Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 100mg/vial (Remicade, Inflectra, Renflexis, Ixifi, Avsola)
- For IV use after reconstitution and further dilution
injection, solution for SC
- 120mg/mL in single-dose prefilled syringe/pen (Zymfentra)
Biosimilars
- Inflectra, Zymfentra (infliximab-dyyb)
- Renflexis (infliximab-abda)
- Ixifi (infliximab-qbtx)
- Avsola (infliximab-axxq)
Rheumatoid Arthritis
Remicade, Inflectra, Renflexis, Ixifi, Avsola
Indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately-to-severely active rheumatoid arthritis in combination with methotrexate
3 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter
If incomplete response is noted, dose may be increased to 10 mg/kg OR increasing the dosing frequency to q4Weeks
Psoriatic Arthritis
Remicade, Inflectra, Renflexis, Ixifi, Avsola
Indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis
5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter
May be used with methotrexate
Plaque Psoriasis
Remicade, Inflectra, Renflexis, Ixifi, Avsola
Indicated for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
Should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician
5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter
Can be used with or without methotrexate
Crohn Disease
IV
- Remicade, Inflectra, Renflexis, Ixifi, Avsola
- Indicated for moderately-to-severely active Crohn disease in patients who have had inadequate response to conventional therapy
- Also, indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn disease
- 5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter
- For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg
- Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue
SC
- Zymfentra
- Indicated for maintenance treatment of moderately to severely active Crohn disease following treatment with an infliximab IV product
- All patients must complete an IV induction regimen (see chosen infliximab product) with an infliximab product before starting SC
- Start at Week 10 or thereafter: 120 mg SC q2Weeks
-
Switching from IV to SC maintenance treatment
- To switch patients who are responding to maintenance therapy with an IV infliximab product, administer first SC dose in place of the next scheduled IV infusion, and then q2Weeks thereafter
Ulcerative Colitis
IV
- Remicade, Inflectra, Renflexis, Ixifi, Avsola
- Indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adults with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
- 5 mg/kg IV at 0, 2, and 6 weeks, then every 8 weeks
SC
- Zymfentra only
- Indicated for maintenance treatment of moderately to severely active ulcerative colitis following treatment with an infliximab IV product
- All patients must complete an IV induction regimen (see chosen infliximab product) with an infliximab product before starting SC
- Start at Week 10 or thereafter: 120 mg SC q2Weeks
-
Switching from IV to SC maintenance treatment
- To switch patients who are responding to maintenance therapy with an IV infliximab product, administer first SC dose in place of the next scheduled IV infusion, and then q2Weeks thereafter
Ankylosing Spondylitis
Remicade, Inflectra, Renflexis, Ixifi, Avsola
Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis
5 mg/kg IV at 0, 2, and 6 weeks, THEN q6Weeks thereafter
Idiopathic Pulmonary Fibrosis (Orphan)
Treatment of idiopathic pulmonary fibrosis
Orphan indication sponsor
- Foundation for Fatal Rare Diseases; Herrengasse 21; Furstentum Liechtenstein; Germany
Dosage Modifications
Moderate-to-severe (NYHA class III or IV) heart failure: Not to exceed 5 mg/kg/dose (see Contraindications)
Dosing Considerations
Prior to initiating treatment and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection
Higher incidence of serious infections in infliximab-treated patients ≥65 years; use with caution
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 100mg/vial (Remicade, Inflectra, Renflexis, Ixifi, Avsola)
- For IV use after reconstitution and further dilution
Biosimilars to Remicade
- Inflectra (infliximab-dyyb)
- Renflexis (infliximab-abda)
- Ixifi (infliximab-qbtx)
- Avsola (infliximab-axxq)
Crohn Disease
Remicade, Inflectra, Renflexis, Ixifi, Avsola
Reduction of signs and symptoms and induction and maintenance of clinical remission in pediatric patients aged ≥6 year with moderately to severely active Crohn disease who have had inadequate response to conventional therapy
<6 years: Not studied
≥6 to 17 years: 5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter
Ulcerative Colitis
Remicade, Inflectra, Renflexis, Ixifi, Avsola
Treatment of moderately to severely active ulcerative colitis in children aged ≥6 yr who have had inadequate response to conventional therapy
<6 years: Not studied
≥6 years: 5 mg/kg IV at 0, 2, and 6 weeks, THEN q8Weeks thereafter
Dosing considerations
- Due to risk of hepatosplenic T-cell lymphoma, a careful risk-benefit assessment should be made when drug is used in combination with other immunosuppressants in pediatric UC patients
Juvenile Rheumatoid Arthritis (Orphan)
Orphan indication sponsor
- Centocor, Inc; 200 Great Valley Parkway; Malvern, PA 19355-1307
Dosing Considerations
Children should be current with immunizations before starting infliximab
Do not administer live vaccines while patient is taking infliximab
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
infliximab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (77)
- abatacept
abatacept, infliximab. Mechanism: pharmacodynamic synergism. Contraindicated. Increased risk of serious infection.
