Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include upper respiratory tract infections common cold, sinus infections , shingles herpes zoster , herpes simplex, bronchitis, nausea, cough, fever, and acne.
Do not split, break, crush, or chew the tablet. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www. If you are having difficulty paying for your medicine, AbbVie may be able to help.
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All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient. Serious infections have happened while taking RINVOQ, including tuberculosis TB and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. You may be at higher risk of developing shingles herpes zoster.
Increased risk of death in people 50 years and older who have at least 1 heart disease cardiovascular risk factor. Cancer and immune system problems. Lymphoma and other cancers, including skin cancers, can happen.
Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Increased risk of major cardiovascular CV events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease CV risk factor, especially if you are a current or past smoker. It explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arava.
Arava is a medicine that contains the active substance leflunomide. It is available as tablets white and round: 10 and mg; yellow and triangular: 20 mg. Arava is used to treat adults with active rheumatoid arthritis an immune-system disease causing inflammation of the joints or active psoriatic arthritis a disease causing red, scaly patches on the skin and inflammation of the joints.
Arava treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis. The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The medicine usually starts to have an effect after four to six weeks.
Its effect may improve further for up to six months. The active substance in Arava, leflunomide, is an immunosuppressant.
With fewer lymphocytes, there is less inflammation, helping to control the symptoms of arthritis. In rheumatoid arthritis, Arava has been studied in four main studies involving over 2, patients, in which it was compared with placebo a dummy treatment , or with methotrexate or sulphasalazine other medicines used to treat rheumatoid arthritis. Two of the studies lasted six months, and two lasted a year. The two longer studies were then extended, with patients remaining on the medicines for at least one more year.
In all of the studies, the main measure of effectiveness was the number of patients who responded to treatment, as defined by disease-specific criteria American College of Rheumatology response rates for rheumatoid arthritis, and the Psoriatic Arthritis treatment Response Criteria for psoriatic arthritis. In rheumatoid arthritis, Arava was more effective than placebo and as effective as sulphasalazine.
These results were maintained in the extension studies. Over the first year of treatment, Arava was as effective as methotrexate, but only when it was taken with folate a type of vitamin B. Arava was not as effective as methotrexate in the extension study. The most common side effects with Arava seen in between 1 and 10 patients in are leucopenia low white-blood-cell counts , mild allergic reactions, increased creatine-phosphokinase levels a marker of muscle damage , paraesthesia abnormal sensations like pins and needles , headache, dizziness, mild increases in blood pressure, diarrhoea, nausea feeling sick , vomiting, inflammation of the mouth such as mouth ulcers, abdominal pain stomach ache , increased liver enzyme levels, hair loss, eczema, rash, pruritus itching , dry skin, tenosynovitis inflammation of the sheath surrounding the tendons , loss of appetite, weight loss and asthenia weakness.
For the full list of all side effects reported with Arava, see the package leaflet. Arava should not be used in people who may be hypersensitive allergic to leflunomide or to any of the other ingredients. Arava must not be used in patients with:. Arava must not be used in pregnant women, in women who may become pregnant, or during breast-feeding. Doctors prescribing Arava need to be aware of the risk of liver problems associated with the medicine.
They also need to take special care when switching a patient to Arava, or when switching a patient who is receiving Arava to another treatment. The marketing authorisation is valid for an unlimited period. For more information about treatment with Arava, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. More detail is available in the summary of product characteristics.
Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
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