RoActemra - Tocilizumab uses, dose and side effects

RoActemra contains the active substance tocilizumab, which is a protein produced from specific immune cells (monoclonal antibody ) that inhibits the effect of a specific protein ( cytokine ) called interleukin -6. This protein participates in inflammatory processes in the body and by inhibiting the protein, inflammation can be reduced in your body. RoActemra is used to treat:

adults with moderate to severely active rheumatoid arthritis (RA or rheumatoid arthritis ) which is an autoimmune disease, if previous treatments have not worked well enough.
adults with severe, active, and progressive rheumatoid arthritis (RA) who have not been treated with methotrexate before.

RoActemra helps to reduce symptoms such as pain and swelling in your joints and you can make it easier to perform your daily chores. RoActemra has been shown to slow down the damage to cartilage and bone in the joints caused by the disease, and can therefore improve the ability to perform normal daily activities.

RoActemra is usually given in combination with another medicine used for RA called methotrexate. If your doctor thinks that methotrexate is not suitable for you, RoActemra can be given alone.

adults who have a disease of the arteries called giant cell arteritis (GCA) and which is caused by inflammation of the largest arteries in the body, especially those that supply the head and neck with blood. Symptoms include headache, fatigue, and jaw pain. Effects may include stroke or blindness.

RoActemra can reduce pain and swelling in the arteries and veins in your head, neck, and arms.

GCA is most often treated with a drug called cortisone. These are usually effective but can have side effects when used in high doses for a long time. A reduction in dose one can also lead to a recurrence of GCA. Adding RoActemra to the treatment means that cortisone can be used for a shorter time and the disease is still kept under control.

children and adolescents, 12 years and older, with active systemic juvenile idiopathic arthritis (sJIA) which is an inflammatory disease that causes pain and swelling in one or more joints as well as fever and rash.

RoActemra is used to improve the symptoms of sJIA and can be given in combination with methotrexate or alone.

children and adolescents 12 years of age or older with active polyarticular juvenile idiopathic arthritis (DJIA). DJIA is an inflammatory disease that causes pain and swelling in one or more joints.

RoActemra is used to improve the symptoms of DJIA and can be given in combination with methotrexate or alone

What you need to know before using RoActemra

Do not use RoActemra

if you or the child you are caring for are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section 6)
if you or the child you are caring for has an active, severe infection.

If any of these apply to you, tell your doctor. Do not use RoActemra.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using RoActemra.

If you get an allergic reaction such as pressure over the chest, wheezing, severe dizziness or fainting, swollen lips, tongue, face or itching of the skin, hives or rash during or after injection, contact a doctor immediately.
If you have experienced symptoms of an allergic reaction after taking RoActemra, do not take the next dose until you have informed your doctor AND your doctor has told you to take the next dose.
If you have any type of infection, either short-term or long-term, or if you often suffer from an infection. Contact a doctor immediately if you do not feel well. RoActemra may reduce the body’s ability to handle infections and may aggravate an ongoing infection or increase the risk of a new infection.
If you have had tuberculosis, talk to your doctor. Your doctor will check for any signs and symptoms of tuberculosis before starting treatment with RoActemra. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection occurs during or after treatment, contact your doctor immediately.
If you have a history of intestinal ulcers or diverticulitis (inflamed pockets on the intestines), talk to your doctor. Symptoms may include abdominal pain and unexplained changes in bowel movements and fever.
If you have any liver disease, talk to your doctor. Before using RoActemra, your doctor may need to take a blood test to measure your liver function.
If you as a patient have recently been vaccinated, or are planning to be vaccinated, talk to your doctor. It is recommended that all patients be immunized according to current vaccination guidelines before starting RoActemra treatment. Certain types of vaccines should not be given during treatment with RoActemra.
If you have cancer, talk to your doctor. Your doctor will need to decide if you can then be treated with RoActemra.
If you have risk factors for cardiovascular disease such as high blood pressure or high cholesterol levels, talk to your doctor. These factors need to be followed during your treatment with RoActemra.
If you have moderate to severe problems with kidney function, your doctor will follow this up.
If you have persistent headaches.

Your doctor will take blood samples before you receive RoActemra, to determine that you do not have too few white blood cells or platelets or too high levels of liver enzymes in your blood.

Children and young people

RoActemra pre-filled pen (ACTPen ® ⁾ is not recommended for children under 12 years of age. RoActemra must not be given to children with sJIA weighing less than 10 kg.

