Dosing & Uses
Dosage Forms & Strengths
injection, prefilled glass syringe
- 10mg/0.1mL (Humira)
- 10mg/0.2mL (Humira, Abrilada, Hyrimoz)
- 20mg/0.2mL (Humira, Amjevita)
- 20mg/0.4mL (Humira, Amjevita, Cyltezo, Abrilada)
- 40mg/0.4mL (Humira, Amjevita)
- 40mg/0.8mL (Humira, Cyltezo, Abrilada, Amjevita, Hadlima, Hyrimoz, Idacio, Yusimry)
- 80mg/0.8mL (Humira, Amjevita)
injection, prefilled syringe/pen
- 20mg/0.4mL (Amjevita, Hulio)
- 40mg/0.4mL (Humira)
- 40mg/0.8mL (Humira, Abrilada, Amjevita, Hadlima, Hulio, Hyrimoz, Idacio)
- 80mg/0.8mL (Humira)
injection, prefilled autoinjector
- 40mg/0.8 mL (Amjevita, Yusimry)
- 40mg/0.8mL (Amjevita)
- 80mg/0.8mL (Amjevita)
injection, vial
- 40mg/0.8mL (Humira)
Biosimilars to Humira
- Abrilada (adalimumab-afzb)
- Amjevita (adalimumab-atto)
- Cyltezo (adalimumab-adbm)
- Hadlima (adalimumab-bwwd)
- Hulio (adalimumab-fkjp)
- Hyrimoz (adalimumab-adaz)
- Idacio (adalimumab-aacf)
- Yusimry (adalimumab-aqvh)
Rheumatoid Arthritis
Indicated for the treatment of moderate-to-severe active rheumatoid arthritis
40 mg SC q2wk
Dosing considerations
- May be administered as monotherapy or combined with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)
- If not taken with concomitant methotrexate, additional benefit may be derived from increasing frequency to 40 mg qWeek or increasing dose to 80 mg every other week
Psoriatic Arthritis
Indicated for the treatment of active psoriatic arthritis
40 mg SC q2wk
Dosing considerations
- May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs
- If not taken with concomitant methotrexate, additional benefit may be derived from increasing frequency to 40 mg qWeek or increasing dose to 80 mg every other week
Ankylosing Spondylitis
Indicated for reduction of signs and symptoms of active ankylosing spondylitis
40 mg SC q2wk
Dosing considerations
- May be administered as monotherapy or combined with methotrexate or other nonbiologic DMARDs
- If not taken with concomitant methotrexate, additional benefit may be derived from increasing frequency to 40 mg qWeek or increasing dose to 80 mg every other week
Plaque Psoriasis
Indicated for treatment of moderate-to-severe chronic plaque psoriasis (Ps) in candidates for systemic therapy or phototherapy and when systemic therapies are inappropriate
80 mg SC once, then, after 1 week, 40 mg SC q2wk
Use in moderate to severe chronic Ps beyond one year has not been evaluated in controlled clinical studies
Humira prescribing information includes patients with moderate-to-severe fingernail psoriasis
Crohn Disease
Indicated for reduction of signs and symptoms and induction and maintenance of clinical remission in moderately to severely active Crohn disease (CD) with inadequate response to conventional therapy
May be used in patients who have lost response to or are intolerant of infliximab
Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15)
Maintenance (beginning Week 4 [Day 29]): 40 mg SC q2wk
Use in CD beyond 1 yr has not been evaluated in controlled clinical studies
Ulcerative Colitis
Indicated for patients unresponsive to immunosuppressants (eg, corticosteroids, azathioprine, 6-mercaptopurine [6-MP])
Induction: 160 mg SC either as 4 injections of 40 mg on day 1 or as 2 injections of 40 mg daily on 2 consecutive days, then 80 mg SC 2 weeks later (day 15)
Maintenance (beginning Week 4 [Day 29]): 40 mg SC q2wk
Continue maintenance dose only if evidence of clinical remission is apparent by 8 weeks of therapy
Limitations of use: Effectiveness not established in patients who have failed or were intolerant to TNF blockers
Hidradenitis Suppurativa
Humira, Abrilada, Cyltezo, Hadlima, Hyrimoz, Hulio, Yusimry only
Indicated for treatment of moderate-to-severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)
Induction
- Day 1: 160 mg SC (given in 1 day or split over 2 consecutive days)
- Day 15: 80 mg SC
Maintenance
- Beginning Day 29: 40 mg SC qWeek or 80 mg SC every other week
Uveitis
Humira, Cyltezo, Hadlima, Hyrimoz only
Indicated for treatment of noninfectious intermediate, posterior, and panuveitis in adults
80 mg SC once, then, after 1 week, 40 mg SC q2wk
Behcet's Disease (Orphan)
Orphan designation for treatment of Behcet's disease
Sponsor
- Mucora; 32b Eisenberg St; Rehovot 7628810 Israel
Dosing Considerations
Cyltezo is interchangeable with Humira
Limitations of use
- UC: Effectiveness not established in patients who have failed or were intolerant to TNF blockers
Dosage Forms & Strengths
injection, prefilled glass syringe