- adalimumab
adalimumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- alefacept
alefacept and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anakinra
anakinra and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anthrax vaccine
infliximab 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 infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
antithymocyte globulin rabbit and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- axicabtagene ciloleucel
infliximab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
azathioprine and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib, infliximab. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.
- basiliximab
basiliximab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
infliximab decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- brexucabtagene autoleucel
infliximab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
canakinumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- certolizumab pegol
infliximab and certolizumab pegol both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid combination because of an increased risk of serious infection.
- ciltacabtagene autoleucel
infliximab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
cyclosporine and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diphtheria & tetanus toxoids
infliximab 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
infliximab 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
infliximab 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 infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- etrasimod
etrasimod, infliximab. Either increases effects of the other by Mechanism: aldehyde dehydrogenase inhibition. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.
- everolimus
everolimus and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
glatiramer and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
golimumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis A vaccine inactivated
infliximab 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
infliximab 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
infliximab decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis b vaccine
infliximab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- human papillomavirus vaccine, nonavalent
infliximab 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
infliximab 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 infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
infliximab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent
infliximab 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
infliximab 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
infliximab 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
infliximab 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
infliximab 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
infliximab 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
infliximab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
infliximab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
infliximab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
infliximab 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
infliximab 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
infliximab 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
infliximab 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
infliximab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
infliximab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pexidartinib
infliximab and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.
- pneumococcal vaccine 13-valent
infliximab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine heptavalent
infliximab decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine polyvalent
infliximab decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pretomanid
infliximab, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.
- rabies vaccine
infliximab decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.
- rabies vaccine chick embryo cell derived
infliximab decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rilonacept
infliximab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
infliximab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rubella vaccine
infliximab decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- selinexor
selinexor, infliximab. 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
infliximab and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) vaccine, live
infliximab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
infliximab and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temsirolimus
infliximab and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus toxoid adsorbed or fluid
infliximab 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
infliximab decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tisagenlecleucel
infliximab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
tocilizumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
infliximab, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tongkat ali
infliximab and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- travelers diarrhea and cholera vaccine inactivated
infliximab 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
infliximab decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid vaccine live
infliximab decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ustekinumab
infliximab and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
infliximab decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- vedolizumab
vedolizumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections
- yellow fever vaccine
infliximab decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- zoster vaccine live
infliximab decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Monitor Closely (34)
- astragalus
infliximab increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- belatacept
belatacept and infliximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cholera vaccine
infliximab 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.
- dengue vaccine
infliximab 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
infliximab, 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.
- echinacea
infliximab increases and echinacea decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of infliximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of infliximab by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- fingolimod
infliximab 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. .
- haemophilus influenzae type b vaccine
infliximab 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, infliximab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- ifosfamide
ifosfamide, infliximab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor.
- influenza virus vaccine quadrivalent, recombinant
infliximab 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
infliximab 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
infliximab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine and infliximab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- maitake
infliximab increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- mechlorethamine
mechlorethamine, infliximab. immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections. .
