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Actemra

Actemra

(tocilizumab)

Actemra (Tocilizumab) belongs to the class of medications called biological response modifiers or interleukin receptor blockers. For adults, Actemra (Tocilizumab) is used in combination with other medications to treat moderate-to-severe Rheumatoid Arthritis.

Available form

Dosage

Injectable Syringe

162MG/0.9ML

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Actemra information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

For the treatment of rheumatoid arthritis, Actemra (Tocilizumab) may be given as an intravenous (IV) infusion or as a subcutaneous injection (under the skin). For the treatment of giant cell arteritis only the subcutaneous injection is used. For other conditions (pJIA, sJIA), only the intravenous infusion may be used. The recommended intravenous adult dose of Actemra (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. Actemra (Tocilizumab) is given once every 4 weeks as an IV infusion over a 1-hour period.

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

The recommended adult dose of the subcutaneous form of Actemra (Tocilizumab) for treatment of rheumatoid arthritis 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.

The recommended adult dose of the subcutaneous form of Actemra (Tocilizumab) for treatment of giant cell arteritis is 162 mg injected subcutaneously once weekly. In some cases your doctor may decrease your dose to once every second week.

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. Actemra (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. Actemra (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 Actemra (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 Actemra (Tocilizumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Actemra (Tocilizumab), or miss an injection, contact your doctor as soon as possible to reschedule your next dose.

Actemra (Tocilizumab) 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 Actemra (Tocilizumab) 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.

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 Actemra (Tocilizumab). If you are concerned about side effects, discuss the risks and benefits of Actemra (Tocilizumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Actemra (Tocilizumab). 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:

chicken pox
Cold Sores
ear infections
gastroenteritis (nausea, vomiting, Diarrhea)
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:

chest pain
signs of macrophage activation syndrome (e.g., sudden fever, confusion, irritability, disorientation)
signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
signs of a Anaphylaxis (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 Actemra (Tocilizumab).

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 Actemra (Tocilizumab).

HEALTH CANADA ADVISORY

May 21, 2019

Health Canada has issued new restrictions concerning the use of Actemra (Tocilizumab). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Allergic reactions: In rare cases, some people may develop a severe allergic reaction to Actemra (Tocilizumab). Even if these reactions do not occur with the first infusion of the medication, they may still happen with future doses of Actemra (Tocilizumab). Your health care provider will monitor you while you are receiving Actemra (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: Actemra (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: Actemra (Tocilizumab) 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 Actemra (Tocilizumab). If you have a history of high blood pressure, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed.

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

Dizziness: Actemra (Tocilizumab) may cause dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how Actemra (Tocilizumab) affects you.

Gastrointestinal problems: People receiving Actemra (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 Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), 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 Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed. Talk to your doctor about managing your risk factors for heart disease.

Infection: Actemra (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 Actemra (Tocilizumab). Actemra (Tocilizumab) may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Actemra (Tocilizumab).

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 Actemra (Tocilizumab). If you have a history of diseases of the nerves or nervous system, discuss with your doctor how Actemra (Tocilizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Actemra (Tocilizumab), 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: Actemra (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 Actemra (Tocilizumab), 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 Actemra (Tocilizumab). Talk to your doctor if you have any concerns.

Vaccinations: Live vaccines are not recommended for people receiving Actemra (Tocilizumab). Talk to your doctor if you need any vaccinations while receiving Actemra (Tocilizumab).

Pregnancy: Actemra (Tocilizumab) 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 Actemra (Tocilizumab). If you become pregnant while receiving Actemra (Tocilizumab), contact your doctor immediately.

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

Children: The safety and effectiveness of Actemra (Tocilizumab) have not been established for children with sJIA or pJIA less than 2 years of age, or children with CRS less than 3 years of age. The safety and effectiveness of Actemra (Tocilizumab) for the treatment of conditions other than sJIA, pJIA, or CRS have not been established for children less than 18 years of age.

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

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All material © 1996-2024 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition.

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