Actemra

Generic name: tocilizumab [ TOE-si-LIZ-oo-mab ]
Drug class: Interleukin inhibitors

What is Actemra?

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

Actemra 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); and
to slow the decline in lung function caused by scleroderma with interstitial lung disease.

Actemra 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).

Actemra is sometimes given together with other medications as part of your complete treatment.

Actemra is also being studied for use in treating coronavirus. The US Food and Drug Administration (FDA) has authorized emergency use of Actemra with steroid medicine to treat adults and 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 your blood).

Actemra has not been approved to treat coronavirus or COVID-19. This medicine is not for use in treating COVID-19 outside of a hospital.

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.

Before taking this medicine

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. This 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.

How is Actemra given?

Use Actemra exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

Actemra is injected under the skin or into a vein. This medicine 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 follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

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. 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 Actemra injection 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.

Throw away a prefilled syringe or autoinjector after one use, even if there is still medicine left inside.

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

Dosing information

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:

Detailed Actemra dosage information

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?

While using Actemra: Do not receive a “live” vaccine or you could develop a serious infection. 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), zoster ( shingles), and nasal flu (influenza) vaccine.
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.

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.

Actemra side effects (more detail)

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.

Actemra drug interactions (more detail)

Popular FAQ

How long should you take Actemra for Giant cell arteritis (GCA)?

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.

How long does Actemra stay in your system?

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.

What is the effect of Actemra on patients with COVID-19?

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.

Actemra has Emergency Use Authorization (EUA) issued by the FDA to be used as a treatment for people with COVID-19 who are receiving corticosteroids plus supplemental oxygen, on a ventilator, or receiving extracorporeal membrane oxygenation (ECMO). This was based on the results of four trials that showed that giving Actemra to people with COVID-19 decreased their risk of dying.

Four trials support using Actemra for COVID-19 and two showed that using Actemra significantly decreased the risk of people dying with COVID-19, to a modest extent. The RECOVERY [Randomized Evaluation of COVID-19 Therapy] trial was a randomized, controlled, open-label trial of 4,116 hospitalized patients with severe COVID-19 pneumonia who were randomized to receive Actemra in addition to usual care (n=2,022) or usual care alone (n=2,094). The probabilities of death by day 28 were estimated to be 30.7% for patients receiving Actemra and 34.9% for patients receiving usual care alone. The median time to hospital discharge was 19 days for patients receiving Actemra and more than 28 days for patients receiving usual care alone.
In the EMPACTA trial, 389 hospitalized patients with COVID-19 pneumonia received Actemra (249 patients) or placebo (128 patients). 12.0% of patients receiving Actemra required mechanical ventilation or died by day 28 compared with 19.3% of those receiving placebo.

In both the COVACTA trial (n=452) and REMDACTA trial (n=649) no statistically significant differences were observed between Actemra and placebo; however, both trials contributed to the assessment of the safety for Actemra when used for the treatment of COVID-19.

Actemra is not FDA-approved to treat COVID-19, it just has an EUA that allows it to be used in hospitalized patients 2 years of age and older on a specified treatment regimen to treat COVID-19. Actemra is FDA approved for the treatment of rheumatoid arthritis and other inflammatory conditions.

Can Actemra cause weight gain?

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.

Can I take Actemra with antibiotics?

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.

Is Actemra a TNF inhibitor?

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.

What is Actemra infusion for?

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.

source :: https://www.drugs.com/actemra.html

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