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HUMIRA (adalimumab) injection, for subcutaneous
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use HUMIRA safely and effectively. See full prescribing information for HUMIRA.
HUMIRA (adalimumab) injection, for subcutaneous use
Initial U.S. Approval: 2002
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
See full prescribing information for complete boxed warning.
SERIOUS INFECTIONS (5.1, 6.1):
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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.
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Discontinue HUMIRA if a patient develops a serious infection or sepsis during treatment.
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Perform test for latent TB; if positive, start treatment for TB prior to starting HUMIRA.
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Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
MALIGNANCY (5.2):
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Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA.
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Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.
RECENT MAJOR CHANGES
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Indications and Usage, Juvenile Idiopathic Arthritis (1.2) |
9/2014 |
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Indications and Usage, Pediatric Crohn’s Disease (1.6) |
9/2014 |
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Indications and Usage, Hidradenitis Suppurativa (1.9) |
9/2015 |
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Dosage and Administration, Juvenile Idiopathic Arthritis (2.2) |
9/2014 |
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Dosage and Administration, Pediatric Crohn’s Disease (2.4) |
9/2014 |
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Dosage and Administration, Hidradenitis Suppurativa (2.7) |
9/2015 |
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Dosage and Administration, General Considerations for Administration (2.9) |
12/2014 |
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Warnings and Precautions, Malignancies (5.2) |
9/2015 |
INDICATIONS AND USAGE
HUMIRA is a tumor necrosis factor (TNF) blocker indicated for treatment of:
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Rheumatoid Arthritis (RA) (1.1): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
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Juvenile Idiopathic Arthritis (JIA) (1.2): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
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Psoriatic Arthritis (PsA) (1.3): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
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Ankylosing Spondylitis (AS) (1.4): Reducing signs and symptoms in adult patients with active AS.
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Adult Crohn’s Disease (CD) (1.5): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
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Pediatric Crohn’s Disease (1.6): Reducing signs and symptoms and inducing and maintaining clinical remission in 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.
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Ulcerative Colitis (UC) (1.7): Inducing and sustaining clinical 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 HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.
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Plaque Psoriasis (Ps) (1.8): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
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Hidradenitis Suppurativa (HS) (1.9): The treatment of moderate to severe hidradenitis suppurativa.
DOSAGE AND ADMINISTRATION
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Administered by subcutaneous injection (2)
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis (2.1):
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40 mg every other week.
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Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.
Juvenile Idiopathic Arthritis (2.2):
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10 kg (22 lbs) to <15 kg (33 lbs): 10 mg every other week
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15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
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≥ 30 kg (66 lbs): 40 mg every other week
Adult Crohn's Disease and Ulcerative Colitis (2.3, 2.5):
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Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)
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Second dose two weeks later (Day 15): 80 mg
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Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week.
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For patients with Ulcerative Colitis only: Only continue HUMIRA in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.
Pediatric Crohn’s Disease (2.4):
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17 kg (37 lbs) to < 40 kg (88 lbs):
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Initial dose (Day 1): 80 mg (two 40 mg injections in one day)
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Second dose two weeks later (Day 15): 40 mg
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Two weeks later (Day 29): Begin a maintenance dose of 20 mg every other week.
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≥ 40 kg (88 lbs):
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Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)
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Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day)
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Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week.
Plaque Psoriasis (2.6):
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80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.
Hidradenitis Suppurativa (2.7):
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Initial dose (Day 1): 160 mg (given as four 40 mg injections on Day 1 or as two 40 mg injections per day on Days 1 and 2)
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Second dose two weeks later (Day 15): 80 mg (two 40 mg injections in one day)
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Third (Day 29) and subsequent doses: 40 mg every week.
DOSAGE FORMS AND STRENGTHS
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Injection: 40 mg/0.8 mL in a single-use prefilled pen (HUMIRA Pen) (3)
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Injection: 40 mg/0.8 mL in a single-use prefilled glass syringe (3)
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Injection: 20 mg/0.4 mL in a single-use prefilled glass syringe (3)
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Injection: 10 mg/0.2 mL in a single-use prefilled glass syringe (3)
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Injection: 40 mg/0.8 mL in a single-use glass vial for institutional use only (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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Serious infections: Do not start HUMIRA during an active infection. If an infection develops, monitor carefully, and stop HUMIRA if infection becomes serious (5.1)
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Invasive fungal infections: For patients who develop a systemic illness on HUMIRA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic (5.1)
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Malignancies: Incidence of malignancies was greater in HUMIRA-treated patients than in controls (5.2)
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Anaphylaxis or serious allergic reactions may occur (5.3)
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Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HUMIRA and begin anti-viral therapy (5.4)
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Demyelinating disease: Exacerbation or new onset, may occur (5.5)
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Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping HUMIRA (5.6)
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Heart failure: Worsening or new onset, may occur (5.8)
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Lupus-like syndrome: Stop HUMIRA if syndrome develops (5.9)
ADVERSE REACTIONS
Most common adverse reactions (incidence >10%): infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
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Abatacept: Increased risk of serious infection (5.1, 5.11, 7.2)
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Anakinra: Increased risk of serious infection (5.1, 5.7, 7.2)
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Live vaccines: Avoid use with HUMIRA (5.10, 7.3)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 9/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Rheumatoid Arthritis
HUMIRA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
1.2 Juvenile Idiopathic Arthritis
HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate.
