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HUMIRA
Arthritis/rheumatic disorders
Colorectal disorders
Psoriasis
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Drug Name:

HUMIRA Rx

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

Company:
AbbVie

e-Prescribe this drug via Surescripts


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 ≥4 years 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 Dose for HUMIRA:

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's Dose for HUMIRA:

<4yrs or <15kg: not recommended. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. 4–17yrs: (15kg to <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.

Pharmacological Class:

Tumor necrosis factor-α blocker.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Lymphoma and other malignancies. 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. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders. Juvenile arthritis: follow up on current immunizations before starting therapy. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

Concurrent abatacept, anakinra, live vaccines, or other TNF blockers: not recommended. Immunosuppressants increase risk of infection.

Adverse Reactions:

Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, hypertension, 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 ulcerative colitis (UC): for inducing and sustaining clinical remission in adults who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-MP.

Adult Dose for HUMIRA:

Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 160mg (as 4 injections in 1 day or divided over 2 days) at week 0, then 80mg at week 2. At week 4, start maintenance of 40mg every other week. May continue aminosalicylates, corticosteroids, or immunomodulatory agents. CD: use beyond 1 year has not been evaluated. UC: only continue if evidence of clinical remission by 8 weeks.

Children's Dose for HUMIRA:

<18yrs: not recommended.

Pharmacological Class:

Tumor necrosis factor-α blocker.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Lymphoma and other malignancies. 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. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders. Juvenile arthritis: follow up on current immunizations before starting therapy. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

Concurrent abatacept, anakinra, live vaccines, or other TNF blockers: not recommended. Immunosuppressants increase risk of infection.

Adverse Reactions:

Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, hypertension, neurological events, antibody formation, lupus-like syndrome.

Generic Availability:

NO

How Supplied:

Single-dose prefilled syringe—2; Single-dose prefilled pen—2, 6 (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 Dose for HUMIRA:

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's Dose for HUMIRA:

<18yrs: not recommended.

Pharmacological Class:

Tumor necrosis factor-α blocker.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal [treat empirically if develops], or other pathogens). Lymphoma and other malignancies. 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. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders. Juvenile arthritis: follow up on current immunizations before starting therapy. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

Concurrent abatacept, anakinra, live vaccines, or other TNF blockers: not recommended. Immunosuppressants increase risk of infection.

Adverse Reactions:

Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, hypertension, neurological events, antibody formation, lupus-like syndrome.

Generic Availability:

NO

How Supplied:

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

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