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Actemra

(tocilizumab)

How does this medication work? What will it do for me?

Tocilizumab belongs to the class of medications called biological response modifiers or interleukin receptor blockers. For adults, tocilizumab is used in combination with other medications to treat moderate-to-severe rheumatoid arthritis.

In children 2 years of age and older, tocilizumab is used to treat systemic juvenile idiopathic arthritis (sJIA) and polyarticular juvenile idiopathic arthritis (pJIA) that has not responded to other treatments. Children may receive tocilizumab alone or with other arthritis medications.

People with this condition have high levels of a protein called interleukin-6, which causes pain, inflammation, and damage to the joints. Tocilizumab works to block the action of interleukin-6, thereby decreasing pain and joint inflammation.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop receiving this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to receive this medication if their doctor has not prescribed it.

How should I use this medication?

For the treatment of rheumatoid arthritis, tocilizumab may be given as an intravenous (IV) infusion or as a subcutaneous injection (under the skin). For other conditions (pJIA, sJIA), only the intravenous infusion may be used. The recommended intravenous adult dose of tocilizumab is based on body weight. The usual starting dose is 4 mg per kilogram, and can be increased up to 8 mg per kilogram depending on how a specific person responds to this medication. Tocilizumab is given once every 4 weeks as an IV infusion over a 1-hour period.

You and your doctor may decide that using this medication at home is an option. Tocilizumab is available in a solution to be injected subcutaneously (under the skin).

The recommended adult dose of the subcutaneous form of tocilizumab is also based on body weight. Generally, adults who weigh less than 100 kg will start by injecting 162 mg subcutaneously, on the same day of the week, every second week. Depending on how well you tolerate the medication, the dose may be increased to 162 mg once weekly. For people who weigh more than 100 kg, you will use 162 mg subcutaneously every week. Your doctor may adjust the frequency of your dose based on how well the medication works for you.

If you are injecting the medication yourself, your doctor or health care professional will show you how to inject the medication properly and have you inject your first dose in the office or clinic. If you have any questions about how to use your medication, contact your doctor or health care professional.

To treat pJIA, the recommended dose for children weighing less than 30 kg is 10 mg per kilogram of body weight. Children and adolescents weighing 30 kg or more receive 8 mg per kilogram of body weight. Tocilizumab is given once every 4 weeks as an IV infusion over a 1-hour period.

To treat sJIA, the recommended dose for children weighing less than 30 kg is 12 mg per kilogram of body weight. Children and adolescents weighing 30 kg or more receive 8 mg per kilogram of body weight. Tocilizumab is given once every 2 weeks as an IV infusion over a 1-hour period.

For children, the dose should be increased only as the child's weight increases as they grow.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor.

The intravenous form of tocilizumab is injected into a vein through a process called intravenous (IV) infusion by a health care professional, usually in a clinical setting such as a hospital clinic, over a period of time.

For the subcutaneous injection, your doctor or nurse may ask you to inject the medication at home once they have instructed you and are certain that you won't have any problems with doing it at home. Do not attempt to inject this medication on your own until you completely understand how to prepare the syringe and inject a dose. Before injecting the medication, check the solution to ensure that it is clear, colourless and has no particles in it. If the solution is not clear and colourless, discard the syringe safely and use a new one. It is important this medication be given exactly as recommended by your doctor. If you miss an appointment to receive tocilizumab, or miss an injection, contact your doctor as soon as possible to reschedule your next dose.

This medication must be refrigerated at 2°C to 8°C. Do not freeze. Once the medication has been removed from refrigeration, it must be used within 8 hours and should not be kept above 30°C. Protect this medication from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Concentrate Solution for IV Infusion
Each mL of sterile concentrate solution for intravenous infusion contains 20 mg of tocilizumab. Nonmedicinal ingredients: disodium phosphate dodecahydrate, polysorbate 80, sodium dihydrogen phosphate dihydrate, sucrose, and water for injection. Preservative-free.

Solution for Subcutaneous Injection
Each ready-to-use, single-use syringe contains 162 mg of tocilizumab in 0.9 mL of sterile solution.  Nonmedicinal ingredients: L-arginine, L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, and water for injection. Preservative-free.

Who should NOT take this medication?

Do not take tocilizumab if you:

  • are allergic to tocilizumab or any ingredients of the medication
  • have an active infection

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain or discomfort
  • dizziness
  • headache
  • blood pressure change
  • itchiness
  • nausea
  • rash
  • reactions at the injection site
  • upper respiratory tract infections (e.g., common cold, sinus infection)

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • cold sores
  • high cholesterol levels
  • mouth sores or blisters
  • persistent headache
  • signs of diverticulitis (e.g., fever, nausea, diarrhea, constipation, persistent severe stomach pain and fever)
  • signs of lung problems (e.g., cough, shortness of breath, trouble breathing)
  • signs of multiple sclerosis (e.g., blurred vision, vision loss, dizziness, numbness, weakness or tingling in the face, arms or legs)
  • symptoms of an infection (e.g., fever, chills, persistent cough, weight loss, throat pain or soreness, wheezing, red or swollen skin blisters, tears, wounds, severe weakness or tiredness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of macrophage activation syndrome (e.g., sudden fever, confusion, irritability, disorientation)
  • signs of multiple sclerosis (blurred vision; loss of vision; eye pain; dizziness; numbness or weakness in the face, arms or legs)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of a severe allergic reaction (e.g., shortness of breath or trouble breathing; skin rash; swelling of the lips, tongue or face; fainting or feeling very dizzy)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: In rare cases, some people may develop a severe allergic reaction to this medication. These reactions may not occur with the first infusion of the medication, and may happen with future doses of tocilizumab. Your health care provider will monitor you while you are receiving tocilizumab by  infusion. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, difficulty breathing, lightheadedness, or dizziness. If any of these occur, contact your doctor immediately.

