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Adalimumab

Pronunciation

(a da LIM yoo mab)

Index Terms

  • Antitumor Necrosis Factor Alpha (Human)
  • D2E7
  • Human Antitumor Necrosis Factor Alpha

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Pen-injector Kit, Subcutaneous [preservative free]:

Humira Pen: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Humira Pen-Crohns Starter: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Humira Pen-Psoriasis Starter: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Prefilled Syringe Kit, Subcutaneous [preservative free]:

Humira: 10 mg/0.2 mL (1 ea); 20 mg/0.4 mL (1 ea); 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Humira Pediatric Crohns Start: 40 mg/0.8 mL (1 ea) [contains polysorbate 80]

Brand Names: U.S.

  • Humira
  • Humira Pediatric Crohns Start
  • Humira Pen
  • Humira Pen-Crohns Starter
  • Humira Pen-Psoriasis Starter

Pharmacologic Category

  • Antirheumatic, Disease Modifying
  • Gastrointestinal Agent, Miscellaneous
  • Monoclonal Antibody
  • Tumor Necrosis Factor (TNF) Blocking Agent

Pharmacology

Adalimumab is a recombinant monoclonal antibody that binds to human tumor necrosis factor alpha (TNF-alpha), thereby interfering with binding to TNFα receptor sites and subsequent cytokine-driven inflammatory processes. Elevated TNF levels in the synovial fluid are involved in the pathologic pain and joint destruction in immune-mediated arthritis. Adalimumab decreases signs and symptoms of psoriatic arthritis, rheumatoid arthritis, and ankylosing spondylitis. It inhibits progression of structural damage of rheumatoid and psoriatic arthritis. Reduces signs and symptoms and maintains clinical remission in Crohn disease and ulcerative colitis; reduces epidermal thickness and inflammatory cell infiltration in plaque psoriasis.

Distribution

Vd: 4.7 to 6 L; Synovial fluid concentrations: 31% to 96% of serum

Time to Peak

Serum: SubQ: 131 ± 56 hours

Half-Life Elimination

Terminal: ~2 weeks (range: 10 to 20 days)

Special Populations: Elderly

In patients with rheumatoid arthritis (RA), there was a trend toward lower clearance with increasing age in patients 40 to >75 years of age.

Use: Labeled Indications

Ankylosing spondylitis: Treatment (to reduce signs/symptoms) of ankylosing spondylitis in adult patients

Crohn disease: Treatment (to reduce signs/symptoms and to induce and maintain clinical remission) of active Crohn disease (moderate to severe) in adult patients with inadequate response to conventional treatment or who have lost response to or are intolerant of infliximab and in pediatric patients (≥6 years of age [US labeling] or ≥13 years of age [Canadian labeling]) who have had an inadequate response to corticosteroids or immunomodulators (such as azathioprine, 6-mercaptopurine, or methotrexate.

Hidradenitis suppurativa: Treatment of moderate to severe hidradenitis suppurativa

Juvenile idiopathic arthritis: Treatment (to reduce signs/symptoms) of active polyarticular juvenile idiopathic arthritis (moderate to severe) in patients ≥2 years of age; may be used alone or in combination with methotrexate

Plaque psoriasis: Treatment of chronic plaque psoriasis (moderate to severe) in adult patients who are candidates for systemic therapy or phototherapy and when other agents are less appropriate (with close monitoring and regular follow-up)

Psoriatic arthritis: Treatment (to reduce signs/symptoms, inhibit progression of structural damage, and improve physical function) of active psoriatic arthritis in adult patients; may be used alone or in combination with methotrexate or other nonbiologic DMARDs

Rheumatoid arthritis: Treatment (to reduce signs/symptoms, to induce major clinical response, inhibit progression of structural damage, and improve physical function) of active rheumatoid arthritis (moderate to severe) in adult patients; may be used alone or in combination with methotrexate or other nonbiologic DMARDs