- 10mg/0.1mL (Humira)
- 10mg/0.2mL (Humira, Abrilada, Hyrimoz)
- 20mg/0.2mL (Humira, Amjevita)
- 20mg/0.4mL (Humira, Amjevita, Cyltezo, Abrilada)
- 40mg/0.4mL (Humira, Amjevita)
- 40mg/0.8mL (Humira, Abrilada, Amjevita, Cyltezo, Hadlima, Hyrimoz, Idacio, Yusimry)
- 80mg/0.8mL (Humira, Amjevita)
injection, prefilled syringe/pen
- 20mg/0.4mL (Amjevita, Hulio)
- 40mg/0.4mL (Humira)
- 40mg/0.8mL (Humira, Abrilada, Amjevita, Hadlima, Hulio, Hyrimoz, Idacio)
- 80mg/0.8mL (Humira)
injection, prefilled autoinjector
- 40mg/0.8 mL (Amjevita, Yusimry)
- 40mg/0.8mL (Amjevita)
- 80mg/0.8mL (Amjevita)
injection, vial
- 40mg/0.8mL (Humira)
Biosimilars to Humira
- Abrilada (adalimumab-afzb)
- Amjevita (adalimumab-atto)
- Cyltezo (adalimumab-adbm)
- Hadlima (adalimumab-bwwd)
- Hulio (adalimumab-fkjp)
- Hyrimoz (adalimumab-adaz)
- Idacio (adalimumab-aacf)
- Yusimry (adalimumab-aqvh)
Juvenile Idiopathic Arthritis
Indicated for reduction of signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis
May be administered with methotrexate, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics
Humira, Cyltezo, or Hulio
- <2 years or <10 kg: Safety and efficacy not established
-
≥2 years
- <15 kg: No dosage forms available for weight-based dosing ≥2 years
- 15 kg to <30 kg: 20 mg SC q2wk
- ≥30 kg: 40 mg SC q2wk
Hadlima, Abrilada, or Amjevita
<2 years or <10 kg: Safety and efficacy not established
≥2 years
- 10 to <15 kg: 10 mg SC q2wk
- 15 to <30 kg: 20 mg SC q2wk
- ≥30 kg: 40 mg SC q2wk
- Only dosage form that allows weight-based dosing for pediatric patients <30 kg is the single-dose glass vial for institutional use only
Hyrimoz
- <2 years: Safety and efficacy not established
-
≥2 years
- 10 to <15 kg: 10 mg SC q2wk
- 15 to <30 kg: No dosage form allows for weight-based dosing
- ≥30 kg: 40 mg SC q2wk
Idacio, Yusimry
- ≥2 years and ≥30 kg: 40 mg SC q2wk
Pediatric Crohn Disease
Indicated to reduce signs and symptoms, and achieve and maintain clinical remission in pediatric patients with moderately to severely active Crohn disease who have had an inadequate response to corticosteroids or immunomodulators (eg, azathioprine, 6-mercaptopurine, methotrexate)
<6 years: Safety and efficacy not established
≥6 years (17 to <40 kg)
- Humira, Abrilada, Amjevita, Cyltezo, Hadlima, Hulio
- Induction: 80 mg SC on Day 1 (administer as two 40-mg injections in 1 day); THEN 2 weeks later (Day 15) give 40 mg
- Maintenance (beginning Week 4 [Day 29]): 20 mg SC q2wk
≥6 years (≥40 kg)
- Humira, Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yusimry
- Induction: 160 mg SC on Day 1 (administer as four 40-mg injections in 1 day or as two 40-mg injection per day for 2 consecutive days); THEN 2 weeks later (Day 15) give 80 mg (as two 40-mg injections in 1 day)
- Maintenance (beginning Week 4 [Day 29]): 40 mg SC q2wk
Ulcerative Colitis
Humira only
Indicated for moderately to severely active Ulcerative colitis in patients aged ≥5 years
<5 years: Safety and efficacy not established
≥5 years (20 to <40 kg)
-
Days 1-15
- Day 1: 80 mg SC
- Day 8: 40 mg SC
- Day 15: 40 mg SC
-
Maintenance (beginning Week 4 [Day 29])
- 40 mg SC q2Weeks, OR
- 20 mg SC qWeek
≥5 years (>40 kg)
-
Days 1-15
- Day 1: 160 mg SC (single dose or split over 2 consecutive days)
- Day 8: 80 mg SC
- Day 15: 80 mg SC
-
Maintenance (beginning Week 4 [Day 29])
- 80 mg SC q2Weeks, OR
- 40 mg SC qWeek
Uveitis
Humira only
Indicated for treatment of noninfectious intermediate, posterior, and panuveitis in patients aged ≥2 years
<2 years or <10 kg: Safety and efficacy not established
≥2 years
- 10 to <15 kg: 10 mg SC q2wk
- 15 to <30 kg: 20 mg SC q2wk
- ≥30 kg: 40 mg SC q2wk
Hidradenitis Suppurativa
Humira only
Indicated for treatment of moderate-to-severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) in adolescents aged ≥12 yr who weigh at least 30 kg
<12 years: Safety and efficacy not established
≥12 years
-
30 kg to <60 kg
- Induction: 80 mg SC on Day 1, then 40 mg SC 1 week later (Day 8)
- Maintenance (beginning Day 29): 40 mg SC q2weeks
-
≥60 kg
- Induction: 160 mg SC on Day 1 (given in 1 day or split over 2 consecutive days), then 80 mg SC 2 weeks later (Day 15)
- Maintenance (beginning Day 29): 40 mg SC qWeek
Dosing Considerations
Cyltezo is interchangeable with Humira
Limitations of use
- UC: Effectiveness not established in patients who have failed or were intolerant to TNF blockers
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- upadacitinib
