What RoActemra 162 mg Solution for Injection in Pre-Filled Syringe is used for and how to use it
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RoActemra 162 mg Solution for Injection in Pre-Filled Syringe - Consumer Medicine Information

Manufacture: Roche
Country: Great Britain
Condition: Arthritis (Rheumatoid Arthritis), Arthritis, Rheumatoid (Rheumatoid Arthritis), Juvenile Rheumatoid Arthritis
Class: Immunosuppressive agents
Form: Liquid solution, Intravenous (IV)
Ingredients: Tocilizumab, L-Histidine, L-Histidine monohydrochloride monohydrate, L-Arginine, L-Arginine hydrochloride, L-Methionine, Polysorbate 80, Water for injections.

What RoActemra is and What it is Used For

RoActemra contains the active substance tocilizumab, which is a protein made from specific immune cells (monoclonal antibody), that blocks the action of a specific protein (cytokine) called interleukin-6. This protein is involved in inflammatory processes of the body, and blocking it can reduce the inflammation in your body.

  • RoActemra is used to treat adults with moderate to severe active rheumatoid arthritis (RA), an autoimmune disease, if previous therapies did not work well enough.
  • RoActemra can also be used to treat adults who have not had previous methotrexate treatment if they have severe, active and progressive rheumatoid arthritis.

RoActemra helps to reduce symptoms such as pain and swelling in your joints and can also improve your performance of daily tasks. RoActemra has been shown to slow the damage to the cartilage and bone of the joints caused by the disease and to improve your ability to do normal daily activities.

RoActemra is usually given in combination with methotrexate. However, RoActemra can be given alone if your doctor determines that methotrexate is inappropriate.

What You Need to Know Before You Use RoActemra

Do Not Use RoActemra

  • if you are allergic to tocilizumab or any of the other ingredients of this medicine (listed in section Contents of the Pack and Other Information).
  • if you have an active, severe infection.

If either of these applies to you, tell a doctor. Do not use RoActemra.

Warnings and Precautions

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

  • If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips, tongue, face or skin itching, hives or rash during or after the injection, then tell your doctor immediately.
  • 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 experienced any allergic reaction symptoms after RoActemra administration.
  • If you have any kind of infection, short- or long-term, or if you often get infections. Tell yourdoctor immediately if you feel unwell. RoActemra can reduce your 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 have had tuberculosis, tell your doctor. Your doctor will check for signs and symptoms of tuberculosis before starting RoActemra. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) or any other infection appear during or after therapy tell your doctor immediately.
  • If you 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 have liver disease, tell your doctor. Before you use RoActemra, your doctor may do a blood test to measure your liver function.
  • If any patient has recently been vaccinated, or is planning a vaccination, tell your doctor. All patients should be up-to-date with all their vaccinations before they start treatment with RoActemra. Certain types of vaccines should not be given while receiving RoActemra.
  • If you have cancer, tell your doctor. Your doctor will have to decide if you can still be given RoActemra.
  • If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor. These factors need to be monitored while receiving RoActemra.
  • If you have moderate to severe kidney function problems, your doctor will monitor you.
  • If you have persistent headaches.

Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.

Children and Adolescents

RoActemra subcutaneous injection is not recommended for use in children under 18 years of age

Other Medicines and RoActemra

Tell your doctor if you are taking any other medicines , or have recently taken any. RoActemra can affect the way some medicines work, and the dose of these may require adjustment. If you are using medicines containing any of the following active substances, tell your doctor:

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

Due to lack of clinical experience, RoActemra is not recommended for use with other biological medicines for the treatment of RA.

Pregnancy, Breast-feeding

RoActemra is not to be used in pregnancy unless clearly necessary. Talk to your doctor if you are pregnant, may be pregnant, or intend to become pregnant.

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

Stop breast-feeding if you are to be given RoActemra, and talk to your doctor. Leave a gap of at least 3 months after your last treatment before you start breast-feeding. It is not known whether RoActemra is passed into breast milk.