Ulcerative colitis: Treatment (to induce and sustain clinical remission) of active ulcerative colitis (moderate to severe) in adult patients unresponsive to immunosuppressants (Note: Efficacy in patients that are intolerant to or no longer responsive to other TNF blockers has not been established.)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to adalimumab or any component of the formulation; severe infection (eg, sepsis, tuberculosis, opportunistic infection); moderate-to-severe heart failure (NYHA class III/IV)

Dosing: Adult

Ankylosing spondylitis: SubQ: 40 mg every other week (may continue methotrexate, other nonbiologic DMARDS, corticosteroids, NSAIDs and/or analgesics)

Crohn disease: SubQ (may continue aminosalicylates and/or corticosteroids; if necessary, azathioprine, mercaptopurine, or methotrexate may also be continued):

Initial: 160 mg (given as four 40 mg injections on day 1 or given as two 40 mg injections per day over 2 consecutive days), then 80 mg 2 weeks later (day 15).

Maintenance: 40 mg every other week beginning day 29. Note: Some patients may require 40 mg every week as maintenance therapy (Lichtenstein 2009).

Hidradenitis suppurativa: SubQ:

Initial: 160 mg (given as four 40 mg injections on day 1 or given as two 40 mg injections per day over 2 consecutive days), then 80 mg 2 weeks later (day 15).

Maintenance: 40 mg every week beginning day 29.

Plaque psoriasis: SubQ:

Initial: 80 mg as a single dose

Maintenance: 40 mg every other week beginning 1 week after initial dose

Psoriatic arthritis: SubQ: 40 mg every other week (may continue methotrexate, other nonbiologic DMARDS, corticosteroids, NSAIDs and/or analgesics)

Rheumatoid arthritis: SubQ: 40 mg every other week (may continue methotrexate, other nonbiologic DMARDS, corticosteroids, NSAIDs, and/or analgesics); patients not taking concomitant methotrexate may increase adalimumab dose to 40 mg every week

Ulcerative colitis: SubQ (may continue aminosalicylates and/or corticosteroids; if necessary, azathioprine, or mercaptopurine may also be continued):

Initial: 160 mg (given as four 40 mg injections on day 1 or given as two 40 mg injections per day over 2 consecutive days), then 80 mg 2 weeks later (day 15).

Maintenance: 40 mg every other week beginning day 29. Note: Only continue maintenance dose in patients demonstrating clinical remission by 8 weeks (day 57) of therapy.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Crohn disease: SubQ:

Children ≥6 years and Adolescents:

US labeling:

17 kg to <40 kg:

Initial: 80 mg (administered as two 40 mg injections on day 1), then 40 mg 2 weeks later (day 15).

Maintenance: 20 mg every other week beginning week 4 (day 29).

≥40 kg:

Initial: 160 mg (administered as four 40 mg injections on day 1 or as two 40 mg injections per day over 2 consecutive days), then 80 mg 2 weeks later (day 15; given as two 40 mg injections on the same day).

Maintenance: 40 mg every other week beginning week 4 (day 29).

Adolescents ≥13 years and ≥40 kg:

Canadian labeling:

Initial: 160 mg (given as four 40 mg injections on day 1 or given as two 40 mg injections per day over 2 consecutive days), then 80 mg 2 weeks later (day 15; given as two 40 mg injections on the same day).

Maintenance: 20 mg every other week beginning week 4 (day 29); may consider increasing dose to 40 mg every other week for disease flare or inadequate response. Potential benefits of continued therapy should be reassessed if inadequate response at 12 weeks.