adalimumab, upadacitinib. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated.
Serious - Use Alternative (73)
- abatacept
abatacept, adalimumab. Mechanism: pharmacodynamic synergism. Contraindicated. Increased risk of serious infection.
- alefacept
adalimumab and alefacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anakinra
adalimumab and anakinra both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- anthrax vaccine
adalimumab decreases effects of anthrax vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- antithymocyte globulin equine
adalimumab and antithymocyte globulin equine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- antithymocyte globulin rabbit
adalimumab and antithymocyte globulin rabbit both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- axicabtagene ciloleucel
adalimumab, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- azathioprine
adalimumab and azathioprine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- baricitinib
baricitinib, adalimumab. 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
adalimumab and basiliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- BCG vaccine live
adalimumab decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- brexucabtagene autoleucel
adalimumab, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- canakinumab
adalimumab and canakinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- certolizumab pegol
adalimumab 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
adalimumab, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- cyclosporine
adalimumab and cyclosporine both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- diphtheria & tetanus toxoids
adalimumab 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
adalimumab 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
adalimumab 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
adalimumab and etanercept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- everolimus
adalimumab and everolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- glatiramer
adalimumab and glatiramer both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- golimumab
adalimumab and golimumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- hepatitis A vaccine inactivated
adalimumab 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
adalimumab 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
adalimumab decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- hepatitis b vaccine
adalimumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- human papillomavirus vaccine, nonavalent
adalimumab 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
adalimumab 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
adalimumab and hydroxychloroquine sulfate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
adalimumab, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- infliximab
adalimumab and infliximab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent
adalimumab 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
adalimumab 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
adalimumab 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
adalimumab 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
adalimumab 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
adalimumab 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
adalimumab decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- leflunomide
adalimumab and leflunomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
adalimumab, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- measles (rubeola) vaccine
adalimumab 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
adalimumab 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
adalimumab 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
adalimumab 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
adalimumab and muromonab CD3 both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- mycophenolate
adalimumab and mycophenolate both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- pneumococcal vaccine 13-valent
adalimumab decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine heptavalent
adalimumab decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- pneumococcal vaccine polyvalent
adalimumab decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rabies vaccine
adalimumab decreases effects of rabies vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants may interfere with development of active immunity.
