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Arava (Generic Leflunomide)

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If you are trying to get pregnant or are already pregnant, avoid taking leflunomide. The foetus could suffer from leflunomide. Leflunomide shouldn’t be used until after a pregnancy test comes back negative and your doctor confirms that you are not pregnant. Before starting to take leflunomide, while taking it, and for two years after treatment, you must utilise a reliable method of birth control. Call your doctor right away if your menstruation is irregular or you miss a period while taking leflunomide. If you intend to become pregnant within two years of ceasing leflunomide therapy, discuss your plans with your doctor. Your doctor may recommend a procedure to hasten the removal of this medicine from your body.

Leflunomide may result in liver damage that is fatal or even life-threatening. People who already have liver disease and those taking other drugs that are known to cause liver damage are more at risk for liver damage. Inform your doctor if you consume or have previously consumed excessive amounts of alcohol, have hepatitis or any other form of liver illness. Inform your doctor and pharmacist if you are taking acetaminophen (Tylenol, found in other over-the-counter products), aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), statins, hydroxychloroquine, iron products, isoniazid (Laniazid, found in Rifamate, in Rifater), methotrexate (Trexall), niacin (nicotinic acid) (Rifadin, Rimactane, in Rifamate, in Rifater). Call your doctor right away if you have any of the following symptoms: nausea, unusual bruising or bleeding, lack of energy, appetite loss, stomach pain in the upper right area, yellowing of the skin or eyes, dark urine, or flu-like symptoms.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to leflunomide, your doctor will prescribe a number of tests.

You should discuss the dangers of taking leflunomide with your doctor.

Why is this medication prescribed?

Rheumatoid arthritis is treated with leflunomide alone or in conjunction with other drugs (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function). Leflunomide belongs to the group of pharmaceuticals known as disease-modifying antirheumatic drugs (DMARDs). It functions by reducing inflammation and slowing the progression of the disease, which can allow rheumatoid arthritis patients be more active.

How should this medicine be used?

Leflunomide is available as an oral tablet. Typically, it is given once day. For the first three days of treatment, your doctor could advise you to take a higher dose of leflunomide. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take leflunomide as prescribed by your doctor. Never take it in larger or less amounts or more frequently than directed by your doctor.

If you encounter certain serious adverse effects, your doctor may need to lower your dose or stop your therapy. During your treatment, be careful to let your doctor know how you are feeling.

Leflunomide does not treat rheumatoid arthritis, however it may help you manage its symptoms. Even if you feel good, keep taking leflunomide. Without consulting your doctor, do not discontinue taking leflunomide.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking leflunomide,

  • If you have an allergy to leflunomide, teriflunomide (Aubagio), any other drugs, or any of the substances in leflunomide tablets, let your doctor and pharmacist know right once. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention the drugs in the IMPORTANT WARNING section as well as any of the following: anticoagulants (also known as “blood thinners”) like cholestyramine (Prevalite), warfarin (Coumadin Jantoven), auranofin (Ridaura), azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), tacrolimus (Astagraf, Prograf), and sirolimus (Rapamune) are immune system suppressors. Penicillamine (Cuprimine, Depen) and tolbutamide are also immune system suppressors. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your physician if you have or have ever had a major illness, or if you frequently contract infections, cancer, or other diseases that affect the bone marrow or the immune system (such as HIV and AIDS), diabetes, or kidney disease.
  • Inform your doctor if you are nursing a child. If you are taking leflunomide, you should not breastfeed.
  • Talk to your doctor about discontinuing leflunomide and getting a treatment to hasten the removal of this medicine from your body if you intend to father a child.
  • Consult your doctor about whether drinking alcohol is safe while taking leflunomide.
  • Leflunomide may make it harder for you to fight infections. Inform your doctor if you currently have an infection or if you experience any infection-related symptoms, such as fever, coughing, or flu-like symptoms. Call your doctor if you have any of the following signs while taking leflunomide: Flu-like symptoms, a warm, red, swollen, or painful area of skin, painful, difficult, or frequent urination, or other infection-related symptoms are examples of flu-like symptoms. If you get an infection, your leflunomide treatment may need to be stopped.
  • Even though you may already have a deadly lung infection called tuberculosis (TB), you could not yet be showing any signs of the illness. Leflunomide can make your infection worse in this instance and give you symptoms. Inform your doctor if you currently have or previously had TB, if you’ve lived in or travelled to a country where TB is prevalent, or if you’ve come into contact with somebody who has. Your doctor will do a skin test to determine your TB status prior to starting your leflunomide therapy. If you do have TB, your doctor will prescribe antibiotics to treat the illness before starting you on leflunomide.
  • Avoid getting any shots without first consulting your doctor.
  • Leflunomide may produce high blood pressure, so you should be aware of that. Before commencing treatment and on a frequent basis going forward, get your blood pressure tested.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If your next dose is approaching, skip the missed one and carry on with your regular dosing regimen. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Leflunomide could have unwanted effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Vomiting
  • Heartburn
  • Headache
  • Dizziness
  • Loss of weight
  • Back ache
  • Aching or weakened muscles
  • Numbness, tingling, burning, or pain in the hands or feet
  • Hair fall
  • Leg twitches
  • Arid skin

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you experience any of the following symptoms or those noted in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Rash if it has a fever or not
  • Hives
  • Skin peeling or blisters
  • Oral sores
  • Itching
  • Having trouble breathing
  • A new or worsening cough
  • Chest pain
  • Light skin

Receiving immune system-suppressing drugs may increase the risk of getting some cancers. Leflunomide clinical trials have not yet revealed a rise in cancer cases. Discuss the dangers of receiving leflunomide with your doctor.

Other negative effects of leflunomide are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it at room temperature, away from sources of extreme heat, moisture, and light (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Symptoms of overdose may include the following:

  • Diarrhea
  • Stomach ache
  • Extreme fatigue
  • Weakness
  • Pale skin
  • Fast heartbeat
  • Breathing difficulty

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Arava®
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