- meningococcal group B vaccine
infliximab 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
infliximab and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ocrelizumab
infliximab and ocrelizumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Coadministration of ocrelizumab with immunomodulators is expected to increase the risk of immunosuppression.
- ofatumumab SC
ofatumumab SC, infliximab. 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
infliximab 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.
- ozanimod
ozanimod, infliximab. 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.
- poliovirus vaccine inactivated
infliximab 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. .
- ponesimod
ponesimod and infliximab 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.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of infliximab by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- siponimod
siponimod and infliximab 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
infliximab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, infliximab. 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, infliximab. 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 infliximab 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
- valoctocogene roxaparvovec
infliximab and valoctocogene roxaparvovec both increase Other (see comment). Use Caution/Monitor. Medications that may cause hepatotoxicity when combined with valoctogene roxaparvovec may potentiate the risk of elevated liver enzymes. Closely monitor these medications and consider alternative medications in case of potential drug interactions.
- zoster vaccine recombinant
infliximab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (1)
- cat's claw
cat's claw, infliximab. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Possible additive immunosuppr'n.
Adverse Effects
>10%
Development of antinuclear antibodies (50%)
Infection (36%)
Upper respiratory tract infection (32%)
Abdominal pain (12%; 26% with Crohn disease)
Nausea (21%)
Infusion-related reaction (20%)
Headache (18%)
Development of antibodies to double-stranded DNA (17%)
Other respiratory infection (eg, sinusitis, cough) (12-14%)
Diarrhea (12%)
Elevated alanine transaminase (ALT), >1 to <3 ULN (12-34%)
1-10% (Adults)
Bronchitis (10%)
Dyspepsia (10%)
Rash (1-10%)
Elevated ALT, ≥3 ULN (2-10%)
Fatigue (9%)
Back pain (8%)
Rhinitis (8%)
Urinary tract infection (8%)
Arthralgia (1-8%)
Fever (7%)
Hypertension (7%)
Pruritus (7%)
Dyspnea (6%)
Candidiasis (5%)
Lupuslike symptoms (<5%)
Elevated ALT, ≥5 ULN (<1-4%)
1-10% (Children)
Leukopenia (9%)
Flushing (9%)
Viral infection (8%)
Neutropenia (7%)
Bone fracture (7%)
Bacterial infection (6%)
Respiratory tract allergic reaction (6%)
Postmarketing Reports
Adults
- Anaphylacticlike reactions, including anaphylactic shock, laryngeal/pharyngeal edema, severe bronchospasm, and seizure
- Myocardial ischemia or infarction and transient visual loss have also been rarely reported during or within 2 hours of infusion
- Serious infections and malignancies, including melanoma, leukemia, and Merkel cell carcinoma
- Neutropenia, agranulocytosis (including infants exposed in utero to infliximab), interstitial lung disease (including pulmonary fibrosis/interstitial pneumonitis and rapidly progressive disease), idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, pericardial effusion, systemic and cutaneous vasculitis, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis
- Peripheral demyelinating disorders (such as Guillain- Barré syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy), new onset and worsening psoriasis (all subtypes including pustular, primarily palmoplantar), transverse myelitis, and neuropathies (additional neurologic reactions have also been observed), acute liver failure, jaundice, hepatitis, and cholestasis, serious infections, malignancies, including melanoma, Merkel cell carcinoma, and cervical cancer
Children
- Malignancies, including hepatosplenic T-cell lymphomas
- Transient hepatic enzyme abnormalities, lupus-like syndromes, and the development of autoantibodies
- Infections (some fatal) including opportunistic infections and tuberculosis
- Infusion reactions
- Hypersensitivity reactions
- Idiopathic thrombocytopenic purpura
- Thrombotic thrombocytopenic purpura
- Stevens-Johnson Syndrome, toxic epidermal necrolysis, linear IgA bullous dermatosis (LABD)
- Acute generalized exanthematous pustulosis (AGEP), new onset and worsening psoriasis (all subtypes including pustular, primarily palmoplantar)
- Lichenoid reactions
Warnings
Black Box Warnings
Serious infection risk
- Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
- Patients older than 65 years may be at greater risk
- Discontinue if patient develops serious infection or sepsis; reported infections include the following:
- (1) Active tuberculosis, including reactivation of latent disease (frequently present with disseminated or extrapulmonary disease); test for latent tuberculosis before use and during therapy; treat latent infection before use
