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Generic Name: adalimumab (ay da LIM yoo mab)
Brand Names: Humira

What is adalimumab?

Adalimumab reduces the effects of a substance in the body that can cause inflammation.

Adalimumab is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. 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 other than those listed in this medication guide.

What is the most important information I should know about adalimumab?

Before you start treatment with adalimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Treatment with adalimumab may increase your risk of developing certain types of cancer or autoimmune disorders (such as a lupus-like syndrome). Talk with your doctor about your individual risk.

Adalimumab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

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

What should I discuss with my healthcare provider before using adalimumab?

Before using adalimumab, tell your doctor if you are allergic to any drugs, or if you have:

• an active or recent infection;

• a history of tuberculosis;

• 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; or

• if you are scheduled to have major surgery or receive any vaccines.

If you have any of these conditions, you may not be able to use adalimumab, or you may need a dosage adjustment or special tests during treatment.

Your name may need to be listed on a Humira pregnancy registry when you start using this medication.

Using this medication may increase your risk of certain types of cancer, such as breast, colon, prostate, or lung cancer, or melanoma (a tumor that usually affects the skin). 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?

Before you start treatment with adalimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Adalimumab is given as an injection under the skin of your stomach or thigh. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to inject your medicine at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

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.

Adalimumab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

It is important to use adalimumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

What should I avoid while using adalimumab?

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

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

Adalimumab side effects

• fever, chills, sore throat, flu symptoms, weight loss;

• joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, unusual thoughts or behavior, and/or seizure (convulsions);

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

• chest pain, ongoing cough, coughing up blood; or

• easy bruising or bleeding, pale skin, unusual weakness.

• feeling short of breath, even with mild exertion;

• swelling of your ankles or feet;

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

• confusion, seizure (convulsions);

• pain or burning when you urinate;

• numbness or tingly feeling, weakness in your legs; or

• jaundice (yellowing of the skin or eyes).

Less serious side effects are more likely to occur, such as:

• pain, redness, itching, swelling, or bleeding where you injected the medication;

• headache;

• stuffy nose, sinus pain; or

• nausea, stomach pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect adalimumab?

There may be other drugs that can affect 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.

Where can I get more information?

• Your pharmacist has information about adalimumab written for health professionals that you may read.

What does my medication look like?

Adalimumab is available with a prescription under the brand name Humira. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 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.
• 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.