Actemra

Generic name: Tocilizumab
Dosage form: intravenous (infusion) injection, subcutaneous injection
Drug class: Interleukin inhibitors

Usage of Actemra

Actemra (tocilizumab) is a FDA approved biological medicine that is given by intravenous infusion or injection under the skin to treat specific patients with COVID-19, rheumatoid arthritis, giant cell arteritis, scleroderma, polyarticular or systemic juvenile idiopathic arthritis, and severe cytokine release syndrome.

Actrema was FDA approved to treat COVID-19 on December 21, 2022, for specific adult patients. Pediatric patients (aged 2 years to 18 years) with COVID-19 still have access to Actrema under emergency use authorization (EUA).

Actrema is a monoclonal antibody that blocks a protein in your body called interleukin-6 (IL-6).  If this protein is activated, it causes your immune system to be overactive which results in inflammation and the signs and symptoms of autoimmune disease. As Actrema blocks the interleukin-6 receptor, this is how it is thought to reduce the immune system from being overactive, so there is less inflammation and a reduction in the signs and symptoms of autoimmune diseases.

At a more technical level the mode of action (MOA) of Actrema is that it binds to IL-6 receptors (sIL-6R and mIL-6R) which have been shown to inhibit IL-6-mediated signaling through these receptors. Interleukin-6 is a pro-inflammatory cytokine that is made by a variety of cell types including T- and B-cells, lymphocytes, monocytes and fibroblasts.

Actemra can be used with other medications as part your complete treatment.

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, 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 Actemra side effects 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.

    Before taking Actemra

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

    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.

    To make sure Actemra is safe for you, tell your doctor if you have:

  • 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 may increase your risk of developing certain types of cancer. Ask your doctor about this risk.

    Tell your doctor if you are pregnant or breastfeeding.

    If you are pregnant: Tell your baby's doctor if you used Actemra 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.

    Relate drugs

    How to use Actemra

    Usual Adult Dose of Actemra for Rheumatoid Arthritis:

    IV: 4 mg/kg IV as a 60-minute single drip infusion once every 4 weeks, 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, doses exceeding 800 mg per infusion are not recommended SUBCUTANEOUS: -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 may be used as monotherapy or concomitantly with methotrexate or other non-biologic DMARDs. -When transitioning from IV to subcutaneous, give the first subcutaneous dose instead of the next IV dose. Use: For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

    Usual Adult Dose of Actemra for Giant Cell Arteritis:

    SUBCUTANEOUS: -In combination with a tapering course of glucocorticoids, 162 mg subcutaneously once a week -Based on clinical considerations, 162 mg subcutaneously once every other week in combination with a tapering course of glucocorticoids may be prescribed Comments: -This drug may be used alone following discontinuation of glucocorticoids. Use: For the treatment of giant cell arteritis (GCA) in adult patients

    Usual Adult Dose for Cytokine-Associated Toxicity:

    IV: -Weight less than 30 kg: 12 mg/kg IV over 60 minutes -Weight 30 kg or above: 8 mg/kg IV over 60 minutes Comments: -Doses exceeding 800 mg per infusion are not recommended. -If no clinical improvement occurs after the first dose, up to 3 additional doses may be administered. -The interval between consecutive doses should be at least 8 hours. -This drug may be used alone or in combination with corticosteroids. -Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS. -Subcutaneous route not approved for CRS. Use: For the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older

    Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

    Polyarticular Juvenile Idiopathic Arthritis (PJIA): IV formulation: 2 years or older -Weight less than 30 kg: 10 mg/kg IV over 60 minutes every 4 weeks -Weight 30 kg or more: 8 mg/kg IV over 60 minutes every 4 weeks SUBCUTANEOUS formulation: -Weight less than 30 kg: 162 mg once every 3 weeks -Weight 30 kg or more: 162 mg once every 2 weeks Systemic Juvenile Idiopathic Arthritis (SJIA): IV formulation: 2 years or older: -Weight less than 30 kg: 12 mg/kg IV over 60 minutes every 2 weeks -Weight 30 kg or more: 8 mg/kg IV over 60 minutes every 2 weeks SUBCUTANEOUS formulation: -Weight less than 30 kg: 162 mg subcutaneously once every 2 weeks -Weight 30 kg or more: 162 mg subcutaneously once a week Comments: -This drug may be used as monotherapy or concomitantly with methotrexate. -Weight may fluctuate; therefore, dose adjustments should not be based on a single weight measurement. -When transitioning from IV to subcutaneous, administer the first subcutaneous dose instead of the next IV dose. Uses: -For the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older -For the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older

    Usual Pediatric Dose for Cytokine-Associated Toxicity:

    IV: -Weight less than 30 kg: 12 mg/kg IV over 60 minutes -Weight 30 kg or above: 8 mg/kg IV over 60 minutes Comments: -Doses exceeding 800 mg per infusion are not recommended. -If no clinical improvement occurs after the first dose, up to 3 additional doses may be administered. -The interval between consecutive doses should be at least 8 hours. -This drug may be used alone or in combination with corticosteroids. -Patients with severe or life-threatening CRS frequently have cytopenias or elevated ALT or AST due to the underlying malignancy, preceding lymphodepleting chemotherapy or the CRS. -Subcutaneous route not approved for CRS. Use: For the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older

    For dosage information on Systemic Sclerosis-Associated Interstitial Lung Disease and Polyarticular Juvenile Idiopathic Arthritis click on the dosage link below.

    For more detailed dosage information other conditions click on the link below.

    Warnings

    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.

    Actemra 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 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.

    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 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 interact with tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Popular FAQ

    Most people take Actemra for up to 1 year to treat Giant cell arteritis (GCA), although the exact length of time you will take it for depends on how well you tolerate any side effects of Actemra, if it works for you, and how long it continues to work for. Actemra will work within 3 to 6 months, if it is going to work at all, although some people may experience some symptom relief as early as 2 weeks after starting treatment. Actemra is given by subcutaneous injection once every 1 to 2 weeks.

    Actemra stays in your system for a very long time, up to 3.5 months or 107 days. This is calculated by using the half-life of Actemra (also called the t1/2), which is the time it takes for 50% of a medicine to leave the body. The t1/2 for Actemra is 21.5 days. Experts have determined that it takes 4 to 5 half-lives for a medicine to be completely eliminated by the body, which works out to be 86 to 107 days (2.9 to 3.5 months) for Actemra.

    Actemra infusion may be used to treat several different conditions that have inflammation as a common characteristic, such as: Rheumatoid Arthritis Giant Cell Arteritis Systemic Sclerosis-Associated Interstitial Lung Disease Polyarticular Juvenile Idiopathic Arthritis Systemic Juvenile Idiopathic Arthritis Cytokine Release Syndrome COVID-19 in hospitalized adults who are receiving corticosteroids plus supplemental oxygen, on non-invasive or invasive mechanical ventilation, or receiving extracorporeal membrane oxygenation (ECMO).

    Yes, Actemra (tocilizumab) can cause a small amount of weight gain; in one trial, the amount of weight gained ranged from 0kg to 2kg over 24 to 72 weeks. Experts are unsure why Actemra causes people to gain weight, but this same study reported that the leptin–adiponectin ratio and levels of adiponectin, leptin, and resistin increased significantly after 24 weeks of tocilizumab treatment. Increased levels of pro-inflammatory adipokines such as interleukin (IL)-1β, IL-6, TNFα, and leptin, and decreased levels of anti-inflammatory adipokines, such as adiponectin, in obesity produce a chronic state of low-grade inflammation which promotes the development of insulin resistance and type-2 diabetes, hypertension, atherosclerosis, and other cardiovascular diseases, and some types of cancer.

