"Sept. 28, 2012 -- The FDA has approved Abbott's Humira for the treatment of moderate to severe ulcerative colitis.
Humira (adalimumab) now is approved for both forms of inflammatory bowel disease (IBD): ulcerative colitis and Crohn's "...
Humira Patient Information including How Should I Take
In this Article
- What is adalimumab (Humira)?
- What are the possible side effects of adalimumab (Humira)?
- What is the most important information I should know about adalimumab (Humira)?
- What should I discuss with my healthcare provider before using adalimumab (Humira)?
- How should I use adalimumab (Humira)?
- What happens if I miss a dose (Humira)?
- What happens if I overdose (Humira)?
- What should I avoid while using adalimumab (Humira)?
- What other drugs will affect adalimumab (Humira)?
- Where can I get more information?
What should I discuss with my healthcare provider before using adalimumab (Humira)?
You should not use this medication if you are allergic to adalimumab, or if you are also being treated with abatacept (Orencia) or anakinra (Kineret).
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. This has occurred mainly in teenagers and young adults using adalimumab or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders may have a higher risk of lymphoma. Talk to your doctor about your individual risk.
To make sure you can safely use adalimumab, tell your doctor if you have any of these other conditions:
- an active or recent infection;
- open sores or skin wounds;
- hepatitis B;
- congestive heart failure;
- an allergy to latex rubber;
- a disease that affects the nerves or muscles, such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome;
- if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common;
- if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or
- if you are scheduled to receive any vaccines.
FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Your name may need to be listed on a Humira pregnancy registry when you start using this medication.
It is not known whether adalimumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using adalimumab.
Adalimumab should not be given to a child younger than 4 years old. Do not give this medication to anyone under 18 years old without medical advice. Children using adalimumab should be current on all childhood immunizations before starting treatment.
Using this medication may increase your risk of certain types of cancer, such as breast, colon, prostate, or lung cancer, lymphoma (cancer of the lymph nodes), or melanoma (a tumor that usually affects the skin). This risk may be greater in children and young adults. You may also develop an autoimmune disorder such as a lupus-like syndrome. Talk with your doctor about your specific risk.
How should I use adalimumab (Humira)?
Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Use adalimumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Before you start treatment with adalimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.
Adalimumab is injected under the skin. You may be shown how to use injections at home. Do not self inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Use each pre-filled syringe of adalimumab only one time. Throw away any unused portion of the medication. Do not save it for later use.
Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Adalimumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly. Serious and sometimes fatal infections may occur during treatment with adalimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, or flu symptoms.
If you need surgery, tell the surgeon ahead of time that you are using adalimumab.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using adalimumab.
Store adalimumab in the refrigerator but do not allow it to freeze. If you travel with the prefilled syringe, keep it in a small cooler with an ice pack and protect it from light.
Do not remove the prefilled syringe from the refrigerator or cooler until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Additional Humira Information
- Humira Drug Interactions Center: adalimumab subq
- Humira Side Effects Center
- Humira Overview including Precautions
- Humira FDA Approved Prescribing Information including Dosage
Humira - User Reviews
Humira User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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