Generic Name: Adalimumab
Class: Disease-modifying Antirheumatic Agents
VA Class: MS190
Special Alerts:
[Posted 09/07/2011] ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNF blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.
Patients treated with TNF blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens.
BACKGROUND: The class of TNF blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.
RECOMMENDATION: The risks and the benefits of TNF blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication for a listing of recommendations for healthcare professionals and patients, as well as a data summary. For more information visit the FDA website at: and .
[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factors (TNF) blockers, as well as with azathioprine, and/or mercaptopurine. TNF blockers include infliximab (Remicade), etancercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia) and golimumab (Simponi).
BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually fatal. The majority of cases reported were in patients being treated for Crohn’s disease or ulcerative colitis, but also included a patient being treated for psoriasis and two patients being treated for rheumatoid arthritis. FDA is now updating the number of reported cases of HSTCL.
Although most reported cases of HSTCL occurred in patients treated with a combination of medicines known to suppress the immune system, including the TNF blockers, azathioprine, and/or mercaptopurine, there have been cases reported in patients receiving azathioprine or mercaptopurine alone.
Educate patients and caregivers about the signs and symptoms of malignancies such as HSTCL so that they are aware of and can seek evaluation and treatment of any signs or symptoms. These may include splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, and weight loss.
Monitor for the emergence of malignancies when a patient has been treated with TNF blockers, azathioprine, and/or mercaptopurine.
Know that people with rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to develop lymphoma than the general U.S. population. Therefore, it may be difficult to measure the added risk of TNF blockers, azathioprine, and/or meracaptopurine.
Read the Drug Safety Communications for other specific recommendations for Healthcare Professionals and Patients and the Data Summary for additional information. For more information visit the FDA website at: and .
REMS:
FDA approved a REMS for adalimumab to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of adalimumab and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
- Serious Infections
Serious, sometimes fatal infections including tuberculosis (frequently disseminated or extrapulmonary), bacterial and viral infections, invasive fungal infections (may be disseminated), and other opportunistic infections reported.1 (See Infectious Complications under Cautions.)
Carefully consider risks and benefits prior to initiating adalimumab therapy in patients with chronic or recurring infections.1
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
Closely monitor patients for infection, including active tuberculosis in those with a negative tuberculin skin test, during and after treatment.1 Discontinue adalimumab if serious infection or sepsis occurs.1 Consider empiric antifungal therapy if serious systemic illness occurs in a patient at risk for invasive fungal infections.1
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
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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 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
Psoriatic Arthritis
Used to manage the signs and symptoms of active arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with psoriatic arthritis.1 14 15 Use alone or in combination with other 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 DMARDs, corticosteroids, salicylates, NSAIAs, and analgesics may be continued in adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.1
Methotrexate, corticosteroids, salicylates, NSAIAs, and analgesics may be continued in pediatric patients with juvenile idiopathic arthritis.1
Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., mercaptopurine, azathioprine) may be continued in adults with Crohn’s disease.1
REMS Program
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
Warnings/Precautions
Warnings
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Infectious Complications
Serious, sometimes fatal infections (including bacterial, mycobacterial, invasive fungal, viral, and other opportunistic infections) reported with adalimumab or other TNF blocking agents, particularly in patients receiving concomitant therapy with other immunosuppressive agents (e.g., methotrexate, corticosteroids).1 19 The most common opportunistic infections include tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis.1 Infections frequently are disseminated.1
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 or recurring 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
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
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 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
Invasive fungal infections often not recognized in patients receiving TNF blocking agents; this 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 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
Increased incidence of serious infection and neutropenia observed with concomitant use of etanercept (another TNF blocking agent) and anakinra (a human interleukin-1 receptor antagonist).1 10 Similar toxicities expected with use of anakinra and other agents that block TNF, including adalimumab.1 (See Specific Drugs under Interactions.)
Increased incidence of infection and serious infection reported with concomitant use of a TNF blocking agent and abatacept.17 (See Specific Drugs under Interactions.)