    If you’re prescribed antibiotics, speak to your rheumatology team or doctor right away and cancel your Actemra infusion or stop using your prefilled ACTPen autoinjector until you have finished the antibiotics and your infection has cleared up. People treated with Actemra are more likely to develop serious infections than people not prescribed Actemra, and these infections are more likely to result in hospitalization, and in some cases, death. You are at an even higher risk if you are also taking other immunosuppressants such as methotrexate or corticosteroids.

    Acetmra is not a TNF inhibitor it is an interleukin inhibitor. Actemra works by binding to interleukin-6 (IL-6) receptors. Interleukin 6 is considered one of the most important cytokines – these are signaling molecules that aid cell to cell communication during an immune response and stimulate the movement of cells towards sites of inflammation, infection, or trauma. IL-6 is also produced by synovial and endothelial cells within a joint. By binding to IL-6 receptors, Actemra decreases inflammation in conditions such as rheumatoid arthritis. TNF inhibitors block the activity of a different, but equally as important, cytokine, called tumor necrosis factor-alpha (TNF-alpha). IL-6 and TNF-alpha are the main factors responsible for the induction of inflammatory proteins such as C-reactive protein and the inflammatory state. Interleukin-6, TNF-alpha, and also interleukin-1 are known as proinflammatory cytokines and are elevated in most, if not all inflammatory states.

    Before receiving Actemra, let your health care provider know if you have any of the following: An infection or symptoms of an infection, such as a fever, sweating or chills, shortness of breath, a rash or sores, fatigue, muscle aches, diarrhea, nausea or vomiting, a cough, or pain when urinating Diabetes, HIV, hepatitis B, or a weak immune system Tuberculosis (TB) Have lived in or recently traveled to certain parts of the U.S (such as the Ohio and Mississippi River valleys and the Southwest) where there is a higher risk of certain fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis Diverticulitis, ulcers, or tears (perforations) of your stomach or intestines Liver problems or symptoms that may suggest liver problems, such as yellowing of your skin or the whites of your eyes (jaundice), appetite loss, abdominal swelling and pain on the right side of your stomach area, light-colored stools, or dark "tea-colored" urine Cancer of any type Multiple sclerosis or any other condition that affects your nervous system. Also, let your doctor know if: You have recently received or are scheduled to receive a vaccine Recent laboratory tests detected low neutrophils, low platelets, or your liver function results were high You plan to have surgery or a medical procedure You are pregnant or plan to become pregnant or are breastfeeding You take any other medications, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Continue reading

    Actemra does not directly target the SARS-COV-2 virus (the virus that causes COVID-19), rather it reduces inflammation by blocking the interleukin-6 receptor, which is on interleukin-6, one of the main proinflammatory cytokines (these are cell-to-cell signaling proteins that stimulate an immune response). In some cases of COVID-19 infection, the immune system can become hyperactive, which may result in worsening disease. Continue reading

    Most people take Actemra for up to 1 year to treat Giant cell arteritis (GCA), although the exact length of time you will take it for depends on how well you tolerate any side effects of Actemra, if it works for you, and how long it continues to work for. Actemra will work within 3 to 6 months, if it is going to work at all, although some people may experience some symptom relief as early as 2 weeks after starting treatment. Actemra is given by subcutaneous injection once every 1 to 2 weeks.

    Actemra stays in your system for a very long time, up to 3.5 months or 107 days. This is calculated by using the half-life of Actemra (also called the t1/2), which is the time it takes for 50% of a medicine to leave the body. The t1/2 for Actemra is 21.5 days. Experts have determined that it takes 4 to 5 half-lives for a medicine to be completely eliminated by the body, which works out to be 86 to 107 days (2.9 to 3.5 months) for Actemra.

    Actemra infusion may be used to treat several different conditions that have inflammation as a common characteristic, such as: Rheumatoid Arthritis Giant Cell Arteritis Systemic Sclerosis-Associated Interstitial Lung Disease Polyarticular Juvenile Idiopathic Arthritis Systemic Juvenile Idiopathic Arthritis Cytokine Release Syndrome COVID-19 in hospitalized adults who are receiving corticosteroids plus supplemental oxygen, on non-invasive or invasive mechanical ventilation, or receiving extracorporeal membrane oxygenation (ECMO).

