Generic Name: Adalimumab
Class: Disease-modifying Antirheumatic Drugs
VA Class: MS190

Warning(s)

  • Serious Infections
  • Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death; tuberculosis (frequently disseminated or extrapulmonary), invasive fungal infections (may be disseminated), bacterial (e.g., legionellosis, listeriosis) and viral infections, and other opportunistic infections reported.1 19 23 (See Infectious Complications under Cautions.)

  • Carefully consider risks and benefits prior to initiating adalimumab therapy in patients with chronic or recurring infections.1 23

  • Evaluate patients for latent tuberculosis infection prior to and periodically during adalimumab therapy; if indicated, initiate appropriate antimycobacterial regimen prior to initiating adalimumab therapy.1 23

  • Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.1 19 23 Discontinue adalimumab if serious infection or sepsis occurs.1 19 Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.1 19 23

  • Malignancy
  • Lymphoma and other malignancies (some fatal) reported in children and adolescents receiving TNF blocking agents.1 18 24 (See Malignancies and Lymphoproliferative Disorders under Cautions.)

  • Aggressive, usually fatal hepatosplenic T-cell lymphoma reported mainly in adolescents and young adults with Crohn’s disease or ulcerative colitis receiving TNF blocking agents, including adalimumab.1 18 24 Most of the patients received a combination of immunosuppressive agents, including TNF blocking agents and thiopurine analogs (azathioprine or mercaptopurine).1 18 24

REMS:

FDA approved a REMS for adalimumab to ensure that the benefits outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Biologic response modifier and disease-modifying antirheumatic drug (DMARD); a recombinant DNA-derived human immunoglobulin G1 (IgG1) monoclonal antibody specific for human tumor necrosis factor (TNF; TNF-α).1

Uses for Humira

Rheumatoid Arthritis in Adults

Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis.1 3 11 Use alone or in combination with methotrexate or other nonbiologic DMARDs.1

Juvenile Arthritis

Management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children.1 20 Use with or without methotrexate.1 20

Slideshow: Top 10 Money-Making Drugs of 2012

Psoriatic Arthritis

Used to manage the signs and symptoms of psoriatic arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with active psoriatic arthritis.1 14 15 Use alone or in combination with other nonbiologic DMARDs.1

Ankylosing Spondylitis

Management of the signs and symptoms of active ankylosing spondylitis.1 16

Crohn’s Disease

Used to reduce signs and symptoms of Crohn’s disease and to induce and maintain clinical remission in adults with moderately to severely active disease who have had inadequate response to conventional therapy.1 Also used to reduce signs and symptoms of the disease and to induce clinical remission in adults with moderately to severely active Crohn’s disease who have lost response to or are intolerant to infliximab.1

Plaque Psoriasis

Management of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and in whom other systemic therapies are medically less appropriate.1 Use only in patients who will be closely monitored and who will have regular follow-up visits with a clinician.1

Humira Dosage and Administration

General

Concomitant Therapy

  • Methotrexate, other nonbiologic DMARDs, corticosteroids, NSAIAs, and/or analgesics may be continued in adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.1

  • Methotrexate, corticosteroids, NSAIAs, and/or analgesics may be continued in pediatric patients with juvenile idiopathic arthritis.1

  • Aminosalicylates and/or corticosteroids may be continued in adults with Crohn’s disease.1 Azathioprine, mercaptopurine, or methotrexate may be continued, if necessary, in adults with Crohn’s disease.1 (See Malignancies and Lymphoproliferative Disorders under Cautions.)

