Humira

What is Humira?

• Humira (adalimumab) is a tumor necrosis factor (TNF) blocker used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis.

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Adalimumab structure

Components of an Adalimumab-Humira pen - annotated

What are the uses of this medicine?

Humira (adalimumab) is used: To reduce the signs and symptoms of:

• moderate to severe RA in adults. Humira can be used alone, with methotrexate, or with certain other medicines.
• moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Humira can be used alone or with methotrexate.
• psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines.
• ankylosing spondylitis (AS) in adults.
• moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.

• To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
• To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if Humira is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
• To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
• To treat non-infectious intermediate, posterior, and panuveitis in adults and children 2 years of age and older.

How does this medicine work?

• Adalimumab (ay" da lim' ue mab) is a human recombinant monoclonal immunoglobulin G1 antibody to TNF alpha which binds avidly to serum and tissue-bound TNF, causing its inactivation and degradation.
• Inhibition of TNF alpha activity leads to modulation of the inflammatory and pain pathways activated by this cytokine.
• Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors.
• Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement.
• TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
• Elevated concentrations of TNF are found in the synovial fluid of patients with RA, JIA, PsA, and AS and play an important role in both the pathologic inflammation and the joint destruction that are hallmarks of these diseases.
• Increased concentrations of TNF are also found in psoriasis plaques.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Humira may affect how other medicines work, and other medicines may affect how Humira works. This can cause serious side effects.

Especially tell your doctor if you use:

• ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use Humira while you are also using one of these medicines.
• RITUXAN (rituximab). Your doctor may not want to give you Humira if you have received RITUXAN (rituximab) recently.
• IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP).

Is this medicine FDA approved?

• Adalimumab was approved in the United States for use in rheumatoid arthritis in 2002, and subsequently its indications have been extended to ankylosing spondylitis, juvenile idiopathic (rheumatoid) arthritis, severe psoriasis and psoriatic arthritis, Crohn disease and ulcerative colitis.
• Adalimumab is considered a disease modifying antirheumatic drug (DMARD), and has been shown to improve symptoms as well as joint and cartilage damage in the inflammatory arthritis.

How should this medicine be used?

Recommended dosage: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: Adults:

• 40 mg every other week.
• Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis or Pediatric Uveitis:

Pediatric Weight
2 Years of Age and Older	Recommended Dosage
10 kg (22 lbs) to less than 15 kg (33 lbs)	10 mg every other week
15 kg (33 lbs) to less than 30 kg (66 lbs)	20 mg every other week
30 kg (66 lbs) and greater	40 mg every other week

Crohn's Disease:

• Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.
• Pediatric Patients 6 Years of Age and Older:

Pediatric Weight	Recommended Dosage	Recommended Dosage
	Days 1 and 15	Starting on Day 29
17 kg (37 lbs) to less than 40 kg (88 lbs)	Day 1: 80 mg Day 15: 40 mg	20 mg every other week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg	40 mg every other week

Ulcerative Colitis:

• Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57).

• Pediatric Patients 5 Years of Age and Older:

Pediatric Weight	Recommended Dosage	Recommended Dosage
	Days 1 and 15	Starting on Day 29
20 kg (44 lbs)to less than 40 kg (88 lbs)	Day 1: 80 mg; Day 8: 40 mg; Day 15: 40 mg	40 mg every other week or 20 mg every week
40 kg (88 lbs) and greater	Day 1: 160 mg (single dose or split over two consecutive days) Day 8: 80 mg Day 15: 80 mg	80 mg every other week or 40 mg every week

Plaque Psoriasis or Adult Uveitis: Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Hidradenitis Suppurativa:

• Adults:
• Day 1: 160 mg (given in one day or split over two consecutive days)
• Day 15: 80 mg
• Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

• Adolescents 12 years of age and older:

Adolescent
Weight	Recommended Dosage
30 kg (66 lbs)
to less than
60 kg (132 lbs)	Day 1: 80 mg ;Day 8 and subsequent doses: 40 mg every other week
60 kg (132 lbs)
and greater	Day 1: 160 mg (given in one day or split over two consecutive days); Day 15: 80 mg ; Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

Administration:

• Humira is given by an injection under the skin. Your doctor will tell you how often to take an injection of Humira. This is based on your condition to be treated. Do not inject Humira more often than you were prescribed.
• See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject Humira.
• Make sure you have been shown how to inject Humira before you do it yourself. You can call your doctor or 1-800-4HUMIRA (1-800-448-6472) if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject Humira.
• Do not try to inject Humira yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of Humira at home, you should receive training on the right way to prepare and inject Humira.
• Do not miss any doses of Humira unless your doctor says it is okay. If you forget to take Humira, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject Humira, call your doctor or pharmacist.
• If you take more Humira than you were told to take, call your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• Single-dose prefilled pen (Humira Pen): 80 mg/0.8 mL, 40 mg/0.8 mL, and 40 mg/0.4 mL.
• Single-dose prefilled glass syringe: 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 mL, 10 mg/0.1 mL.
• Single-dose glass vial for institutional use only: 40 mg/0.8 mL

This medicine is available in fallowing brand namesː

• Humira

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site reactions
• upper respiratory infections (including sinus infections)
• headaches
• rash

Humira can cause serious side effects, including:

• Serious Infections
• Hepatitis B infection in people who carry the virus in their blood
• Allergic reactions
• Nervous system problems
• Blood problems
• New heart failure or worsening of heart failure you already have
• Immune reactions including a lupus-like syndrome
• Liver problems
• Psoriasis

What special precautions should I follow?