If a child has previously had macrophage activation syndrome (an activation and uncontrolled increase in specific blood cells), talk to your doctor. Your doctor must decide if they can then be treated with RoActemra.

Other medicines and RoActemra

Tell your doctor if you are taking or have recently taken any other medicines. RoActemra may affect the way some medicines work and the dose of one of your medicines may need to be adjusted. Tell your doctor if you are taking medicines that contain any of the following active substances:

Methylprednisolone, and dexamethasone, is used to reduce inflammation
simvastatin or atorvastatin is used to reduce cholesterol levels
calcium antagonist (eg amlodipine), is used to treat high blood pressure
theophylline is used to treat asthma
warfarin or phenprocoumon, is used as a blood thinner
phenytoin used to treat epilepsy
ciclosporin is used to inhibit the immune system in connection with organ transplantation
benzodiazepines (eg temazepam), are used to relieve anxiety.

Due to the lack of clinical experience, the use of RoActemra in combination with other biologics for the treatment of RA, sJIA, DJIA, or GCA is not recommended.

Pregnancy, breastfeeding, and fertility

RoActemra should not be used during pregnancy unless necessary. Talk to your doctor if you are pregnant, possibly pregnant, or planning to become pregnant.

Women of childbearing potential must use effective contraception during and up to 3 months after treatment.

Stop breastfeeding if you are going to receive RoActemra, and talk to your doctor. Take a break for at least 3 months after your last treatment before starting breastfeeding. It is unknown whether RoActemra passes into breast milk.

Driving and using machines

This medicine may cause dizziness. If you experience dizziness, do not drive or use machines.

How to use RoActemra

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.

The treatment will be prescribed and started by healthcare professionals who have experience in the diagnosis and treatment of RA, sJIA, DJIA, or GCA.

The recommended dose is one

The dose of RA or GCA for all adults is 162 mg (contained in 1 pre-filled pen ) given once a week.

Children and adolescents with sJIA (12 years or older)

The usual dose of RoActemra depends on the weight of the patient.

If the patient weighs less than 30 kg, the dose is 162 mg (the contents of a pre-filled pen ) once every two weeks.
If the patient weighs 30 kg or more, the dose is 162 mg (the contents of a pre-filled pen ) once a week.

The pre-filled pen should not be used to treat children under 12 years of age.

Children and adolescents with DJIA (12 years or older)

The usual dose of RoActemra depends on the weight of the patient.

If the patient weighs less than 30 kg, the dose is 162 mg (the contents of a pre-filled pen ) once every three weeks.
If the patient weighs 30 kg or more, the dose is 162 mg (the contents of a pre-filled pen ), once every two weeks.

The pre-filled pen should not be used to treat children under 12 years of age.

RoActemra is given as an injection under the skin ( subcutaneously ). Initially, your doctor or nurse may inject RoActemra (ACTPen®). Your doctor may also decide that you can inject RoActemra yourself. In this case, you will learn to inject RoActemra yourself. Parents and caregivers receive training in how to inject RoActemra for patients who cannot inject themselves, such as children.

Talk to your doctor if you have any questions about injecting RoActemra or a child you are taking care of yourself. You will find detailed instructions for injection at the end of this leaflet.

If you use more RoActemra than you should

Because RoActemra is given with a pre-filled pen, it is unlikely that you will get too much. If you are still worried, talk to your doctor, pharmacist, or nurse.

If you forget to use RoActemra

If an adult patient with RA or GCA or a child or adolescent with sJIA misses or misses a dose

It is very important to use RoActemra exactly as your doctor has told you. Keep track of when to take your next dose.

If you have forgotten your weekly dose and it has not been more than 7 days, take your dose on the next scheduled day.
If you forget your dose that is taken every two weeks and it has not been more than 7 days, inject one dose as soon as you remember and take your next dose on your usual scheduled day.
If you have forgotten your weekly dose or dose taken every two weeks for more than 7 days or are not sure when to inject RoActemra, call your doctor or pharmacist.

If a child or adolescent with pJIA misses or misses a dose

It is very important to use RoActemra exactly as your doctor has told you. Keep track of your next dose.

If one dose is missed within 7 days of scheduled dosing, inject one dose as soon as you remember and give the next dose as usual on the scheduled day.
If a dose is missed by more than 7 days after the scheduled dose or if you are not sure when to inject RoActemra, call your doctor or pharmacist.

