ADALIMUMAB

(AY da LIM ue mab) Brand: Humira, Humira Pen, Humira Pen Crohns Disease/Ulcerative Colitis Starter Package

What is the most significant information I must know about 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 malady or ulcerative colitis.

• Call your doctor at once if you have any of the next symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a little amount, pain in your upper stomach that may spread to your shoulder, nausea, light bruising or bleeding, pale skin, feeling light-headed, rapid heart course, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Adalimumab 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 around people who are sick or have infections. Avoid activities that may magnify your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with adalimumab. Speak your doctor at once if you develop signs of infection.

• Do not receive a "live" vaccine while you are being treated with adalimumab.

What is adalimumab?

Adalimumab reduces the effects of a stuff in the body that can reason 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 malady or ulcerative colitis in adults, after another drugs have been tried without successful treatment of symptoms.

Adalimumab may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till using adalimumab?

• You must not use this medicine 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 malady or ulcerative colitis. However, people with autoimmune disorders may have a higher risk of lymphoma. Conversation to your doctor about your individual risk.

• To create certain you can safely use adalimumab, speak your doctor if you have any of these another conditions:

· an active or last infection;

· open sores or skin wounds;

· hepatitis B;

· congestive heart failure;

· lupus;

· an allergy to latex rubber;

· a malady 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 general;

· 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 medicine is not expected to be deleterious to an unborn child. Speak 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 child. You must not breast-feed while you are using adalimumab.

Adalimumab must not be given to a baby younger than 4 years old. Do not give this medicine to anyone under 18 years old without medical advice. Children using adalimumab must be current on all childhood immunizations till starting treatment.

• Using this medicine may magnify your risk of determined types of cancer, such as breast, colon, prostate, or lung cancer, lymphoma (cancer of the lymph nodes), or melanoma (a tumor that generally affects the skin). This risk may be greater in children and young adults. You may also develop an autoimmune mess such as a lupus-like syndrome. Conversation with your doctor about your specific risk.

How must I use adalimumab?

• Follow the directions on your prescription label. Do not use this medication in larger or less amounts or for longer than recommended. Use adalimumab regularly to get the most benefit. Get your prescription refilled till you run out of medication completely.

• Till you start treatment with adalimumab, your doctor may perform trials to create certain you do not have tuberculosis or another infections.

• Some infections are more likely to occur in determined areas of the world. Speak 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 house. Do not self inject this medication if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

• Use every pre-filled syringe of adalimumab only one time. Throw away any unused portion of the medicine. 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). Hold 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 create it easier for you to bleed from an injury or get sick from being near 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, speak the surgeon onward of time that you are using adalimumab.

If you have hepatitis B you may develop liver symptoms after you stop taking this medicine, even months after stopping. Your doctor may want to check your liver function for different months after you stop using adalimumab.

• Store adalimumab in the refrigerator but do not let it to freeze. If you travel with the prefilled syringe, hold it in a little cooler with an ice pack and protect it from light.

Do not remove the prefilled syringe from the refrigerator or cooler before you are ready to give yourself an injection. Do not use the medicine 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 medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include severe forms of some of the side effects listed in this medicine guide.

What must I avoid while using adalimumab?

• Avoid injecting adalimumab into skin that is bruised, red, tender, or hard.

• Avoid being around people who are sick or have infections. Speak 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 malady. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of adalimumab?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, 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 little amount;

· pain in your upper stomach that may spread to your shoulder;

· light bruising or bleeding, pale skin, feeling light-headed, rapid heart course; or

· liver problems--nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

• Stop using adalimumab and call your doctor at once if you have any of these another serious side effects:

· 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;

· sudden numbness or weakness, sudden severe headache, problems with vision or balance;

· chest pain, sudden or ongoing cough, wheezing, rapid breathing, coughing up mucus or blood;

· tingly feeling, weakness or prickly feeling in your fingers or toes;

· problems with balance or eye movement, trouble speaking or swallowing;

· severe lower back pain, loss of bladder or bowel control;

· pain, swelling, warmth, or redness in one or both legs;

· red, purple, or scaly skin rash, hair loss, muscle pain, mouth sores;

· joint pain or swelling, swollen glands, muscle aches, unusual thoughts or behavior; or

· patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

• Another general side effects may include:

· headache;

· stuffy nose, sinus pain;

· mild 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect adalimumab?

• Another drugs may interact with adalimumab, including prescription, over-the-counter, vitamin, and herbal commodity. Speak your doctor about all medications you use, and those you start or stop using during your treatment with adalimumab.

Where can I get more information?

• Your pharmacist can provide more information about adalimumab.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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