Generic Name: adalimumab (ay da LIM yoo mab)Brand Names: Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package
What is Humira Pen (adalimumab)?
Adalimumab reduces the effects of a substance in the body that can cause inflammation.
Adalimumab is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It is also used to treat Crohn's disease after other drugs have been tried without successful treatment of symptoms.
Adalimumab may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Humira Pen (adalimumab)?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. Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Adalimumab can lower blood cells that help your body fight infections. 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 adalimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, cough, or flu symptoms.
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.
Do not receive a "live" vaccine while you are being treated with adalimumab.
What should I discuss with my healthcare provider before using Humira Pen (adalimumab)?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 (including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, and psoriasis) may have a higher risk of lymphoma. Talk to your doctor about your individual risk.
Before using adalimumab, tell your doctor 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.
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-
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 recently been vaccinated with BCG (Bacille Calmette-Guerin)- or
if you are scheduled to receive any vaccines.
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. Children using this medication should be current on all childhood immunizations before starting treatment with adalimumab.
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 Humira Pen (adalimumab)?
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.
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
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.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Adalimumab is usually given every other week, although you may need to use it once a week. Follow your doctor's instructions.
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.
Throw away used needles and syringes in a puncture-proof container. If your medicine does not come with such a container, ask your pharmacist where you can get one. Keep this container out of the reach of children and pets. Your pharmacist can tell you how to properly dispose of the container.
Use adalimumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.Adalimumab can lower blood cells that help your body fight infections. 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 adalimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, or flu symptoms.
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.If you need surgery, tell the surgeon ahead of time that you are 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.
What happens if I miss a dose?
Use the medication 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.
What happens if I overdose?Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Humira Pen (adalimumab)?
Avoid injecting adalimumab 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), Bacillus Calmette-Gu rin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.
Humira Pen (adalimumab) side effectsGet emergency medical help if you have any of these signs of an allergic reaction: hives- difficulty breathing- swelling of your face, lips, tongue, or throat. Stop using adalimumab and call your doctor right away if you have any of these symptoms of lymphoma:
fever, night sweats, weight loss, tiredness-
feeling full after eating only a small amount-
pain in your upper stomach that may spread to your shoulder-
easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate- or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms)-
shortness of breath with swelling of your ankles or feet-
confusion, neck stiffness, seizure (convulsions)-
pain or burning when you urinate-
chest pain, ongoing cough, coughing up mucus or blood-
numbness or tingly feeling, weakness in your legs-
red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores-
joint pain or swelling with fever, swollen glands, muscle aches, vomiting, unusual thoughts or behavior, and/or seizure (convulsions)- or
patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).
Less serious side effects may include:
stuffy nose, sinus pain-
nausea, stomach pain- or
pain, redness, itching, swelling, or bleeding where you injected the medication.
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.
What other drugs will affect Humira Pen (adalimumab)?
There may be other drugs that can interact with adalimumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about adalimumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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