Adalimumab

Humira

Adalimumab has not been adequately studied in pregnant women.

Use of adalimumab by nursing mothers has not been adequately evaluated.

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up the missed dose.

Contraindications

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

Warnings/Precautions

Warnings

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

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.1 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

Anaphylaxis, angioedema, and other allergic reactions (e.g., allergic rash, anaphylactoid reactions, fixed drug eruption, nonspecified drug reaction, urticaria) 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

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

New onset or exacerbation of central or peripheral nervous system demyelinating disorders (e.g., multiple sclerosis, optic neuritis, 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

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

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

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

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.)

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

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

Category B.1 (See Pediatric Use under Cautions.)

Distributes into milk in small amounts; appears unlikely to be absorbed by breast-fed infants.1 34 Although used in 2 nursing women without apparent adverse effects on their breast-fed infants, systemic bioavailability from milk and any effect of this exposure on nursing infants is unknown.34 Potential for absorption by neonates and preterm infants also unknown.1 Use with caution.1 (See Pediatric Use under Cautions.)

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.)

Neonates and infants exposed to adalimumab in utero may have impaired immune responses.1 Data suggest adalimumab crosses the placenta; clinical importance of elevated concentrations in infants is unknown.1 Consider risks and benefits of administering live vaccines to infants exposed to adalimumab in utero; safety of live vaccines in these infants is unknown.1

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

Absorption

Bioavailability

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

Distribution

Extent

Distributed into synovial fluid.1

Distributed into milk in small amounts.1 34 Appears to cross placenta.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

• Importance of patients reading the manufacturer’s patient information (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 36 37

• 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.)

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

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

Store at 2°C to 8°C (36°F to 46°F) in original container to protect from light; do not freeze. Do not use if frozen even if it has been thawed. Do not store in extreme heat or cold. 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.

Applies to adalimumab: subcutaneous solution

Along with its needed effects, adalimumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking adalimumab:

• Abdominal or stomach fullness
• body aches or pain
• cough or hoarseness
• ear congestion
• gas with abdominal or stomach pain
• lightheadedness
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• pain or tenderness around the eyes or cheekbones
• rapid and sometimes shallow breathing
• shivering
• sunken eyes
• thirst
• trouble sleeping
• warmth on the skin
• wrinkled skin

• Abdominal or stomach pain
• abnormal vaginal bleeding or discharge
• agitation
• arm, back, or jaw pain
• black, tarry stools
• bleeding from the gums or nose
• blindness
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the stool or change in bowel habits
• bloody or cloudy urine
• blurred vision
• broken bones
• change in size, shape, or color of an existing mole
• change in skin color
• chest pain
• chest tightness or heaviness
• chills
• clear or bloody discharge from the nipple
• cold hands and feet
• confusion
• constipation
• cough
• coughing or spitting up blood
• decreased urination
• decreased vision
• depression
• difficult or frequent urination
• difficulty with breathing
• difficulty, burning, or painful urination
• dimpling of the breast skin
• dizziness
• drowsiness
• eye pain
• fainting
• fast, slow, or irregular heartbeat
• fever
• forgetfulness
• frequent urge to urinate
• general feeling of illness
• hair loss
• hallucinations
• headache
• increased thirst
• inverted nipple
• irregular breathing
• irregular pulse
• irritability
• itching or rash
• light colored stools
• loss of appetite
• lump in the breast or under your arm
• lump or swelling in the abdomen or stomach
• mole that leaks fluid or bleeds
• muscle cramps or spasms
• nausea
• new mole
• night sweats
• no blood pressure or pulse
• noisy breathing
• numbness or tingling in your arms, legs, or face
• pain, redness, or swelling in the arms or legs without any injury present
• pale skin
• persistent non-healing sore on your skin
• pink growth
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised, firm, or bright red patch
• redness or swelling of the breast
• seizures
• sharp back pain just below your ribs
• shiny bump on your skin
• slurred speech or problems with swallowing
• sneezing
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots on the lips or mouth
• spitting up blood
• stiff neck
• stopping of the heart
• sudden high fever or low grade fever for months
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• swollen neck veins
• tightness in the chest
• tiredness
• trouble breathing with activity
• trouble thinking
• unconsciousness
• unexplained bruising or bleeding
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight gain or loss
• visual disturbances
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow skin or eyes