If you stop using RoActemra

You should not stop using RoActemra without first discussing it with your doctor.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, RoActemra can cause side effects, although not everybody gets them.

Side effects can occur up to at least 3 months after your last dose of RoActemra.

Possible serious side effects: Talk to a doctor immediately.
These are common and may affect up to 1 in 10 users

Allergic reactions during or after the injection:

difficulty breathing, pressure over the chest or dizziness
rash, itching, hives, swollen lips, tongue, or face.

If you experience any of these, talk to your doctor immediately.

Signs of serious infections:

fever and chills
blisters in the mouth or skin
magnet.

Signs and symptoms of liver toxicity

It May affect up to 1 in 1,000 users

fatigue
abdominal pain
jaundice (yellowish discoloration of skin and eyes)

If you experience any of these, talk to your doctor as soon as possible.

Very common side effects:

It May affect more than 1 user in 10

upper respiratory tract infection with typical symptoms such as cough, nasal congestion, runny nose, sore throat, headache
high blood fat ( cholesterol ) levels.
injection site reactions.

Common side effects:

It May affect up to 1 in 10 users

pneumonia _ _ _
shingles ( herpes zoster)
sores on the lips (cold sores), blisters
skin infection ( cellulite ) sometimes with fever and chills
rash and itching, hives
allergic (hypersensitivity) reactions
eye infection ( conjunctivitis )
headache, dizziness, high blood pressure
cold sores, stomach pain
fluid retention ( edema ) in the lower legs, weight gain
cough, shortness of breath
low white blood cell count measured by blood tests ( neutropenia, leukopenia )
abnormal liver function values (elevated transaminases )
elevated bilirubin measured by blood tests
decreased levels of fibrinogen in the blood (a protein involved in blood coagulation).

Uncommon side effects:

It May affect up to 1 in 100 users

diverticulitis (inflamed pockets in the intestine that cause fever, nausea, diarrhea, constipation, abdominal pain)
red and swollen parts of the mouth
high blood fats ( triglycerides )
gastric ulcer
kidney stone
hypothyroidism. _

Rare side effects

It May affect up to 1 in 1,000 users

Stevens-Johnson syndrome (skin rash that can lead to severe blisters and skin loosening)
fatal allergic reactions ( anaphylaxis [fatal])
inflammation of the liver ( hepatitis ), jaundice

Very rare side effects:

It May affect up to 1 in 10,000 users

low blood counts for white blood cells, red blood cells, and platelets are shown by blood tests
liver failure

Side effects are in children and adolescents with sJIA or JPA

Side effects in children and adolescents with sJIA or DJIA are generally similar to those in adults. Some side effects are more common in children and adolescents such as inflammation of the nose and throat, headache, nausea, and lower white blood cell count.

How to store RoActemra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton (EXP or EXP). The expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. The pre-filled pen can be stored for up to 2 weeks at a maximum of 30 ° C after being taken out of the refrigerator.

Store the pre-filled pens in the outer carton. Sensitive to light. Moisture sensitive.

Do not use this medicine if it is cloudy or contains particles, if the solution has a color other than clear to slightly yellowish or if any part of the pre-filled pen appears to be damaged.

The pen must not be shaken. After removing the cap, RoActemra must be injected within 3 minutes to prevent the drug from drying out and blocking the needle. If the pre-filled pen is not used within 3 minutes after removing the cap, discard it in a non-stick container and use a new pre-filled pen.

If the purple indicator does not move after pressing the activation button, discard the pre-filled pen in a non-stick container. Do not attempt to reuse the pre-filled pen. Do not repeat the injection with a new pre-filled pen. Contact your doctor for assistance.

Contents of the pack and other information

What RoActemra contains

The active substance is tocilizumab. Each pre-filled pen contains 162 mg of tocilizumab in 0.9 ml.
The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, L-arginine / L-arginine hydrochloride, L-methionine, Polysorbate 80, and water for injections.

What the medicine looks like and the contents of the pack

RoActemra is a solution for injection. The solution is colorless to slightly yellowish.

RoActemra is supplied as a 0.9 ml pre-filled pen containing 162 mg of tocilizumab solution for injection.

Each pack contains 4 pre-filled pens with a multi-pack containing 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Str. 1