Administration

Sub-Q Injection

Administer by sub-Q injection every other week or every week.1

Administer sub-Q injections into thighs or abdomen; do not make abdominal injections within 5.18 cm (2 inches) of the umbilicus.2 Rotate injection sites.2 Give new injections ≥2.54 cm (1 inch) from an old site; do not make injections into areas where the skin is tender, bruised, red, or hard, or into scars or stretch marks.2

Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up as necessary.1 The initial self-administered dose should be made under the supervision of a health-care professional.1

Dosage

Pediatric Patients

Juvenile Arthritis
Sub-Q

Children 4–17 years of age weighing 15 to <30 kg: 20 mg once every other week.1

Children 4–17 years of age weighing ≥30 kg: 40 mg once every other week.1

Adults

Rheumatoid Arthritis
Sub-Q

40 mg once every other week.1

Patients not receiving methotrexate may obtain additional benefit from once weekly doses of 40 mg.1

Psoriatic Arthritis
Sub-Q

40 mg once every other week.1

Ankylosing Spondylitis
Sub-Q

40 mg once every other week.1

Crohn’s Disease
Sub-Q

160 mg once on day 1 (as four 40-mg injections in one day or as two 40-mg injections per day for two consecutive days), followed by 80 mg once 2 weeks later (on day 15).1 Start maintenance dosage of 40 mg once every other week on day 29 (2 weeks after the 80-mg dose).1

Plaque Psoriasis
Sub-Q

Initially, 80 mg followed by 40 mg once every other week (maintenance dosage) starting 1 week after the initial dose.1

Prescribing Limits

Adults

Crohn’s Disease

Manufacturer states safety and efficacy of continuing adalimumab beyond 1 year have not been evaluated in clinical studies.1

Plaque Psoriasis

Manufacturer states safety and efficacy of continuing adalimumab beyond 1 year have not been evaluated in clinical studies.1

Cautions for Humira

Contraindications

  • Known hypersensitivity to adalimumab or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Infectious Complications

Increased risk of serious infections involving various organ systems and sites that may require hospitalization or result in death.1 23 Opportunistic infections caused by bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens (e.g., aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, tuberculosis) reported, particularly in patients receiving concomitant therapy with immunosuppressive agents (e.g., methotrexate, corticosteroids).1 19 23 Infections frequently are disseminated.1 (See Boxed Warning.)

Increased incidence of serious infections observed with concomitant use of a TNF blocking agent and anakinra or abatacept.1 10 17 (See Specific Drugs under Interactions.)

Patients >65 years of age, with comorbid conditions, and/or receiving concomitant therapy with immunosuppressive agents (e.g., corticosteroids, methotrexate) may be at increased risk of infection.1 23

Do not initiate adalimumab in patients with active infections, including localized infections.1 Consider potential risks and benefits of the drug prior to initiating therapy in patients with a history of chronic, recurring, or opportunistic infections; patients with underlying conditions that may predispose them to infections; and patients who have been exposed to tuberculosis or who have resided or traveled in regions where tuberculosis or mycoses such as histoplasmosis, coccidioidomycosis, and blastomycosis are endemic.1 23

Closely monitor patients during and after adalimumab therapy for signs or symptoms of infection (e.g., fever, malaise, weight loss, sweats, cough, dyspnea, pulmonary infiltrates, serious systemic illness including shock).1 19 23

If new infection occurs during therapy, perform thorough diagnostic evaluation (appropriate for immunocompromised patient), initiate appropriate anti-infective therapy, and closely monitor patient.1 19 Discontinue adalimumab if serious infection or sepsis develops.1 19

Evaluate all patients for active or latent tuberculosis and for risk factors for tuberculosis prior to and periodically during therapy.1 23 When indicated, initiate appropriate antimycobacterial regimen for treatment of latent tuberculosis infection prior to adalimumab therapy.1 Also consider antimycobacterial therapy prior to adalimumab therapy for individuals with a history of latent or active tuberculosis in whom an adequate course of antimycobacterial treatment cannot be confirmed and for individuals with a negative tuberculin skin test who have risk factors for tuberculosis.1 Consultation with a tuberculosis specialist is recommended when deciding whether to initiate antimycobacterial therapy.1

Monitor all patients, including those with negative tuberculin skin tests, for active tuberculosis.1 Strongly consider tuberculosis in patients who develop new infections while receiving adalimumab, especially if they previously have traveled to countries where tuberculosis is highly prevalent or have been in close contact with an individual with active tuberculosis.1

