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Humira (adalimumab) is a tumor necrosis factor (TNF) blocker that reduces the effects of a substance in the body that can cause inflammation.
Humira is used to treat many inflammatory conditions in adults, such as ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a skin condition called hidradenitis suppurativa.
Humira is also used in adults and children to treat Crohn's disease, juvenile idiopathic arthritis or uveitis.
Humira affects your immune system. Some people using adalimumab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. Adalimumab can also lower blood cells that help your body fight infections and help your blood to clot. Serious and sometimes fatal infections may occur during treatment with Humira.
Before or during treatment with Humira, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.
Humira can lower blood cells that help your body fight infections and help your blood to clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with Humira. Tell your doctor at once if you develop signs of infection.
You should not use Humira if you are allergic to adalimumab.
Before you start using this medicine , tell your doctor if you have signs of infection--fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.
Humira should not be given to a child younger than 2 years old (or 6 years old if treating Crohn's disease). Children using this medicine should be current on all childhood immunizations before starting treatment.
Tell your doctor if you have ever had:
tuberculosis (or if anyone in your household has tuberculosis);
cancer;
hepatitis B (adalimumab can cause hepatitis B to come back or get worse);
diabetes;
congestive heart failure;
any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
an allergy to latex rubber;
if you are scheduled to have major surgery; or
if you have recently received or are scheduled to receive any vaccine.
Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common to certain areas of the world.
Humira may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant. Make sure any doctor caring for your newborn baby knows if you used adalimumab while you were pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
Use Humira exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Humira is injected under the skin. A healthcare provider will teach you how to properly use this medicine by yourself.
Do not start using this medicine if you have any signs of an infection. Call your doctor for instructions.
Read and carefully follow any instruction sheet provided with your medicine. Do not use Humira if you do not understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.
The dose schedule for Humira is highly variable and depends on the condition you are treating. Follow your doctor's dosing instructions very carefully.
Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.
Humira affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.
Store this medicine in its original carton in a refrigerator. Do not freeze. If you are traveling, carefully follow all patient instructions for storing your medicine during travel.
Throw away any Humira that has become frozen.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Usual Adult Dose for Rheumatoid Arthritis:
40 mg subcutaneously every other week
In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.
Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.
Usual Adult Dose of Humira for Psoriatic Arthritis:
40 mg subcutaneously every other week
In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.
Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.
Usual Adult Dose for Crohn's Disease -- Acute:
Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with adalimumab.
The use of adalimumab for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.
Usual Adult Dose of Humira for Crohn's Disease -- Maintenance:
Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with Humira.
The use of adalimumab for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.
Usual Adult Dose for Ulcerative Colitis:
Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with Humira.
The use of adalimumab for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.
Usual Adult Dose for Plaque Psoriasis:
Initial dose: 80 mg subcutaneously.
Maintenance dose: 40 mg subcutaneously every other week, starting one week after initial dose.
Usual Pediatric Dose for Juvenile Idiopathic Arthritis:
4 to 17 years:
Limited data are available for Humira treatment in pediatric patients with a weight below 15 kg.
15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week
Greater than or equal to 30 kg (66 lbs): 40 mg every other week
Methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics may be continued during treatment with Humira.
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.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Do not inject Humira into skin that is bruised, red, tender, or hard.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using adalimumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).
Get emergency medical help if you have any of these signs of an allergic reaction to Humira: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor right away if you have any symptoms of lymphoma:
fever, swollen glands, night sweats, general feeling of illness;
joint and muscle pain, skin rash, easy bruising or bleeding;
pale skin, feeling light-headed or short of breath, cold hands and feet;
pain in your upper stomach that may spread to your shoulder; or
loss of appetite, feeling full after eating only a small amount, weight loss.
Also call your doctor at once if you have:
new or worsening psoriasis (raised, silvery flaking of the skin);
liver problems - fever, body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).
Older adults may be more likely to develop infections or cancer while using adalimumab.