- (2) Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, cryptococcosis, candidiasis, aspergillosis, salmonellosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may yield negative results in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops
- (3) Infections caused by other opportunistic pathogens, including bacteria (eg, Legionella, Listeria), mycobacteria (eg, Mycobacterium tuberculosis), and viruses (eg, hepatitis B virus)
Malignancy
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers
- Manufacturer is required to report all malignancies to FDA for complete and consistent analysis
Hepatosplenic T-cell lymphoma
- Hepatosplenic T-cell lymphoma (HSTCL) is an aggressive, rare type of T-cell lymphoma (usually fatal)
- Rare postmarketing cases of HSTCL are reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with infliximab
- Reports have also included 1 patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis
- Most reported cases with infliximab have occurred with concomitant treatment with azathioprine or 6-mercaptopurine (6-MP), though cases have been reported in patients receiving azathioprine or 6-MP alone
- In the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network, HSTCL cases have been identified in association with the following agents: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), and 6-MP (3)
Contraindications
Active serious infections
Documented hypersensitivity
Doses >5 mg/kg in patients with moderate-to-severe heart failure (NYHA Class III/IV)
Cautions
Patients should be closely monitored for development of signs and symptoms of infection during and after treatment
Hypersensitivity reactions reported; most hypersensitivity reactions, which include anaphylaxis, urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hr of infusion
Caution in neurologic disorder
Moderate-to-severe chronic obstructive pulmonary disease
Monitor closely for signs and symptoms of demyelinating disease (eg, confusion, numbness, vision changes); consider termination of therapy if significant CNS reactions develop
Risk of tuberculosis, histoplasmosis, and other opportunistic infections, as well as hepatitis B reactivation; test for HBV infection before starting infliximab; monitor HBV carriers during and several months after therapy
Consider discontinuance if hematologic disorder occurs (eg, leukopenia, thrombocytopenia, neutropenia, pancytopenia)
Consider discontinuance if lupuslike symptoms occur
Readministration after period of no treatment resulted in higher incidence of infusion reactions than was seen with regular maintenance treatment (4% vs <1%)
Consider empiric antifungal therapy for patients who develop a systemic illness on infliximab and reside or travel to regions where mycoses are endemic
Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hr of initiation of infliximab infusion; cases of transient visual loss have been reported during or within 2 hr of infliximab infusion; monitor patients during infusion and if serious reaction occurs, discontinue infusion
Use caution in patients with history of seizures; discontinue therapy if significant adverse reactions develop
Use caution in patients with mild heart failure (NYHA Class I, II) or decreased left ventricular function; worsening and new-onset heart failure reported
Before initiating therapy in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines
Neurologic reactions
- Associated with CNS manifestation of systemic vasculitis, seizure and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome
- Prescribers should exercise caution in considering use of therapy in patients with these neurologic disorders and should consider discontinuation of drug if these disorders develop
Hepatoxicity
- Severe hepatic reactions (eg, acute liver failure, jaundice, hepatitis and cholestasis), have been reported in postmarketing data
- Severe hepatic reactions occurred between 2 weeks to more than 1 year after initiation of infliximab; elevations in hepatic aminotransferase levels were not noted prior to discovery of the liver injury in many of these cases
- Some fatal or necessitating liver transplantation; stop therapy in cases of jaundice and/or marked liver enzyme elevations (≥5 ULN)
Malignancies
- Increased risk of lymphoma (including hepatosplenic T-cell lymphoma, especially if given with azathioprine or 6-MP), pneumonia, hepatotoxicity (including acute liver failure, jaundice, hepatitis, cholestasis)
- Increased risk of lymphoma and other cancers is reported in children and adolescents
- Skin cancer (eg, melanoma, Merkel cell carcinoma) is reported with TNF blockers
- Increased incidence of invasive cervical cancer in women reported; a causal relationship between infliximab and cervical cancer cannot be excluded; periodic screening should continue in women receiving therapy
- Occurrence of leukemia and new-onset psoriasis also with TNF blockers
Tuberculosis
- Cases of reactivation of tuberculosis or new tuberculosis infections reported, including patients who have previously received treatment for latent or active tuberculosis; cases of active tuberculosis have also occurred during treatment for latent tuberculosis