• Patients treated with Humira are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Do not start Humira during an active infection. If an infection develops, monitor carefully, and stop Humira if infection becomes serious.
• 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.
• Consider the risks and benefits of TNF-blocker treatment including Humira prior to initiating therapy in patients with a known malignancy. Incidence of malignancies was greater in Humira-treated patients than in controls.
• Anaphylaxis or serious hypersensitivity reactions may occur. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of Humira and institute appropriate therapy.
• Use of TNF blockers, including Humira, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Humira and begin anti-viral therapy.
• Use of TNF blocking agents, including Humira, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
• Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., thrombocytopenia, leukopenia) have been infrequently reported with Humira. Advise patients to seek immediate medical attention if symptoms develop, and consider stopping Humira.
• Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Worsening or new onset, may occur.
• Treatment with Humira may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Stop Humira if syndrome develops.
• The safety of administering live or live-attenuated vaccines in infants exposed to Humira in utero is unknown.
• Concurrent use of anakinra (an interleukin-1 antagonist) and another TNF-blocker, was associated with a greater proportion of serious infections and neutropenia. Therefore, the combination of Humira and anakinra is not recommended.
• Adalimumab has been associated with a low rate of serum aminotransferase elevations during therapy, but these have been transient, mild and asymptomatic, and have rarely required dose modification. ALT levels above 3 times ULN have been reported in 1 to 3.5% of adalimumab recipients compared to 0.9 to 1.8% of controls. Rare instances of clinically apparent liver injury have been reported with adalimumab, resembling the hepatic injury that has been described with infliximab therapy. In at least one instance, liver injury arising during adalimumab therapy did not recur on switching to etanercept. The onset of injury was within 3 months and the pattern of serum enzyme elevations was hepatocellular. The injury promptly resolved on stopping adalimumab.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities.

Treatment of overdosage:

• In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Can this medicine be used in pregnancy?

• Available studies with use of adalimumab during pregnancy do not reliably establish an association between adalimumab and major birth defects.

Can this medicine be used in children?

The safety and effectiveness of Humira have been established for:

• reducing signs and symptoms of moderately to severely active polyarticular JIA in pediatric patients 2 years of age and older.
• the treatment of moderately to severely active Crohn’s disease in pediatric patients 6 years of age and older.
• the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.
• the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
• the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older.

What are the active and inactive ingredients in this medicine?

• Active ingredient: adalimumab
• Humira Pen 40 mg/0.8 mL, Humira 40 mg/0.8 mL prefilled syringe, Humira 20 mg/0.4 mL prefilled syringe, Humira 10 mg/0.2 mL prefilled syringe, and Humira 40 mg/0.8 mL institutional use vial:

• Inactive ingredients: citric acid monohydrate, dibasic sodium phosphate dihydrate, mannitol, monobasic sodium phosphate dihydrate, polysorbate 80, sodium chloride, sodium citrate and Water for Injection. Sodium hydroxide is added as necessary to adjust pH.
• Humira Pen 80 mg/0.8 mL, Humira 80 mg/0.8 mL prefilled syringe, Humira Pen 40 mg/0.4 mL, Humira 40 mg/0.4 mL prefilled syringe, Humira 20 mg/0.2 mL prefilled syringe and Humira 10 mg/0.1 mL prefilled syringe:

• Inactive ingredients: mannitol, polysorbate 80, and Water for Injection.

Who manufactures and distributes this medicine?

• Manufactured by: AbbVie Inc., North Chicago, IL, U.S.A.

What should I know about storage and disposal of this medication?

• Store Humira in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store Humira in the original carton until use to protect it from light.
• Do not freeze Humira. Do not use Humira if frozen, even if it has been thawed.
• Refrigerated Humira may be used until the expiration date printed on the Humira carton, dose tray, Pen or prefilled syringe. Do not use Humira after the expiration date.
• If needed, for example when you are traveling, you may also store Humira at room temperature up to 77°F (25°C) for up to 14 days. Store Humira in the original carton until use to protect it from light.
• Throw away Humira if it has been kept at room temperature and not been used within 14 days.
• Record the date you first remove Humira from the refrigerator in the spaces provided on the carton and dose tray.
• Do not store Humira in extreme heat or cold.
• Do not use a Pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
• Do not drop or crush Humira. The prefilled syringe is glass.

• Dailymed label info on Humira
• FDA Humira

Humira Resources
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