Arava

Arava Medication Information:

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Arava medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.

Arava 10 mg
Arava 20 mg

About Arava

IMPORTANT INFORMATION AND WARNING: Arava may cause severe birth defects.

What Arava is used for

Arava is used to treat adult patients who have active rheumatoid arthritis.

What Arava does

In rheumatoid arthritis, the immune system (body's defenses against infection and foreign substances) turns against a patient's own joint tissue. This causes inflammation and the patient can have pain, stiffness, and swelling, which over many months can lead to deformities of the joints.

Arava works in rheumatoid arthritis by reducing or suppressing to a certain extent the abnormal activation and multiplication of cells responsible for the inflammation.

From the results of studies in patients with rheumatoid arthritis you can expect Arava to reduce your arthritis signs and symptoms. It may take about 4 weeks until you start to feel an improvement in your symptoms.

When Arava should not be used

Tell your doctor and do not start treatment with Arava:

  • if you suspect that you may be pregnant, you must inform your doctor and you must not start taking Arava. Arava may increase the risk of having a baby with a birth defect.

  • if you are of childbearing age, it must be confirmed with a pregnancy test that you are not pregnant just before you begin treatment with Arava. There is also a risk that male patients taking Arava might father a deformed baby. Both male and female patients should read below in the Warnings and Precautions “What Are the Risks of Birth Defects With Arava?”

  • if you have a disease of the liver. Otherwise, your disease may get worse;

  • if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction, for example red rash, skin peeling, blisters) or to any of the other ingredients (see What the important nonmedicinal ingredients are:);

  • if you suffer from a disease (for example, AIDS) which decreases the strength of your body's defenses against infection. Otherwise the weakening of your body's defenses against infection worsen;

  • if your bone marrow does not work well or if the number of red cells, white cells, or platelets in your blood is very much decreased. Again Arava could worsen this problem;

  • if you are suffering from a serious infection, as your infection may be more difficult to treat;

  • if you have a disease of the kidney, because the kidney plays a role in the elimination of Arava.

  • if you are nursing your baby, as Arava passes into breast milk and its effect on the nursing infant are not known;

  • if you are younger than 18 years of age, it is not recommended that you take Arava. This is because there is not enough experience of its use in children and adolescents.

What the medicinal ingredient is

The tablets contain the active drug, leflunomide.

What the important nonmedicinal ingredients for Arava are

Lactose monohydrate.

The other nonmedicinal ingredients are: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, starch, talc, titanium dioxide, yellow ferric oxide (20 mg tablet only).

What dosage forms Arava comes in

Arava comes as tablets of 3 different strengths:

  1. a 100 mg white round tablet with 'ZBP' code on one side;

  2. a 20 mg light yellow triangular tablet with 'ZBO' code on one side

  3. a 10 mg white round tablet with 'ZBN' code on one side


Warnings and Precautions

The medication can stay in your body for a long period of time. Therefore some precautions and side effects may follow from this characteristic of the drug.

What Are the Risks of Birth Defects With Arava?

For female patients

You may be at high risk of having a deformed baby if you do not follow the following instructions:

If you are pregnant, or suspect that you may be, you must tell your doctor and you must not start taking Arava.

If you are of childbearing age (women who might get pregnant), it must be confirmed with a pregnancy test that you are not pregnant just before beginning your treatment.

Women must use reliable birth control methods when taking Arava. If you are of childbearing age, discuss methods to avoid becoming pregnant with your doctor.

The risk of giving birth to a deformed baby can best be estimated by the amount of Arava remaining in your body when you become pregnant. If you plan to become pregnant after stopping Arava, it is important to inform your doctor beforehand. Once you stop taking Arava, you must wait a period of 2 years before trying to get pregnant. However, this waiting period may be shortened to a few weeks by taking a certain medicine that will speed up the elimination of Arava from your body. If this option is chosen, inform your doctor if you are taking an oral contraceptive pill. The medicine that speeds up the elimination of Arava may lower the effect of your contraceptive pill and you may need another contraceptive method during this period. In either case it should be confirmed by two blood tests two weeks apart that Arava has been sufficiently eliminated from your body before you try to become pregnant. Your doctor can give you more information about the options available to reach low blood levels of Arava. For information regarding blood levels measurements, please also contact your doctor.

If you are currently taking Arava, or if you have taken it within the last 2 years and you believe that you may be pregnant, it is VERY IMPORTANT that you contact your doctor immediately. You must have a pregnancy test at the first delay of your period, and if the test confirms that you are pregnant, discuss with your doctor the risk of the treatment to your baby. Your doctor may propose at the first delay of your period to rapidly start the treatment which speeds up elimination of Arava from the body, as this may decrease the risk to your baby.

