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Additional information about the drug Leflunomide


Leflunomide is the generic form of the brand-name medicine Arava, which is used to treat rheumatoid arthritis (a condition in which the body attacks its own joints).
This prescription medication is also sometimes used to help treat psoriatic arthritis (a condition that causes joint pain and scaly skin).
Leflunomide belongs to a class of drugs called disease-modifying antirheumatic drugs (DMARDs).
It works by suppressing blood cells that cause inflammation.
The U.S.
Food and Drug Administration (FDA) approved leflunomide in 1998.
It’s marketed as Arava by Sanofi-Aventis.
Leflunomide Warnings Leflunomide contains a black box warning because it may cause serious liver problems that could potentially lead to death.
Tell your doctor immediately if you experience any of the following symptoms while taking this medicine: Yellowing of the skin or eyes ( jaundice ) Dark-colored urine Pale-colored stools Pain in the upper right part of the stomach Severe or persistent nausea Loss of appetite Extreme tiredness Unusual bleeding or bruising Your doctor will monitor your liver function carefully while you take this medicine.
Don’t take leflunomide if you have any type of liver problem.
Drinking alcohol while you’re on leflunomide may increase the risk of liver complications.
Tell your doctor if you drink, or have ever drunk large amounts of alcohol.
Also, tell your doctor if you’re taking any of the following medicines before starting on leflunomide: Tylenol (acetaminophen) Aspirin and other nonsteroidal anti-inflammatory drugs ( NSAIDs ), such as Advil or Motrin ( ibuprofen ) and Aleve or Naprosyn ( naproxen ) Cholesterol -lowering medications ( statins ) Hydroxychloroquine Iron products Laniazid, Rifamate, or Rifater ( isoniazid ) Trexall (methotrexate) Niacin Rifadin, Rimactane, Rifamate, or Rifater ( rifampin ) Leflunomide may lower your body’s ability to fight infections.
Tell your doctor right away if you experience any of the following symptoms while taking this medicine: Fever Sore throat Cough Flu -like symptoms Red, warm, swollen, or painful skin Difficult, painful, or frequent urination Don’t receive any vaccines while taking leflunomide without first discussing it with your doctor.
Tell your doctor if you’re prone to getting infections or if you currently have an infection.
It’s possible that you could have tuberculosis (TB — a serious lung infection) and not know it.
Your doctor will perform a skin test or do a blood test (quantiferon gold) to determine whether you have an inactive form of TB before you start on leflunomide.
Tell your doctor if you have or have ever had TB, have been around someone with TB, or have traveled to areas where TB is common.
Also, let your doctor know if you have, or have ever had, any of the following before taking leflunomide: Cancer Diabetes Kidney disease Human immunodeficiency virus ( HIV ) or acquired immunodeficiency syndrome (AIDS) Hepatitis B or C High blood pressure Leflunomide may cause high blood pressure.
Your healthcare provider will probably want to check your blood pressure before you start on the drug, and frequently throughout your treatment.
Leflunomide may cause birth defects and other serious problems in the offspring of both women and men.
This medicine can stay in your body for up to two years after you stop taking it.
Both women and men who use leflunomide should use effective forms of birth control to prevent pregnancy for as long as your doctor recommends.
If you’re a man who wants to father a child, talk to your doctor about stopping leflunomide and receiving a therapy that helps remove the medicine from your body more quickly.
Pregnancy and Leflunomide Leflunomide contains a black box warning because it could harm an unborn baby.
Don’t take this medicine if you’re pregnant or plan to become pregnant.
You’ll need to use an effective form of birth control before taking leflunomide, during your treatment, and for two years after your treatment ends.
Call your doctor immediately if you think you might be pregnant while using leflunomide.
Let your doctor know if you want to become pregnant within two years of stopping this medicine.
Your healthcare provider may prescribe a treatment that can remove this drug from your body more quickly.
It’s not known whether leflunomide passes into breastmilk or could hurt a breastfeeding baby.
Don’t breastfeed while taking this medicine.
BasicDescription Back to Top Leflunomide Side Effects Common Side Effects of Leflunomide Tell your doctor if any of the following side effects become severe or don’t go away: Diarrhea Vomiting Heartburn Headache Runny nose Dizziness Weight loss Mild muscle aches Back pain Dry skin Hair loss Serious Side Effects of Leflunomide Tell your doctor immediately if you experience any of the symptoms listed in the Leflunomide Warnings section above, or any of the following serious side effects: A rash with or without a fever Mouth sores Itching Blisters on the skin, eyes, or nose Peeling of the skin Chest pain Fast or irregular heartbeat Pale skin New or worsening cough Leg cramps Muscle pain or weakness Pain, burning, numbness, or tingling in the hands or feet Severe or persistent vomiting Severe or persistent headache or dizziness Vision changes Signs of a severe allergic reaction (may include hives, difficulty breathing, tightness in the chest, or swelling of the mouth, face, lips, or tongue) Back to Top Leflunomide Interactions Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you’re taking, especially those listed in the Leflunomide Warnings section above, and any of the following: Blood thinners, such as Coumadin (warfarin) Prevalite ( cholestyramine ) Gold compounds, such as Ridaura (auranofin) Medications to treat cancer Other medications that suppress the immune system, such as Azasan or Imuran ( azathioprine ), Gengraf, Neoral, or Sandimmune ( cyclosporine ), Rapamune (sirolimus), and Astagraf or Prograf ( tacrolimus ) Cuprimine or Depen (penicillamine) Tolbutamide Leflunomide and Other Interactions Leflunomide can cause dizziness.
Don’t drive, operate machinery, or perform any task that requires alertness until you know how this medicine affects you.
Leflunomide and Alcohol Drinking alcohol while taking leflunomide can worsen certain side effects and increase your risk of developing liver problems.
Talk to your doctor before consuming alcoholic beverages while using this medicine.
Back to Top Leflunomide Dosage Leflunomide comes as a tablet to take by mouth, typically once a day.
The tablets come as 10 milligrams (mg) or 20 mg.
The usual dose is 20 mg per day.
Your doctor may start you on a higher dose of leflunomide for the first few days of treatment.
Follow the instructions or your prescription label carefully when taking this medicine.
Don’t take more or less leflunomide than your doctor recommends.
It could take four weeks or longer before you notice the benefits of leflunomide.
Continue to take this medicine even if you feel well.
Don’t stop using it without first talking with your doctor.
Leflunomide Overdose Symptoms of a leflunomide overdose may include: Stomach pain Diarrhea Weakness Extreme tiredness Pale skin Shortness of breath Fast heartbeat If you suspect an overdose, contact a poison control center or emergency room immediately.
You can get in touch with a poison control center at 800-222-1222.
Missed Dose of Leflunomide If you miss a dose of leflunomide, take it as soon as you remember.
But if it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular medication schedule.
Don’t take extra medicine to make up for a missed dose.
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