Pronunciation:

le-FLOO-noh-mide

Brand Names:

• Arava

Dosage Forms:

• Tablet

Warnings:

Pregnancy must be excluded before the start of treatment with leflunomide. Leflunomide is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during leflunomide treatment or prior to the completion of the drug elimination procedure after leflunomide treatment .

Pregnancy must be excluded before the start of treatment with leflunomide. Leflunomide is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during leflunomide treatment or prior to the completion of the drug elimination procedure after treatment .

Classifications:

Therapeutic—

Immune Suppressant

Pharmacologic—

Dihydroorotate Dehydrogenase Inhibitor

Uses of This Medicine:

Leflunomide is used to relieve some 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.

Before Using This Medicine:

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.

Children—

Although there is no specific information comparing use of leflunomide in children with use in any other age group, use is not recommended in children up to 18 years of age.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of leflunomide in the elderly with use in other age groups. However, elderly people may be more sensitive to the effects of leflunomide. This may increase the chance of side effects during treatment.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast-feeding—

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.

Other medicines—

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

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 problems, history—May make side effects worse

• Disease of the immune system or
• Infections, severe—Leflunomide may decrease the body's ability to fight infection

• Liver disease, including hepatitis B or C or
• Renal disease—The chance of side effects may be increased

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often 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:
    • Adults—At first, 100 mg once a day for three days, then 20 mg once a day. Your doctor may decrease the dose as needed.
    • Children—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.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Leflunomide may cause birth defects in humans if taken during pregnancy. Therefore, if you suspect that you may have become pregnant, stop taking this medicine immediately and check with your doctor.

Leflunomide may cause birth defects in the children of the men taking it during the time of conception. Therefore, 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 doctors.

Studies have not been done in animals or humans to determine if leflunomide will cause birth defects in the children of men taking leflunomide at the time of conception. However, it is recommended that men taking this medicine use condoms as a form of birth control during sexual intercourse. Men taking leflunomide who intend to father a child, should stop taking the medicine and tell their doctor immediately.

Check with your doctor right away if you begin having symptoms of lung problems such as cough or shortness of breath with or without a fever

Do not drink alcohol while using this medicine. Alcohol can increase the chance of liver problems.

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

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

More common

Bloody or cloudy urine

congestion in chest

cough

difficult, burning, or painful urination

difficult or painful breathing

dizziness

fever

frequent urge to urinate

headache

loss of appetite

nausea and/or vomiting

sneezing

sore throat

yellow eyes and/or skin

Less common

Burning feeling in chest or stomach

burning, prickling, or tingling sensation in fingers and/or toes

chest pain

diarrhea

fast heartbeat

indigestion

joint or muscle pain or stiffness

pounding heartbeat

severe stomach pain

shortness of breath

tenderness in stomach area

unusual tiredness or weakness

Incidence not known

Area rash

black or tarry stools

bleeding gums

blistering, peeling, loosening of skin

bloating

blood in 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 face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

light-colored stools

lightheadedness

loss of appetite

lower back or side pain

painful or difficult urination

pains in stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on skin

rapid, shallow breathing

red, irritated eyes

red skin lesions, often with a purple center

sores, ulcers, or white spots in mouth or on 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 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

constipation

decreased appetite

dry mouth

gas

irritation or soreness of mouth

itching of the skin

pain or burning in 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.