Lefluniclo
Lefluniclo (leflunomide / diclofenac) is a prepackaged kit that comes with leflunomide tablets that are taken by mouth and diclofenac gel that's applied to the skin. This kit is used for people with rheumatoid arthritis (RA). Lefluniclo (leflunomide / diclofenac) can raise your risk for certain serious side effects, such as liver problems and stomach bleeds. If you've been taking Lefluniclo (leflunomide / diclofenac) and want to stop, let your provider know. Leflunomide can stay in your body for a long time even after you've stopped taking it, so your provider will ask you to go through a procedure to quickly remove it from your body.
What is Lefluniclo (leflunomide / diclofenac)?
What is Lefluniclo (leflunomide / diclofenac) used for?
How Lefluniclo (leflunomide / diclofenac) works
Lefluniclo (leflunomide / diclofenac) is a prepackaged kit that contains two medications that work together to lower inflammation, which helps to treat symptoms of rheumatoid arthritis:
Leflunomide is a non-biologic disease-modifying antirheumatic drug (DMARD). It blocks certain proteins and cells of the immune system from activating and overgrowing.
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking proteins in your body called cyclooxygenase 1 and 2 (COX-1 and COX-2) from making chemicals called prostaglandins. Prostaglandins can cause pain and swelling, which are common symptoms of rheumatoid arthritis.
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What are the side effects of Lefluniclo (leflunomide / diclofenac)?
Common Side Effects
- Diarrhea (up to 27%
- Headache (up to 13%)
- Nausea (up to 13%)
- Rash (up to 12%)
- Abnormal liver labs (up to 10%)
- Hair thinning or hair loss (up to 9%)
- High blood pressure (up to 9%)
- Redness, rash, itchiness of the skin (contact dermatitis, 4%)
Other Side Effects
- Weakness
- Back pain
- Stomach pain
Serious Side Effects
- Stroke: tiredness, lightheadedness, blurred vision, difficulty speaking, difficulty walking, weakness on one side of the body
- Serious lung problems (interstitial lung disease): new or worsening cough, trouble catching your breath, fever
- Severe asthma attack: chest pain, cough, difficulty breathing, wheezing
- Heart attack: dizziness, tiredness, cold sweat, trouble breathing, chest pain or tightness, anxiety
- Heart failure: trouble breathing, tiredness, swelling in your body, sudden weight gain
- Serious liver problems: severe stomach pain, yellowing of the skin or whites of the eyes, nausea, vomiting, loss of appetite
- Stomach bleeding: vomiting blood, bloody or dark stools, severe stomach pain or discomfort
- Serious allergic or skin reaction: fever, body aches, cough, peeling skin, rash, trouble breathing, swelling of the face, painful blisters all over your body
- Serious infections: fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, chills, burning when you urinate, urinating more frequently
Source: DailyMed
Pros and cons of Lefluniclo (leflunomide / diclofenac)
Pros
Combines two medications in one kit for convenience
Might be able to use with some other pain medications (except NSAIDs)
Leflunomide is taken by mouth once daily
Diclofenac gel can be applied directly to painful areas of your body.
Cons
Leflunomide isn't a first-choice option for RA.
Can't take a shower for at least 1 hour after using diclofenac gel
Can't be used in children less than 18 years old
Leflunomide requires regular blood tests to check for low blood cell counts.
Pharmacist tips for Lefluniclo (leflunomide / diclofenac)
Store Lefluniclo (leflunomide / diclofenac) at room temperature in a cool, dry place and up and away out of children's reach and sight. This prevents them from accidentally swallowing medication that's left out. If you think that your child might’ve accidentally swallowed Lefluniclo (leflunomide / diclofenac), call your Poison Control Center at 1-800-222-1222 right away even if you aren't completely sure.
Tips for leflunomide
Take leflunomide at the same time every day with or without food.
Make sure you're up to date with all vaccines before starting Lefluniclo (leflunomide / diclofenac). If you're due for a vaccine while still taking Lefluniclo (leflunomide / diclofenac), ask your provider if it's safe for you to receive the vaccine. They might recommend for you to get that vaccine when you're no longer taking leflunomide.
Avoid getting live vaccines while taking leflunomide because this medication weakens your immune system. This means that live vaccines might not work as well for you and there's also a chance you might get sick from them. Some examples of live vaccines include the FluMist Quadrivalent (the nasal spray flu vaccine) and the measles, mumps, rubella (MMR) vaccine. After you stop Lefluniclo (leflunomide / diclofenac), don't get a live vaccine until your provider says it's safe for you to do so.
If you want to stop taking leflunomide, let your provider know. This medication can stay in your body for up to 2 years after you've stopped taking it. When you want to stop leflunomide, your provider will have you go through a procedure to quickly remove leflunomide from your body. This involves taking either cholestyramine or activated charcoal suspension for 11 days. Ask your provider for more information about this procedure.
