What is Leflunomide?

QUICK LINKS

• Blackbox Warning
• Overview
• Proper Use
• Dosing
• Missed Dose
• Use & Storage
• Before Using
• Allergies
• Pediatric
• Geriatric
• Breast Feeding
• Drug Interactions
• Other Interactions
• Other Medical Problems
• Precautions

Blackbox WarningTOP

OverviewTOP

Leflunomide is used to relieve symptoms caused by active 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.

Proper UseTOP

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.

DosingTOP

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—
      • For patients who are at low-risk for liver disease and bone marrow problems caused by Arava®: At first, 100 milligrams (mg) once a day for 3 days, then 20 mg once a day. Your doctor may adjust the dose as needed. Your doctor may adjust your dose as needed and tolerated.
      • For patients who are at high-risk for liver disease and bone marrow problems caused by Arava®: 20 mg once a day. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed DoseTOP

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.

Use & StorageTOP

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Do not keep outdated medicine or medicine no longer needed.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.

Before UsingTOP

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:

AllergiesTOP

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.

PediatricTOP

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.

GeriatricTOP

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of leflunomide in the elderly. However, elderly patients are more likely to have age-related nerve problems, which may require caution in patients receiving leflunomide.

Breast FeedingTOP

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 InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Teriflunomide

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.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Methotrexate
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Repaglinide
• Rosuvastatin
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Warfarin
• Yellow Fever Vaccine

Other InteractionsTOP

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 ProblemsTOP

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
• Tuberculosis, history of or
• Weak immune system—Use is not recommended in patients with these conditions.

• Diabetes or
• Nerve problems—May increase your risk for more serious side effects.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Should not be used in patients with these condition.

• Lung disease (eg, interstitial lung disease), history of—Use with caution. May make this condition worse.

PrecautionsTOP

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.

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.

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.

Do not use this medicine if you are also using teriflunomide. Using these medicines together may cause unwanted serious side effects.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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.

This medicine may cause drug reaction with eosinophilia and systemic reactions (DRESS), including serious skin reactions. Check with your doctor right away if you have any blistering, peeling, or loose 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.

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.

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.

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

While you are being treated with leflunomide, and after you stop using it, do not have any vaccinations without your doctor's approval. Live virus vaccines should not be given while receiving this medicine.

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.