- rabies vaccine chick embryo cell derived
adalimumab decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rilonacept
adalimumab and rilonacept both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- rotavirus oral vaccine, live
adalimumab decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- rubella vaccine
adalimumab decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- selinexor
selinexor, adalimumab. 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
adalimumab and sirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- smallpox (vaccinia) vaccine, live
adalimumab decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tacrolimus
adalimumab and tacrolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- temsirolimus
adalimumab and temsirolimus both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tetanus toxoid adsorbed or fluid
adalimumab 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
adalimumab decreases effects of tick-borne encephalitis vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- tisagenlecleucel
adalimumab, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tocilizumab
adalimumab and tocilizumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tongkat ali
adalimumab and tongkat ali both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- travelers diarrhea and cholera vaccine inactivated
adalimumab 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
adalimumab decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- typhoid vaccine live
adalimumab decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- ustekinumab
adalimumab and ustekinumab both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- varicella virus vaccine live
adalimumab decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- vedolizumab
vedolizumab and adalimumab 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
adalimumab decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
- zoster vaccine live
adalimumab decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.
Monitor Closely (24)
- astragalus
adalimumab increases and astragalus decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- belatacept
belatacept and adalimumab both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- dengue vaccine
adalimumab 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
adalimumab, 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
adalimumab 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 adalimumab 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 adalimumab 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
adalimumab 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
adalimumab 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, adalimumab. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of immunosuppression.
- influenza virus vaccine quadrivalent, recombinant
adalimumab 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
adalimumab 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
adalimumab and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- lomustine
lomustine and adalimumab 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
adalimumab increases and maitake decreases immunosuppressive effects; risk of infection. Effect of interaction is not clear, use caution. Use Caution/Monitor.
- meningococcal group B vaccine
adalimumab 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
adalimumab and mercaptopurine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- ofatumumab SC
ofatumumab SC, adalimumab. 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
adalimumab 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.
- poliovirus vaccine inactivated
adalimumab 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. .
- rozanolixizumab
rozanolixizumab will decrease the level or effect of adalimumab 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.
- sipuleucel-T
adalimumab decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- ublituximab
ublituximab and adalimumab 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
- zoster vaccine recombinant
adalimumab decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant.
Minor (2)
- cat's claw
cat's claw, adalimumab. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Possible additive immunosuppr'n.
- methotrexate
methotrexate decreases levels of adalimumab by decreasing renal clearance. Minor/Significance Unknown. Methotrexate reduced adalimumab apparent clearance after single and multiple dosing by 29% and 44%, respectively. Dosage adjustment is not needed.
