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Class: Immunotherapy

Generic Name: leflunomide

Trade Name: Arava®

How is this Arava used? Arava is approved for adults with active rheumatoid arthritis (RA).

What is Arava's mechanism of action? Arava is an immunomodulatory drug (DMARD) that works by suppressing the immune system to prevent it from damaging tissues and joints. The immune system helps protect the body from harmful substances such as infectious agents and bacteria. In people with RA, however, the immune system attacks and destroys normal tissue—namely, the tissue around the joints. This leads to inflammation and damage to the cartilage and bone and causes pain. Specifically, Arava blocks the action of a certain enzyme to decrease the proliferation of rapidly dividing white blood cells.

How is Arava given (administered)? Arava is taken orally. Dosage depends on drug tolerance and other factors.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Arava. Before treatment, blood pressure will be taken and blood will be drawn to check levels of platelets, white blood cell counts, and hemoglobin or hematocrit. Patients will be checked monthly for 6 months against baseline numbers., then every 6-8 weeks thereafter. If Arava is being used as well as an immunosuppressant such as methotrexate, you will be monitored more frequently. Liver enzyme levels will be monitored to check for liver damage or disease.

Upon discontinuation of Arava, it may take up to 2 years for the active ingredients to be cleared from the system without undergoing the drug elimination procedure. Patients who receive a reduction in dosage will be monitored carefully to check for plasma concentrations.

What are the most common side effects of treatment with Arava?

  • Diarrhea
  • Headache
  • Nausea
  • Elevated liver enzymes
  • Hair loss
  • Rash
  • Hypertension
  • Back pain
  • Stomach pain
  • Abdominal pain
  • Allergic reaction
  • Bronchitis
  • Dizziness
  • Mouth sores
  • Itching
  • Sinus infection
  • Vomiting
  • Tendon sheath inflammation

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What are some of the less common but potentially serious side effects of Arava?

  • Liver damage
  • Immunosuppression
  • Bone marrow suppression
  • Numbness and pain in the hands and feet
  • Interstitial lung disease

Are there any special precautions patients should be aware of before starting treatment?

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  • Pregnancy must be excluded before taking Arava. Females must avoid becoming pregnant until the drug elimination procedure has been completed and must use a reliable form of contraception.
  • Arava is not recommended for patients who are hypersensitive to leflunomide or teriflunomide.
  • Severe infections may occur when using Arava. Patients with an active infection will not start treatment. Patients will be screened for tuberculosis (TB) before treatment with Arava.
  • Stevens-Johnson syndrome, a rare disorder of the skin and mucous membranes, has been known to occur. Treatment with Arava will be stopped immediately and patients will undergo accelerated elimination procedure.
  • Interstitial lung disease may occur and may be fatal. If new or worsening symptoms occur, Arava will be stopped immediately and patients will undergo accelerated elimination procedure.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines and all herbal supplements as other medicines may affect each other and cause serious side effects.

What should patients be aware of upon cessation of treatment with Arava? It is recommended that an accelerated drug elimination procedure be used to reduce the plasma concentrations of the active metabolite, teriflunomide.

When should patients notify their physician?

Contact your healthcare professional immediately in case of any of the following:

  • You have symptoms of an infection. These include: fever; unusual tiredness; cough; flu-like symptoms; and warm, red, or painful skin.
  • You have symptoms of an allergic reaction. These include: hives, rash, or mucous membrane lesions.
  • You have symptoms of liver dysfunction or disease. These include: unusual tiredness, abdominal pain, or jaundice.
  • You have symptoms of a blood deficiency. These include: bruising or bleeding easily, recurrent infections, fever, paleness, or unusual tiredness.
  • You have symptoms of lung disease. These include: cough, shortness of breath, nail deformity, unusual tiredness, or weight loss.
  • You become pregnant.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 01/17.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.