Juvenile idiopathic arthritis (JIA): SubQ:

Children ≥2 years and Adolescents:

US labeling:

10 to <15 kg: 10 mg every other week

15 kg to <30 kg: 20 mg every other week

≥30 kg: 40 mg every other week

Canadian labeling:

2 to <4 years (≥10 kg): 24 mg/m2/dose (maximum: 20 mg/dose) every other week

4 to 17 years (≥10 kg): 24 mg/m2/dose (maximum: 40 mg/dose) every other week

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Administration

For SubQ injection at separate sites in the thigh or lower abdomen (avoiding areas within 2 inches of navel); rotate injection sites. May leave at room temperature for ~15 to 30 minutes prior to use; do not remove cap or cover while allowing product to reach room temperature. Do not use if solution is discolored or contains particulate matter. Do not administer to skin which is red, tender, bruised, or hard. Needle cap of the prefilled syringe or needle cover for the adalimumab pen may contain latex. Prefilled pens and syringes are available for use by patients and the full amount of the syringe should be injected (self-administration); the vial is intended for institutional use only. Vials do not contain a preservative; discard unused portion.

Storage

Store at 2°C to 8°C (36°F to 46°F) in original container; do not freeze. Do not use if frozen even if it has been thawed. Do not store in extreme heat or cold. Protect from light. Allow to reach room temperature for 15 to 30 minutes prior to administration. If needed, may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days; discard if not used within 14 days.

Drug Interactions

Abatacept: Anti-TNF Agents may enhance the adverse/toxic effect of Abatacept. An increased risk of serious infection during concomitant use has been reported. Avoid combination

Anakinra: Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. Avoid combination

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab. Avoid combination

Canakinumab: Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Avoid combination

Certolizumab Pegol: Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

CycloSPORINE (Systemic): Adalimumab may decrease the serum concentration of CycloSPORINE (Systemic). Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

InFLIXimab: Adalimumab may enhance the immunosuppressive effect of InFLIXimab. Avoid combination

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Rilonacept: Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Theophylline Derivatives: Adalimumab may decrease the serum concentration of Theophylline Derivatives. Exceptions: Dyphylline. Monitor therapy

Tocilizumab: May enhance the immunosuppressive effect of Anti-TNF Agents. Avoid combination

Tofacitinib: Anti-TNF Agents may enhance the adverse/toxic effect of Tofacitinib. Avoid combination

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Avoid combination

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Avoid combination

Vedolizumab: Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. Avoid combination

Warfarin: Adalimumab may decrease the serum concentration of Warfarin. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Headache (12%)

Dermatologic: Skin rash (6% to 12%)

Hematologic & oncologic: Positive ANA titer (12%)

Immunologic: Antibody development (3% to 26%; significance unknown)

Local: Injection site reaction (12% to 20%; includes erythema, itching, hemorrhage, pain, swelling)

Neuromuscular & skeletal: Increased creatine phosphokinase (15%)

Respiratory: Upper respiratory tract infection (17%), sinusitis (11%)

1% to 10%:

Cardiovascular: Hypertension (5%), atrial fibrillation (<5%), cardiac arrest (<5%), cardiac arrhythmia (<5%), chest pain (<5%), coronary artery disease (<5%), deep vein thrombosis (<5%), hypertensive encephalopathy (<5%), myocardial infarction (<5%), palpitations (<5%), pericardial effusion (<5%), pericarditis (<5%), peripheral edema (<5%), subdural hematoma (<5%), syncope (<5%), tachycardia (<5%)

Central nervous system: Confusion (<5%), myasthenia (<5%), paresthesia (<5%), thorax pain (<5%)

Dermatologic: Cellulitis, erysipelas

Endocrine & metabolic: Hyperlipidemia (7%), hypercholesterolemia (6%), dehydration (<5%), ketosis (<5%), menstrual disease (<5%), parathyroid disease (<5%)

Gastrointestinal: Nausea (9%), dental caries (≤9%), gastroenteritis (≤9%), rotavirus (≤9%), varicella (≤9%), abdominal pain (7%), cholecystitis (<5%), cholelithiasis (<5%), esophagitis (<5%), gastrointestinal hemorrhage (<5%), vomiting (<5%), diverticulitis

Genitourinary: Urinary tract infection (≤8%), hematuria (5%), cystitis (<5%), pelvic pain (<5%)

