Dosing & Uses
Dosage Forms & Strengths
tablet
- 10mg
- 20mg
- 100mg
Rheumatoid Arthritis
100 mg PO qDay for 3 day initially, THEN 10-20 mg PO qDay
Dosage Modifications
Renal impairment
- No dosage adjustment provided by the manufacturer; use with caution
Hepatic Impairment
- Preexisting liver disease: Not recommended
- Baseline ALT >2 times ULN: Not recommended
- Severe hepatic impairment: Contraindicated
- Hepatotoxicity following administration: Discontinue therapy and determine cause; if lefluonamide induced, discontinue treatment and initiate accelerated drug elimination process
Dosing Considerations
Discontinuing leflunomide
- Drug elimination process recommended to achieve nondetectable plasma levels (ie, <0.02 mg/L) after discontinuation
- Step 1: Administer cholestyramine 8 g PO TID 11 days; the 11 days do not need to be consecutive unless there is a need to lower the plasma level rapidly
- Step 2: Verify plasma levels <0.02 mg/L by 2 separate tests at least 14 days apart; if plasma levels >0.02 mg/L, consider additional cholestyramine treatment
- Without the drug elimination procedure, it may take up to 2 years to reach plasma M1 metabolite levels <0.02 mg/L due to individual variation in drug clearance
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (74)
- adalimumab
adalimumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alefacept
alefacept and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anakinra
anakinra and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anthrax vaccine
leflunomide decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin equine
antithymocyte globulin equine and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- axicabtagene ciloleucel
leflunomide, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
azathioprine and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- basiliximab
basiliximab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
leflunomide decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- beclomethasone, inhaled
beclomethasone, inhaled increases toxicity of leflunomide by unspecified interaction mechanism. Avoid or Use Alternate Drug. May increase risk of hematologic toxicities; should monitor for bone marrow suppression at least monthly throughout duration of concurrent therapy when leflunomide is given with another immunosuppressants.
- brexucabtagene autoleucel
leflunomide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
canakinumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
leflunomide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
cyclosporine and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- darolutamide
darolutamide will increase the level or effect of leflunomide by Other (see comment). Avoid or Use Alternate Drug. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).
- diphtheria & tetanus toxoids
leflunomide decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/ acellular pertussis vaccine
leflunomide decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine
leflunomide decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- etanercept
etanercept and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- everolimus
everolimus and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
glatiramer and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
golimumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis A vaccine inactivated
leflunomide decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/b vaccine
leflunomide decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis a/typhoid vaccine
leflunomide decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis b vaccine
leflunomide decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- human papillomavirus vaccine, nonavalent
leflunomide decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- human papillomavirus vaccine, quadrivalent
leflunomide decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
leflunomide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
infliximab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent
leflunomide decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, adjuvanted
leflunomide decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine quadrivalent, cell-cultured
leflunomide decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine quadrivalent, intranasal
leflunomide decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent
leflunomide decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- influenza virus vaccine trivalent, adjuvanted
leflunomide decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- Japanese encephalitis virus vaccine
leflunomide decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- lasmiditan
lasmiditan increases levels of leflunomide by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.
- leniolisib
leniolisib will increase the level or effect of leflunomide by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates
- lisocabtagene maraleucel
leflunomide, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
leflunomide decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles mumps and rubella vaccine, live
leflunomide decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- measles, mumps, rubella and varicella vaccine, live
leflunomide decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- meningococcal A C Y and W-135 polysaccharide vaccine combined
leflunomide decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- muromonab CD3
leflunomide and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
leflunomide and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pneumococcal vaccine 13-valent
leflunomide decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine heptavalent
leflunomide decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine polyvalent
leflunomide decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rabies vaccine
leflunomide decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.
