- Very bad and sometimes deadly infections have happened in patients who take Humira (adalimumab prefilled pens and syringes). Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
- TB (tuberculosis) has been seen in patients started on this medicine. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting Humira.
- Lymphoma and other cancers have happened in people who take this medicine or drugs like it. This has been deadly in some cases. Talk with the doctor.
- A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with Humira and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or 6-mercaptopurine). Most of the time, this happened during treatment for Crohn's disease or ulcerative colitis. Also, most cases were in male teenagers or young men. Talk with the doctor.
Uses of Humira:
- It is used to treat rheumatoid arthritis.
- It is used to treat psoriatic arthritis.
- It is used to treat Crohn's disease.
- It is used to treat ankylosing spondylitis.
- It is used to treat plaque psoriasis.
- It is used to treat ulcerative colitis.
- It is used to treat juvenile arthritis.
- It is used to treat a skin problem called hidradenitis suppurativa.
- It is used to treat uveitis.
- It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take Humira?
- If you have an allergy to adalimumab or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you are taking any of these drugs: Abatacept or anakinra.
- If you are using another drug like this one.
This is not a list of all drugs or health problems that interact with Humira.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Humira?
- Tell all of your health care providers that you take Humira. This includes your doctors, nurses, pharmacists, and dentists.
- If you have a latex allergy, talk with your doctor.
- You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
- If you have had hepatitis B before or carry the virus, talk with your doctor. Drugs like this one can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems.
- Hepatitis B testing needs to be done as you were told by the doctor. Talk with the doctor.
- You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
- Make sure you are up to date with all your vaccines before treatment with this medicine.
- Talk with your doctor before getting any vaccines. Use with Humira may either raise the chance of an infection or make the vaccine not work as well.
- Do not get a weakened bacteria like BCG for bladder cancer while you use this medicine. Talk with your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- If you have sunburn or other skin problems, talk with your doctor.
- Have your skin checked. Tell your doctor if you have any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
- Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in your arms or legs.
- This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Humira with your other drugs.
- Unsafe blood cell count problems have happened with this medicine. This includes a type of anemia called aplastic anemia and a type of low white blood cell count. Report any fever or chills, shortness of breath, feeling very tired or weak, any unexplained bruising or bleeding, or purple "splotches" on your skin to your doctor right away.
- If you are 65 or older, use Humira (adalimumab prefilled pens and syringes) with care. You could have more side effects.
- Use with care in children. Talk with the doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
- If you used Humira when you were pregnant, tell your baby's doctor.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (Humira) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into the fatty part of the skin.
- If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
- Wash your hands before and after use.
- Follow how to use as you have been told by the doctor or read the package insert.
- Do not shake the solution.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not give if the solution is not clear and colorless.
- Do not give into red or irritated skin.
- Move the site where you give the shot with each shot.
- If it makes the shot feel better, Humira can be taken out of the refrigerator 15 to 30 minutes before using. Allow to sit at room temperature without removing the cap or cover. Do not heat this medicine.
- Throw syringe away after use. Do not use the same syringe more than one time.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
What do I do if I miss a dose?
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- If you are not sure what to do if you miss a dose, call your doctor.
See also: Dosage Information (in more detail)
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Chest pain or pressure.
- Night sweats.
- A big weight loss.
- Fever that does not go away.
- Swollen gland.
- A skin lump or growth.
- Blood in the urine.
- Pale skin.
- Very bad irritation where the shot was given.
- Red scaly patches or bumps that are pus filled.
- Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Heart failure has happened with Humira, as well as heart failure that has gotten worse in people who already have it. Tell your doctor if you have heart disease. Call your doctor right away if you have shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
What are some other side effects of Humira?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Signs of a common cold.
- Belly pain.
- Upset stomach.
- Back pain.
- Irritation where the shot is given.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also: Side effects (in more detail)
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Humira?
- Store in a refrigerator. Do not freeze.
- Do not use if it has been frozen.
- Store in the original container or in another container that protects this medicine from light.
- If needed, you may store at room temperature for up to 14 days. Write down the date you take Humira out of the refrigerator. If stored at room temperature and not used within 14 days, throw this medicine away.
- Protect from heat.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Humira is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Disclaimer: This information should not be used to decide whether or not to take Humira or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Humira (adalimumab prefilled pens and syringes). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: February 7, 2018
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