Bleeding: Tocilizumab may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Blood pressure: This medication can cause an increase in blood pressure that is associated with an increased risk of heart disease. Your blood pressure should be monitored after starting this medication. If you have a history of high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Cancer: People taking tocilizumab for rheumatoid arthritis in clinical trials developed cancer more often than the general population. The role of tocilizumab in developing cancer is not known.

Gastrointestinal problems: People receiving tocilizumab have experienced perforations in the lining of their digestive system, usually as a complication of diverticulitis (infection of the large intestine). If you have a history of ulcers or diverticulitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart disease: People with rheumatoid arthritis are at an increased risk for heart and blood vessel disorders. If you have heart disease or are at risk of developing heart disease or blood vessel disorders, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Talk to your doctor about managing your risk factors for heart disease.

Infection: Tocilizumab can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function: People with active liver disease or liver dysfunction should not take tocilizumab. Tocilizumab may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Macrophage activation syndrome: This is a serious life-threatening complication of sJIA, in which the body's immune system becomes over-activated. This condition develops quickly and may be identified by a sudden fever that doesn't go away, irritability, confusion, and tiredness. This condition is a medical emergency, as it may be fatal. If you notice any of these signs, contact your doctor or get medical attention as soon as possible.

Multiple Sclerosis: There have been rare reports of multiple sclerosis in people receiving tocilizumab. If you have a history of diseases of the nerves or nervous system, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any symptoms such as blurred vision; loss of vision; eye pain; dizziness; or numbness or weakness in the face, arms, or legs to your doctor.

Serious infections: Tocilizumab can increase the risk of developing serious infections, including blood infections (sepsis), tuberculosis (TB), fungal, and different opportunistic infections. If any of the symptoms of infection appear (e.g., fever, chills, persistent cough, weight loss, throat pain or soreness, wheezing, red or swollen skin blisters, wounds, severe weakness or tiredness), contact your doctor immediately to get appropriate treatment. Before starting this medication, your doctor may test you to see if you have TB, hepatitis, or other active infections.

People infected with hepatitis B or C virus (an infection that can damage the liver) may have a relapse of their condition while receiving this medication. Talk to your doctor if you have any concerns.

Vaccinations: Live vaccines are not recommended for people receiving tocilizumab. Talk to your doctor if you need any vaccinations while receiving this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Effective birth control must be used to prevent pregnancy during treatment and for 3 months after the last dose of tocilizumab. If you become pregnant while receiving this medication, contact your doctor immediately.

Breast-feeding: It is not known if tocilizumab passes into breast milk. If you are a breast-feeding mother and are receiving this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 2 years of age. The safety and effectiveness of this medication for the treatment of conditions other than sJIA and pJIA have not been established for children less than 18 years of age.

Seniors: Serious infections occur more often in people older than 65 receiving tocilizumab compared to people under 65 years old. Talk to your doctor if you have any questions.

What other drugs could interact with this medication?

There may be an interaction between tocilizumab and any of the following:

  • abatacept
  • adalimumab
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amiodarone
  • anti-cancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, etoposide, ifosfamide, irinotecan, vincristine)
  • apixaban
  • aprepitant
  • aripiprazole
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • benzodiazepines (e.g., clonazepam, diazepam, lorazepam)
  • birth control pills
  • boceprevir
  • buprenorphine
  • buspirone
  • calcitriol
  • calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
  • carbamazepine
  • chloroquine
  • conivaptan
  • cyclosporine
  • dantrolene
  • dapsone
  • denosumab
  • dexamethasone
  • disopyramide
  • dronedarone
  • echinacea
  • etanercept
  • everolimus
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • etanercept
  • ethosuxamide
  • everolimus
  • felbamate
  • flutamide
  • golimumab
  • haloperidol
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • infliximab
  • leflunomide
  • lenalidomide
  • lidocaine
  • losartan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maraviroc
  • mefloquine
  • mestranol
  • methadone
  • mirtazapine
  • modafinil
  • montelukast
  • nateglinide
  • nefazodone
  • nitrates (e.g., isosorbide dinitrate,  isosorbide mononitrate)
  • ondansetron
  • oxycodone
  • paclitaxel
  • perampanel
  • pimecrolimus
  • pimozide
  • pomalidomide
  • praziquantel
  • primaquine
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • quetiapine
  • quinidine
  • quinine
  • repaglinide
  • rifabutin
  • rivaroxaban
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • roflumilast
  • romidepsin
  • sirolimus
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • tacrolimus
  • tamoxifen
  • telaprevir
  • teniposide
  • tetracycline
  • theophylline
  • ticagrelor
  • ticlopidine
  • tolterodine
  • tolvaptan
  • trabectedin
  • tramadol
  • trazodone
  • trimethoprim
  • tyrosine kinase inhibitors (e.g., bosutinib, dasatinib, imatinib, nilotinib)
  • vaccines
  • venlafaxine
  • warfarin
  • zolpidem
  • zonisamide
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Actemra

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