Hematologic & oncologic: Adenoma (<5%), agranulocytosis (<5%), paraproteinemia (<5%), polycythemia (<5%), carcinoma (including breast, gastrointestinal, skin, urogenital), malignant lymphoma, malignant melanoma

Hepatic: Increased serum alkaline phosphatase (5%), hepatic necrosis (<5%)

Hypersensitivity: Hypersensitivity reaction (children 6%; adults 1%)

Infection: Herpes simplex infection (≤4%), herpes zoster (≤4%), sepsis

Local: Injection site reaction (8%; other than erythema, itching, hemorrhage, pain, swelling)

Neuromuscular & skeletal: Back pain (6%), arthritis (<5%), arthropathy (<5%), bone disease (<5%), bone fracture (<5%), limb pain (<5%), muscle cramps (<5%), myasthenia (<5%), osteonecrosis (<5%), septic arthritis (<5%), synovitis (<5%), tendon disease (<5%), tremor (<5%), arthralgia (3%; plaque psoriasis)

Ophthalmic: Cataract (<5%)

Renal: Nephrolithiasis (<5%), pyelonephritis

Respiratory: Flu-like symptoms (7%), asthma (<5%), bronchospasm (<5%), dyspnea (<5%), pleural effusion (<5%), respiratory depression (<5%), pharyngitis (juvenile idiopathic arthritis: ≤4%), pneumonia (≤4%), tuberculosis (including reactivation of latent infection; disseminated, miliary, lymphatic, peritoneal, and pulmonary)

Miscellaneous: Accidental injury (10%), abnormal healing (<5%), postoperative complication (infection)

<1% (Limited to important or life-threatening): Abscess (limb, perianal), alopecia, anal fissure, anaphylactoid reaction, anaphylaxis, angioedema, aplastic anemia, appendicitis, bacterial infection, basal cell carcinoma, cardiac failure, cerebrovascular accident, cervical dysplasia, circulatory shock, cytopenia, dermal ulcer, endometrial hyperplasia, erythema multiforme, fixed drug eruption, fulminant necrotizing fasciitis, fungal infection, Guillain-Barré syndrome, hepatic failure, hepatitis B (reactivation), hepatosplenic T-cell lymphomas (children, adolescents, and young adults), hepatotoxicity (idiosyncratic) (Chalasani 2014), histoplasmosis, hypersensitivity angiitis, increased serum transaminases, interstitial pulmonary disease (eg, pulmonary fibrosis), intestinal obstruction, intestinal perforation, leukemia, leukopenia, liver metastases, lupus-like syndrome, lymphadenopathy, lymphocytosis, malignant neoplasm of ovary, meningitis (viral), Merkel cell carcinoma, multiple sclerosis, mycobacterium avium complex, myositis (children and adolescents), neutropenia, optic neuritis, pancreatitis, pancytopenia, protozoal infection, psoriasis (including new onset, palmoplantar, pustular, or exacerbation), pulmonary embolism, respiratory failure, sarcoidosis, septic shock, skin granuloma (annulare; children and adolescents), Stevens-Johnson syndrome, streptococcal pharyngitis (children and adolescents), systemic lupus erythematosus, testicular neoplasm, thrombocytopenia, vasculitis (systemic), viral infection

ALERT: U.S. Boxed Warning

Serious infections:

Patients treated with adalimumab are at increased risk of developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.

Discontinue adalimumab if a patient develops a serious infection or sepsis. Reported infections include the following:

Active tuberculosis (TB), including reactivation of latent TB. Patients with TB frequently have presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab use and during therapy. Initiate treatment for latent infection prior to adalimumab use.

Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk of invasive fungal infections who develop severe systemic illness.

Bacterial, viral, and other infections caused by opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with adalimumab prior to initiating therapy in patients with chronic or recurrent infection.

