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Arava
Arava
(Active Ingredient: Leflunomide)
Arava is used to relieve symptoms caused by rheumatoid arthritis, such as inflammation, swelling, stiffness, and joint pain. This medicine works by stopping the body from producing too many of the immune cells that are responsible for the swelling and inflammation.
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  • INDICATIONS

    ARAVA is indicated in adults for the treatment of active rheumatoid arthritis (RA):

    • to reduce signs and symptoms
    • to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
    • to improve physical function

    INSTRUCTIONS 

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    For oral dosage form (tablets):

    For rheumatoid arthritis:

    • Adults—At first, 100 milligrams (mg) once a day for three days, then 20 mg once a day. Your doctor may adjust the dose as needed.
    • Children—Use and dose must be determined by your doctor. 

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    STORAGE

    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Store the medicine in a closed container at room temperature, away from heat, moisture.

     Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Store the medicine in a closed container at room temperature, away from heat, moisture.

     

  • PRECAUTIONS:

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

    Leflunomide may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men taking leflunomide should use condoms as a form of birth control during sexual intercourse. A man intending to father a child should stop taking this medicine and check with his doctor right away.

    Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, or loosening of the skin; chills; itching; joint or muscle pain; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

    Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; loss of appetite; nausea or vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

    Leflunomide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

    • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination
    • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
    • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
    • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
    • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
    • Avoid contact sports or other situations where bruising or injury could occur.

    Check with your doctor right away if you have a cough with or without a fever, shortness of breath, or any difficulty with breathing.

    You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test.

    Using this medicine may increase your risk of getting serious infections or cancer. Talk to your doctor if you have concerns about this risk.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

  • Stop using this medicine and check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

    Adverse reactions associated with the use of leflunomide in RA include diarrhea, elevated liver enzymes (ALT and AST), alopecia and rash.

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:
    More common
    Bloody or cloudy urine
    cough
    difficult or painful breathing
    difficult, burning, or painful urination
    dizziness
    fever
    frequent urge to urinate
    headache
    loss of appetite
    nausea or vomiting
    sneezing
    sore throat
    tightness in the chest
    yellow eyes or skin
    Less common
    Burning feeling in the chest or stomach
    burning, prickling, or tingling sensation in the fingers or toes
    chest pain
    diarrhea
    fast heartbeat
    indigestion
    joint or muscle pain or stiffness
    pounding heartbeat
    severe stomach pain
    shortness of breath
    tenderness in the stomach area
    unusual tiredness or weakness
    Incidence not known
    Area rash
    black or tarry stools
    bleeding gums
    blistering, peeling, or loosening of the skin
    bloating
    blood in the stools
    burning, numbness, tingling, or painful sensations
    chills
    clay-colored stools
    confusion
    constipation
    continuing vomiting
    cough or hoarseness
    dark urine
    fainting
    fever with or without chills
    general feeling of tiredness or weakness
    high fever
    large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    light-colored stools
    lightheadedness
    lower back or side pain
    pains in the stomach, side, or abdomen, possibly radiating to the back
    pale skin
    pinpoint red spots on the skin
    rapid, shallow breathing
    red skin lesions, often with a purple center
    red, irritated eyes
    sores, ulcers, or white spots in the mouth or on the lips
    swollen glands
    unexplained bleeding or bruising
    unpleasant breath odor
    unsteadiness or awkwardness
    unusual bleeding or bruising
    upper right abdominal or stomach pain
    vomiting of blood
    weakness in the arms, hands, legs, or feet

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
    More common
    Back pain
    hair loss
    heartburn
    skin rash
    stomach pain
    weight loss (unexplained)
    Less common
    Acne
    anxiety
    decreased appetite
    dry mouth
    gas
    irritation or soreness of the mouth
    itching of the skin
    pain or burning in the throat
    runny nose

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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