- rabies vaccine chick embryo cell derived
leflunomide decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rilonacept
leflunomide and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
leflunomide decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rubella vaccine
leflunomide decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- selinexor
selinexor, leflunomide. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- sirolimus
leflunomide and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) vaccine, live
leflunomide decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
leflunomide and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temsirolimus
leflunomide and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus toxoid adsorbed or fluid
leflunomide decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tick-borne encephalitis vaccine
leflunomide decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tisagenlecleucel
leflunomide, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
tocilizumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
leflunomide, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tongkat ali
leflunomide and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- travelers diarrhea and cholera vaccine inactivated
leflunomide decreases effects of travelers diarrhea and cholera vaccine inactivated by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid polysaccharide vaccine
leflunomide decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid vaccine live
leflunomide decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ustekinumab
leflunomide and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
leflunomide decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- yellow fever vaccine
leflunomide decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- zoster vaccine live
leflunomide decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Monitor Closely (62)
- acalabrutinib
acalabrutinib increases levels of leflunomide by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.
- apalutamide
apalutamide will decrease the level or effect of leflunomide by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.
- astragalus
leflunomide increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- belatacept
belatacept and leflunomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- carvedilol
leflunomide will increase the level or effect of carvedilol by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- cholera vaccine
leflunomide decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- cholestyramine
cholestyramine decreases levels of leflunomide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- dengue vaccine
leflunomide decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
leflunomide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- dichlorphenamide
dichlorphenamide and leflunomide both decrease serum potassium. Use Caution/Monitor.
- echinacea
leflunomide increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- eltrombopag
leflunomide will increase the level or effect of eltrombopag by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- eluxadoline
eluxadoline increases levels of leflunomide by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered BCRP substrates.
- encorafenib
encorafenib will increase the level or effect of leflunomide by Other (see comment). Modify Therapy/Monitor Closely. Encorafenib (a BCRP inhibitor) may increase the concentration and toxicities of BCRP substrates. Closely monitor for signs and symptoms of increased exposure and consider adjusting the dose of these substrates.
- ethotoin
leflunomide will increase the level or effect of ethotoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- etravirine
leflunomide will increase the level or effect of etravirine by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- fingolimod
leflunomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- fosphenytoin
leflunomide will increase the level or effect of fosphenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- fostamatinib
fostamatinib will increase the level or effect of leflunomide by decreasing metabolism. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of BCRP substrate drugs. Monitor for toxicities of BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.
- fostemsavir
fostemsavir will increase the level or effect of leflunomide by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.
- glecaprevir/pibrentasvir
glecaprevir/pibrentasvir will increase the level or effect of leflunomide by decreasing metabolism. Use Caution/Monitor. Glecaprevir/pibrentasvir may increase plasma concentration of BCRP substrates.
- haemophilus influenzae type b vaccine
leflunomide decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .
- hydroxyurea
hydroxyurea, leflunomide. Other (see comment). Use Caution/Monitor. Comment: Combination therapy may lead to increased risk of infection.
- ifosfamide
ifosfamide increases toxicity of leflunomide by Other (see comment). Use Caution/Monitor. Comment: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.
- influenza virus vaccine quadrivalent, recombinant
leflunomide decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- influenza virus vaccine trivalent, recombinant
leflunomide decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immune response to vaccine may be decreased in immunocompromised individuals.
- isavuconazonium sulfate
leflunomide and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine increases toxicity of leflunomide by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.
- losartan
leflunomide will increase the level or effect of losartan by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. May inhibit the conversion of losartan to its active metabolite E-3174. Importance of interaction not established; monitor individual therapeutic response to determine losartan dosage.
leflunomide decreases effects of losartan by decreasing metabolism. Use Caution/Monitor. May inhibit the conversion of losartan to its active metabolite E-3174. Importance of interaction not established; monitor individual therapeutic response to determine losartan dosage. - maitake
leflunomide increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- mechlorethamine
mechlorethamine increases toxicity of leflunomide by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.
- melphalan
melphalan, leflunomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.
- meningococcal group B vaccine
leflunomide decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- mercaptopurine
leflunomide and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- methotrexate
leflunomide increases levels of methotrexate by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Additive hepatotoxicity, pancytopenia. If leflunomide and methotrexate are given concomitantly, monitor liver toxicity with ALT, AST, and serum albumin testing. Also, monitor platelets, WBC count, hemoglobin, or hematocrit at baseline and monthly for 6 months following initiation and every 6-8 weeks thereafter.
- nateglinide
leflunomide will increase the level or effect of nateglinide by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- ocrelizumab
ocrelizumab increases toxicity of leflunomide by unknown mechanism. Modify Therapy/Monitor Closely. Coadminstration of leflunomide and ocrelizumab may cause increased risk of infections, pancytopenia, agranulocytosis and thrombocytopenia.
- ofatumumab SC
ofatumumab SC, leflunomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
leflunomide and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- oteseconazole
oteseconazole will increase the level or effect of leflunomide by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.
- oxaliplatin
oxaliplatin increases toxicity of leflunomide by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.
- ozanimod
ozanimod, leflunomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration with immunosuppressive therapies may increase the risk of additive immune effects during therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs in order to avoid unintended additive immunosuppressive effects.
- parecoxib
leflunomide will increase the level or effect of parecoxib by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- phenytoin
leflunomide will increase the level or effect of phenytoin by affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor.
- poliovirus vaccine inactivated
leflunomide decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .
- ponatinib
ponatinib increases levels of leflunomide by Other (see comment). Use Caution/Monitor.
- ponesimod
ponesimod and leflunomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- procarbazine
procarbazine increases toxicity of leflunomide by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.
- regorafenib
regorafenib will increase the level or effect of leflunomide by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.
- safinamide
safinamide will increase the level or effect of leflunomide by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.
- siponimod
siponimod and leflunomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
leflunomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- sofosbuvir/velpatasvir
sofosbuvir/velpatasvir will increase the level or effect of leflunomide by Other (see comment). Use Caution/Monitor. Velpatasvir is an inhibitor of the drug transporter BCRP. Coadministration may increase systemic exposure of drugs that are BCRP substrates.
- stiripentol
stiripentol will increase the level or effect of leflunomide by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered.
- tafamidis
tafamidis will increase the level or effect of leflunomide by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- tafamidis meglumine
tafamidis meglumine will increase the level or effect of leflunomide by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- tamoxifen
leflunomide, tamoxifen. affecting hepatic enzyme CYP2C9/10 metabolism. Use Caution/Monitor. CYP2C9/10 inhibition decreases tamoxifen metabolism to active metabolites.
- trastuzumab
trastuzumab, leflunomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, leflunomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and leflunomide both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
- warfarin
leflunomide increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
- zoster vaccine recombinant
leflunomide decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (17)
- activated charcoal
activated charcoal decreases levels of leflunomide by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- alosetron
leflunomide will increase the level or effect of alosetron by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- bosentan
leflunomide will increase the level or effect of bosentan by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- celecoxib
leflunomide will increase the level or effect of celecoxib by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- diclofenac
leflunomide will increase the level or effect of diclofenac by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- flurbiprofen
leflunomide will increase the level or effect of flurbiprofen by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- fluvastatin
leflunomide will increase the level or effect of fluvastatin by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- ibuprofen
leflunomide will increase the level or effect of ibuprofen by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- ibuprofen IV
leflunomide will increase the level or effect of ibuprofen IV by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- meloxicam
leflunomide will increase the level or effect of meloxicam by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- piroxicam
leflunomide will increase the level or effect of piroxicam by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- ramelteon
leflunomide will increase the level or effect of ramelteon by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- rifampin
rifampin increases effects of leflunomide by increasing metabolism. Minor/Significance Unknown. Leflunomide's effects due to its active metabolite.
- shark cartilage
leflunomide, shark cartilage. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced anti angiogenesis (theoretical interaction).