Hepatitis B Virus (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
Malignancies and Lymphoproliferative Disorders
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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
In controlled studies, lymphoma was reported more frequently in patients receiving adalimumab or other TNF blocking agents than in control patients.1 Patients with rheumatoid arthritis, especially those with highly active disease, may be at increased risk of lymphoma.1
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
Role of TNF blocking agents in development of malignancies not fully determined.1 18
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
Nervous System Effects
Exacerbation of clinical manifestations and/or radiographic evidence of demyelinating disorders, including multiple sclerosis, 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 CNS demyelinating disorders.1
Hematologic Effects
Possible pancytopenia (including aplastic anemia), leukopenia, or thrombocytopenia.1 Consider discontinuance in patients with confirmed hematologic abnormalities.1
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylaxis 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
Latex Sensitivity
The needle cover of prefilled syringes of adalimumab contains dry natural rubber (latex) and should not be handled by individuals sensitive to latex.1
General Precautions
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
Immunosuppression
No evidence of depression of delayed-type hypersensitivity, decrease in immunoglobulin concentrations, or change in the enumeration of effector cell populations, monocytes/macrophages, or neutrophils observed.1
Safety and efficacy in patients with immunosuppression not evaluated.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, reported with TNF blocking agents, including adalimumab.1 18 Onset observed weeks to years following initiation of drug.18 Some patients required hospitalization.18 Most patients experienced improvement following discontinuance of the TNF blocking agent.18 FDA has concluded that there is a possible association between use of TNF blocking agents and development of psoriasis.18
Exacerbation of existing psoriasis also reported.1
Consider possibility of and monitor for manifestations (e.g., new rash) of new or worsening psoriasis, particularly pustular and palmoplantar psoriasis.18
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.1 18 (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: Upper respiratory tract infection, injection site pain, headache, rash, sinusitis.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
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 arthritis17
|
Concomitant use not recommended17
|
Anakinra
|
Increased incidence of serious infections and increased risk of neutropenia, without additional clinical benefit, reported with anakinra and etanercept (another TNF blocking agent) in rheumatoid arthritis;1 10 similar toxicities expected with adalimumab and anakinra1
|
Concomitant use not recommended1
|
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 needed1
|
Pneumococcal polysaccharide vaccine
|
No difference in antibody response between adalimumab- and placebo-treated rheumatoid arthritis patients1
|
|
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.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
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
A copy of the manufacturer’s patient information (medication guide) for adalimumab must be provided to all patients with each prescription of the drug. (See REMS Program under Dosage and Administration.)1 18 Advise patients about potential benefits and risks of adalimumab.1 18
If the patient or caregiver is to administer adalimumab, provide careful instructions regarding proper dosage and administration of adalimumab, including proper aseptic technique, and proper disposal of needles and syringes.1 2
Importance of advising patients to seek immediate medical attention if signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) develop.1
Risk of lymphoma, leukemia, or other malignancies with TNF blocking agents.1 18 Importance of informing patients and families about the increased risk of cancer development in children and adolescents, taking into account the clinical utility of TNF blocking agents, the benefits and risks of other immunosuppressive drugs, and the risks associated with untreated disease.1 18 Importance of promptly informing clinicians if signs and symptoms of cancer occur (e.g., unexplained weight loss; fatigue; swollen lymph nodes in the neck, underarm, or groin; easy bruising or bleeding).18
Risk of new-onset psoriasis or worsening of existing psoriasis with TNF blocking agents.1 18 Importance of informing clinicians of any manifestations of new or worsening psoriasis (e.g., new rash).1 18
Importance of alerting clinician if allergy to latex exists.1 2
Importance of taking the drug as prescribed and of not altering or discontinuing therapy without first consulting with a clinician.18
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, and other illnesses (e.g., concomitant or recurrent infections, history of tuberculosis, history of HBV infection).1 2 19
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 (preservative-free; available as disposable prefilled syringes)
|
Abbott
|
|
|
40 mg/0.8 mL
|
Humira (preservative-free; 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 10/2011. 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/$2,029.90 or 6/$5,821.23
Humira 40MG/0.8ML Kit (ABBOTT): 2/$1,947.08 or 4/$3,851.13
Humira Pen 40MG/0.8ML Kit (ABBOTT): 2/$1,946.00 or 4/$3,828.76
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. 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; 2009 Nov.
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/Wyeth Corporation. Embrel (etanercept) for subcutaneous injection prescribing information. Thousand Oaks, CA: 2004 Sep 27.
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; 2009 Aug.
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.
More Humira resources
- Humira Side Effects (in more detail)
- Humira Use in Pregnancy & Breastfeeding
- Humira Drug Interactions
- Humira Support Group
- 84 Reviews for Humira - Add your own review/rating
- Humira Prescribing Information (FDA)
- Humira Consumer Overview
- Humira Advanced Consumer (Micromedex) - Includes Dosage Information
- Humira MedFacts Consumer Leaflet (Wolters Kluwer)
- Adalimumab Professional Patient Advice (Wolters Kluwer)
Compare Humira with other medications
- Ankylosing Spondylitis
- Behcet's Disease
- Crohn's Disease
- Crohn's Disease, Acute
- Crohn's Disease, Maintenance
- Juvenile Idiopathic Arthritis
- Psoriasis
- Psoriatic Arthritis
- Reiter's Syndrome
- Rheumatoid Arthritis
