Arava

The active ingredient in Arava is leflunomide. In the body, leflunomide is converted into its active metabolite teriflunomide which acts as an inhibitor of immune cell production. In this way, it helps calm down your overactive immune system. Depending on the severity of the disease, your healthcare provider may use it in combination with other DMARDs such as sulfasalazine or hydroxychloroquine.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Arava. However, the following is a synopsis of the general guidelines for the use of Arava:

• Typically, Arava is taken by mouth once a day with or without food.
• Arava is a medication with a long half-life meaning that it takes some time for levels to build up in the body before it starts working. For this reason, your healthcare provider may recommend a loading dose so it builds up quickly.
• Use exactly as prescribed. Do not exceed the recommended dose or duration of use.
• Prior to starting Arava, your healthcare provider may recommend certain tests to ensure Arava is a safe and appropriate choice for you. These may include a pregnancy test, tuberculosis screening, blood pressure screening, and other relevant blood tests.
• Live vaccines cannot be used during treatment with Arava. Your healthcare provider will check your immunization record and ensure you are up to date before starting Arava.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Arava include:

• Diarrhea
• Hair loss
• Nausea
• Loss of appetite and weight loss
• Heachache
• Rash
• Abnormal liver enzymes
• Indigestion
• Increased incidence of respiratory infections
• Back pain

Some individuals may experience serious side effects while using Arava. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of liver problems such as jaundice or yellowing of the skin or eyes, unusual tiredness, loss of appetite, right-sided abdominal pain, or dark urine
• Signs of a serious infection such as fever, trouble breathing, sore throat, weakness, cough, sweating, chills, stomach pain, diarrhea, burning while urinating, or urinating more often
• Signs of low blood cell count such as easy bruising or bleeding, recurrent infections, fever, unusual tiredness, or pallor of the skin.
• Signs of a serious skin reaction such as a widespread skin rash with fever, blisters, or peeling of the skin. These symptoms may be the first signs of a life-threatening drug reaction such as Stevens-Johnson Syndrome or toxic epidermal necrolysis (TEN).
• Skin ulcers and mouth ulcers
• Signs of peripheral neuropathy such as numbness or tingling of the hands or feet
• Signs of interstitial lung disease such as cough, shortness of breath, chest pain, or fever
• Signs of an allergic reaction such as hives, rash, itching, difficulty breathing, or swelling of the face, lips, tongue, or throat

These are not all of the possible side effects of Arava. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Arava, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Recent, current, or severe infection (including tuberculosis)
• Cancer
• Low blood counts or pancytopenia
• Thrombocytopenia (low platelets)
• Agranulocytosis (low white blood cells)
• Diabetes
• Peripheral neuropathy
• Diseases of the immune system or immunosuppression
• Bone marrow disease or a blood disorder
• High blood pressure
• Heart disease
• Kidney disease
• Liver disease (including hepatitis)
• Alcohol abuse
• Lung disease
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Boxed Warning

• Arava is teratogenic and can cause birth defects in the unborn child. The use of Arava is contraindicated in pregnant women.
• Arava can cause severe liver injury and fatal liver failure. The use of Arava is contraindicated in those with hepatic impairment. Do not use Arava if there is a history of liver disease or abnormal liver function tests.

Do not use Arava if you have:

• Liver problems
• An allergy to leflunomide or any of the other ingredients found in Arava
• Are currently using teriflunomide
• Are pregnant or plan to become pregnant

Arava does take some to work. It may take several weeks of consistent use to see the benefit. While you wait for Arava to kick in, your healthcare provider may start you on a corticosteroid or NSAID to manage the inflammation in the meantime.

When Arava is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Rifampin
• Paclitaxel
• Pioglitazone
• Rosiglitazone
• Repaglinide
• Warfarin
• Oral contraceptives or birth control
• Alosetron
• Duloxetine
• Theophylline
• Tizanidine
• Cefaclor
• Cimetidine
• Ciprofloxacin
• Penicillin G
• Ketoprofen
• Furosemide
• Methotrexate
• Zidovudine
• Rosuvastatin, atorvastatin, pravastatin, simvastatin
• Mitoxantrone
• Nateglinide
• Cholestyramine

Arava film-coated tablets are available in the following strengths:

• 10 mg tablet
• 20 mg tablet
• 100 mg tablet

Arava should be stored at room temperature away from light and out of reach of children.

Arava is manufactured by the pharmaceutical company Sanofi-Aventis.

Yes, a generic is available of the brand name Arava.

Arava can stay in the body for a long time so your healthcare provider may prescribe a course of cholestyramine to speed up the washout of the medication from the body. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Arava.

Arava can cause harm to the unborn child and should not be used if you are pregnant. If you can become pregnant, you should use an effective form of birth control while you are on this medication. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

Arava can cause harm to the breastfeeding infant. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.