Adverse Effects
>10%
Injection site pain (12-20%)
Upper respiratory tract infection (URTI) (17%)
Increased creatine phosphokinase (15%)
Headache (12%)
Rash (12%)
Sinusitis (11%)
1-10%
Nausea (9%)
Urinary tract infection (UTI) (8%)
Abdominal pain (7%)
Flulike syndrome (7%)
Hyperlipidemia (7%)
Back pain (6%)
Hypercholesterolemia (6%)
Hematuria (5%)
Hypertension (5%)
Increased alkaline phosphatase (5%)
<1%
Allergic reactions
Hematologic disorder (leukopenia, thrombocytopenia, pancytopenia, aplastic anemia)
Postmarketing Reports
General disorders and administration site conditions: Pyrexia
Hepatobiliary disorders: Liver failure, hepatitis
Immune system disorders: Sarcoidosis
Neoplasms benign, malignant, and unspecified (incl cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Nervous system disorders: Demyelinating disorders (eg, optic neuritis, Guillain-Barré syndrome), cerebrovascular accident
Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism
Skin reactions: Stevens-Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia, lichenoid skin reaction
Vascular disorders: Systemic vasculitis, deep vein thrombosis
Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis
Infections: Pneumonia, septic arthritis, prosthetic and post-surgical infections, erysipelas, cellulitis, and pyelonephritis
Warnings
Black Box Warnings
Serious infection risk
- Increased risk for developing serious infections resulting in hospitalization or death; patients with comorbid conditions and/or 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:
- Active TB, including reactivation of latent TB (frequently present with disseminated or extrapulmonary disease); test for latent TB before use and during therapy; treat latent infection before use
- Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, 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
- Other bacterial (eg, Legionella, Listeria), mycobacterial (eg, tuberculosis), and viral (eg, hepatitis B) opportunistic pathogens
Malignancy
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF) blockers
- Cases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in rheumatoid arthritis (RA) and other indications; patients with RA may be at higher risk (approximately 2-fold) for leukemia than general population
- Manufacturers are required to report all malignancies to FDA for complete and consistent analysis
Hepatosplenic T-cell lymphoma
- HSTCL is an aggressive, rare type of T-cell lymphoma (usually fatal)
- Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL) reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers
- Reports have also included 1 patient being treated for psoriasis and 2 patients being treated for RA
- Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-MP, though cases have been reported with 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), 6-MP (3)
Contraindications
None
Cautions
Consider discontinuance if hematologic disorder occurs (thrombocytopenia, pancytopenia, aplastic anemia, leukopenia); use caution in patients with a history of significant hematologic abnormalities
Coadministration with interleukin (IL)-1 blockers (eg, anakinra, ustekinumab) may lead to serious infections and neutropenia
Coadministration of TNF blockers with abatacept showed increased rate of serious infections in controlled trials as compared with TNF blockers alone
Treatment should not be initiated in patients with an active infection, including localized infections
Risk of serious infection, including tuberculosis or hepatitis B virus; despite prophylactic treatment for TB, reactivation has occurred (see Black Box Warnings)
Decreases immune response of live virus vaccines; also increases risk of infection with concomitant live virus vaccines; safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero unknown; risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants
If possible, patients with JIA should be current with immunization guidelines prior to initiating adalimumab; may receive concurrent vaccinations (except for live vaccines) while taking adalimumab
Autoimmunity may result in formation of autoantibodies and, rarely, development of lupuslike syndrome; if patient develops symptoms suggestive of lupus-like syndrome following treatment with adalimumab, discontinue treatment
Hypersensitivity reactions (eg, anaphylaxis, angioedema) are reported rarely
Worsening or new onset congestive heart failure (HF) reported with TNF blockers; exercise caution when using in patients who have HF; TNFalpha inhibitors should only be considered in patients with HF if there are no other reasonable treatment options, and then consider only in patients with compensated HF
Infection and malignancy reported in elderly at higher rate; use caution
Monitor closely for infection in patients undergoing surgical procedures while on therapy; not studied; consider long half-life
With monotherapy, patients receiving every other week dosing may develop antibodies against this drug more frequently than those receiving weekly dosing; in patients receiving the recommended dosage of 40 mg every other week as monotherapy, the adalimumab clinical response was lower among antibody-positive patients than among antibody-negative patients; the long-term immunogenicity of adalimumab products is unknown
Neurologic reactions
- Use of TNF blocking agents, including this medication, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome
- Exercise caution in considering use in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of therapy should be considered if any of these disorders develop; there is a known association between intermediate uveitis and central demyelinating disorders
Malignancies
- Most frequently observed malignancies, other than lymphoma and non-melanoma skin cancer (NMSC), have included breast, colon, prostate, lung, and melanoma
