Description

LeflunomideInformation :

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 Do not keep outdated medicine or medicine no longer needed.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 Do not keep outdated medicine or medicine no longer needed.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

SIDE EFFECTS OF Arava (leflunomide)

In addition to its needed effects, some unwanted effects may be caused by leflunomide. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking leflunomide:

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 of the side effects that can occur with leflunomide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional: