Humira Generic Name: Adalimumab
Serious and sometimes fatal infections including tuberculosis, fungal infection, and other types of infection have occurred in patients using Humira . Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate).
Patients should receive a tuberculosis (TB) skin test before using Humira . Patients who test positive for TB should begin treatment for TB before starting Humira . All patients should also be monitored for signs of TB while using Humira even if their TB test is negative.
Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin; increased or painful urination).
Humira is used for:
Treating a variety of moderate to severe inflammatory conditions (eg, rheumatoid arthritis, juvenile rheumatoid arthritis [JRA], psoriatic arthritis, ankylosing spondylitis). It is also used to treat certain patients with moderate to severe Crohn disease and certain patients with chronic plaque psoriasis. It may be used alone or in combination with other medicine. It may also be used for other conditions as determined by your doctor.
Humira is a tumor necrosis factor (TNF) blocker. It works by blocking a protein (TNF-alpha) found in the body that causes inflammation.
Do NOT use Humira if:
- you are allergic to any ingredient in Humira
- you are using abatacept or anakinra, or if you will be receiving a live vaccine
- you have a severe infection (eg, sepsis) or any other active infection
Contact your doctor or health care provider right away if any of these apply to you.
Before using Humira :
Some medical conditions may interact with Humira . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances, including rubber or latex
- if you have a history of an infection that keeps coming back; TB infection or positive TB skin test; hepatitis B infection; heart problems (eg, heart failure); high cholesterol; high blood pressure; cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis, Guillain-Barre syndrome)
- if you have an autoimmune disorder (eg, lupus) or other immune system problems, have recently received a vaccine, are scheduled to receive a vaccine, or are scheduled to have surgery
- if you have open cuts or sores on your body, have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection
- if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB
- if you live or have lived in certain parts of the country (eg, Ohio or Mississippi river valleys) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common
- if you take medicine that may decrease your immune system (eg, cyclosporine)
Some MEDICINES MAY INTERACT with Humira . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abatacept, anakinra, corticosteroids (eg, prednisone), or methotrexate because the risk of serious infection may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if Humira may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Humira :
Use Humira as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Humira comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Humira refilled.
- Humira is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Humira . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Humira if it contains particles, is cloudy or discolored, or if the syringe or pen is cracked or damaged.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
- Rotate injection sites. New injections should be given at least 1 inch from an old site. Do not inject into areas where the skin is tender, bruised, red, or hard, or where you have scars or stretch marks.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Humira , use it as soon as you remember. Then go back to your regular dosing schedule.
Ask your health care provider any questions you may have about how to use Humira .
Important safety information:
- Humira may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Humira with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Humira may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- TNF blockers may increase the risk of developing certain types of cancer. Patients with rheumatoid arthritis who use Humira , especially those with more severe rheumatoid arthritis, have an increased risk of developing lymphoma. Talk with your doctor if you have questions about your risk of developing any type of cancer while using Humira .
- Tell your doctor or dentist that you take Humira before you receive any medical or dental care, emergency care, or surgery.
- Humira may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Humira . Talk with your doctor before you receive any vaccine.
- Lab tests, including TB tests, liver function, and complete blood cell counts, may be performed while you use Humira . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Humira with caution in the ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection and certain types of cancer.
- Humira should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Humira while you are pregnant. It is not known if Humira is found in breast milk. Do not breast-feed while taking Humira .
Possible side effects of Humira :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Back pain; headache; mild pain, redness, or swelling at the injection site; nausea; sinus inflammation; stomach pain.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in the urine or stools; butterfly-shaped rash on the nose and cheeks; chest pain; fainting; fast or irregular heartbeat; mental or mood changes; muscle pain or weakness; new or worsening joint pain; numbness, tingling, or pain in the hands or feet; open sore that does not heal; persistent cough; persistent pain, swelling, or redness at the injection site; red, swollen, or blistered skin; severe or persistent headache or dizziness; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or persistent sore throat; warm, red, or painful skin; increased or painful urination); swelling of the ankles, hands, or feet; unexplained weight loss; unusual bruising or bleeding; unusual lumps; unusual tiredness or weakness; unusually pale skin; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Humira :
Store Humira in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Store in the original container until ready to use. If you need to take Humira with you, such as when traveling, store it in a cool carrier with an ice pack and protect it from light. Do not use after the expiration date on the dose tray label or prefilled syringe. Do not use Humira if it has ever been frozen. Keep Humira out of the reach of children and away from pets.
- If you have any questions about Humira , please talk with your doctor, pharmacist, or other health care provider.
- Humira is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Humira . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Humira Prescribing Information (FDA)
- Humira Consumer Overview
- Humira Detailed Consumer Information (PDR)
- Humira Advanced Consumer (Micromedex) - Includes Dosage Information
- Adalimumab Professional Patient Advice (Wolters Kluwer)