adalimumab

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

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

What is adalimumab?

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

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

Adalimumab is also used in adults and children to treat Crohn's disease, juvenile idiopathic arthritis, or uveitis.

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

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

Before you start using adalimumab, 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.

Adalimumab should not be given to a child younger than 2 years old (or 6 years old if treating Crohn's disease). Children using adalimumab 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.

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.

How should I use adalimumab?

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

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

Do not use adalimumab if you do not understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.

The dose schedule for adalimumab 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.

Throw away any adalimumab 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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while using adalimumab?

Do not inject adalimumab 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).

What are the possible side effects of adalimumab?

• 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.

• 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 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.

What other drugs will affect adalimumab?

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 adalimumab, 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.

Where can I get more information?

Your pharmacist can provide more information about adalimumab.