Humira Pen is used alone or in combination with methotrexate to treat rheumatoid arthritis and juvenile idiopathic arthritis.

Humira Pen may also be used in adults and children to treat many inflammatory conditions such as Crohn's disease, juvenile idiopathic arthritis, uveitis, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and hidradenitis suppurativa. Some brand forms of adalimumab are used only in adults.

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

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems. Before you use Humira Pen, your doctor should test you for tuberculosis or other infections.

If you've had hepatitis B, it may come back or get worse after you stop using Humira Pen. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes. You may need liver function tests for several months.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Humira Pen is injected under the skin. A healthcare provider will teach you how to properly use this medicine by yourself. Do not inject into the same place two times in a row.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Ask your doctor or pharmacist if you don't understand how to use an injection.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

Before you use Humira Pen, your doctor will test you for tuberculosis or other infections. Your blood will be tested before and during treatment with this medicine.

If you've had hepatitis B, it may come back or get worse during the treatment or after you stop using Humira Pen. You may need liver function tests while using this medicine and for several months after you stop.

Store this medicine in its original container in the refrigerator, do not freeze. Protect from light. Carefully follow all instructions for storing your medicine during travel. Avoid extreme heat or cold.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Throw away a prefilled syringe or auto-injector after one use, even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Before you start using Humira Pen, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you've had or been exposed to tuberculosis or fungal infection, or if you recently traveled or plan to travel. Some infections are more common in certain parts of the world, and you may be exposed during travel.

Tell your doctor if you have or have ever had:

• tuberculosis (or if anyone in your household has tuberculosis);

• an active or chronic infection;

• cancer;

• hepatitis B (Humira Pen can cause hepatitis B to come back or get worse);

• diabetes;

• congestive heart failure;

• any numbness or tingling, or a nerve-muscle disorder such as, multiple sclerosis or Guillain-Barre syndrome;

• an allergy to latex or rubber;

• scheduled to have major surgery; or

• recently received or are scheduled to receive any vaccine.

Make sure you are current on all vaccines before you start using Humira Pen.

Using Humira Pen may increase your risk of developing other cancers. Ask your doctor about this risk.

It is not known if Humira Pen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your baby's doctor if you used Humira Pen during pregnancy. It could affect your baby's vaccination schedule.

Ask a doctor if it is safe to breastfeed while using Humira Pen.

Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid injecting into skin that is hard, red, bruised, swollen, tender, has scars, or stretch marks.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have any symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, not feeling well;

• pale skin, rash, easy bruising or bleeding;

• cold hands and feet, feeling light-headed or short of breath;

• pain in your upper stomach that may spread to your shoulder; or

• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• skin changes such as red scaly patches or pus filled bumps;

• new or worsening heart problems--swelling, rapid weight gain, feeling short of breath;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• lupus-like symptoms--muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight;

• nervous system problems--numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or

• signs of tuberculosis--fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of Humira Pen may include:

• headache, skin rash;

• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat; or

• pain, redness, rash, bruising, itching, or swelling where an injection was given.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• abatacept, etanercept;

• anakinra;

• azathioprine, 6-mercaptopurine; or

• certolizumab, golimumab, infliximab, rituximab.

This list is not complete. Other drugs may affect Humira Pen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.