Failure to recognize invasive fungal infections has led to delays in appropriate treatment.19 Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.1 19 23 Whenever feasible, consult specialist in fungal infections when making decisions regarding initiation and duration of antifungal therapy.1 19

When deciding whether to reinitiate TNF blocking agent therapy following resolution of an invasive fungal infection, reevaluate risks and benefits, particularly in patients who reside in regions where mycoses are endemic.19 Whenever feasible, consult specialist in fungal infections.19

Malignancies and Lymphoproliferative Disorders

Lymphoma and other malignancies (some fatal) reported during postmarketing surveillance in children and adolescents receiving TNF blocking agents, particularly in those receiving other immunosuppressive agents (e.g., azathioprine, methotrexate) concomitantly.1 18 Malignancies included lymphomas (about 50% of the cases) (e.g., Hodgkin’s disease, non-Hodgkin’s lymphoma) and various other malignancies (e.g., leukemia, melanoma, solid organ cancers), including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children and adolescents (e.g., leiomyosarcoma, hepatic malignancies, renal cell carcinoma).1 18 Median time to occurrence was 30 months (range: 1–84 months) after the initial TNF blocking agent dose.1 FDA has concluded that there is an increased risk of malignancy with TNF blocking agents in children and adolescents; however, the strength of the association is not fully characterized.18

Hepatosplenic T-cell lymphoma (a rare, aggressive, usually fatal T-cell lymphoma) reported mainly in adolescents and young adults with Crohn’s disease or ulcerative colitis receiving TNF blocking agents and/or thiopurine analogs (mercaptopurine or azathioprine).1 24 Most of the patients received a combination of immunosuppressive agents, including TNF blocking agents and thiopurine analogs.1 24 Unclear whether occurrence is related to use of a TNF blocking agent or use of a TNF blocking agent in conjunction with other immunosuppressive agents.1

In controlled studies, lymphoma was reported more frequently in patients receiving adalimumab or other TNF blocking agents than in control patients.1 Patients with Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, or other chronic inflammatory diseases, especially those with highly active disease and/or chronic exposure to immunosuppressive therapies, may be at increased risk of lymphoma, even in the absence of TNF blocking agent therapy;1 24 may be difficult to measure added risk of TNF blocking agents, azathioprine, and/or mercaptopurine.24

Acute and chronic leukemias (some fatal) reported during postmarketing surveillance of TNF blocking agents in adults and pediatric patients, particularly in those receiving other immunosuppressive agents concomitantly.1 18 Leukemia (most commonly acute myeloid leukemia, chronic lymphocytic leukemia, and chronic myeloid leukemia) generally occurred during first 2 years of therapy.18 FDA has concluded that there is a possible association between TNF blocking agents and development of leukemia; interpretation of findings is complicated because patients with rheumatoid arthritis may be at increased risk for leukemia independent of any treatment with TNF blocking agents.1 18

Other malignancies (e.g., breast, colorectal, lung, prostate, melanoma, nonmelanoma skin cancer) have occurred in patients receiving adalimumab.1

In controlled studies of other TNF blocking agents in adults at increased risk of malignancies (e.g., patients with COPD and a history of heavy smoking, patients with Wegener’s granulomatosis receiving concomitant cyclophosphamide), a greater proportion of malignancies occurred in patients receiving the TNF blocking agent compared with control patients.1

Some immune-related diseases (e.g., Crohn’s disease) have been shown to increase risk of cancer independent of treatment with TNF blocking agents, while for others (e.g., juvenile idiopathic arthritis) it is unknown whether there is an increased risk of cancer.18

Consider possibility of and monitor for occurrence of malignancies during and following treatment with TNF blocking agents.18 24

Consider risks and benefits of TNF blocking agents, including adalimumab, prior to initiating therapy in patients with a known malignancy (other than successfully treated nonmelanoma skin cancer) or when deciding whether to continue therapy in patients who develop a malignancy.1 Carefully consider risks and benefits of these agents, especially in adolescents and young adults and especially in the treatment of Crohn’s disease or ulcerative colitis.24