For male patients

You may be at high risk of fathering a deformed baby if you do not follow the following instructions:

Once you start taking Arava, you should take every precaution to avoid getting your partner pregnant. You should use a reliable birth control as recommended by your doctor, during Arava therapy. If you have any questions about reliable birth control methods, consult your doctor.

If you wish to father a child after having stopped Arava, it is important to inform your doctor beforehand. Once you stop taking Arava, you must wait a period of 2 years before trying to father a child. However, this waiting period may be shortened to a few weeks by taking a certain medicine that will speed up the elimination of Arava from your body. In either case it should be confirmed by two blood tests that Arava has been sufficiently eliminated from your body and you should then wait for another 3 months before you try to get your partner pregnant. Your doctor can give you more information about the options available to reach low blood levels of Arava. For information regarding blood level measurements, please also contact your doctor.

If you are currently taking Arava, or if you have taken it within the last 2 years and your partner suspects that she may be pregnant you must both immediately contact your doctors. Your partner must have a pregnancy test at the first delay of her period, and if the test confirms that she is pregnant, you should discuss with your doctors the risk of the treatment to the baby.

What are Other Precautions With Arava?

All patients

Before you start to take Arava, and also while you are taking Arava, your doctor will carry out blood tests to monitor your blood cells and your liver at regular intervals. Similarly, your blood pressure will need to be checked regularly. It is important to keep your medical appointments.

Tell your doctor if you have ever suffered from tuberculosis. If you have ever had tuberculosis, your doctor will carefully monitor you, in order to be able to treat you without delay in case it becomes active again.

In certain circumstances (serious side effects, changing antirheumatic treatment or in case of a desired pregnancy) your doctor will decide that you should take a certain medicine which speeds up the elimination of Arava from your body.


Interactions with Arava

Drinking alcohol with Arava

It is not recommended to drink alcohol during treatment with Arava. Drinking alcohol while taking Arava may result in harm to your liver more than you would usually expect.

Taking other medicines together with Arava

Medication to relieve pain and inflammation such as nonsteroidal anti-inflammatory drugs (NSAIDs) or cortisone can be taken together with Arava. However, your doctor will give you specific instructions about these medicines.

You must not receive any type of live vaccinations while treated with Arava or within 6 months after stopping Arava. Check ahead with the clinic if you have to be vaccinated.

Before you start taking Arava, be sure to tell your doctor about all medicines you are taking or have taken recently including any that you bought without a prescription or any natural products. This is because the effects of Arava or the other medicines may be changed or you might get side effects. Furthermore, do not start any new medicine, whether prescription, non-prescription or natural products without first checking with your doctor.

Examples of drugs that may interact with Arava are:

  • activated charcoal

  • antimalarial drugs

  • azathioprine

  • cholestyramine

  • D penicillamine

  • gold

  • methotrexate

  • phenytoin

  • rifampin

  • tolbutamide

  • warfarin

Arava can stay in your body for a long period of time after you stop taking it. Therefore, when Arava is stopped and another drug (for example methotrexate) is started to treat your rheumatoid arthritis, there is a possibility of increased risks of adverse events. Your doctor may give you a certain medicine that will speed up the elimination of Arava from your body before starting the other drug.


Proper Use of Arava

Usual dose

Arava has been prescribed for you alone. Do not share it with anyone else, even if their symptoms are the same as yours, as it may bring more harm than good.

Arava is supplied as film-coated tablets of 10, 20, and 100 mg strengths. Your doctor will usually want you to build up the amount of Arava in your body. For doing so, you will usually start the treatment by taking a tablet of 100 mg once daily for the first 3 days. Thereafter, your doctor will usually reduce the dose to a tablet of 20 mg to be taken once daily. For some people, their doctor will instead prescribe a tablet of 10 mg once daily.

You should always follow your doctor's instructions. Do not take any more or any less tablets than what your doctor says. You will normally take Arava over long periods of time. However, your doctor will advise you if and when you need to stop taking Arava.

You can take Arava during meals or at any time between meals. However, it works best if you take it at the same time every day. Swallow the tablet whole with a glass of water or another fluid.

Overdose

If you accidentally take one tablet too many, nothing is likely to happen. If you accidentally take several tablets too many, contact 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 may lead to increased symptoms as described under Side Effects and What to Do About Them:. Should this happen, it is possible that medicine may be administered by your doctor in order to speed up the elimination of Arava from your body.

 

Technical Information