Common Humira side effects may include:
headache;
cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
rash; or
redness, bruising, itching, or swelling where the injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Some drugs should not be used together with adalimumab. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Humira, especially:
abatacept, etanercept;
anakinra;
azathioprine, mercaptopurine; or
certolizumab, golimumab, infliximab, rituximab.
This list is not complete. Other drugs may interact with adalimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Humira only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Humira Pen-cd/uc/hs Start (www.drugs.com/humira.html).
Note: This document contains side effect information about adalimumab. Some of the dosage forms listed on this page may not apply to the brand name Humira.
Common side effects of Humira include: upper respiratory tract infection, headache, injection site reaction, skin rash, antibody development, sinusitis, and pain at injection site. Other side effects include: urinary tract infection, abdominal pain, and flu-like symptoms. See below for a comprehensive list of adverse effects.
Applies to adalimumab: subcutaneous solution
Subcutaneous route (Solution)
Patients treated with adalimumab are at increased risk of infection, some of which may become serious and lead to hospitalization or death. These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria. The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection. Evaluate for latent TB and treat if necessary prior to initiating therapy. Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment. Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers such as adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis. Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine.
Subcutaneous route (Solution)
Patients treated with adalimumab-atto are at increased risk of infection, some of which may become serious and lead to hospitalization or death. These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria. The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection. Evaluate for latent TB and treat if necessary prior to initiating therapy. Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment. Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab products, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis. Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine.
Subcutaneous route (Solution)
Patients treated with adalimumab-adbm are at increased risk of infection, some of which may become serious and lead to hospitalization or death. These infections have included TB, invasive fungal infections, bacterial, viral, and those caused by opportunistic pathogens including Legionella and Listeria. The risks and benefits of therapy should be carefully considered prior to treatment initiation in patients with chronic or recurrent infection. Evaluate for latent TB and treat if necessary prior to initiating therapy. Monitor patients closely for signs and symptoms of infection during and after treatment, including the possible development of TB in patients who tested negative prior to treatment. Consider empirical antifungal therapy in at-risk patients who develop severe systemic illness. Lymphoma and other malignancies, some fatal, have been reported in pediatric and adolescent patients treated with tumor necrosis factor (TNF) blockers such as adalimumab-adbm. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with TNF blockers including adalimumab-adbm, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis. Most cases occurred in patients receiving concomitant treatment with azathioprine or 6-mercaptopurine.
Along with its needed effects, adalimumab (the active ingredient contained in Humira) 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:
More common
Less common
Incidence not known
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:
More common
Less common
Applies to adalimumab: subcutaneous kit, subcutaneous solution
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
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
Uncommon (0.1% to 1%): Parathyroid disorder
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
Common (1% to 10%): Urinary tract infection, hematuria
Uncommon (0.1% to 1%): Cystitis, kidney calculus, menstrual disorder, pyelonephritis
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
Uncommon (0.1% to 1%): Liver failure, hepatitis
Rare (less than 0.1%): Hepatic enzymes increased, hepatic necrosis
Postmarketing reports: Hepatic failure
Frequency not reported: Anaphylaxis, angioneurotic edema
Common (1% to 10%): Flu syndrome
Uncommon (0.1% to 1%): Sarcoidosis
Frequency not reported: Development of autoantibodies
Very common (10% or more): Injection site pain (12%)
Common (1% to 10%): Injection site reaction
Common (1% to 10%): Hypercholesterolemia, hyperlipidemia
Uncommon (0.1% to 1%): Dehydration, ketosis, paraproteinemia, increased alkaline phosphatase
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
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
Uncommon (0.1% to 1%): Optic neuritis, cataract
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
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
Frequency not reported: Renal pain, renal impairment
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
Common (1% to 10%): Mood alterations (including depression), anxiety, insomnia
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Humira Pen-cd/uc/hs Start (www.drugs.com/humira.html).
June 26, 2020
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June 27, 2020
July 10, 2020
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