- Consider risks and benefits of TNF blocker treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing a TNF blocker in patients who develop a malignancy
- Non-melanoma skin cancer (NMSC) reported in clinical trials; examine all patients, and in particular patients with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment for presence of NMSC prior to and during treatment
- Post-marketing cases of acute and chronic leukemia reported in association with TNF blocker use in RA and other indications
- Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, reported in patients treated with TNF blockers including adalimumab products; these cases have had a very aggressive disease course and have been fatal; the majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and majority were in adolescent and young adult males; almost all of the patients had received treatment with the immunosuppressants azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis; it is uncertain whether occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants; the potential risk with the combination of azathioprine or 6-mercaptopurine and this drug should be carefully considered
Pregnancy & Lactation
Pregnancy
Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects
Clinical data are available from the Organization of Teratology Information Specialists (OTIS)/Mother-To-Baby HUMIRA Pregnancy Registry in pregnant women with rheumatoid arthritis (RA) or Crohn disease (CD)
Registry results showed a rate of 10% for major birth defects with first trimester use of adalimumab in pregnant women with RA or CD and a rate of 7.5% for major birth defects in the disease matched comparison cohort
The lack of pattern of major birth defects is reassuring and differences between exposure groups may have impacted the occurrence of birth defects
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant
Animal studies
- In an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with IV administration during organogenesis and later in gestation, at doses that produced exposures up to ~373 times maximum recommended human dose (MRHD) of 40 mg SC without methotrexate
Clinical consideration
-
Disease-associated maternal and embryo/fetal risk
- Published data suggest that the risk of adverse pregnancy outcomes in women with RA or inflammatory bowel disease (IBD) is associated with increased disease activity
- Adverse pregnancy outcomes include preterm delivery (ie, <37 weeks gestation), low birth weight (ie, <2500 g) infants, and small for gestational age at birth
-
Fetal/neonatal adverse reaction
- Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester
- Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab in utero owing to possible effect on infant immune system
Lactation
Limited data from case reports in published literature describe presence of adalimumab in human milk at infant doses of 0.1-1% of maternal serum level; there are no reports of adverse effects of adalimumab on breastfed infant and no effects on milk production; 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 human anti-TNF-α IgG1 monoclonal antibody; blocks inflammatory activity of TNF-α; specifically binds to TNF-α and blocks its interaction with p55 and p75 cell surface TNF receptors; also lyses surface TNF-expressing cells in vitro and modulates biologic responses responsible for leukocyte migration
Absorption
Bioavailability: 64%
Peak plasma time (40-mg dose): 131 ± 56 hr
Peak plasma concentration: 4.7 ± 1.6 mcg/mL
Distribution
Vd: 4.7-6 L
Elimination
Half-life: 10-20 days
Total body clearance: 12 mL/hr
Administration
SC Administration
Inject full amount in the syringe, according to the directions provided
Separate sites in the thigh or abdomen; rotate injection sites and do not give injections into areas where the skin is tender, bruised, red, or hard
Storage
-
All formulations
- Refrigerate at 2-8ºC (36-46ºF); do not freeze; protect from light
- Do not use if frozen even if thawed
- If needed, store at room temperature up to a maximum of 25ºC (77ºF) for a period of up to 14 days, with protection from light
- Discard if not used within the 14-day period
- Do not store in extreme heat or cold
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Humira Pen Psoriasis Starter Pack subcutaneous - | 40 mg/0.8 mL device |  | |
| Humira(CF) Pen Psoriasis-Uveitis-Adolesc H.Sup. subcutaneous - | 80 mg/0.8 mL-40 mg/0.4 mL device |  | |
| Humira(CF) subcutaneous - | 40 mg/0.4 mL syringe |  | |
| Humira(CF) Pen subcutaneous - | 40 mg/0.4 mL device |  | |
| Humira(CF) Pen Crohns-Ulcerative Colitis-H.Sup. subcutaneous - | 80 mg/0.8 mL device |  | |
| Humira subcutaneous - | 40 mg/0.8 mL syringe |  | |
| Humira Pen Crohn's-Ulc Colitis-Hidr Sup Starter subcutaneous - | 40 mg/0.8 mL device |  | |
| Humira Pen subcutaneous - | 40 mg/0.8 mL device |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
adalimumab subcutaneous
ADALIMUMAB - INJECTION
(AY-da-LIM-ue-mab)
COMMON BRAND NAME(S): Amjevita, Cyltezo, Hadlima, Hulio, Humira, Hyrimoz, Idacio, Yuflyma, Yusimry
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). 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. Tell your doctor right away if you develop signs of infection (see Side Effects section).Your doctor will test you for tuberculosis (TB) infection before and during treatment with this drug. If you are diagnosed with TB, your doctor will first prescribe treatment for this to prevent a serious TB infection while using adalimumab.Though it is very unlikely to happen, there is a 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. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as a fever that doesn't go away, unusual lumps/growths, swollen glands, unexplained weight loss, or night sweats.
