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Humira Generic Name & Formulations
Legal Class
Rx
General Description
Adalimumab 10mg/0.1mL, 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use prefilled syringe—2; Single-use pen (40mg)—2; Starter Package (pen)—4, 6 (40mg), 3 (80mg), 3 (80mg + 40mg); Pediatric Starter Package (syringe)—3, 6 (40mg), 3 (80mg), 2 (80mg + 40mg)
Manufacturer
Generic Availability
NO
Humira Indications
Indications
To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in moderately to severely active rheumatoid arthritis (RA); may be used alone or with methotrexate (MTX) or DMARDs. To reduce signs/symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ≥2yrs of age; may be used alone or with MTX. To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in active psoriatic arthritis; may be used alone or with DMARDs. To reduce signs and symptoms of active ankylosing spondylitis.
Humira Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 40mg every other week. May use with MTX, DMARDs, glucocorticoids, salicylates, NSAIDs, and/or analgesics. RA (without MTX): may increase frequency to once weekly.
Children
<2yrs or <10kg: not recommended. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. 2–17yrs: (10–<15kg): 10mg every other week (use 10mg prefilled syringe); (15–<30kg): 20mg every other week (use 20mg prefilled syringe); (≥30kg): 40mg every other week (use Pen or 40mg prefilled syringe). May use with MTX, glucocorticoids, NSAIDs, and/or analgesics.
Humira Contraindications
Not Applicable
Humira Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Humira Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.
Humira Pharmacokinetics
See Literature
Humira Interactions
Interactions
Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.
Humira Adverse Reactions
Adverse Reactions
Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.
Humira Clinical Trials
See Literature
Humira Note
Not Applicable
Humira Patient Counseling
See Literature
Humira Generic Name & Formulations
Legal Class
Rx
General Description
Adalimumab 10mg/0.1mL, 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use prefilled syringe—2; Single-use pen (40mg)—2; Starter Package (pen)—4, 6 (40mg), 3 (80mg), 3 (80mg + 40mg); Pediatric Starter Package (syringe)—3, 6 (40mg), 3 (80mg), 2 (80mg + 40mg)
Manufacturer
Generic Availability
NO
Humira Indications
Indications
For moderately to severely active Crohn's disease (CD) in adults and pediatric patients ≥6yrs of age. For moderately to severely active ulcerative colitis (UC) in adults and pediatric patients ≥5yrs of age.
Limitations of Use
UC: not established in patients who have lost response to or were intolerant to TNF blockers.
Humira Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. Initially 160mg on Day 1 (given in 1 day or divided over 2 days), followed by 80mg on Day 15. On Day 29, start maintenance of 40mg every other week. May continue aminosalicylates, corticosteroids, or immunomodulatory agents. UC: discontinue in those without evidence of clinical remission by 8 weeks of therapy.
Children
<6yrs (CD) or <5yrs (UC): not recommended. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥6yrs (CD): (17–<40kg): initially 80mg on Day 1, then 40mg on Day 15. On Day 29, start maintenance of 20mg every other week; (≥40kg): initially 160mg on Day 1 (given in 1 day or divided over 2 days), then 80mg on Day 15. On Day 29, start maintenance of 40mg every other week. ≥5yrs (UC): (20–<40kg): initially 80mg on Day 1, then 40mg on Day 8 and Day 15. On Day 29, start maintenance of 40mg every other week or 20mg every week; (≥40kg): initially 160mg on Day 1 (given in 1 day or divided over 2 days), then 80mg on Day 8 and Day 15. On Day 29, start maintenance of 80mg every other week or 40mg every week. Continue recommended UC pediatric dosage in those who turn 18yrs of age and are well-controlled.
Humira Contraindications
Not Applicable
Humira Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Humira Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.
Humira Pharmacokinetics
See Literature
Humira Interactions
Interactions
Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.
Humira Adverse Reactions
Adverse Reactions
Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.
Humira Clinical Trials
See Literature
Humira Note
Not Applicable
Humira Patient Counseling
See Literature
Humira Generic Name & Formulations
Legal Class
Rx
General Description
Adalimumab 10mg/0.1mL, 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use prefilled syringe—2; Single-use pen (40mg)—2; Starter Package (pen)—4, 6 (40mg), 3 (80mg), 3 (80mg + 40mg); Pediatric Starter Package (syringe)—3, 6 (40mg), 3 (80mg), 2 (80mg + 40mg)
Manufacturer
Generic Availability
NO
Humira Indications
Indications
Moderate to severe hidradenitis suppurativa.
Humira Dosage and Administration
Adults and Children
<12yrs: not established. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥12yrs (30–<60kg): initially 80mg on Day 1, followed by 40mg on Day 8, then 40mg every other week for subsequent doses; (≥60kg): initially 160mg on Day 1 (given in 1 day or divided over 2 days), followed by 80mg on Day 15. On Day 29, start maintenance of 40mg every week.
Humira Contraindications
Not Applicable
Humira Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Humira Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.
Humira Pharmacokinetics
See Literature
Humira Interactions
Interactions
Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.
Humira Adverse Reactions
Adverse Reactions
Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.
Humira Clinical Trials
See Literature
Humira Note
Not Applicable
Humira Patient Counseling
See Literature
Humira Generic Name & Formulations
Legal Class
Rx
General Description
Adalimumab 10mg/0.1mL, 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use prefilled syringe—2; Single-use pen (40mg)—2; Starter Package (pen)—4, 6 (40mg), 3 (80mg), 3 (80mg + 40mg); Pediatric Starter Package (syringe)—3, 6 (40mg), 3 (80mg), 2 (80mg + 40mg)
Manufacturer
Generic Availability
NO
Humira Indications
Indications
Non-infectious intermediate, posterior and panuveitis.
Humira Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: initially 80mg, followed by 40mg every other week starting one week after initial dose.
Children
<2yrs or <10kg: not established. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥2yrs (10–<15kg): 10mg every other week (use 10mg prefilled syringe); (15–<30kg): 20mg every other week (use 20mg prefilled syringe); (≥30kg): 40mg every other week (use Pen or 40mg prefilled syringe). May use with MTX, glucocorticoids, NSAIDs, and/or analgesics.
Humira Contraindications
Not Applicable
Humira Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Humira Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.
Humira Pharmacokinetics
See Literature
Humira Interactions
Interactions
Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.
Humira Adverse Reactions
Adverse Reactions
Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.
Humira Clinical Trials
See Literature
Humira Note
Not Applicable
Humira Patient Counseling
See Literature
Humira Generic Name & Formulations
Legal Class
Rx
General Description
Adalimumab 10mg/0.1mL, 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.
Pharmacological Class
Tumor necrosis factor (TNF) blocker.
How Supplied
Single-use prefilled syringe—2; Single-use pen (40mg)—2; Starter Package (pen)—4, 6 (40mg), 3 (80mg), 3 (80mg + 40mg); Pediatric Starter Package (syringe)—3, 6 (40mg), 3 (80mg), 2 (80mg + 40mg)
Manufacturer
Generic Availability
NO
Humira Indications
Indications
Moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
Humira Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: initially 80mg, followed by 40mg every other week starting one week after initial dose.
Children
<18yrs: not established.
Humira Contraindications
Not Applicable
Humira Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Humira Warnings/Precautions
Warnings/Precautions
Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.
Humira Pharmacokinetics
See Literature
Humira Interactions
Interactions
Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.
Humira Adverse Reactions
Adverse Reactions
Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.
Humira Clinical Trials
See Literature
Humira Note
Not Applicable
Humira Patient Counseling
See Literature
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