Examine all patients, but particularly those with a history of prior prolonged immunosuppressive therapy or a history of psoralen and UVA light (PUVA) therapy, for nonmelanoma skin cancer before and during adalimumab therapy.1

Other Warnings/Precautions

Sensitivity Reactions

Anaphylaxis and angioedema reported rarely.1 Other allergic reactions (e.g., allergic rash, anaphylactoid reactions, fixed drug eruption, nonspecified drug reaction, urticaria) also observed.1 If serious allergic reaction or anaphylaxis occurs, immediately discontinue adalimumab and initiate appropriate therapy.1

The needle cover of prefilled syringes of adalimumab contains dry natural rubber (latex) and should not be handled by individuals sensitive to latex.1

HBV Reactivation

Increased risk of reactivation of HBV infection in patients who are chronic carriers of the virus (i.e., hepatitis B surface antigen-positive [HBsAg-positive]).1 Use of multiple immunosuppressive agents may contribute to HBV reactivation.1

Screen at-risk patients prior to initiation of therapy.1 Evaluate and monitor HBV carriers before, during, and for up to several months after therapy.1 Safety and efficacy of antiviral therapy for prevention of HBV reactivation not established.1 Discontinue adalimumab and initiate appropriate treatment (e.g., antiviral therapy) if HBV reactivation occurs.1 Not known whether adalimumab can be readministered once control of a reactivated HBV infection is achieved; caution advised in this situation.1

Nervous System Effects

New onset or exacerbation of central or peripheral nervous system demyelinating disorders (e.g., multiple sclerosis, Guillain-Barré syndrome) reported rarely in patients receiving adalimumab or other TNF blocking agents.1

Exercise caution when considering adalimumab therapy in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.1

Hematologic Effects

Possible pancytopenia (including aplastic anemia), leukopenia, or thrombocytopenia.1 Consider discontinuance in patients with confirmed hematologic abnormalities.1

Cardiovascular Effects

Worsening CHF and new-onset CHF reported in patients receiving adalimumab or other TNF blocking agents.1 Use with caution and carefully monitor patients with heart failure.1

Immunologic Reactions and Antibody Formation

Possible formation of autoimmune antibodies.1 Lupus-like syndrome reported.1 If manifestations suggestive of lupus-like syndrome develop, discontinue adalimumab.1

Antibodies to adalimumab may develop.1 Long-term immunogenicity remains to be determined.1

Immunization

Patients may receive inactivated vaccines.1 Avoid live vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, smallpox vaccine, typhoid vaccine live oral, varicella virus vaccine live, yellow fever vaccine).1 (See Interactions.)

Psoriasis

New-onset psoriasis, including pustular and palmoplantar psoriasis, and exacerbation of existing psoriasis reported with TNF blocking agents, including adalimumab.1 18 Most patients experienced improvement following discontinuance of the TNF blocking agent.18

Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.18

Hepatic Effects

Severe hepatic reactions, including acute liver failure, reported in patients receiving TNF blocking agents.1 Serum ALT elevations of ≥3 times the ULN observed in patients receiving adalimumab; causal relationship not clear because many patients received concomitant therapy with drugs known to increase liver enzyme concentrations (e.g., methotrexate, NSAIAs).1

Specific Populations

Pregnancy

Category B.1

Pregnancy registry at 877-311-8972.1

Lactation

Not known whether adalimumab is distributed into milk or is absorbed systemically following ingestion.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy for uses other than juvenile idiopathic arthritis not established in pediatric patients.1 9

Safety and efficacy for the management of juvenile idiopathic arthritis established in pediatric patients 4–17 years of age.1 Not studied in children <4 years of age; data in patients weighing <15 kg limited.1

Review vaccination status of the child and administer all age-appropriate vaccines, if possible, prior to initiation of adalimumab.1

Malignancies, some fatal, reported in children and adolescents who received TNF blocking agents, including adalimumab.1 18 24 (See Malignancies and Lymphoproliferative Disorders under Cautions.)