- sulfamethoxazole
leflunomide will increase the level or effect of sulfamethoxazole by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- tolbutamide
leflunomide will increase the level or effect of tolbutamide by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
- voriconazole
leflunomide will increase the level or effect of voriconazole by affecting hepatic enzyme CYP2C9/10 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Diarrhea (17%)
Respiratory infections (15%)
1-10% (selected)
Alopecia (10%)
Hypertension (10%)
Rash (10%)
Nausea (9%)
Bronchitis (7%)
Headache (7%)
Abdominal pain (5%)
Abnormal LFT's (5%)
Accidental injury (5%)
Back pain (5%)
Dyspepsia (5%)
UTI (5%)
Dizziness (4%)
Infection (4%)
Joint disorder (4%)
Pruritus (4%)
Weight loss (4%)
Anorexia (3%)
Cough (3%)
Gastroenteritis (3%)
Pharyngitis (3%)
Stomatitis (3%)
Tenosynovitis (3%)
Vomiting (3%)
Weakness (3%)
Allergic reaction (2%)
Chest pain (2%)
Dry skin (2%)
Eczema (2%)
Pain (2%)
Paresthesia (2%)
Pneumonia (2%)
Rhinitis (2%)
Sinusitis (2%)
Synovitis (2%)
Postmarketing Reports
Body as a whole: Opportunistic infections, severe infections including sepsis that may be fatal
Gastrointestinal: Pancreatitis; colitis, including microscopic colitis
Hematologic: Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia
Hypersensitivity: Angioedema
Hepatic: Hepatitis, jaundice/cholestasis, severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
Respiratory: Interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis, which may be fatal; pulmonary hypertension
Nervous system: Peripheral neuropathy
Skin and appendages: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis including cutaneous necrotizing vasculitis, cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis; rare cases of drug reaction with eosinophilia and systemic symptoms (DRESS) reported
Warnings
Black Box Warnings
Contraindicated in pregnancy
Do not use in pregnant women or in women of childbearing age who do not use reliable contraception
Avoid pregnancy during treatment and during the drug elimination period following treatment (ie, M1 metabolite <0.02 mcg/mL)
Severe liver injury
- 49 cases of severe liver injury identified, including 14 cases of fatal liver failure
- Do not use with pre-existing liver disease
- Do not use if elevated liver enzymes (ALT >2 X ULN)
- Coadministration with other drugs that cause liver injury increases risk
- Recommend ALT monitoring monthly for 6 months after initiating, and q6-8weeks thereafter
- If ALT rises to >3X ULN, interrupt therapy while investigating probable cause; if likely leflunomide-induced, initiate cholestyramine washout to speed elimination and conduct follow-up LFTs at least weekly until ALT value within normal range; if not leflunomide-induced ALT elevation, may consider resuming leflunomide
Contraindications
Pregnancy
Hypersensitivity
Severe hapatic impairment
Current treatment with teriflunomide
Cautions
Hepatotoxicity reported (see Black Box Warnings)
Vaccination with live vaccines not recommended
Potential increase risk for malignancy
Increase in blood pressure reported with therapy; check blood pressure before initiating therapy and periodically thereafter
Rare cases of drug reaction with eosinophilia and systemic symptoms (DRESS) reported; discontinue therapy; a drug elimination procedure recommended
Co-administration of teriflunomide with leflunomide not recommended, as leflunomide is parent compound of teriflunomide
Peripheral neuropathy reported; most recover after discontinuing drug; risk factors include age >60 years, concomitant neurotoxic drugs, and diabetes; if patient develops peripheral neuropathy, consider discontinuing and performing accelerated elimination procedure
Interstitial lung disease (ILD) reported and has been associated with fatal outcomes; risk increased with prior history of ILD; if pulmonary symptoms worsen in patients with pre-exixting ILD, consider discontinuing therapy and performing accelerated drug elimination procedure
Active metabolite has very long half-life and this should be considered when administering live vaccines or planning pregnancy; all women of childbearing potential are advised to receive cholestyramine 8 g TID x11 days to hasten elimination of metabolite
If inadvertent pregnancy occurs discontinue immediately and call (877) 311-8972; cholestyramine may reduce risk to fetus
May cause immunosuppression; not recommended for patients with severe immunodeficiency, bone marrow dysplasia, or severe, uncontrolled infections; if a serious infection occurs, consider interrupting therapy and initiating accelerated drug elimination procedure
Cases of tuberculosis reported in clinical studies; prior to initiating therapy, screen all patients for active and inactive (“latent”) tuberculosis infection as per commonly used diagnostic tests; drug not studied in patients with positive tuberculosis screen; safety in individuals with latent tuberculosis infection unknown; treat patients testing positive for tuberculosis with standard medical practice prior to therapy; monitor carefully during treatment for possible reactivation of infection
