Humira is a tumor necrosis factor (TNF) blocker that reduces the effects of a substance in the body that can cause inflammation.

Humira is used to treat many inflammatory conditions in adults, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a skin condition called hidradenitis suppurativa.

Humira is also used in adults and children to treat Crohn's disease, juvenile idiopathic arthritis, ulcerative colitis and uveitis.

Humira affects your immune system. Adalimumab can lower the ability of your immune system to fight infections and you may get infections more easily. Serious infections caused by viruses, fungi or bacteria have happened in people taking this medicine. Some people have died from these infections.

Serious infections include tuberculosis (TB). Your doctor should test you for TB before starting and during treatment with Humira.

Before or during treatment with Humira, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Use Humira exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Humira is injected under the skin. A healthcare provider will teach you how to properly use this medicine by yourself.

Do not start using this medicine if you have any signs of an infection. Call your doctor for instructions.

Read and carefully follow any instruction sheet provided with your medicine. Do not use Humira if you do not understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.

The dose schedule for Humira is highly variable and depends on the condition you are treating. Follow your doctor's dosing instructions very carefully.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.

Humira affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store this medicine in its original carton in a refrigerator. Do not freeze. If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold.

Throw away any Humira that has become frozen.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

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 of Humira for Psoriatic 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 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 adalimumab.

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

Usual Adult Dose of Humira 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 adalimumab for Crohn's disease beyond one year had not been evaluated in controlled clinical studies.

Usual Adult Dose for Ulcerative Colitis:

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 adalimumab 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.

You should not use Humira if you are allergic to adalimumab.

Before you start using this medicine , tell your doctor if you have signs of infection--fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Humira should not be given to a child younger than 2 years old (or 6 years old if treating Crohn's disease). Children using this medicine should be current on all childhood immunizations before starting treatment.

Tell your doctor if you have ever had:

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

• a chronic infection;

• cancer;

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

• diabetes;

• heart failure;

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

• an allergy to latex rubber;

• if you are scheduled to have major surgery; or

• if you have recently received or are scheduled to receive any vaccine.

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common to certain areas of the world.

Humira may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant. Make sure any doctor caring for your newborn baby knows if you used adalimumab while you were pregnant.

It may not be safe to breastfeed a baby while you are using this medicine. Ask your doctor about any risks.

Use the medicine 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.

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

Do not inject 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 adalimumab. 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), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

Get emergency medical help if you have any of these signs of an allergic reaction to Humira: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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

• fever, swollen glands, night sweats, general feeling of illness;
• joint and muscle pain, skin rash, easy bruising or bleeding;
• pale skin, feeling light-headed or short of breath, cold hands and feet;
• pain in your upper stomach that may spread to your shoulder; or
• loss of appetite, feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis - confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems - body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).

Older adults may be more likely to develop infections or cancer while using adalimumab.

Common side effects of Humira may include:

• headache;
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
• rash; or
• redness, bruising, itching, or swelling where the 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.

Some drugs should not be used together with adalimumab. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Humira, especially:

• abatacept, etanercept;

• anakinra;

• azathioprine, 6-mercaptopurine; or

• certolizumab, golimumab, infliximab, rituximab.

This list is not complete. Other drugs may interact with adalimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.