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Generic Name: adalimumab (AY da LIM ue mab)
Brand Names: Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package

What is Humira?

Humira (adalimumab) reduces the effects of a substance in the body that can cause inflammation.

Humira 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 or ulcerative colitis in adults, after other drugs have been tried without successful treatment of symptoms.

Humira may also be used for purposes not listed in this medication guide.

Important information

Some people using Humira 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 Humira 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, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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Humira 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 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 Humira. Tell your doctor at once if you develop signs of infection.

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

Before using Humira

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

Some people using Humira 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 Humira or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders may have a higher risk of lymphoma. Talk to your doctor about your individual risk.

To make sure you can safely use Humira, tell your doctor if you have any of these other conditions:

  • 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 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 recently been vaccinated with BCG (Bacille Calmette-Guerin); or

  • if you are scheduled to receive any vaccines.

FDA pregnancy category B. Humira 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.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Humira.

Humira should not be given to a child younger than 4 years old. Do not give this medication to anyone under 18 years old without medical advice. Children using Humira should be current on all childhood immunizations before starting treatment.

Using Humira 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?

Use Humira exactly as prescribed by your doctor. Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Use Humira regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Humira is usually given every other week, although you may need to use it once a week. Follow your doctor's instructions.

Before you start treatment with Humira, 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.

Humira 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.

Use each pre-filled syringe of Humira only one time. Throw away any unused portion of the medication. 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). Keep this container out of the reach of children and pets.

Humira can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around 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 Humira. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, or flu symptoms.

If you need surgery, tell the surgeon ahead of time that you are using Humira.

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 Humira.

Store Humira 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.

Humira dosing information

Usual Adult Dose for Rheumatoid Arthritis:

40 mg subcutaneously every other week

In some patients not taking concomitant methotrexate, the dosing interval may be increased to 40 mg every week.

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.

Usual Adult Dose for Ankylosing Spondylitis:

40 mg subcutaneously every other week

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.

Usual Adult Dose for Psoriatic Arthritis:

40 mg subcutaneously every other week

Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, analgesics, or other disease modifying agents may be given concomitantly.

Usual Adult Dose for Crohn's Disease -- Acute:

Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with Humira.

The use of Humira for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Crohn's Disease -- Maintenance:

Initial dose: 160 mg subcutaneously on Day 1.
The initial dose may be given as 4 injections on Day 1, or as 2 injections per day for 2 consecutive days (Days 1 and 2).
Week 2: 80 mg subcutaneously on Day 15.
Maintenance dose: Beginning week 4 (Day 29), 40 mg every other week.

Aminosalicylates, corticosteroids, and/or immunomodulatory agents may be continued during treatment with Humira.

The use of Humira for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Plaque Psoriasis:

Initial dose: 80 mg subcutaneously.
Maintenance dose: 40 mg subcutaneously every other week, starting one week after initial dose.

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

4 to 17 years:

Limited data are available for Humira treatment in pediatric patients with a weight below 15 kg.

15 kg (33 lbs) to less than 30 kg (66 lbs): 20 mg every other week

Greater than or equal to 30 kg (66 lbs): 40 mg every other week

Methotrexate, glucocorticoids, salicylates, NSAIDs, or analgesics may be continued during treatment with Humira.

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.

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

What should I avoid?

Avoid injecting Humira 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 Humira. 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-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Humira 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.

Stop using Humira 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, rapid heart rate; or

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

Stop using Humira and call your doctor at once if you have any of these other 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).

Less serious 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 report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Humira?

Other drugs may interact with Humira, including prescription, over-the-counter, vitamin, and herbal products. Tell your doctor about all medications you use, and those you start or stop using during your treatment with Humira.

Where can I get more information?

  • Your pharmacist can provide more information about Humira.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Humira only for the indication prescribed.
  • 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 1996-2014 Cerner Multum, Inc. Version: 9.02. Revision Date: 2013-01-22, 11:16:03 AM

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