Humira
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Uses
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).
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.
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.
HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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.
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.
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)].
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)].
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 ColitisHUMIRA 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 PsoriasisHUMIRA 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)].
History
There is currently no drug history available for this drug.
Other Information
HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal antibody specific for human tumor necrosis factor (TNF). HUMIRA was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
HUMIRA is supplied as a sterile, preservative-free solution of adalimumab for subcutaneous administration. The drug product is supplied as either a single-use, prefilled pen (HUMIRA Pen), as a single-use, 1 mL prefilled glass syringe, or as a single-use institutional use vial. Enclosed within the pen is a single-use, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2.
Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-use institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab 40 mg, citric acid monohydrate 1.04 mg, dibasic sodium phosphate dihydrate 1.22 mg, mannitol 9.6 mg, monobasic sodium phosphate dihydrate 0.69 mg, polysorbate 80 0.8 mg, sodium chloride 4.93 mg, sodium citrate 0.24 mg and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.
Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab 20 mg, citric acid monohydrate 0.52 mg, dibasic sodium phosphate dihydrate 0.61 mg, mannitol 4.8 mg, monobasic sodium phosphate dihydrate 0.34 mg, polysorbate 80 0.4 mg, sodium chloride 2.47 mg, sodium citrate 0.12 mg and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.
Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab 10 mg, citric acid monohydrate 0.26 mg, dibasic sodium phosphate dihydrate 0.31 mg, mannitol 2.4 mg, monobasic sodium phosphate dihydrate 0.17 mg, polysorbate 80 0.2 mg, sodium chloride 1.23 mg, sodium citrate 0.06 mg and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.
Sources
Humira Manufacturers
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Abbvie Inc.
![Humira (Adalimumab) Kit Humira (Adalimumab) Injection, Solution [Abbvie Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Humira | Abbvie Inc.
HUMIRA is administered by subcutaneous injection.
2.1 Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing SpondylitisThe 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 ArthritisThe 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.
Patients
(2 years of age and older) Dose 10 kg (22 lbs) to <15 kg (33 lbs) 10 mg every other week
(10 mg Prefilled Syringe) 15 kg (33 lbs) to <30 kg (66 lbs) 20 mg every other week
(20 mg Prefilled Syringe) ≥30 kg (66 lbs) 40 mg every other week
(HUMIRA Pen or 40 mg Prefilled Syringe)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 DiseaseThe 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 evaluated in controlled clinical studies.
2.4 Pediatric Crohn’s DiseaseThe 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:
Pediatric Patients Induction Dose Maintenance Dose
Starting at Week 4 (Day 29) 17 kg (37 lbs) to < 40 kg (88 lbs) 80 mg on Day 1 (administered as two 40 mg injections in one day); and 40 mg two weeks later (on Day 15) 20 mg every other week ≥ 40 kg (88 lbs) 160 mg on Day 1 (administered as four injections in one day or as two 40 mg injections per day for two consecutive days); and 80 mg two weeks later (on Day 15) (administered as two 40 mg injections in one day) 40 mg every other week 2.5 Ulcerative ColitisThe 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 PsoriasisThe 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 evaluated in controlled clinical studies.
2.7 Hidradenitis SuppurativaThe 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 SafetyPrior to initiating HUMIRA and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions (5.1)].
2.9 General Considerations for AdministrationHUMIRA 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.
2.4 Pediatric Crohn’s DiseaseThe 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:
Pediatric Patients Induction Dose Maintenance Dose
Starting at Week 4 (Day 29) 17 kg (37 lbs) to < 40 kg (88 lbs) 80 mg on Day 1 (administered as two 40 mg injections in one day); and 40 mg two weeks later (on Day 15) 20 mg every other week ≥ 40 kg (88 lbs) 160 mg on Day 1 (administered as four injections in one day or as two 40 mg injections per day for two consecutive days); and 80 mg two weeks later (on Day 15) (administered as two 40 mg injections in one day) 40 mg every other week
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