LEFLUNOMIDE (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
- Antirheumatic (disease-modifying)
Description
Leflunomide (le-FLUN-o-mide) is used to relieve somesymptoms caused by rheumatoid arthritis, such as inflammation, swelling, stiffness,and joint pain. This medicine works by stopping the body from producing toomany of the immune cells that are responsible for the swelling and inflammation.
This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For leflunomide, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to leflunomide. Also tell your health care professionalif you are allergic to any other substances, such as foods, preservatives,or dyes.
Pregnancy?Leflunomide must not be takenduring pregnancy because it may cause birth defects in humans. Womenof childbearing age are advised to use reliable contraception before receivingleflunomide.
Breast-feeding?It is not known whether leflunomide passes intothe breast milk. However, leflunomide is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.
Children?Although there is no specific information comparinguse of leflunomide in children with use in any other age group, use is notrecommended in children up to 18 years of age.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way as they do in younger adults or if they cause different sideeffects or problems in older people. There is no specific information comparinguse of leflunomide in the elderly with use in other age groups. However, elderlypeople may be more sensitive to the effects of leflunomide. This may increasethe chance of side effects during treatment.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescriptionor nonprescription (over-the-counter [OTC] medicine.
Other medical problems?The presence of other medicalproblems may affect the use of leflunomide. Make sure you tell your doctorif 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 abilityto 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 moreor less of it, and do not take it more often than your doctor ordered.
Dosing?The dose of leflunomide will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of leflunomide. If your dose is different,do not change it unless your doctor tells you to do so.
- For oral dosage form (tablets):
- For rheumatoid arthritis:
- Adults?At first, 100 mg once a day for three days, then 20mg 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 assoon as possible. However, if you do not remember the missed dose until thenext day, skip the missed dose and go back to your regular dosing schedule.Do not double doses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It is important that your doctor check your progress at regularvisits to make sure that this medicine is working properly and to checkfor unwanted effects.
Leflunomide may cause birth defects in humans if takenduring 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 childrenof the men taking it during the time of conception. Therefore, men takingleflunomide 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 checkwith his doctors.
Studies have not been done in animals or humans to determine if leflunomidewill cause birth defects in the children of men taking leflunomide at thetime of conception. However, it is recommended that men taking this medicineuse condoms as a form of birth control during sexual intercourse. Men takingleflunomide who intend to father a child, should stop taking the medicineand tell their doctor immediately.
Check with your doctor right away if you beginhaving symptoms of lung problems such as cough or shortness of breath withor 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 treatmentwith it, do not have any immunizations (vaccinations)without your doctor's approval.
Side Effects of This Medicine
Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.
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-coloredstools; confusion; constipation; continuing vomiting; cough or hoarseness; dark urine; fainting; fast heartbeat; fever with or without chills; general feeling oftiredness 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 ordifficult urination; pains in stomach, side, or abdomen,possibly radiating to the back; pale skin; pinpoint red spots on skin; rapid, shallowbreathing; red, irritated eyes; red skin lesions, often with a purple center; sores,ulcers, or white spots in mouth or on lips; swollenglands; unexplained bleeding or bruising; unpleasant breath odor; unsteadinessor awkwardness; unusual bleeding or bruising; upper right abdominal pain; vomitingof blood; weakness in arms, hands, legs, or feet
Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Developed: 12/01/1998
Revised: 12/21/2004
