What is 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 other purposes not listed in this medication guide.

Precautions

You should not use this medication if you are allergic to adalimumab, or if you are also being treated with anakinra (Kineret).

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.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using adalimumab, tell your doctor if you have:

  • an active or recent infection;
  • open sores or skin wounds;
  • hepatitis B;
  • congestive heart failure;
  • lupus;
  • 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.

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. Do not use adalimumab without first talking to your doctor if you are breast-feeding a baby.

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.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

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

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

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of adalimumab is not expected to produce life-threatening symptoms.

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.

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Side Effects

Get 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.

Serious and sometimes fatal infections may occur during treatment with adalimumab. Stop using adalimumab and call your doctor right away if you have signs of infection such as:

  • fever, sweating, chills, tired feeling;
  • feeling short of breath;
  • cough, sore throat; or
  • flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

  • shortness of breath with swelling of your ankles or feet;
  • confusion, seizure (convulsions);
  • pain or burning when you urinate;
  • chest pain, ongoing cough, coughing up blood;
  • easy bruising or bleeding, pale skin, unusual weakness;
  • numbness or tingly feeling, weakness in your legs;
  • jaundice (yellowing of the skin or eyes);
  • 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:

  • headache;
  • 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

There may be other drugs that can interact with adalimumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Other Names

Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package, adalimumab, and Humira Pen Psoriasis Starter Package

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Disclaimer

Every 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 outside 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 should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid 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.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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