• Blistering, peeling, or loosening of the skin
• diarrhea
• joint or muscle pain
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• red, scaling, or crusted skin
• unusual bleeding or bruising

Some side effects of adalimumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bladder pain
• bleeding
• burning
• coldness
• discoloration of the skin
• feeling of pressure
• general feeling of discomfort or illness
• hives
• lumps
• numbness
• pounding in the ears
• redness
• scarring
• soreness
• stinging
• swelling
• tenderness
• tingling
• ulceration
• warmth

• Abnormal healing
• decrease in height
• difficulty with moving
• difficulty with swallowing
• difficulty with walking
• dry mouth
• heartburn
• indigestion
• loss of hearing
• loss of strength or energy
• menstrual changes
• muscle or joint stiffness, tightness, or rigidity
• muscle pain or weakness
• pain in the back, ribs, arms, or legs
• shakiness in the legs, arms, hands, and feet
• sores
• stomach pain, fullness, or discomfort
• swelling or redness in the joints
• weakness

Applies to adalimumab: subcutaneous kit, subcutaneous solution

Cardiovascular

Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Arrhythmia, atrial fibrillation, chest pain, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, syncope, tachycardia, congestive heart failure, peripheral edema, systemic vasculitis, deep vein thrombosis
Rare (less than 0.1%): Vascular occlusion, aortic stenosis, thrombophlebitis, aortic aneurysm[Ref]

Dermatologic

Very common (10% or more): Rash (12%)
Common (1% to 10%): Dermatitis, eczema, pruritus, cellulitis, urticaria, psoriasis, ecchymosis, increased bruising, purpura, erysipelas, cutaneous vasculitis, herpes zoster
Postmarketing reports: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all subtypes including pustular and palmoplantar), alopecia, erythema multiforme, panniculitis[Ref]

Endocrine

Uncommon (0.1% to 1%): Parathyroid disorder[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting, stomatitis, mouth ulceration
Uncommon (0.1% to 1%): Cholecystitis, cholelithiasis, gastroenteritis, gastrointestinal hemorrhage, gastritis, dyspepsia, gastrointestinal disorder, gastrointestinal hemorrhage, rectal hemorrhage, abdominal bloating
Rare (less than 0.1%): Esophagitis, intestinal stenosis, colitis, enteritis
Frequency not reported: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, hematuria
Uncommon (0.1% to 1%): Cystitis, kidney calculus, menstrual disorder, pyelonephritis[Ref]

Hematologic

Common (1% to 10%): Lymphopenia, agranulocytosis, granulocytopenia, leucopenia, thrombocytopenia, anemia, lymphadenopathy, leukocytosis
Rare (less than 0.1%): Pancytopenia, polycythemia, idiopathic thrombocytopenia purpura, lymphoma-like reaction, leg thrombosis, hypertriglyceridemia[Ref]

Hepatic

Uncommon (0.1% to 1%): Liver failure, hepatitis
Rare (less than 0.1%): Hepatic enzymes increased, hepatic necrosis
Postmarketing reports: Hepatic failure[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, angioneurotic edema[Ref]

Immunologic

Common (1% to 10%): Flu syndrome
Uncommon (0.1% to 1%): Sarcoidosis
Frequency not reported: Development of autoantibodies[Ref]

Local

Very common (10% or more): Injection site pain (12%)
Common (1% to 10%): Injection site reaction[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia, hyperlipidemia
Uncommon (0.1% to 1%): Dehydration, ketosis, paraproteinemia, increased alkaline phosphatase[Ref]