Geriatric Use

No substantial differences in efficacy relative to younger adults.1

The incidence of serious infection and malignancy in adalimumab-treated patients >65 years of age is higher than the incidence in younger adults.1 The overall incidence of infection and malignancy is higher in the geriatric population in general than in younger adults; use with caution.1

Common Adverse Effects

Adults: Infection (e.g., upper respiratory tract infection, sinusitis), injection site reactions, headache, rash.1

Pediatric patients 4–17 years of age: Infection, injection site pain, injection site reaction, hypersensitivity reaction (e.g., localized allergic sensitivity reaction, rash), increased CPK concentration.1

Interactions for Humira

Administered concomitantly with aminosalicylates, methotrexate, other DMARDs, corticosteroids, other immunomodulatory agents, and/or NSAIAs in clinical studies.1 (See Concomitant Therapy under Dosage and Administration.)

Biologic Antirheumatic Agents

For abatacept, anakinra, rituximab, and tocilizumab, see Specific Drugs under Interactions. For other biologic agents used in the management of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, or plaque psoriasis, manufacturer states data are insufficient to provide recommendations regarding concomitant use with adalimumab.1

Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase the risk of infection.29

Vaccines

Patients may receive inactivated vaccines.1

Avoid live vaccines.1 No data available on secondary transmission of infection by live vaccines in adalimumab-treated patients.1

Specific Drugs

Drug

Interaction

Comments

Abatacept

Increased incidence of infection and serious infection, without additional clinical benefit, reported with abatacept and TNF blocking agents in rheumatoid arthritis1 17

Concomitant use not recommended1 17

Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection29

Anakinra

Increased incidence of serious infections and neutropenia, without additional clinical benefit, reported with anakinra and etanercept (another TNF blocking agent) in rheumatoid arthritis1 10

Concomitant use not recommended1

Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection29

Influenza virus vaccine inactivated

Antibody titers in adalimumab-treated rheumatoid arthritis patients were protective, albeit lower than in placebo-treated patients1

Methotrexate

Decreased adalimumab clearance1

Dosage adjustment not necessary1

Natalizumab

Increased risk of progressive multifocal leukoencephalopathy (PML) or other serious infections28

Avoid concomitant use in the management of Crohn’s disease28

Pneumococcal polysaccharide vaccine

No difference in antibody response between adalimumab- and placebo-treated rheumatoid arthritis patients1

Rituximab

Increased risk of serious infection reported in patients who received rituximab and subsequently received a TNF blocking agent1

Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection29

Tocilizumab

Concomitant use not studied; possibility of increased immunosuppression and increased risk of infection25

Avoid concomitant use25

Use caution when switching from one biologic DMARD to another, since overlapping biologic activity may further increase risk of infection29

Humira Pharmacokinetics

Absorption

Bioavailability

Bioavailability is approximately 64%.1 Peak serum concentrations achieved in 131 hours.1

Distribution

Extent

Distributed into synovial fluid.1

Not known whether adalimumab is distributed into milk.1

Elimination

Metabolism

Metabolic fate undetermined.1

Elimination Route

Unknown.1

Half-life

2 weeks (range: 10–20 days).1

Special Populations

In patients with adalimumab antibodies, clearance of adalimumab is higher.1

Clearance of adalimumab is lower with increasing age in patients 40–>75 years of age.1

Stability

Storage

Parenteral

Injection

2–8°C.1 Do not freeze; do not use solutions that have been frozen.1 During travel, store in a cool carrier with an ice pack.1 Protect from light; store in original carton until time of administration.1

Actions

  • Potent antagonist of TNF biologic activity.1 3 8

  • Has high specificity and affinity for TNF (TNF-α); does not bind to or inactivate lymphotoxin α (TNF-β).1 3 8 Prevents the binding of TNF to cell surface TNF receptors, thereby blocking the biologic activity of TNF.1 3 8