USES: Adalimumab is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, juvenile idiopathic, ankylosing spondylitis). This medication is also used to treat certain skin disorders (such as plaque-type psoriasis, hidradenitis suppurativa). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage in arthritis as well as red scaly patches in psoriasis. Adalimumab belongs to a class of drugs known as TNF blockers. By reducing joint swelling, this medication helps to reduce further joint damage and preserve joint function.Adalimumab is also used to treat certain bowel conditions (Crohn's disease, ulcerative colitis) and a certain eye disease (uveitis).This monograph is about the following adalimumab products: adalimumab, adalimumab-aacf, adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, adalimumab-aqvh, adalimumab-atto, adalimumab-bwwd, and adalimumab-fkjp.
HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using adalimumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you are removing this medication from the refrigerator, leave it at room temperature for 15 to 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water.Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. New injections should be given at least 1 inch (2.5 centimeter) from an old site. Do not inject into any areas of the skin that are sore, bruised, red, or hard.Use this medication exactly as prescribed. Inject this medication under the skin on the thigh or abdomen as directed by your doctor, usually every other week or once a week in some cases. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. If you are using this medication to treat psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, or uveitis, your doctor may prescribe a different schedule/higher dose at the start of your treatment. Carefully follow your doctor's directions for using this medication.Learn how to store and discard medical supplies safely.Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive this medication. Do not increase your dose or use this drug more often or for longer than prescribed.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: See also Warning section.Redness, itching, pain, or swelling at the injection site 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 develop signs of infection while using this drug, such as: sore throat that doesn't go away, cough that doesn't go away, fever, chills, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).Tell your doctor right away if you have any serious side effects, including: fast/irregular/pounding heartbeat, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), blood in the stools, mental/mood changes, severe headache, easy bruising/bleeding, leg pain/swelling, numbness or tingling of the arms/hands/legs/feet, unsteadiness, unexplained muscle weakness, difficulty with speaking/chewing/swallowing/facial movements, vision changes, joint pain, butterfly-shaped rash on the nose and cheeks.Adalimumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for several months after your last treatment. Get medical help right away if you have any symptoms of liver damage, including: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.Get medical help right away if you have any very serious side effects, including: seizures, chest pain.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.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: See also Warning section.Before using adalimumab, tell your doctor or pharmacist if you are allergic to it; or to any adalimumab products; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), 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: current/recent/repeated infections (such as hepatitis B, TB infection, histoplasmosis), blood/bone marrow problems (such as low red/white blood cells and platelets), seizures, certain brain/nerve disorders (such as multiple sclerosis, Guillain-Barre syndrome), cancer, heart disease (especially heart failure), lupus.Adalimumab 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 adalimumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at greater risk for infections and cancer while using this drug.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. 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 include: other TNF blockers (such as etanercept, infliximab), other drugs that weaken the immune system (such as abatacept, anakinra).
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) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: 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: Store in the refrigerator. Do not freeze. If needed, some brands of this medication may also be stored at room temperature. Ask your pharmacist or read the product package to see if your medication can be stored at room temperature and for how long. Once the medication has been stored at room temperature, it should not be put back in the refrigerator. Keep the medication in the original container to protect from light. Discard any unused portion of the medication. 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 July 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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- View the formulary and any restrictions for each plan.
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