adalimumab (Rx)

Brand and Other Names:Humira, Amjevita, more...adalimumab-atto, Cyltezo, adalimumab-adbm
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled syringe/pen

  • 40mg/0.8mL (Humira, Amjevita)

Biosimilars to Humira

  • Amjevita (adalimumab-atto)
  • Cyltezo (adalimumab-adbm)
more...

Rheumatoid Arthritis

Humira, Amjevita, Cyltezo

Indicated for reduction of signs and symptoms, induction of major clinical response, inhibition of progression of structural damage, and improvement of physical function in adults with 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 adalimumab dosing frequency to once weekly

Psoriatic Arthritis

Humira, Amjevita, Cyltezo

Indicated for reduction of signs and symptoms, inhibition of progression of structural damage, and improvement of physical function in adults with 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 adalimumab dosing frequency to once weekly

Ankylosing Spondylitis

Humira, Amjevita, Cyltezo

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 adalimumab dosing frequency to once weekly

Plaque Psoriasis

Humira, Amjevita, Cyltezo

Indicated for treatment of moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy and for whom other systemic therapies are inappropriate

80 mg SC once, then, after 1 week, 40 mg SC q2wk

Humira prescribing information includes patients with moderate-to-severe fingernail psoriasis

Crohn Disease

Humira, Amjevita, Cyltezo

Indicated for reduction of signs and symptoms and induction and maintenance of clinical remission in adults with moderately to severely active Crohn disease who have had 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

Dosing considerations

  • Some patients may require weekly 40-mg dose for maintenance (Inflamm Bowel Dis 2011 Jan 17(1):141-51; Am J Gastroenterology 2009;104:465-83)

Ulcerative Colitis

Humira, Amjevita, Cyltezo

Indicated for treatment of ulcerative colitis 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

Hidradenitis Suppurativa

Humira

Indicated for treatment of moderate-to-severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)

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 qwk

Uveitis

Humira

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

Dosage Forms & Strengths

prefilled syringe/pen

  • 20mg/0.4mL (Humira, Amjevita)
  • 40mg/0.8mL (Humira, Amjevita)

Biosimilars to Humira

  • Amjevita (adalimumab-atto)
  • Cyltezo (adalimumab-adbm)
more...

Juvenile Idiopathic Arthritis

Humira, Amjevita

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

  • <2 years or <10 kg: Safety and efficacy not established
  • ≥2 years
    • 10 kg to <15 kg: 10 mg SC q2wk
    • 15 kg to <30 kg: 20 mg SC q2wk
    • ≥30 kg: 40 mg SC q2wk

Amjevita, Cyltezo

  • <4 years: Safety and efficacy not established
  • ≥4 years
    • Amjevita: 15 kg to <30 kg: 20 mg SC q2wk
    • Amjevita or Cyltezo: ≥30 kg: 40 mg SC q2wk

Pediatric Crohn Disease

Humira

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 kg to <40 kg)

  • Induction: 80 mg SC on Day 1 (administer as two 40 mg injections in one day); THEN 2 weeks later (Day 15) give 40 mg
  • Maintenance (beginning Week 4 [Day 29]): 20 mg SC q2wk

≥6 years (>40 kg)

  • Induction: 160 mg SC on Day 1 (administer as four 40 mg injections in one day or as two 40 mg injection per day for two consecutive days); THEN 2 weeks later (Day 15) give 80 mg (as two 40 mg injections in one day)
  • Maintenance (beginning Week 4 [Day 29]):40 mg SC q2wk

Ulcerative Colitis (Orphan)

Orphan designation for pediatric ulcerative colitis

Orphan sponsor

  • Abbott Laboratories; Global Pharmaceutical Research & Development; Abbott Park, IL 60064
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Interactions

Interaction Checker

and adalimumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

            Hepato-biliary 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

            Vascular disorders: Systemic vasculitis, deep vein thrombosis

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            Warnings

            Black Box Warnings

            Serious infection risk

            • Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
            • Patients older than 65 years may be at greater risk
            • Discontinue if patient develops serious infection or sepsis
            • Reported infections include the following:
            • (1) Active 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
            • (2) 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
            • (3) 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 lymphome (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 listed on FDA-approved label

            Cautions

            Consider discontinuance if hematologic disorder occurs (thrombocytopenia, pancytopenia, leukopenia)

            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

            Risk of serious infection, including tuberculosis or hepatitis B virus; despite prophylactic treatment for TB, reactivation has occurred (see Black Box Warnings)

            Possible increased risk of demyelinating disorders, including multiple sclerosis, optic neuritis, and peripheral demyelinating disease (including Guillain-Barre syndrome); discontinue therapy if any of these disorders develop

            Increased risk of lymphoma and other cancers reported in children and adolescents (see Black Box Warnings)

            Occurrence of leukemia and new-onset psoriasis reported in patients treated with TNF blockers (see Black Box Warnings)

            Potential increased risk of malignancy when coadministered with azathioprine or 6-mercaptopurine

            Enhanced safety surveillance requirements to capture malignancy data: Manufacturers are required to report all malignancies to FDA for complete and consistent analysis

            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 reported with TNF blockers; Exercise caution when using in patients who have heart failure; 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

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            Pregnancy & Lactation

            Pregnancy

            Limited clinical data are available from Pregnancy Registry; excluding lost-to-follow-up, data from registry reports a rate of 5.6% for major birth defects with first trimester use of adalimumab in pregnant women with rheumatoid arthritis (RA), and a rate of 7.8% and 5.5% for major birth defects in disease-matched and non-diseased comparison groups; adalimumab is actively transferred across placenta during third trimester of pregnancy and may affect immune response in the in-utero exposed infant; in an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times maximum recommended human dose (MRHD) of 40 mg subcutaneous without methotrexate

            Monoclonal antibodies are increasingly transported across placenta as pregnancy progresses, with largest amount transferred during third trimester; risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to drug

            Lactation

            Limited data from case reports in published literature describe presence of adalimumab in human milk at infant doses of 0.1% to 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.

            more...
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            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

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            Administration

            Instructions

            Instruct patients using the pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided

            Injections should occur at 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

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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