Actemra ® SC 162 mg Solution

Actemra SC contains the active substance tocilizumab, a monoclonal antibody that blocks the action of a specific protein (cytokine) called interleukin-6. Actemra SC is used to treat your disease called rheumatoid arthritis (RA) or giant cell arteritis (GCA), a disease of the arteries, if previous therapies did not work well enough.

Actemra SC is used to treat your child, if older than 2 years of age, if he/she has polyarticular juvenile idiopathic arthritis (pJIA), an inflammatory disease that causes pain and swelling in one or more of his/her joints. Actemra SC is used to treat your child, aged 1 year and older, if he/she has systemic juvenile idiopathic arthritis (sJIA), an inflammatory disease that causes pain and swelling in one or more of his/her joints.

Do not use Actemra SC

• If you or your child are allergic (hypersensitive) to Actemra SC or to any other ingredients of Actemra SC (listed under “What Actemra SC contains”).
• If you or your child have active, severe infections.
• If you have or have had active liver disease/hepatitis.
• If your liver function is impaired before or during treatment.
• You have active or chronic hepatitis B.
• You are taking medicines which could be toxic to your liver, other than methotrexate.

Take special care before you use Actemra SC

If you or your child experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the injection, then tell your doctor immediately.

If you or your child experience any allergic reaction symptom after receiving Actemra SC, you or your child must not take the next dose until you have informed your doctor and your doctor has told you that you or your child may take the next dose.

If you or your child have any kind of infection, including short- or long-term, or if you or your child often get infections. Tell your doctor immediately if you feel unwell. Actemra SC can reduce your or your child’s body’s ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection.

If you or your child have had tuberculosis, tell your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting Actemra SC. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately. Your doctor will give you or your child medicine to prevent you getting tuberculosis before you start treatment with Actemra SC and will monitor you throughout your treatment with Actemra SC.

If you or your child have had intestinal ulcers or diverticulitis, tell your doctor. Symptoms would include abdominal pain and unexplained changes in bowel habits with a fever.

If you or your child have liver disease tell your doctor. Before you receive Actemra SC, your doctor [may] will do a blood test to measure your or your child’s liver function. Your doctor will decide whether you or your child can continue having Actemra treatment.

If you or your child have recently got or are planning to get vaccinated, tell your doctor. Certain types of vaccines should not be given while receiving Actemra SC. You should receive all immunisations in agreement with current immunisation guidelines prior to initiating Actemra SC therapy.

If you or your child have cancer, tell your doctor. Your doctor will have to decide if you can still be given Actemra SC.

If you or your child have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor. These factors need to be monitored while receiving Actemra SC.

If you or your child have moderate to severe kidney function problems, your doctor will monitor you or your child. Your doctor will perform a blood test before you or your child receive Actemra SC, to determine if you or your child have a low white blood cell count, low platelet count or high liver enzymes. Actemra SC is not recommended for use in children under the age of two years.

Children and adolescents

Actemra SC is not recommended for use in children under 1 year of age. Actemra SC must not be given to children with sJIA weighing less than 10 kg.

Other medicines and Actemra SC

Using other medicines with Actemra SC

Always tell your healthcare professional if you or your child are taking any other medicine. (This includes complementary or traditional medicines.) Actemra SC can affect the way some medicines work, and the dose of these may require adjustment. You should tell the doctor if you or your child are using medicines containing any of the following active substances:

• atorvastatin, used to reduce cholesterol levels
• calcium channel blockers (e.g.) amlodipine, used to treat raised blood pressure
• theophylline, used to treat asthma
• warfarin, used as a blood thinning agent
• phenytoin, used to treat convulsions
• ciclosporin, used to suppress your or your child’s immune system during organ transplants
• benzodiazepines, used to relieve anxiety

Taking Actemra with food and drink

You or your child can take food and drink as normal while receiving Actemra SC.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, may be pregnant or intend to become pregnant or if you are breastfeeding your baby. Actemra SC should not be used during pregnancy.

It is not known whether Actemra SC is excreted in breast milk. You should stop breastfeeding your baby if you are to be given Actemra SC. Before you start[ing] breastfeeding, your last treatment with Actemra SC should be at least 3 months ago.

Driving and using machines

There are no studies on the effects of Actemra SC on the ability to drive or use machines. However, if you experience dizziness, a common side effect, then you should not drive or use machines.

Your doctor will prescribe the dose you or your child should receive and the duration of your treatment. Always use Actemra SC exactly as your or your child’s doctor, pharmacist or nurse has told you. You should check with your or your child’s doctor, pharmacist or nurse if you are not sure.

The recommended dose is 1 pre-filled syringe containing 162 mg Actemra SC, once a week if you are taking it for rheumatoid arthritis (RA) or giant cell arteritis (GCA). If your child is taking Actemra RA for his/her polyarticular rheumatoid arthritis (pJIA), the recommended Actemra SC dose is:

• 1 pre-filled syringe containing 162 mg once every three weeks if your child weighs less than 30 kg or
• 1 pre-filled syringe containing 162 mg once every two weeks if your child weighs 30 kg or more.

If your child is taking Actemra sJIA for his/her systemic juvenile idiopathic arthritis (sJIA), the recommended Actemra SC dose is:

• 1 pre-filled syringe containing 162 mg once every two weeks if your child weighs less than 30 kg or
• 1 pre-filled syringe containing 162 mg once every every weeks if your child weighs 30 kg or more.

Actemra SC is given by injection under the skin (subcutaneously). At the start, your doctor or nurse may inject your Actemra SC dose. However, your doctor may decide that you may inject Actemra SC yourself. In this case you will receive training on how to inject Actemra SC yourself.

Your child’s doctor will give him/her the initial injection. After the first few injections [he] your doctor may assess the suitability for you or the child’s guardian/carer to administer the injection to your child. In this case your doctor will train you or the child’s guardian/carer on how to inject your child. If you are injecting yourself or your child, you and your child must agree to see your doctor for follow-up consultations. If you or your child experience any signs of an allergic reaction such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the injection, you must inform your doctor or healthcare professional immediately.

Talk to your doctor if you have any questions about giving yourself or your child an injection. See detailed instructions for administration below.

Actemra SC can cause side effects. Side effects may occur at least up to 3 months after your or your child’s last dose of Actemra SC. Possible serious side effects include serious infections and allergic (hypersensitivity) reactions, that may be life-threatening. If you or your child notice any of the following signs of allergic reactions during or after the injection, tell your doctor immediately:

• difficulty with breathing, chest-tightness or light-headedness
• rash, itching, hives, swelling of the lips, face, tongue, throat

If you or your child notice any of the following signs of infections, tell your doctor as soon as possible:

• fever and chills
• mouth or skin blisters
• stomach ache
• persistent headaches

Elevated liver enzymes, tell your doctor immediately:

• yellowing of your skin and the whites of your eyes (jaundice)
• abdominal pain
• dark urine
• fever
• nausea and/or vomiting
• weakness and fatigue
• a general sense of feeling unwell (malaise)
• disorientation or confusion sleepiness

The symptoms described above can be signs of the side effects listed below, all of which have been observed with Actemra SC in clinical studies and post-marketing reports:

Frequent side effects:

• upper respiratory tract infections like coughs and colds,
• high cholesterol levels,
• Lung infection (pneumonia),
• cold sores (oral herpes simplex),
• blisters,
• shingles (herpes zoster),
• skin infection sometimes with fever and chills (cellulitis),
• low white blood cell counts shown by blood tests (neutropenia, leucopenia),
• injection site reactions which include redness of the skin (erythema),
• itchiness (pruritus),
• pain and a swelling that contains blood (haematoma),
• headache,
• dizziness,
• high blood pressure,
• mouth ulceration,
• stomach pain abnormal liver function tests (increased transaminases),
• increased bilirubin shown by blood tests,
• rash and itching, hives,
• fluid retention (oedema) in the lower legs,
• cough,
• shortness of breath,
• increased weight,
• eye infection (conjunctivitis),
• allergic (hypersensitivity) reactions,
• hypofibrinogenaemia (abnormally low concentration of fibrinogen in the blood plasma).

Less frequent side effects:

• diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain due to large bowel disease),
• red swollen (inflamed) areas in the mouth,
• high blood fat (triglycerides),
• stomach ulcer,
• kidney stones,
• underactive thyroid,
• low red blood cells and platelet counts,
• Stevens-Johnson syndrome (skin rash which may lead to severe blistering and peeling of the skin),
• An abnormally low level of red blood cells, white blood cells, and platelets in the blood (pancytopenia),
• medicine-induced liver injury
• inflammation of the liver (hepatitis)
• liver failure
• jaundice

Children with pJIA

In general, the side effects in children with pJIA were similar in type to those seen in adults with RA as stated above, with the exception of injection site reactions which were reported more frequently. If any of the side effects gets serious, or if you or your child notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Not all side effects reported for Actemra SC are included in this leaflet. Should your general health worsen while taking this medicine, consult your doctor, pharmacist or other healthcare professional for advice.

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Report Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Store in a refrigerator between 2 and 8 °C. Do not freeze. Store all medicines out of reach of children. Keep the pre-filled syringe in the outer carton in order to protect from light and keep dry. Do not use after the expiry date stated on the pack. Once removed from the refrigerator, Actemra SC must be administered within 8 hours and should not be kept at or above 30 °C. Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to slightly yellowish, or if any part of the pre-filled syringe appears to be damaged.