Arava (Leflunomide) -

Patient Questions and Answers

David L Scott, Department of Rheumatology, GKT School of Medicine, Dulwich Hospital
Original article: 19/04/2002
Reviewed: 27/04/2010
Next review due: 27/04/2012

• What is rheumatoid arthritis (RA)?
• How does Arava work
• What is Arava?
• How long has Arava been available on the National Health Service?
• Why has my doctor prescribed Arava?
• How can Arava be used in the management of RA?
• What are the results of the main clinical trials?
• How will I know that Arava is working?
• Can anyone take Arava?
• How do I Take Arava?
• How long will I need to take Arava?
• Does Arava cause side effects?
• Are there any special precautions I need to be aware of?
• Can I take Arava is I am planning to start a family?
• Can I take Arava with other medicines?
• What happens if I take too much Arava?
• What happens if I forget to take Arava?

What is rheumatoid arthritis (RA)?

Rheumatoid arthritis (RA) is a form of arthritis that affects the lining of the joints, causing inflammation and, in the long term, damage to the joints themselves.

RA usually starts with pain, swelling and stiffness in one or more joints, commonly in the finger or wrist joints. It can also affect the joints in the ankle, foot, hip, elbow, jaw, neck, knee and shoulder.

Although the cause of RA is not clear, it is thought to be an auto-immune disorder caused by the body mistakenly attacking its own tissue.

How does Arava work?

An increased number of lymphocytes move into the joints producing substances that destroy the joint lining, giving rise to symptoms. Arava reduces the number of active lymphocytes in the joints thus reducing inflammation and damage.

What is Arava?

Arava is a disease modifying anti-rheumatic drug (DMARD), which is used to control the symptoms of RA and limit the damage to the joints.

How long has Arava been available on the National Health service?
Arava has been available in the UK since November 1999.

Why has my doctor prescribed Arava?

Your doctor has prescribed Arava in order to control your rheumatoid arthritis and to try to prevent the damage which this disease could do, if left untreated.

Arava can be prescribed to newly diagnosed RA sufferers and those who have not responded to, or have experienced unacceptable side effects on, other treatments.

What are the results of the main clinical trials?

Large Phase III clinical trials have shown that Arava is effective in treating RA in adult patients both with new onset disease and also those having longer standing RA (greater than 2 years). In two placebocontrolled clinical trials the effect of Arava was shown to be statistically superior to placebo.

Arava reduces the signs and symptoms of RA and slows down structural damage.

How will I know that Arava is working?

Arava usually takes about 4-6 weeks to start working, further improvement can occur over the following

4-6 months. You will recognise its effect when you experience an improvement in joint swelling and tenderness and find that you are able to carry out daily tasks more easily.

Can anyone take Arava?

Arava should only be given to people over the age of 18 who have active RA.

Women who are pregnant or planning to become pregnant, and those who are breast-feeding, should not take Arava. Men who are trying to father a child should not take ARAVA.

Other people who should not take Arava include those who have:

• Impairment of liver function
• Severe hypoproteinaemia (marked reduction in blood protein concentration e.g. due to kidney disease)
• Some diseases which affect the immune system, making them more prone to infections (e.g. AIDS)
• Bone marrow impairment
• Serious infections
• Moderate to severe impairment of kidney function
• Remember; do not give your Arava tablets to anyone else, even if they have the same symptoms as you.

Only doctors experienced in the treatment of rheumatoid diseases may prescribe Arava.

How do I take Arava?

When Arava was introduced a loading dose was used to ensure rapid response. This meant that for the first three days of treatment patients took a 100mg Arava tablet once a day. This initial dose allowed the active drug to begin working as soon as possible. Thereafter, most people were given a dose of 10mg or 20mg once daily.

More recently a more cautious approach has been taken and patients are started on 10mg or 20mg once a day, without a loading dose. The treatment takes longer to work but there are fewer side effects.

Your doctor may tailor your dose regimen of Arava on an individual basis.

You can take Arava with or without food. You should not drink alcohol whilst on Arava treatment.

To make it easier to remember to take Arava, it is advised to take it at the same time every day.

How long will I need to take Arava?

Arava is not a cure for RA. It can, however, help alleviate symptoms and slow the rate of damage RA can cause to your joints. Most people with RA will need treatment for the rest of their lives.

It is important to follow your doctor's advice and comply with your treatment programme to make sure you get the maximum benefits in symptom control and joint damage limitation.

Does ARAVA cause side effects?

Like all medicines, Arava can cause side effects but the frequency of serious adverse events is low.

The most common side effects are diarrhoea, nausea, rash and hair loss.

The frequency of serious adverse events was low (< 5%) in placebo-controlled studies comparing Arava with sulphasalazine and methotrexate.

Most frequently reported adverse events in Arava treated patients

(Only those, which were more common than placebo). Patients in all studies n=1339*

• Diarrhoea 17%
• Rash 10%
• Hypertension**(Raised blood pressure) 10%
• Alopecia (Hair loss) 10%
• Nausea 9%
• Headache 7%
• Dyspepsia (Indigestion) 5%
• Abnormal liver blood tests 5%

*All controlled and uncontrolled trials with Arava (Phase II and III).

** Hypertension as a pre-existing condition was over-represented in all Arava treatment groups in Phase

III trials. Analysis of new onset hypertension revealed no difference among the treatment groups.

Diarrhoea

• Most cases (92.8%) were mild or moderate
• Therapy was discontinued in only 2.2% of cases

Alopecia (Hair loss)

• Most cases (99.1%) were mild or moderate
• 65.4% of cases resolved during treatment
• Alopecia was reversible in the 1% who discontinued treatment

Are there any other special precautions I need to be aware of?

Before you start taking Arava, and also whilst taking Arava, your doctor will carry out blood tests to monitor your blood count and your liver function at regular intervals. Your blood pressure will also need to be checked regularly as Arava might cause an increase in blood pressure.

If you plan to travel and require vaccinations, consult your doctor for advice.

Please also refer to the information leaflet inside your pack of Arava.

Can I take Arava if I am planning to start a family?

Women are strictly advised against becoming pregnant while taking Arava. Before starting Arava you must be sure you are not pregnant, as Arava could affect your baby. Women taking Arava must use reliable contraception. If you suspect that you may be pregnant call your doctor immediately.

If you plan to become pregnant you will have to stop Arava treatment. However, Arava lasts in the body for a long time and as a result, you will have to wait for 2 years before becoming pregnant. This waiting period can be shortened if you receive the special 'washout' procedure to help eliminate Arava from your body. For further information please refer to the information leaflet inside your pack of Arava or discuss with your doctor.

Men must also use reliable contraception whilst on Arava treatment.

Can I take Arava with other medicines?

Most drugs can be given with Arava, including non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids commonly used to treat RA.

However, caution is advised when Arava is given with phenytoin, warfarin and tolbutamide. Be sure to tell your doctor about all the medications you are taking so he or she can advise you accordingly.

What happens if I take too much Arava?

If you accidentally take one tablet too many, nothing is likely to happen. If you take several too many, consult your doctor or get other medical advice. If possible, take your tablets or the box with you to show the doctor.

In general an overdose of Arava increases the side effects it causes. Special treatment can be administered by your doctor to counteract this.

What happens if I forget to take Arava?

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not double up on the next dose to make up for the one missed.

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