RoActemra (tocilizumab) - United Kingdom[英国药品]

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RoActemra (tocilizumab)

2014-05-25 14:59:18 来源: 作者: 【大中小】浏览:333次评论:0条

Main use	Active ingredient	Manufacturer
Arthritis	Tocilizumab	Roche

How does it work?

RoActemra infusion contains the active ingredient tocilizumab, which is a type of medicine called a human monoclonal antibody. It works by suppressing part of the immune system and modifying the process of inflammation.

Tocilizumab works in a similar way to the natural antibodies produced by our immune system. Our natural antibodies recognise foreign invaders and bind to them, helping our immune systems to attack them and protect us from infections. Monoclonal antibodies like tocilizumab are made in laboratories and are designed to recognise particular proteins in a similar way.

Tocilizumab specifically recognises and binds to a protein produced by the body called interleukin-6. This protein is involved in causing inflammation and is found at high levels in people with rheumatoid arthritis. By preventing the action of interleukin-6 tocilizumab reduces the inflammation and other symptoms of rheumatoid arthritis. It improves physical function of the joints and reduces the rate of joint damage. When treating arthritis, tocilizumab is referred to as a disease-modifying antirheumatic drug (DMARD).

Tocilizumab is only given under the supervision of specialists in arthritis. It is given as a drip into a vein (intravenous infusion) over a period of one hour. This is repeated every four weeks.

What is it used for?

Moderate to severe rheumatoid arthritis.

Tocilizumab is used for rheumatoid arthritis that has not responded adequately to treatment with DMARDs, eg sulfasalazine, methotrexate. It can be used in combination with methotrexate, or on its own for people who cannot take methotrexate.

Warning!

This medicine can compromise the body's ability to fight infections and for this reason it is important to try and avoid exposure to infections during your treatment. Let your doctor know immediately if you get any symptoms of any infection so that it can be treated without delay. This applies for up to three months after finishing treatment, as this is how long it may take for the medicine to be removed from the body. Be aware that this medicine can mask some of the usual symptoms of infection, such as a high temperature (fever), so it is important to be extra vigilant. If you develop a serious infection, further treatment with this medicine should not be given until the infection has cleared up.
You should be tested for tuberculosis (TB) before treatment. Tell your doctor immediately if you experience persistent coughing, weight loss or fever during treatment, as these can be symptoms of TB.
If you experience any abdominal pain, bleeding from the rectum and/or an unexplained change in your bowel habits with a fever while being treated with this medicine you should let your doctor know straight away, as these could be signs of potentially serious inflammation in your gut.
You will need to have a blood test to check your liver function every 4 to 8 weeks for the first 6 months of treatment with this medicine, followed by every 12 weeks thereafter.
You will also need to have regular blood tests to monitor the levels of white blood cells, platelets and fats such as cholesterol in your blood during treatment.
Women who could get pregnant should use effective contraception to prevent pregnancy both during treatment with this medicine, and for at least three months after their last treatment. Seek medical advice from your doctor.

Use with caution in

Liver disease or decreased liver function.
Carriers of hepatitis virus.
Moderate to severely decreased kidney function.
People with low levels of white blood cells or platelets in their blood.
People with currently inactive tuberculosis infection.
People with a history of recurrent or long-term infections.
People with conditions that increase the risk of getting infections, such as diabetes.
People who are or who have recently been receiving treatment that suppresses the activity of the immune system, eg long-term oral corticosteroids, chemotherapy, radiotherapy, medicines to prevent transplant rejection.
People with increased risk factors for cardiovascular diseases, such as high blood pressure or high cholesterol.
People with inflammation in the gut or abdomen or a history of this (eg diverticulitis, stomach ulcers, colitis associated with chemotherapy).
History of or current cancer.
Heavy smokers.

Not to be used in

Active tuberculosis.
People with severe active infections, eg abscesses, sepsis, opportunistic infections.
This medicine is not recommended for children and adolescents under 18 years of age.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.

If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

There is no information about the safety of this medicine during pregnancy, and it is not recommended for use during pregnancy unless considered essential by your doctor. Women who could get pregnant should use effective contraception to avoid pregnancy during treatment, and for at least three months after their last treatment.
It is not known whether this medicine passes into breast milk. Women should not breastfeed during treatment with this medicine, or for three months after their last dose.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

Upper respiratory tract infections such as cough and cold.
Inflammation of the nose and throat (nasopharyngitis).
Raised cholesterol levels.

Common (affect between 1 in 10 and 1 in 100 people)

High blood pressure.
Headache.
Dizziness.
Infection in the tissues under the skin (cellulitis).
Pneumonia.
Cold sores.
Shingles.
Inflammation of the stomach (gastritis).
Abdominal pain.
Mouth ulcers.
Conjunctivitis.
Decrease in the number of white blood cells in the blood.
Fluid retention causing swollen ankles or feet (peripheral oedema).
Rash.
Itching.
Hypersensitivity reactions.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Diverticulitis.
Stomach ulcer.
Inflammation of the lining of the mouth (stomatitis).
Increased levels of fats called triglycerides in the blood.
Kidney stones.
Underactive thyroid gland (hypothyroidism).

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while being treated this one, to ensure that the combination is safe.

Tocilizumab may decrease the blood levels of the following medicines:

atorvastatin
benzodiazepines, such as temazepam, diazepam
calcium channel blockers, such as verapamil, nifedipine
ciclosporin
phenytoin
theophylline
warfarin.

This medicine may decrease the body's immune response. This means that vaccines may potentially be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. It is recommended that live vaccines are not given to people being treated with this medicine.