Tips for diclofenac gel
Don't apply diclofenac gel regularly every day for more than 3 weeks at a time. Using it longer than directed by your provider can put you at higher risk for side effects, such as heart problems or stomach bleeding. If you don't get any pain relief after using diclofenac gel for a week, contact your provider.
Use the dosing card that comes with the diclofenac gel to accurately measure out your dose. Wash the dosing card with water after you're done using it.
Wash your hands right after applying diclofenac gel to avoid getting the medication on pets or other people on accident. But if the area you're treating is your hands, wait up to 1 hour before you wash your hands.
Don't shower or bathe for at least 1 hour after applying diclofenac gel.
After you apply the diclofenac gel, wait at least 10 minutes before putting clothing over the area where you just applied the medication.
Don't cover the treated area with any bandages. Doing so might affect how much diclofenac gel your body absorbs.
Frequently asked questions about Lefluniclo (leflunomide / diclofenac)
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What are the risks and warnings for Lefluniclo (leflunomide / diclofenac)?
Lefluniclo (leflunomide / diclofenac) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not for use during pregnancy
Lefluniclo (leflunomide / diclofenac) shouldn't be used during pregnancy due to the risk of severe harm to babies. If applicable, your provider will have you take a pregnancy test before starting Lefluniclo (leflunomide / diclofenac) to make sure you're not pregnant. If you're able to become pregnant, you'll need to use birth control during and after treatment until your provider tells you it's safe to stop. Typically, you'll need to wait until isn't any more leflunomide in the body - something your provider will confirm with a blood test there.
If you do become pregnant while taking Lefluniclo (leflunomide / diclofenac), let your provider know right away. They'll have you undergo a procedure to quickly remove leflunomide from your body.
Liver problems and liver failure
Risk factors: History of liver damage | Taking other medications that can cause liver damage
The leflunomide in Lefluniclo can cause serious liver problems that can lead to liver failure. Your provider will order regular blood tests (every 1 to 2 months) to make sure your liver is working properly. If there are signs of liver damage, your provider will ask you to stop this medication and have you undergo a procedure to quickly remove this medication from your body. Seek medical attention immediately if you notice swelling of your stomach, yellowing of your skin or the whites of your eyes, stool changes (black, tarry, or bloody stools), coughing or vomiting blood, confusion, slurred speech, mood swings, or changes in personality.
Heart attack and stroke
Risk factors: History of heart problems | Using high doses of Lefluniclo (leflunomide / diclofenac) | Using Lefluniclo (leflunomide / diclofenac) for a long time | History of or planned heart surgery
NSAIDs, like diclofenac gel can raise your risk of heart attacks and strokes. To prevent heart attack or stroke, your provider will prescribe the lowest possible dose of diclofenac gel for the shortest amount of time that works well for you. If you have heart problems, talk to your healthcare provider before starting this medication. Don't use diclofenac gel if you've had or will be having heart bypass surgery. Call 911 or seek immediate help if you experience chest pain, shortness of breath, weakness on one side of your body, or trouble speaking or walking.
Stomach bleeding and ulcers
Risk factors: History of stomach bleeding or ulcers | Older adults | Taking other medications that can cause stomach problems | Drinking alcohol | Smoking | Having poor health | Bleeding problems | Liver problems | Using topical diclofenac for a long time | Using higher doses of topical diclofenac
Diclofenac gel in Lefluniclo (leflunomide / diclofenac) can put you at risk for stomach ulcers (sores) and bleeds. Stomach bleeding is a dangerous condition that requires treatment right away. Make sure to tell your provider or pharmacist about all of your conditions and medications before starting diclofenac gel so they can determine your risk for stomach bleeding. Some medications, such as oral corticosteroids and blood thinners, can raise your risk of stomach bleeding. If you're feeling faint, vomiting blood, have bloody or dark stools, or have severe stomach pain or discomfort that doesn't go away while using diclofenac gel, seek medical attention right away.
Serious infections
Risk factors: Active, chronic, or recurrent infection | Older adult | Having other conditions that raise your risk of infection | Living in or traveling to places with high rates of infections | Taking medications that weaken your immune system
Lefluniclo (leflunomide / diclofenac) can affect your body's ability to fight infections, which can raise your risk of serious or life-threatening bacterial, viral, or fungal infections. If you already have a weakened immune system because of a medical condition (e.g., cancer) or other medications (e.g., transplant medications), then your provider will likely recommend a different treatment for your RA. If your provider thinks Lefluniclo (leflunomide / diclofenac) is an appropriate treatment for you, they will likely screen you for infections, such as tuberculosis (TB) before you start.
If you develop symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) while taking Lefluniclo (leflunomide / diclofenac), go to the hospital right away so you can be tested for an infection. You might have to stop taking Lefluniclo (leflunomide / diclofenac) so your body can fight the infection.