- Evaluate for tuberculosis risk factors and test for latent infection prior to initiating treatment and periodically during therapy; treatment of latent tuberculosis infection prior to therapy with TNF blockers has been shown to reduce the risk of tuberculosis reactivation during therapy; consider tuberculin skin test with an induration ≥5 mm is a positive test result when assessing if treatment for latent tuberculosis is needed before initiating treatment, even for patients previously vaccinated with Bacille Calmette-Guérin (BCG)
- Consider antitubercular therapy before initiating treatment in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection
- Consult with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating antitubercular therapy is appropriate for an individual patient
- Consider tuberculosis if a new infection develops during treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis
Heart failure
- Worsening or new-onset congestive HF reported with TNF blockers; exercise caution when using in patients who have heart failure; consider TNF therapy in patients with HF if there are no other reasonable treatment options, and then consider only in patients with compensated HF
- Doses >5 mg/kg are contraindicated in patients with moderate or severe HF; 10 mg/kg-dose has been associated with an increased incidence of death and hospitalization due to worsening HF; new-onset and worsening HF, with and without identifiable precipitating factors (eg, pre-existing cardiovascular disease), reported in postmarketing data
- If administering doses ≤5 mg/kg to patients with moderate or severe HF or to administer it (any approved dose) to patients with mild HF, closely monitor these patients during therapy, and discontinue if new or worsening symptoms of HF appear
Drug interactions overview
-
Anakinra
- Coadministration not recommended
- Serious infections and neutropenia reported with concurrent use of anakinra and etanercept (another TNF blocker)
- Similar toxicities may result with concomitant use of anakinra with other TNF blockers
-
Abatacept
- Coadministration not recommended
- Coadministration of abatacept with TNF blockers may increase the risk of infections
-
Other biologic products
- Coadministration not recommended
- Insufficient data are available regarding coadministration of infliximab products with other biological products
- Concurrent use with these biological products may increase the risk of infection
-
Vaccinations
- Coadministration with live vaccines is not recommended
- Before initiating in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines
- In patients receiving TNF blockers, limited data are available on response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines
- Infliximab products cross the placenta and can detected up to 6 months following birth; recommend waiting at least 6 months following birth before administering of any live vaccine to infants exposed in utero to infliximab products
-
Therapeutic infectious agents
- Coadministration not recommended
- Other uses of therapeutic infectious agents such as live attenuated bacteria (eg, BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections
-
CYP450 substrates
- Monitor of effect (eg, warfarin) or drug concentration (eg, cyclosporine, theophylline) and the individual dose of the drug product may be adjusted as needed
- Upon initiation or discontinuation of infliximab in patients being treated with CYP450 substrates with a narrow therapeutic index, monitor effect (eg, warfarin) or drug concentration (eg, cyclosporine or theophylline) and adjust the individual dose of the CYP450 substrate may be adjusted as needed
- Formation of CYP450 enzymes may be suppressed by increased levels of cytokines (eg, TNFα, IL-1, IL-6, IL-10, IFN) during chronic inflammation
- Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as infliximab, the formation of CYP450 enzymes could be normalized
-
Methotrexate (MTX) and other concomitant medications
- Use with caution
- Specific drug interaction studies, including interactions with MTX, have not been conducted
- Concomitant MTX use may decrease the incidence of anti-drug antibody production and increase infliximab product concentrations
Pregnancy & Lactation
Pregnancy
Available observational studies in pregnant women exposed to infliximab products showed no increased risk of major malformations among live births as compared to those exposed to non- biologics; however, findings on other birth and maternal outcomes were not consistent across studies of different study design and conduct
Monoclonal antibodies such as infliximab products are transferred across placenta during third trimester of pregnancy and may affect immune response in the in utero exposed infant
Because infliximab products do not cross-react with TNF in species other than humans and chimpanzees, animal reproduction studies have not been conducted with infliximab products
In a developmental study conducted in mice using an analogous antibody, no evidence of maternal toxicity or fetal harm was observed
