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HUMIRA
Arthritis/rheumatic disorders
Colorectal disorders
Miscellaneous dermatological conditions
Miscellaneous ocular agents
Psoriasis
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Drug Name:

HUMIRA Rx

Generic Name and Formulations:
Adalimumab 10mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.

Company:
AbbVie

Therapeutic Use:

Indications for HUMIRA:

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.

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, 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 (10mg prefilled syringe should be used); (15–<30kg): 20mg every other week (20mg prefilled syringe should be used); (≥30kg): 40mg every other week. May use with MTX, glucocorticoids, salicylates, NSAIDs, or analgesics.

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.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

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.

Generic Availability:

NO

How Supplied:

Single-dose prefilled syringe—2; Single-dose prefilled pen (40mg)—2

Indications for HUMIRA:

In moderately-to-severely active Crohn's disease (CD): to reduce signs/symptoms and to induce and maintain clinical remission in adult patients with inadequate response to conventional therapy; and to reduce signs/symptoms and to induce clinical remission in these patients who have also lost response to or are intolerant to infliximab. In moderately-to-severely active CD: to reduce signs/symptoms and to induce and maintain clinical remission in children ≥6yrs of age with inadequate response to corticosteroids or immunomodulators (azathioprine, 6-MP, or methotrexate). In moderately-to-severely active ulcerative colitis (UC): for inducing and sustaining clinical remission in adults with inadequate response to immunosuppressants (corticosteroids, azathioprine or 6-MP).

Adult:

Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 160mg (in 1 day or divided over 2 days) on Day 1, followed by 80mg on Day 15. On Day 29, start maintenance of 40mg every other week. May continue aminosalicylates, corticosteroids, or immunomodulatory agents. CD: use beyond 1yr has not been evaluated. UC: only continue if evidence of clinical remission by 8 weeks.

Children:

<6yrs (CD) or <18yrs (UC): not recommended. ≥6yrs: (17–<40kg): 80mg on Day 1, then 40mg on Day 15. At Day 29, start maintenance of 20mg every other week; (≥40kg): 160mg (in 1 day or divided over 2 days) on Day 1, then 80mg (as 2 injections in 1 day) on Day 15. At Day 29, start maintenance of 40mg every other week.

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.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

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.

Generic Availability:

NO

How Supplied:

Single-dose prefilled syringe—2; Single-dose prefilled syringe (40mg, 80mg; Pediatric Starter Package)—3, 6; Single-dose prefilled pen (40mg, 80mg)—2, 6 (Starter Package)

Indications for HUMIRA:

Moderate-to-severe hidradenitis suppurativa.

Adult:

Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 160mg (in 1 day or divided over 2 days) on Day 1, followed by 80mg on Day 15. On Day 29, start maintenance of 40mg every week.

Children:

<18yrs: not established.

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.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

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.

Generic Availability:

NO

How Supplied:

Single-dose prefilled syringe—2; Single-dose prefilled pen (40mg, 80mg)—2, 6 (Starter Package

Indications for HUMIRA:

Non-infectious intermediate, posterior and panuveitis.

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.

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.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

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.

Generic Availability:

NO

How Supplied:

Single-dose prefilled syringe—2; Single-dose prefilled pen (40mg, 80mg)—2, 4 (Starter Package)

Indications for HUMIRA:

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.

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.

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.

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.

Pharmacological Class:

Tumor necrosis factor (TNF) blocker.

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.

Generic Availability:

NO

How Supplied:

Single-dose prefilled syringe—2; Single-dose prefilled pen (40mg, 80mg)—2, 4 (Starter Package)

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