Pancytopenia, agranulocytosis and thrombocytopenia reported with therapy; most frequently reported in patients who received concomitant treatment with methotrexate or other immunosuppressive agents, or who had recently discontinued these therapies; in some cases, patients had a prior history of a significant hematologic abnormality
Perform white blood cell count and hemoglobin or hematocrit at baseline and monthly for six months following initiation of therapy and every 6-to 8 weeks thereafter; monitor monthly if administered concomitantly with methotrexate or other potential immunosuppressive agents; discontinue treatment if bone marrow suppression occurs in patients taking therapy and perform accelerated drug elimination procedure
When decision is made to switch to another anti-rheumatic agent with potential for hematologic suppression, consider monitoring for hematologic toxicity as systemic exposure to both compounds may overlap
Stevens-Johnson syndrome and toxic epidermal necrolysis reported (rare); discontinue therapy and perform accelerated drug elimination procedure
Severe and disabling arthralgia reported in patients taking DPP-4 inhibitors; consider as a possible cause for severe joint pain and discontinue drug if appropriate
Accelerated elimination
- The active metabolite of leflunomide, teriflunomide, is eliminated slowly from plasma; use of accelerated drug elimination procedure will rapidly reduce plasma concentrations of leflunomide and active metabolite, teriflunomide
- Without use of accelerated drug elimination procedure, may take up to 2 years to reach plasma teriflunomide concentrations of less than 0.02 mg/L, the plasma concentration not associated with embryo-fetal toxicity in animals
- Consider accelerated elimination procedure at any time after discontinuation of therapy, and in particular, when patient has experienced a severe adverse reaction (eg, hepatotoxicity, serious infection, bone marrow suppression, Steven Johnson Syndrome, toxic epidermal necrolysis, peripheral neuropathy, interstitial lung disease), suspected hypersensitivity, or has become pregnant
- All women of childbearing potential recommended to undergo accelerated elimination procedure after stopping treatment
Pregnancy & Lactation
Pregnancy
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to therapy during pregnancy; health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972 or visit http://www.pregnancystudies.org/participate-ina-study/
Drug is contraindicated for use in pregnant women because of potential for fetal harm; pregnancy exposure registry data are not available to inform presence or absence of drug-associated risk with use of drug during pregnancy
Lowering plasma concentration of active metabolite, teriflunomide, by instituting an accelerated drug elimination procedure as soon as pregnancy is detected may decrease risk to fetus from therapy; the accelerated drug elimination procedure includes verification that plasma teriflunomide concentration is less than 0.02 mg/L
Advise females to notify healthcare provider immediately if pregnancy occurs or is suspected during treatment; women receiving treatment who wish to become pregnant should discontinue drug and undergo an accelerated drug elimination procedure to achieve plasma teriflunomide concentrations < 0.02 mg/L (0.02 mcg/mL)
Exclude pregnancy in females of reproductive potential before starting treatment
Advise females of reproductive potential to use effective contraception during treatment and while undergoing a drug elimination procedure until verification that the plasma teriflunomide concentration is < 0.02 mg/L
Animal data
- In animal reproduction studies, oral administration of leflunomide during organogenesis at a dose of 1/10 of and equivalent to maximum recommended human dose (MRHD) based on AUC, respectively in rats and rabbits, caused teratogenicity (rats and rabbits) and embryo-lethality (rats)
Lactation
Clinical lactation studies not conducted to assess presence of drug in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions in a breastfed infant, advise a nursing woman to discontinue breastfeeding during therapy
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Not fully understood
Metabolite inhibits pyrimidine nucleotide synthesis; antiproliferative for T-cells
Absorption
Bioavailability: 80%
Peak plasma time: 6-12 hr
Detectable for up to 2 years
Distribution
Protein bound: >99%
Vd: 0.13 L/kg
Metabolism
GI mucosa, liver
Metabolites: A77 1726 (active)-undergoes hepatic recirculation
Elimination
Half-life: 14-18 days
Clearance: 31 mL/hr
Renal elimination predominant during first 96 hr, thereafter fecal elimination predominates
Excretion: Feces 48%; urine: 43%
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| leflunomide oral - | 10 mg tablet |  | |
| leflunomide oral - | 20 mg tablet |  | |
| leflunomide oral - | 10 mg tablet |  | |
| leflunomide oral - | 10 mg tablet |  | |
| leflunomide oral - | 20 mg tablet |  | |
| leflunomide oral - | 10 mg tablet |  | |
| leflunomide oral - | 20 mg tablet |  | |
| leflunomide oral - | 20 mg tablet |  | |
| leflunomide oral - | 20 mg tablet |  | |
| leflunomide oral - | 10 mg tablet |  | |
| leflunomide oral - | 20 mg tablet |  | |
| leflunomide oral - | 10 mg tablet |  | |
| Arava oral - | 20 mg tablet | | |
| Arava oral - | 10 mg tablet | |
Copyright © 2010 First DataBank, Inc.
