Leflunomide (Oral Route)

Description

Leflunomide 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.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of leflunomide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of leflunomide in the elderly.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Methotrexate


• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bacillus of Calmette and Guerin Vaccine, Live


• Cholestyramine


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rifampin


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood or bone marrow problems, history of or


• Bone marrow dysplasia or


• Immune system problem or


• Infection, severe or uncontrolled or


• Liver disease, including hepatitis B or C or


• Lung disease, history of or


• Tuberculosis, history of or


• Weak immune systema€”Use with caution. May make these conditions worse.

• Kidney diseasea€”Use with caution. Effects may be increased because of slower removal of the medicine from the body .

Proper Use

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.

Dosing

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:
    
    
    
    • Adultsa€”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.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

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 the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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. 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 pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; loss of appetite; nausea and 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 .

While you are being treated with leflunomide, and after you stop using it, do not have any immunizations (vaccinations) without your doctor`s approval.

You will need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor .

Side Effects

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


• Congestion in the chest


• Cough


• Difficult, burning, or painful urination


• Difficult or painful breathing


• Dizziness


• Fever


• Frequent urge to urinate


• Headache


• Loss of appetite


• Nausea or vomiting


• Sneezing


• Sore throat


• 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


• Chest pain


• Chills


• Clay-colored stools


• Confusion


• Constipation


• Continuing vomiting


• Cough or hoarseness


• Dark urine


• Fainting


• Fast heartbeat


• 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


• Loss of appetite


• 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, irritated eyes


• Red skin lesions, often with a purple center


• 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 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


• Red or irritated eyes


• Runny nose

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.