Musculoskeletal

Common (1% to 10%): Back pain
Uncommon (0.1% to 1%): Arthritis, bone disorder, bone fracture (not spontaneous), bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder, pelvic pain
Rare (less than 0.1%): Rhabdomyolysis[Ref]

Nervous system

Very common (10% or more): Headache (12%)
Uncommon (0.1% to 1%): Confusion, paraesthesia, subdural hematoma, tremor, demyelinating disorders (e.g., optic neuritis, Guillain-Barre syndrome), cerebrovascular accident, multiple sclerosis,
Very rare (less than 0.01%): Hypertrophic pachymeningitis[Ref]

Ocular

Uncommon (0.1% to 1%): Cataract[Ref]

Oncologic

Uncommon (0.1% to 1%): Adenoma, Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
Rare (less than 0.1%): Skin papilloma, carcinomas (breast, gastrointestinal, skin, testicular), lymphoma, melanoma, cancer of the white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), mostly in adolescents and young adults[Ref]

Other

Very common (10% or more): Accidental injury (10%)
Uncommon (0.1% to 1%): Pain in extremity, thorax pain
Rare (less than 0.1%): Pyrexia
Frequency not reported: Sepsis, pain in thorax, opportunistic infections, tuberculosis, histoplasmosis, abscess, joint infection, wound infection, superficial fungal infections[Ref]

Renal

Frequency not reported: Renal pain, renal impairment[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (17%), sinusitis (11%), pneumonia, pharyngitis, nasopharyngitis
Uncommon (0.1% to 1%): Asthma, bronchospasm, dyspnea, lung function decreased, pleural effusion, interstitial lung disease (including pulmonary fibrosis), pulmonary embolism
Frequency not reported: Cough, upper respiratory infection, pharyngeal edema, nasal congestion, pulmonary edema, pleural effusion, pleurisy[Ref]

Psychiatric

Common (1% to 10%): Mood alterations (including depression), anxiety, insomnia[Ref]

Some side effects of adalimumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

-Initial dose: 160 mg subcutaneously on Day 1 (given in one day or split over 2 consecutive days), followed by 80 mg subcutaneously 2 weeks later (Day 15)
-Maintenance dose (beginning 2 weeks later [Day 29]): 40 mg subcutaneously every other week

Comments:
-Aminosalicylates and/or corticosteroids may be continued during treatment.
-Azathioprine, 6-mercaptopurine (6-MP), or methotrexate (MTX) may be continued during treatment if necessary.
-Treatment beyond one year in Crohn's Disease has not been established.
-Treatment in ulcerative colitis should only be continued in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.

Uses:
-To reduce signs and induce and maintain remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy; to reduce signs and induce remission in these patients if they have also lost response to or are intolerant to infliximab
-To induce and maintain remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine (6-MP) (the effectiveness of this drug in patients who have lost response to or were intolerant to TNF blockers has not been established)

6 years and older:
-For 17 kg (37 pounds) to less than 40 kg (88 pounds):
Initial dose: 80 mg subcutaneously (Day 1), then 40 mg subcutaneously 2 weeks later (Day 15)
Maintenance dose: 20 mg subcutaneously every other week
-For 40 kg (88 pounds) or greater:
Initial dose: 160 mg subcutaneously (Day 1) given in one day or split over 2 consecutive days, then 80 mg subcutaneously 2 weeks later (Day 15)
Maintenance dose: 40 mg subcutaneously every other week

Uses: To reduce symptoms and induce and maintain clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate

US BOXED WARNINGS:
-SERIOUS INFECTIONS: There is an increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. This drug should be discontinued if a patient develops a serious infection or sepsis during treatment. A test should be performed for latent TB; if positive, treatment for TB should be started prior to starting therapy with this drug. All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.
-MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers. Cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescents and young adults with inflammatory bowel disease treated with TNF blockers.

-Pediatric Crohn's Disease: Safety and effectiveness have not been established in patients younger than 6 years.
-Pediatric Polyarticular JIA: Safety and effectiveness have not been established in patients younger than 2 years.

Consult WARNINGS section of additional precautions.