Actemra

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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause mouth irritation and sores; it may cause headaches; it may cause stomach ache; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it could make you more prone to respiratory infections; it may cause a skin reaction. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Concentrate Solution for IV Infusion
Each mL of sterile concentrate solution for intravenous infusion contains 20 mg of Actemra (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 Actemra (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. Latex-free.

Do not take Actemra (Tocilizumab) if you:

• are allergic to Actemra (Tocilizumab) or any ingredients of the medication
• have an active infection

There may be an interaction between Actemra (Tocilizumab) and any of the following:

• Abatacept
• Abiraterone
• Adalimumab
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• Amiodarone
• Anakinra
• anticancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• Apixaban
• Apremilast
• Aprepitant
• Aripiprazole "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Baricitinib
• benzodiazepines (e.g., Clonazepam, Diazepam, Lorazepam)
• birth control pills
• Bisoprolol
• Buprenorphine
• Buspirone
• Calcitriol
• calcium channel blockers (e.g., Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Certolizumab Pegol
• chloroquine
• conivaptan
• Cyclosporine
• Dantrolene
• Dapsone
• Darifenacin
• Denosumab
• Dexamethasone
• Disopyramide
• Dronedarone
• echinacea
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Etanercept
• Everolimus
• Fingolimod
• Golimumab
• Haloperidol
• Hepatitis C antivirals (e.g., asunaprevir, dasabuvir, velpatasvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Infliximab
• Leflunomide
• Lenalidomide
• lidocaine
• Linagliptin
• Losartan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• Methadone
• mifepristone
• Mirtazapine
• Modafinil
• Montelukast
• Natalizumab
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• Oxycodone
• 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
• rilpivirine
• Rituximab
• Rivaroxaban
• Roflumilast
• Romidepsin
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sildenafil
• Sirolimus
• Solifenacin
• "statin" anticholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• suvorexant
• Tacrolimus
• Tamoxifen
• Tetracycline
• Ticagrelor
• Ticlopidine
• Tofacitinib
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• Trimethoprim
• tyrosine kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib)
• Ulipristal
• vaccines
• Venlafaxine
• Zolpidem
• 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 Actemra (Tocilizumab). 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.

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.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this.