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Malignancy:

Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with tumor necrosis factor (TNF)–blockers. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF-blockers. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF-blocker cases have occurred in patients with Crohn disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF-blocker or a TNF-blocker in combination with these other immunosuppressants.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: May rarely cause hypersensitivity, anaphylaxis, anaphylactoid reactions, or angioedema; medications for the treatment of hypersensitivity reactions should be available for immediate use.

• Autoimmune disorder: Positive antinuclear antibody titers have been detected in patients (with negative baselines). Rare cases of autoimmune disorder, including lupus-like syndrome, have been reported; monitor and discontinue if symptoms develop.

• Demyelinating disease: Rare cases of new-onset or exacerbation of demyelinating disorders (eg, multiple sclerosis, optic neuritis, Guillain-Barré syndrome) have been reported. Consider discontinuing use in patients who develop peripheral or central nervous system demyelinating disorders during treatment. Use with caution in patients with preexisting or recent onset central or peripheral nervous system demyelinating disorders.

• Heart failure (HF): Worsening and new-onset HF has been reported with adalimumab and other TNF blockers. Use with caution in patients with HF or decreased left ventricular function. Canadian labeling contraindicates use in heart failure (NYHA class III/IV).

• Hepatitis B: Rare reactivation of hepatitis B (HBV) has occurred in chronic carriers of the virus, usually in patients receiving concomitant immunosuppressants; evaluate for HBV prior to initiation in all patients. Monitor during and for several months following discontinuation of treatment in HBV carriers; interrupt therapy if reactivation occurs and treat appropriately with antiviral therapy; if resumption of therapy is deemed necessary, exercise caution and monitor patient closely.

• Infections: [US Boxed Warning]: Patients receiving adalimumab are at increased risk for serious infections which may result in hospitalization and/or fatality; infections usually developed in patients receiving concomitant immunosuppressive agents (eg, methotrexate or corticosteroids) and may present as disseminated (rather than local) disease. Active tuberculosis (or reactivation of latent tuberculosis), invasive fungal (including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, and pneumocystosis) and bacterial, viral or other opportunistic infections (including legionellosis and listeriosis) have been reported in patients receiving TNF-blocking agents, including adalimumab. Monitor closely for signs/symptoms of infection. Discontinue for serious infection or sepsis. Consider risks versus benefits prior to use in patients with a history of chronic or recurrent infection. Consider empiric antifungal therapy in patients who are at risk for invasive fungal infection and develop severe systemic illness. Caution should be exercised when considering use in the elderly or in patients with conditions that predispose them to infections (eg, diabetes) or residence/travel from areas of endemic mycoses (blastomycosis, coccidioidomycosis, histoplasmosis), or with latent or localized infections. Do not initiate adalimumab therapy with clinically important active infection. Patients who develop a new infection while undergoing treatment should be monitored closely.

• Malignancy: [US Boxed Warning]: Lymphoma and other malignancies (some fatal) have been reported in children and adolescent patients receiving TNF-blocking agents, including adalimumab. Half the cases are lymphomas (Hodgkin and non-Hodgkin) and the other cases are varied, but include malignancies not typically observed in this population. Most patients were receiving concomitant immunosuppressants. [US Boxed Warning]: Hepatosplenic T-cell lymphoma (HSTCL), a rare T-cell lymphoma, has also been reported primarily in patients with Crohn disease or ulcerative colitis treated with adalimumab and who received concomitant azathioprine or mercaptopurine; reports occurred predominantly in adolescent and young adult males. Use may affect defenses against malignancies; impact on the development and course of malignancies is not fully defined. As compared to the general population, an increased risk of lymphoma has been noted in clinical trials; however, rheumatoid arthritis has been previously associated with an increased rate of lymphoma. A higher incidence of nonmelanoma skin cancers was noted in adalimumab-treated patients (0.7/100 patient years), when compared to the control group (0.2/100 patient years).

• Pancytopenia: Rare cases of pancytopenia (including aplastic anemia) have been reported with TNF-blocking agents; with significant hematologic abnormalities, consider discontinuing therapy.