Driving and Using Machines

This medicine can cause dizziness. If you feel dizzy, do not drive or use machines.

How to Use RoActemra

Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA.

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose is 162 mg (the content of 1 pre-filled syringe) given once a week.

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

Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed "Instructions for administration" at the end of this leaflet.

If You Use More RoActemra Than You Should

Because RoActemra is given in one pre-filled syringe, it is unlikely that you will receive too much. However, if you are worried, talk to your doctor, pharmacist or nurse.

If You Forget to Use RoActemra

It is very important to use RoActemra exactly as prescribed by your doctor. Keep track of your next dose. If you miss your weekly dose within 7 days, take your dose on the next scheduled day. If you miss your once every other weekly dose within 7 days, inject a dose as soon as you remember and take your next dose at your regular scheduled time. If you miss your weekly or once every other weekly dose more than 7 days or are not sure when to inject RoActemra, call your doctor or pharmacist.

If You Stop Using RoActemra

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

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

Possible side effects

Like all medicines, RoActemra can cause side effects, although not everybody gets them. Side effects could occur 3 months or more after your last dose of RoActemra.

Possible Serious Side Effects: Tell a Doctor Straight Away.

These are common: they may affect up to 1 in every 10 users

Allergic reactions

During or after injection:

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

    If you notice any of these, tell your doctor immediately.

Signs of Serious nfections

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

If you notice any of these, tell your doctor as soon as possible.

Very common side effects

These may affect 1 in 10 patients or more

  • upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache
  • high blood fat (cholesterol) levels.

Common side effects

These may affect up to 1 in 10 patients

  • lung infection (pneumonia)
  • shingles (herpes zoster)
  • cold sores (oral herpes simplex), blisters
  • skin infection (cellulitis) sometimes with fever and chills
  • rash and itching, hives
  • allergic (hypersensitivity) reactions
  • eye infection (conjunctivitis)
  • headache, dizziness, high blood pressure
  • mouth ulceration, stomach pain
  • fluid retention (oedema) in the lower legs, weight increase
  • cough, shortness of breath
  • low white blood cell counts shown by blood tests (neutropenia, leucopenia)
  • abnormal liver function tests (increased transaminases)
  • increased bilirubin shown by blood tests
  • injection site reactions.

Uncommon side effects

These may affect up to 1 in every 100 patients

  • diverticulitis (fever, nausea, diarrhoea, constipation, stomach pain)
  • red swollen areas in the mouth
  • high blood fat (triglycerides)
  • stomach ulcer
  • kidney stones
  • underactive thyroid.

Very rare side effects

These may affect up to1in every 10,000 patients

  • stevens-johnson syndrome (skin rash, which may lead to severe blistering and peeling of the skin)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie/
e-mail:medsafety@hpra.ie

Malta

ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

United Kingdom

Yellow Card Scheme
Website: https://yellowcard.mhra.gov.uk/

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 syringe label and carton (EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C). Do not freeze.

Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.

Once removed from the refrigerator, RoActemra must be administered within 8 hours and should not be kept above 30°C.

Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to yellowish, or any part of the pre-filled syringe appears to be damaged.

The syringe should not be shaken. After removing the cap the injection must be started within 5 minutes to prevent the medicine from drying out and blocking the needle. If the pre-filled syringe is not used within 5 minutes of cap removal, you must dispose of it in a puncture resistant container and use a new pre-filled syringe.

If following insertion of the needle, you cannot depress the plunger, you must dispose of the pre-filled syringe in a puncture resistant container and use a new pre-filled syringe.

Contents of the Pack and Other Information

What RoActemra contains

  • The active substance is tocilizumab.

    Each pre-filled syringe contains 162 mg 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 RoActemra Looks Like and Contents of the Pack

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

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

Each pack contains 4 pre-filled syringes with multipacks containing 12 (3 packs of 4) pre-filledsyringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Great Britain