Published data suggest that there is increased risk of adverse pregnancy outcomes in women with inflammatory bowel disease or rheumatoid arthritis associated with increased disease activity
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2.5 kg) and small for gestational age at birth
As with other IgG antibodies, infliximab products cross the placenta; infliximab products have been detected in the serum of infants up to 6 months following birth
Animal data
- No evidence of maternal toxicity, embryotoxicity or teratogenicity observed in a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF alpha
Lactation
Published literature show that infliximab is present at low levels in human milk
Systemic exposure in a breastfed infant is expected to be low because infliximab products are largely degraded in the gastrointestinal tract
A U.S. multi-center study of 168 women treated with infliximab for inflammatory bowel disease (breast milk samples obtained, n=29) showed that infants exposed to infliximab through breast milk had no increase in rates of infections and developed normally
There are no data on effects of infliximab products on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
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
Recombinant humanized monoclonal anti-TNF-α antibody; prevents synovial and intestinal inflammation
Absorption
Onset: 2 wk (Crohn disease)
Duration: 12 wk
Distribution
Vd: 3-6 L
Metabolism
Unknown
Elimination
Half-life: 7.7-9.5 days
Development of antibodies to infliximab increased infliximab clearance
Excretion: Unknown
Administration
IV Compatibility
0.9% NaCl
IV Incompatibilities
Do not infuse with other agents
IV Preparation
Reconstitute vials aseptically with 10 mL SWI; swirl vial gently to dissolve powder, and do not shake
Allow solution to stand for 5 minutes
Remove volume from 250-mL sterile 0.9% NaCl infusion bag equal to drug volume of reconstituted infliximab being added
Slowly add reconstituted infliximab solution to 250-mL infusion bag; gently mix; final diluted concentration: 0.4 - 4 mg/mL
Discard if particulate matter is present or discoloration observed
Begin infusion within 3 hr of preparation (product contains no preservatives)
SC Preparation (Zymfentra)
Inspected visually for particulate matter and discoloration before administration; solution should appear clear to opalescent, colorless to pale brown
Discard if particulates or discoloration observed
IV Administration
Infuse over ≥2 hr
Use an infusion set with an in-line, sterile, non-pyrogenic, low-protein-binding filter (pore size of 1.2 µm or less)
Do not infuse in same line as other drugs
Discontinue if infusion reaction occurs
Vials do not contain antibacterial preservatives; discard any unused portion
SC Administration (Zymfentra)
Intended for use under guidance and supervision of a healthcare professional
If a healthcare professional determines that it is appropriate, patients may self-inject or caregivers may inject
Inject SC into front of thighs, abdomen (except for 2 inches around the navel), or the outer area of upper arms (caregiver only)
Rotate injection site at each administration
Allow at least 1.2 inches between the new injection site and the previous injection site Do not into areas where skin is red, bruised, tender, or indurated
Do not use syringe or pen if it has been dropped or is visibly damaged (may not function properly)
Do not reuse or shake the syringe or pen at any time
Missed dose
- If an injection is missed, inject the next dose as soon as possible and then every 2 weeks thereafter
Storage
Unopen vials for IV
- Refrigerate at 2-8ºC (36-46ºF) or at temperatures up to 30°C (86°F) for a single period of up to 6 months but not exceeding the original expiration date
- New expiration date must be written on the carton
- Upon removal from refrigerator, vials cannot be returned to refrigerated storage
Diluted IV solutions
- 0.4 mg/mL solutions: Refrigerate at 4°C for up to 14 days (Ikeda 2012)
SC (Zymfentra)
- Refrigerate at 2-8ºC (36-46ºF)
- Do not freeze
- Keep product in its outer carton until time of administration to protect from light
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Remicade intravenous - | 100 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
infliximab intravenous
INFLIXIMAB - INJECTION
(in-FLIX-i-mab)
COMMON BRAND NAME(S): Avsola, Inflectra, Remicade, Renflexis
WARNING: This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infections to watch out for, and get medical help right away if you have any of these symptoms.The immune system also helps prevent and control cancer. There is a very small risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition. A rare, mostly fatal cancer (hepatosplenic T-cell lymphoma) has occurred in people receiving this medication along with certain other drugs (azathioprine or 6-mercaptopurine) to treat Crohn's disease or ulcerative colitis. Talk to your doctor about the risks and benefits of treatment. Tell your doctor right away if you have symptoms such as unusual lumps/growths, swollen glands, swollen or painful abdomen, unexplained weight loss, unusual tiredness, loss of appetite, fever that doesn't go away, or night sweats.