• Tuberculosis: Tuberculosis (disseminated or extrapulmonary) has been reactivated while on adalimumab; most cases have been reported within the first 8 months of treatment. [US Boxed Warnings]: Patients should be evaluated for latent tuberculosis infection with a tuberculin skin test prior to therapy. Treatment of latent tuberculosis should be initiated before use. Patients with initial negative tuberculin skin tests should receive continued monitoring for tuberculosis throughout treatment; active tuberculosis has developed in this population during treatment. An induration of ≥5 mm should be considered a positive skin test result, even for patients previously vaccinated with BCG vaccine. Use with caution in patients who have traveled to or resided in regions where tuberculosis is endemic

Concurrent drug therapy issues:

• Abatacept: Serious infections were reported when abatacept was used with TNF-blocking agents; therefore, concurrent use of adalimumab and abatacept is not recommended.

• Anakinra: Neutropenia or serious infections were reported when anakinra was used with TNF-blocking agents; therefore, concurrent use of adalimumab and anakinra is not recommended.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Infection and malignancy has been reported at a higher incidence in elderly patients compared to younger adults; use caution in elderly patients.

• Pediatric: Malignancies have been reported among children and adolescents receiving TNF-blocking agents.

• Surgery patients: Limited experience with patients undergoing surgical procedures while on therapy; consider long half-life with planned procedures. Monitor closely for infection.

Dosage form specific issues:

• Latex: The packaging (needle cover of prefilled syringe) may contain latex.

• Multiple dose injection pens: According to the Centers for Disease Control and Prevention (CDC), pen-shaped injection devices should never be used for more than one person (even when the needle is changed) because of the risk of infection. The injection device should be clearly labeled with individual patient information to ensure that the correct pen is used (CDC 2012).

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Immunizations: Patients should be brought up to date with all immunizations before initiating therapy; live vaccines should not be given concurrently. There are no data available concerning the effects of therapy on vaccination or secondary transmission of live vaccines in patients receiving therapy.

Monitoring Parameters

Monitor improvement of symptoms and physical function assessments. Latent TB screening prior to initiating and during therapy; signs/symptoms of active infection, including tuberculosis (prior to, during, and following therapy); CBC with differential; signs/symptoms/worsening of heart failure; HBV screening prior to initiating (all patients), HBV carriers (during and for several months following therapy); signs and symptoms of hypersensitivity reaction; symptoms of lupus-like syndrome; signs/symptoms of malignancy (eg, splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss), including periodic skin examination.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Adalimumab crosses the placenta and can be detected in cord blood at birth at concentrations higher than those in the maternal serum. In one study of pregnant women with inflammatory bowel disease, adalimumab was found to be measurable in a newborn for up to 11 weeks following delivery. Maternal doses of adalimumab were 40 mg every other week (n=9) or 40 mg weekly (n=1) and the last dose was administered 0.14-8 weeks prior to delivery (median 5.5 weeks) (Mahadevan 2013). If therapy for inflammatory bowel disease is needed during pregnancy, adalimumab should be discontinued before 30 weeks gestation in order to decrease exposure to the newborn. In addition, the administration of live vaccines should be postponed until anti-TNF concentrations in the infant are negative (Habal 2012; Mahadeven 2013; Zelinkova 2013).

Women exposed to adalimumab during pregnancy for the treatment of an autoimmune disease (eg, inflammatory bowel disease) may contact the OTIS Autoimmune Diseases Study at 877-311-8972.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience rhinitis, rhinorrhea, abdominal pain, back pain, or injection site irritation. Have patient report immediately to prescriber signs of infection, signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs), signs of breathing problems (shortness of breath, wheezing, coughing, or breathing gets worse), excessive weight gain, swelling of arm or leg, angina, severe headache, loss of strength and energy, burning or numbness feeling, severe dizziness, passing out, bruising, bleeding, big weight loss, night sweats, mole changes, skin growth, blood in urine, pale skin, severe skin irritation, or signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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