Leflunomide

Leflunomide slows down the body’s immune system and modifies the process of inflammation. Leflunomide tablets are used to treat patients with rheumatoid arthritis or a form of arthritis called psoriatic arthritis that can occur in people with the skin condition psoriasis. Leflunomide reduces inflammation of the joints, which helps relieve pain, stiffness and swelling.

Leflunomide is an immunosuppressive medicine, which means that it works by reducing the activity of the immune system. Leflunomide rheumatoid arthritis: In rheumatoid and psoriatic arthritis this action helps to reduce inflammation and thus pain and swelling in the joints. Because Leflunomide acts to reduce damage to the joints, rather than just relieve the pain, it belongs to the group of medicines called disease-modifying antirheumatic drugs (DMARDs).

Leflunomide does not work straight away. It usually takes four to six weeks for any noticeable improvement to occur. The full effect may take up to 26 weeks.

Leflunomide is prescribed to treat the following conditions:

• Rheumatoid arthritis: An autoimmune disease in which the body’s immune system attacks normal, healthy tissue, in this case, the joints. As a result, the lining of the joint becomes inflamed, causing damage to joint tissue. This tissue damage can cause long-lasting or chronic pain, stiffness and swelling in, for example, the hands, wrists, ankles and feet.
• Psoriatic arthritis: A form of arthritis in people with the skin condition psoriasis. Like rheumatoid arthritis, psoriatic arthritis is an autoimmune disease, meaning it occurs when the body’s immune system mistakenly attacks healthy tissue, in this case, the joints and skin.

Leflunomide works by reducing the activity of the immune system and thus inflammation in the joints. This helps relieve the associated symptoms. Leflunomide is used when other DMARDs have not been effective.

Always use this medication as directed by your doctor. The general guidelines for use are as follows: Leflunomide 20mg is taken by mouth in tablet form. The tablets should be swallowed whole, with some water. Taking Leflunomide with food can help to prevent nausea. The daily leflunomide doses should be taken at the same time each day to avoid missing any doses.

If you have forgotten to take a dose of leflunomide, you should take it as soon as you remember if it’s still more than eight hours until your next scheduled dose. If it’s less than eight hours until your next dose, skip the dose you missed and take the next scheduled dose as normal. See the package leaflet for more information on the use of Leflunomide.

Leflunomide is available in tablet form in two strengths: leflunomide 10 and leflunomide 20 mg. Leflunomide doses should be determined by a doctor and monitored properly. The general guidelines for use are as follows:

Leflunomide rheumatoid arthritis:

Adults: 100 mg once daily for the first three days followed by 10-20 mg once daily, depending on the severity of the disease.

Leflunomide psoriatic arthritis:

Adults: 100 mg once daily for the first three days, followed by 20 mg once daily.

The same guidelines apply to patients with kidney disease or patients over 65 years. Safety and effectiveness have not been established in children and adolescents under 18 years of age. Therefore, Leflunomide is not recommended for this age group.

For more dosage information, see the package leaflet.

Like all medicines, Leflunomide can cause side effects. The following are some of the side effects that are known to be associated with this medicine:

• Disturbances of the gut such as nausea, vomiting, diarrhoea or abdominal pain;
• Weight loss;
• Headache;
• Dizziness;
• Tiredness;
• Ulcers or sores inside the mouth;
• Change in taste or loss of taste;
• Skin reactions (e.g. rash, itching, hives);
• Tendinitis;
• Raised blood pressure;
• Increased risk of infection, e.g. respiratory infection. This is because this medicine can compromise the body’s ability to fight infections;
• Anaemia or bleeding;
• Liver inflammation (hepatitis) or inflammation of the pancreas (pancreatitis).

For a complete list of side effects, see the package leaflet. Consult a doctor if you experience severe side effects.

Leflunomide is not suitable for everyone and should not be used if:

• You are allergic to leflunomide or any other ingredients in this medicine, or other DMARD or immunosuppressive medicines;
• You are pregnant or trying to conceive.
  Leflunomide could cause abnormalities in a developing baby. Contraception should be started before your treatment begins and continued all the time you are taking this medicine. You should continue to use contraception to prevent pregnancy for at least two years after your treatment is finished. Men who are taking this medicine should avoid fathering a child, as this medicine can reduce DNA integrity in sperm;
• You are breastfeeding. Leflunomide passes into breast milk and could be harmful to the baby. You have a disease affecting the immune system (e.g. AIDS);
• You have a bone marrow disorder;
• You have a serious infection;
• You have a kidney or liver condition.

Before starting treatment with this medicine you will need to have blood tests to check liver function and blood clotting anomalies. These tests should also be carried out throughout treatment.

For more information on contraindications and warnings, see the package leaflet.

Some medicines interact with one another. The interaction may increase the side effects or decrease the effectiveness of the medicines.

The following medicines are known to interact with Leflunomide:

• Medicines that are harmful to the liver;
• Other immunosuppressive medicines, e.g. methotrexate and teriflunomide;
• Blood-diluting medicines (anticoagulants), e.g. acenocoumarol and phenprocoumon;
• Vaccines made from live attenuated micro-organisms;
• Colestyramine or charcoal tablets;
• Rosuvastatin (a medicine used to lower cholesterol);
• Rifampicin (a medicine for tuberculosis and meningitis).

For more information on interactions, see the package leaflet. If you are taking any of the medicines listed above, it is important to tell your doctor before you start treatment with Leflunomide.

Leflunomide can cause side effects such as dizziness. If this happens to you, do not drive a car or operate machinery until you feel better. Dizziness is a common symptom that usually occurs during the first days of treatment.

Alcohol should be avoided whilst taking this medicine. Both Leflunomide and alcohol can damage the liver. Drinking alcohol while taking this medicine increases the risk of side effects on the liver.

Leflunomide is only available at pharmacies or online pharmacies.

Leflunomide is a prescription-only medicine. This means you need a prescription from a registered doctor to obtain it.

Centrafarm BV. (2017, December). Package leaflet Leflunomide CF 10/20 mg, film-coated tablets. Consulted on 19 June 2020 on https://www.geneesmiddeleninformatiebank.nl/Bijsluiters/h106041.pdf

Royal Dutch Pharmaceutical Society. (2020, 21 January). Leflunomide – Apotheek.nl. Consulted on 19 June 2020 on https://www.apotheek.nl/medicijnen/leflunomide#!

Dutch College of General Practitioners. (2017, 2 November.) I have rheumatoid arthritis | Thuisarts. Consulted on 19 June 2020 on https://thuisarts.nl/reumatoï-artritis/ik-heb-reumatoï-artritis

Dutch National Health Care Institute. (n.d.). Leflunomide – Farmacotherapeutisch Kompas. Consulted on 19 June 2020 on https://www.farmacotherapeutischkompas.nl/bladeren/preparaatteksten/l/leflunomide