1.3 Psoriatic Arthritis
HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs.
1.4 Ankylosing Spondylitis
HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
1.5 Adult Crohn’s Disease
HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
1.6 Pediatric Crohn’s Disease
HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining 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.
1.7 Ulcerative Colitis
HUMIRA is indicated for inducing and sustaining clinical 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 HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7)].
1.8 Plaque Psoriasis
HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Boxed Warning and Warnings and Precautions (5)].
1.9 Hidradenitis Suppurativa
HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa.
2 DOSAGE AND ADMINISTRATION
HUMIRA is administered by subcutaneous injection.
2.1 Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
The recommended dose of HUMIRA for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with HUMIRA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosing frequency of HUMIRA to 40 mg every week.
2.2 Juvenile Idiopathic Arthritis
The recommended dose of HUMIRA for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with HUMIRA.
HUMIRA has not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.
2.3 Adult Crohn’s Disease
The recommended HUMIRA dose regimen for adult patients with Crohn’s disease (CD) is 160 mg initially on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with HUMIRA. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with HUMIRA if necessary. The use of HUMIRA in CD beyond one year has not been eva luated in controlled clinical studies.
2.4 Pediatric Crohn’s Disease
The recommended HUMIRA dose regimen for pediatric patients 6 years of age and older with Crohn’s disease (CD) is based on body weight as shown below:
2.5 Ulcerative Colitis
The recommended HUMIRA dose regimen for adult patients with ulcerative colitis (UC) is 160 mg initially on Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) continue with a dose of 40 mg every other week.
Only continue HUMIRA in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy. Aminosalicylates and/or corticosteroids may be continued during treatment with HUMIRA. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] may be continued during treatment with HUMIRA if necessary.
2.6 Plaque Psoriasis
The recommended dose of HUMIRA for adult patients with plaque psoriasis (Ps) is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of HUMIRA in moderate to severe chronic Ps beyond one year has not been eva luated in controlled clinical studies.
2.7 Hidradenitis Suppurativa
The recommended dose of HUMIRA for adult patients with hidradenitis suppurativa (HS) is 160 mg (given as four 40 mg injections on Day 1 or as two 40 mg injections per day on Days 1 and 2), followed by 80 mg two weeks later (Day 15). Begin 40 mg weekly dosing two weeks later (Day 29).
2.8 Monitoring to Assess Safety
Prior to initiating HUMIRA and periodically during therapy, eva luate patients for active tuberculosis and test for latent infection [see Warnings and Precautions (5.1)].
2.9 General Considerations for Administration
HUMIRA is intended for use under the guidance and supervision of a physician. A patient may self-inject HUMIRA or a caregiver may inject HUMIRA using either the HUMIRA Pen or prefilled syringe if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.
You may leave HUMIRA at room temperature for about 15 to 30 minutes before injecting. Do not remove the cap or cover while allowing it to reach room temperature. Carefully inspect the solution in the HUMIRA Pen, prefilled syringe, or single-use institutional use vial for particulate matter and discoloration prior to subcutaneous administration. If particulates and discolorations are noted, do not use the product. HUMIRA does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe. NOTE: Instruct patients sensitive to latex not to handle the needle cover of the syringe because it contains dry rubber (latex).
Instruct patients using the HUMIRA Pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided in the Instructions for Use [see Instructions for Use].
Injections should occur at separate sites in the thigh or abdomen. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.
The HUMIRA single-use institutional use vial is for administration within an institutional setting only, such as a hospital, physician’s office or clinic. Withdraw the dose using a sterile needle and syringe and administer promptly by a healthcare provider within an institutional setting. Only administer one dose per vial. The vial does not contain preservatives; therefore, discard unused portions.
3 DOSAGE FORMS AND STRENGTHS
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Pen
Injection: A single-use pen (HUMIRA Pen), containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg/0. |
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