adalimumab

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Pronunciation: AY da LIM ue mab

Brand: Amjevita, Humira

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

Some people using adalimumab have developed a rare fast-growing type of lymphoma (cancer), which can be fatal. Adalimumab can also lower blood cells that help your body fight infections and help your blood to clot. Serious and sometimes fatal infections may occur.

Call your doctor at once if you have symptoms such as fever, night sweats, weight loss, feeling full after eating only a small amount, pain in your upper stomach, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes).

What is adalimumab?

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

Adalimumab is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a chronic skin condition called hidradenitis suppurativa. It is also used to treat Crohn's disease or ulcerative colitis, after other drugs have been tried without successful treatment of symptoms.

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

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

You should not use this medicine if you are allergic to adalimumab, or if you have an active infection.

Some people using adalimumab 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 adalimumab or similar medicines to treat Crohn's disease or ulcerative colitis. However, people with autoimmune disorders may have a higher risk of lymphoma.

To make sure adalimumab is safe for you, tell your doctor if you have ever had:

  • chronic infections;
  • cancer;
  • hepatitis B;
  • congestive heart failure;
  • any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
  • an allergy to latex rubber; or
  • if you have recently received or are scheduled to receive any vaccine.

Make sure you are current on all vaccines before you start treatment with adalimumab.

Tell your doctor 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.

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.

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

If you have a baby after receiving adalimumab during pregnancy, tell the baby's doctor before your baby is given any vaccines.

It is not known whether adalimumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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.

Using adalimumab may increase your risk of certain types of cancer, such as lymphoma (cancer of the lymph nodes), 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?

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

The dose schedule for adalimumab is highly variable and depends on the condition you are treating. You may need an injection only every other week. Or you may need up to 4 injections in 1 day for 2 days in a row. Follow your doctor's dosing instructions very carefully.

Do not start using adalimumab if you have any signs of an infection (fever, chills, night sweats, weight loss, body aches, tiredness, cough with mucus, feeling short of breath, skin sores, stomach pain, diarrhea, pain or burning when you urinate). Call your doctor for instructions.

Adalimumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes. Do not inject adalimumab into skin that is bruised, red, tender, or hard.

Each adalimumab prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside. Do not use a prefilled syringe if the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Adalimumab 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. Serious and sometimes fatal infections may occur during treatment with adalimumab. 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 adalimumab.

If you have ever had hepatitis B, adalimumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

Store in a refrigerator. If you travel with a 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 freeze adalimumab, and throw away the medicine if it has become frozen.

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?

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

What should I avoid while using adalimumab?

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), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of adalimumab?

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 adalimumab 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 --upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

  • signs of infection --fever, chills, sore throat, vomiting, diarrhea, flu symptoms, pain or burning when you urinate;
  • signs of tuberculosis --fever with ongoing cough, weight loss (fat or muscle);
  • pale skin, easy bruising or bleeding (nosebleeds, bleeding gums);
  • numbness, tingly feeling, weakness or prickly feeling;
  • vision problems;
  • shortness of breath with swelling of your ankles or feet; or
  • new or worsening psoriasis (raised, silvery flaking of the skin).

Older adults may be more likely to develop an infection 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;
  • anakinra;
  • azathioprine, 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.

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.

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