Patient Handout
leflunomide oral
LEFLUNOMIDE - ORAL
(leh-FLEW-no-mide)
COMMON BRAND NAME(S): Arava
WARNING: Leflunomide must not be used during pregnancy because it may cause serious harm (possibly death) to an unborn baby. Women of childbearing age must have a negative pregnancy test before starting this medication. They must also use reliable forms of birth control before starting leflunomide, while taking it, and after stopping it until they have finished taking another drug that helps leflunomide leave the body and confirmed through 2 blood tests that the leflunomide levels are very low (see How to Use section). If you become pregnant or think you may be pregnant, inform your doctor right away (see Precautions section).This drug may rarely cause serious (possibly fatal) liver disease. Most cases occur within 6 months of taking this drug. If you already have liver disease (such as hepatitis B or C), leflunomide should not be used. Liver function (blood) tests must be performed periodically while taking leflunomide. Tell your doctor right away if you notice nausea/vomiting that doesn't stop, dark urine, light-colored stools, stomach/abdominal pain, yellowing eyes/skin. See Drug Interactions section.
USES: This medication is used to treat rheumatoid arthritis, a condition in which the body's defense system (immune system) fails to recognize the body as itself and attacks the healthy tissues around the joints. Leflunomide helps to reduce the joint damage/pain/swelling and helps you to move better. It works by weakening your immune system and decreasing swelling (inflammation).
HOW TO USE: Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Take this medication exactly as prescribed. You may be instructed to take a higher dose for the first 3 days of treatment.Dosage is based on your medical condition and response to therapy.Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.After treatment is stopped, a different drug (cholestyramine) may be given as directed to help remove leflunomide from your body. This procedure is used if you need a rapid removal of the drug from your system (for example, if you are a female/male planning to have children, or suffering from severe side effects). Without the procedure, the drug may stay in your body for up to 2 years. Consult your doctor or pharmacist for more details.Tell your doctor if your symptoms last or get worse.
SIDE EFFECTS: Diarrhea, nausea, and dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: cough, numbness/tingling of hands/feet, hair loss, chest pain, fast/pounding heartbeat, increased thirst/urination, muscle cramp/pain, mental/mood changes, vision changes, easy bruising/bleeding, unusual growths/lumps, unexplained weight loss, unusual tiredness.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Get medical help right away if you have any signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Leflunomide can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking leflunomide, tell your doctor or pharmacist if you are allergic to it; or to teriflunomide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system disorder (such as HIV infection), current/recent infection (such as tuberculosis), cancer, bone marrow/blood disorder, kidney disease, liver disease (such as hepatitis B or C), alcohol abuse, heart disease (such as congestive heart failure), high blood pressure, lung disease.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may also cause liver disease.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.Leflunomide can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.This medication must not be used during pregnancy. It may harm an unborn baby. Before starting this medication, women of childbearing age must have a negative pregnancy test before starting this medication. Men and women must use effective forms of birth control (such as condoms and birth control pills) while taking this medication. Consult your doctor for more details and to discuss reliable forms of birth control. (See also Warning section.)It is not known whether this medication affects the sperm. To minimize any possible risk, the manufacturer recommends that men wishing to father a child should consider stopping the medication and using another drug (cholestyramine) as directed to help this drug leave the body before attempting to father a child. (See How to Use section.) Consult your doctor for more details.This drug may pass into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also How to Use Section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: warfarin, drugs affecting the liver (such as methotrexate), cholestyramine, other drugs that weaken the immune system (such as tacrolimus, cyclosporine).Because teriflunomide (used to treat multiple sclerosis) is very similar to this medication, do not take it while you are taking leflunomide.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.A skin test to check for tuberculosis should be performed before you start this medication. Lab and/or medical tests (such as liver function, blood counts, blood pressure) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
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