  • An immunoglobulin G1 (IgG1) made by phage display technology with amino acid sequences from the human germline; does not contain nonhuman components or artificially fused human peptide sequences.3 8 Indistinguishable in structure and function from naturally occurring human IgG.3 8

  • Produced by recombinant DNA technology in a mammalian cell expression system; purified by a process that includes specific viral inactivation and removal steps.1

Advice to Patients

  • A copy of the manufacturer’s patient information (medication guide) for adalimumab should be provided to all patients or their caregivers with each prescription of the drug.1 18 Importance of advising patients about potential benefits and risks of adalimumab.1 18 23 24 Importance of patients reading the medication guide prior to initiation of therapy and each time the prescription is refilled.1 23 24

  • Importance of instructing patient and/or caregiver regarding proper dosage and administration of adalimumab, including the use of aseptic technique, and proper disposal of needles and syringes if it is determined that the patient and/or caregiver is competent to safely administer the drug.1 2

  • Increased susceptibility to infection.1 Importance of seeking immediate medical attention if signs and symptoms suggestive of infection (e.g., fever; fatigue; cough; warm, red, or painful skin; sores on the body; muscle aches; diarrhea; stomach pain; shortness of breath; weight loss; burning on urination; urinary frequency) develop.1 2

  • Risk of lymphoma, including hepatosplenic T-cell lymphoma, leukemia, or other malignancies with use of TNF blocking agents.1 18 24 Importance of informing patients and caregivers about the increased risk of cancer development in children, adolescents, and young adults, taking into account the clinical utility of TNF blocking agents, the relative risks and benefits of these and other immunosuppressive drugs, and the risks associated with untreated disease.18 24 Importance of promptly informing clinicians if signs and symptoms of malignancies (e.g., unexplained weight loss; fatigue; abdominal pain; persistent fever; night sweats; easy bruising or bleeding; swollen lymph nodes in the neck, underarm, or groin; hepatomegaly or splenomegaly) occur.18 24

  • Importance of informing clinician of any new or worsening medical conditions (e.g., neurologic conditions [e.g., demyelinating disorders], heart failure, autoimmune disorders [e.g., lupus-like syndrome], psoriasis, cytopenias).1 18

  • Importance of alerting clinician if allergy to latex exists.1 2

  • Importance of promptly contacting a clinician if manifestations of an allergic reaction (e.g., urticaria, facial swelling, difficulty breathing) occur.1

  • Importance of taking the drug as prescribed and of not altering or discontinuing therapy without first consulting with a clinician.18 24

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or any history of cancer, tuberculosis, HBV infection, or other chronic or recurring infections.1 2 23

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Adalimumab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for subcutaneous use

20 mg/0.4 mL

Humira (available as disposable prefilled syringes)

Abbott

40 mg/0.8 mL

Humira (available as disposable prefilled syringes and as prefilled injection pen)

Abbott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Humira 20MG/0.4ML Kit (ABBOTT): 2/$2,144.99 or 6/$6,163.92

Humira 40MG/0.8ML Kit (ABBOTT): 2/$2,040.01 or 4/$4,036.14

Humira Pen 40MG/0.8ML Kit (ABBOTT): 2/$2,055.07 or 4/$4,046.03

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 21, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Abbott Laboratories. Humira (adalimumab) injection prescribing information. North Chicago, IL; 2011 Sep.

2. Abbott Laboratories. Humira (adalimumab) patient information. North Chicago, IL; 2006 Nov.

3. Weinblatt ME. Keystone EC, Furst DE et al. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate. The ARMADA trial. Arthritis Rheum. 2003; 48:35-45. [IDIS 492001] [PubMed 12528101]

4. Felson DT, Anderson JJ, Boers M et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-35. [PubMed 7779114]

5. Felson DT, Anderson JJ, Boers M et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993; 36:729-40. [PubMed 8507213]

6. Felson DT, Anderson JJ, Lange MLM et al. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent. Arthritis Rheum. 1998; 41:1564-70. [IDIS 411264] [PubMed 9751088]

