actemra, there are no specific foods that you must exclude from your diet when receiving Actemra.

Before receiving Actemra, tell your doctor about all of your medical conditions including if you:

• are allergic to Actemra or to any of its ingredients
• have an infection
• have liver problems
• have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your 
  stomach or intestines 
• have had a reaction to Actemra or any of the ingredients in Actemra
• have or had a condition that affects your nervous system, such as multiple sclerosis
• have recently received or are scheduled to receive a vaccine. People who take Actemra should not receive live vaccines. 
• plan to have surgery or a medical procedure
• have any other medical conditions
• are pregnant
• are breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. It is not known if Actemra will harm your unborn baby. 

Tell your doctor if you plan to breastfeed or are breastfeeding.

It is not known if Actemra is excreted in human breast milk. You and your doctor should decide if you will take Actemra or breastfeed. You should not do both.

You will receive Actemra from a healthcare provider through a needle placed in a vein in your arm (IV or intravenous infusion). The infusion will take about 1 hour to give you the full dose of medicine.

This medication is also injected under the skin for giant cell arteritis. 

Your doctor will determine your Actemra dose based on your weight. The recommended dose of Actemra is 4-8 mg/kg administered as a single 60 minute intravenous (into a vein) infusion every 4 weeks for treating RA or PJIA.

For SJIA, you will receive a dose of Actemra about every 2 weeks.

For giant cell arteritis, you will receive a dose of Actemra (162mg) once every week. In some cases, some will receive Actemra once every other week.

For CRS, you will receive one dose of Actemra, which can be repeated up to 3 additional doses 8 hours apart. The usually dosage for patients weighing less than 30 kg is 12 mg/kg and for patients weighing at or above 30 kg is 8 mg/kg given as a 60-minute intravenous (into a vein) infusion. 

Actemra is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if an overdose is suspected, seek emergency medical attention.

It is important you keep all of your medical and laboratory appointments while receiving Actemra. Call your doctor for instructions if you miss an appointment for your Actemra injection.

WARNING: RISK OF SERIOUS INFECTIONS

Patients treated with Actemra are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt Actemra until the infection is controlled.

Reported infections include:

• Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before Actemra use and during therapy. Treatment for latent infection should be initiated prior to Actemra use.
• Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
• Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with Actemra should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Actemra, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.