Serious skin reactions
Lefluniclo (leflunomide / diclofenac) might cause sudden and serious skin reactions (e.g., DRESS). Symptoms can include fever, body aches, rash, peeling skin, painful blisters all over your body, and swelling of the face. Stop using Lefluniclo (leflunomide / diclofenac) and get medical attention right away if you experience these symptoms.
Nerve pain
Risk factors: Age 60 years and older | Taking other medications that can worsen nerve pain | Diabetes
Leflunomide can cause nerve pain. For most people, it goes away after they stopped the medication. But few people continue to experience nerve pain even after they stopped leflunomide. If you start to have nerve pain, your provider might ask you to stop Lefluniclo (leflunomide / diclofenac) and have you go through a procedure to help get rid of leflunomide from your body quickly. Contact your provider if you have any pain, numbness, or tingling in your hands or feet.
Slow removal of leflunomide from your body
After you stop taking Lefluniclo (leflunomide / diclofenac), it can take up to two years for your body to completely get rid of leflunomide. If you're planning on becoming pregnant or have unwanted side effects, your provider might give you cholestyramine (Prevalite) or activated charcoal for 11 days to speed up the process of removing leflunomide from your body.
Lung problems
Risk factors: History of lung or breathing problems
Serious lung injury has been reported in people taking leflunomide. Sometimes, this can be life-threatening. Contact your provider if you notice new or worsening cough, trouble breathing, or fever. You might need to stop taking Lefluniclo (leflunomide / diclofenac).
High blood pressure
Lefluniclo (leflunomide / diclofenac) can potentially raise your blood pressure. Your provider will have you check your blood pressure before you start treatment and regularly while taking Lefluniclo (leflunomide / diclofenac). If you notice that your blood pressure is higher than what it was before you started Lefluniclo (leflunomide / diclofenac), let your provider know.
Liver damage
Risk factors: History of liver damage | Taking other medications that can cause liver damage
Very rarely, topical diclofenac can cause life-threatening liver damage. This can happen as early as within the first month of starting this medication. Your risk is higher if you use topical diclofenac with other medications that can also cause liver damage, such as acetaminophen (Tylenol) and Augmentin (amoxicillin / clavulanate). Liver damage can happen with or without symptoms so if you use this medication for a long time, you might need to get lab work to check your liver regularly. Stop topical diclofenac and talk to your healthcare provider right away if you experience symptoms such as fever, chills, fatigue, nausea, vomiting, yellowing of the skin or whites of the eyes, clay-colored stool, and dark urine.
Lefluniclo (leflunomide / diclofenac) dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 100g/20mg of 1% | 1 kit | $3456.00 | $3456.00 |
Typical dosing for Lefluniclo (leflunomide / diclofenac)
Leflunomide 20 mg tablets: The typical dose is 20 mg by mouth once daily.
Diclofenac 1% gel: Apply to the affected area(s) 4 times daily for up to 3 weeks (or as instructed by your provider) when experiencing arthritis pain. Use the dosing card to measure out your dose. Don't use it on more than 2 body areas at the same time.
Upper body dose (hand, wrist, or elbow): The typical amount for each dose is 2 grams.
Lower body dose (foot, ankle, or knee): The typical amount for each dose is 4 grams.
How much does Lefluniclo (leflunomide / diclofenac) cost?
Lefluniclo (leflunomide / diclofenac) contraindications
Severe allergic reaction to an NSAID or leflunomide
History of asthma, hives, or other allergic reactions after taking aspirin or another NSAID
Major open heart surgery
Severe liver problems
Pregnancy
Taking Aubagio (teriflunomide)
Lefluniclo (leflunomide / diclofenac) images
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References
Best studies we foundAlembic Pharmaceuticals Inc. (2021). Leflunomide - leflunomide tablet [package insert]. DailyMed.
American College of Rheumatology. (n.d.). Rheumatoid arthritis guideline.
Centers for Disease Control and Prevention. (2022). Live attenuated influenza vaccine [LAIV] (the nasal spray flu vaccine).
Centers for Disease Control and Prevention. (2023). Put your medicines up and away and out of sight.
Fitzsimmons, E. D., et al. (2023). Embryology, amniotic fluid. StatPearls.
GSK Consumer Healthcare. (2018). Voltaren gel (diclofenac sodium topical gel), 1%, for topical use only [package insert].
Li, E. K., et al. (2004). Leflunomide in the treatment of rheumatoid arthritis. Clinical Therapeutics.
National Heart, Lung, and Blood Institute. (2022). What is coronary artery bypass grafting?
U.S. Food and Drug Administration. (2022). FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid.
V2 Pharma, LLC. (2023). Lefluniclo- leflunomide and diclofenac sodium gel kit [package insert]. DailyMed.
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