    If you’re prescribed antibiotics, speak to your rheumatology team or doctor right away and cancel your Actemra infusion or stop using your prefilled ACTPen autoinjector until you have finished the antibiotics and your infection has cleared up. People treated with Actemra are more likely to develop serious infections than people not prescribed Actemra, and these infections are more likely to result in hospitalization, and in some cases, death. You are at an even higher risk if you are also taking other immunosuppressants such as methotrexate or corticosteroids.

    Yes, Actemra (tocilizumab) can cause a small amount of weight gain; in one trial, the amount of weight gained ranged from 0kg to 2kg over 24 to 72 weeks. Experts are unsure why Actemra causes people to gain weight, but this same study reported that the leptin–adiponectin ratio and levels of adiponectin, leptin, and resistin increased significantly after 24 weeks of tocilizumab treatment. Increased levels of pro-inflammatory adipokines such as interleukin (IL)-1β, IL-6, TNFα, and leptin, and decreased levels of anti-inflammatory adipokines, such as adiponectin, in obesity produce a chronic state of low-grade inflammation which promotes the development of insulin resistance and type-2 diabetes, hypertension, atherosclerosis, and other cardiovascular diseases, and some types of cancer.

    Acetmra is not a TNF inhibitor it is an interleukin inhibitor. Actemra works by binding to interleukin-6 (IL-6) receptors. Interleukin 6 is considered one of the most important cytokines – these are signaling molecules that aid cell to cell communication during an immune response and stimulate the movement of cells towards sites of inflammation, infection, or trauma. IL-6 is also produced by synovial and endothelial cells within a joint. By binding to IL-6 receptors, Actemra decreases inflammation in conditions such as rheumatoid arthritis. TNF inhibitors block the activity of a different, but equally as important, cytokine, called tumor necrosis factor-alpha (TNF-alpha). IL-6 and TNF-alpha are the main factors responsible for the induction of inflammatory proteins such as C-reactive protein and the inflammatory state. Interleukin-6, TNF-alpha, and also interleukin-1 are known as proinflammatory cytokines and are elevated in most, if not all inflammatory states.

    Before receiving Actemra, let your health care provider know if you have any of the following: An infection or symptoms of an infection, such as a fever, sweating or chills, shortness of breath, a rash or sores, fatigue, muscle aches, diarrhea, nausea or vomiting, a cough, or pain when urinating Diabetes, HIV, hepatitis B, or a weak immune system Tuberculosis (TB) Have lived in or recently traveled to certain parts of the U.S (such as the Ohio and Mississippi River valleys and the Southwest) where there is a higher risk of certain fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis Diverticulitis, ulcers, or tears (perforations) of your stomach or intestines Liver problems or symptoms that may suggest liver problems, such as yellowing of your skin or the whites of your eyes (jaundice), appetite loss, abdominal swelling and pain on the right side of your stomach area, light-colored stools, or dark "tea-colored" urine Cancer of any type Multiple sclerosis or any other condition that affects your nervous system. Also, let your doctor know if: You have recently received or are scheduled to receive a vaccine Recent laboratory tests detected low neutrophils, low platelets, or your liver function results were high You plan to have surgery or a medical procedure You are pregnant or plan to become pregnant or are breastfeeding You take any other medications, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Continue reading

    Actemra does not directly target the SARS-COV-2 virus (the virus that causes COVID-19), rather it reduces inflammation by blocking the interleukin-6 receptor, which is on interleukin-6, one of the main proinflammatory cytokines (these are cell-to-cell signaling proteins that stimulate an immune response). In some cases of COVID-19 infection, the immune system can become hyperactive, which may result in worsening disease. Continue reading

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