USES: This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, which slows or stops the damage from the disease.This monograph is about the following infliximab products: infliximab, infliximab-abda, infliximab-axxq, and infliximab-dyyb.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using infliximab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein over at least 2 hours as directed by your doctor. The dosage is based on your medical condition, weight, and response to treatment. After the first dose, this medication is usually given again after 2 weeks and 6 weeks, then every 8 weeks (or every 6 weeks for arthritis of the spine), as directed by your doctor.Symptoms of an infusion reaction that may occur during infliximab treatment include pain/swelling at the injection site, shortness of breath, flushing, chills, fever, headache, and rash. If you have any of these symptoms, your healthcare professional may need to adjust/stop your infusion and treat your symptoms.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Do not shake this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Your doctor may direct you to use other medications (to help prevent side effects) before using infliximab. Use those medications exactly as directed.Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: See also Warning and How to Use section.Headache, stomach pain, or nausea 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: joint/muscle pain, easy bruising/bleeding, seizures, confusion, muscle weakness, numbness/tingling of arms/legs, butterfly-shaped facial rash, pain/redness/swelling of arms or legs, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Tell your doctor right away if you develop signs of infection while using this drug, such as: cough/sore throat that doesn't go away, fever, chills, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: extreme tiredness, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.This medication may cause serious heart problems (such as heart attack) during the infusion and up to 24 hours after the start of the infusion. Get medical help right away if you have any symptoms of heart problems such as chest/jaw/left arm pain, shortness of breath, unusual sweating, lightheadedness, dizziness, fainting, vision changes, or fast/irregular/slow heartbeat.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, difficulty swallowing.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 using infliximab, tell your doctor or pharmacist if you are allergic to it; or to other infliximab products; 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: tuberculosis (previous infection or positive skin test), past/recent/current infections (such as cold sores, valley fever), heart disease (such as heart failure), blood/bone marrow disorder (such as leukopenia, thrombocytopenia), nervous system disorder (such as numbness/tingling, seizures, multiple sclerosis), cancer (such as breast cancer, skin cancer, lymphoma), a certain lung disorder (chronic obstructive pulmonary disease-COPD), liver disease (such as hepatitis B), light treatment for psoriasis (phototherapy).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Infliximab 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.Tell your health care professional that you are using infliximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Older adults may be more sensitive to the side effects of this drug, especially risk for infections.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using infliximab. Infliximab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 6 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. If this medication is used during pregnancy, be sure to tell your baby's doctors about its use. The doctor may change the baby's vaccination schedule to decrease the risk of infection.This drug may pass into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: 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 are: other drugs that weaken the immune system/increase the risk of infection (such as abatacept, anakinra), treatment with weakened bacteria/viruses (such as live vaccines, BCG for bladder cancer).
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.Lab and/or medical tests (such as complete blood count, liver function test, skin exams, Pap smear) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Consult the product instructions and your pharmacist for storage details. 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
Adding plans allows you to compare formulary status to other drugs in the same class.
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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