7. Sharp JT. Scoring radiographic abnormalities in rheumatoid arthritis. Radiol Clin North Am. 1996; 34:233-41. [PubMed 8633113]

8. Rau R. Adalimumab (a fully human anti-tumor necrosis factor α monoclonal antibody) in the treatment of active rheumatoid arthritis: the initial results of five trials. Ann Rheum Dis. 2002; 61(Suppl II):ii70-3. [IDIS 489164] [PubMed 12379628]

9. Abbott Laboratories, Abbott Park, IL: Personal communication.

10. Amgen/Pfizer Corporation. Enbrel (etanercept) for subcutaneous injection prescribing information. Thousand Oaks, CA: 2011 Sep.

11. Keystone EC, Kavanaugh AF, Sharp JT et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum. 2004; 50:1400-11. [IDIS 516423] [PubMed 15146409]

12. Weinblatt ME, Keystone EC, Furst DE et al. Long-term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4-year extended study. Ann Rheum Dis. 2005 Dec 1 (Epub ahead of print)

13. Navarro-Sarabia F, Ariza-Ariza R, Hernandez-Crus B et al. Adalimumab for treating rheumatoid arthritis. Cochrane Database Syst Rev. 2005; 3: CD005113.

14. Mease PJ, Gladman DD, Ritchlin CT et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005; 52:3279-89. [IDIS 543446] [PubMed 16200601]

15. Gladman DD, Mease PJ, Cifaldi MA et al. Adalimumab improves joint- and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2006 Nov 9. Epub

16. van der Heijde D, Kivitz A, Schiff MH et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2006; 54:2136-46. [PubMed 16802350]

17. Bristol-Myers Squibb. Orencia (abatacept) prescribing information. Princeton, NJ; 2011 Sep.

18. Food and Drug Administration, Center for Drug Evaluation and Research. Information for healthcare professionals: Tumor necrosis factor (TNF) blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi). FDA alert. Rockville MD; 2009 Aug 4. Available from FDA website. Accessed 2009 Nov 3.

19. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). Rockville MD: Food and Drug Administration; 2008 Sep 4. Available from FDA website. Accessed 2008 Oct 20.

20. Lovell DJ, Ruperto N, Goodman S et al.. Adalimumab with or without methotrexate in αjuvenile rheumatoid arthritis. N Engl J Med. 2008; 359:810-20. [PubMed 18716298]

21. Targan SR, Hanauer SB, Van Deventer SJH. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor α for Crohn’s disease. N Engl J Med. 1997; 337:1029-35. [IDIS 393095] [PubMed 9321530]

22. Humira (adalimumab) risk evaluation and mitigation strategy (REMS). From FDA website (http: / / www.fda.gov / downloads / Drugs / DrugSafety / PostmarketDrugSafetyInformationforPatientsandProviders / UCM224377.pdf). Accessed 2010 Oct. 15.

23. US Food and Drug Administration. FDA drug safety communication: Drug labels for the tumor necrosis factor-alpha (TNFα) blockers now include warnings about infection with Legionella and Listeria bacteria. Rockville, MD; 2011 Sep 7. From FDA website. Accessed 2011 Oct 2.

24. US Food and Drug Administration. FDA drug safety communication: Safety review update on reports of hepatosplenic T-cell lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine. Rockville, MD; 2011 Apr 14. From FDA website. Accessed 2011 Jul 26.

25. Genentech. Actemra (tocilizumab) injection prescribing information. South San Francisco, CA; 2011 Apr.

26. Papp K, Crowley J, Ortonne JP et al. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011; 164:434-41. [PubMed 21083543]

27. Genentech. Rituxan (rituximab) injection prescribing information. South San Francisco, CA; 2011 Apr.

28. Biogen Idec Inc. Tysabri (natalizumab) injection prescribing information. Cambridge, MA; 2011 Sep.

29. Janssen Biotech Inc. Simponi (golimumab) injection prescribing information. Horsham, PA; 2011 Sep.

When it’s more than a bad back. Learn about ankylosing spondylitis. Click Here

Close
Hide
(web1)