Adalimumab (ay-da-LIM-ue-mab)

Treats arthritis, plaque psoriasis, ankylosing spondylitis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, and uveitis.

Brand Name(s):

Abrilada, Abrilada Pen, Amjevita, Amjevita 40MG/0.4ML AutoInjector, Amjevita 40MG/0.4ML PFS, Amjevita 80MG/0.8ML AutoInjector, Amjevita SureClick, Cyltezo PEN, Cyltezo PEN Starter Pack Crohn's,UC,HS, Cyltezo PEN Starter Pack Psoriasis, Cyltezo PEN Starter Pack Psoriasis/Uveitis, Cyltezo PFS, Hadlima, Hadlima Push Touch, Hulio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given at the front of your thighs or stomach.
• A nurse or other health provider will give you this medicine.
• This medicine is available in 2 forms. You may use a prefilled pen or a prefilled syringe.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, or hard. If you have psoriasis, do not inject into a raised, thick, red, or scaly skin patch or into skin lesions.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Prefilled pen or syringe:
  • First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
  • Wash your hands with soap and water before and after using this medicine.
  • Remove the carton with the syringe or pen from the refrigerator and place it on the cloth.
  • Allow 15 to 30 minutes for the syringe or pen to warm up to room temperature. Do not warm this medicine in any other way.
  • Do not remove the needle cover on the prefilled syringe or pen while allowing the medicine to reach room temperature. Only remove the cover right before use.
  • Check the liquid in the syringe or pen using the viewing window. It should be clear and colorless. If it is cloudy, discolored, or has particles floating in it, do not use the syringe or pen.
  • Check that the amount of liquid in the pen is the same or close to the fill line seen on the window. The fill line shows a full dose of the medicine. If the pen does not have the full amount of liquid, do not use it. Call your pharmacist.
  • If the liquid is clear, place the syringe or pen on a clean, flat surface. Do not shake the medicine.
  • Check the expiration date on the prefilled syringe or pen, and make sure the date has not passed. Do not use the medicine if the date has passed.
  • Choose an injection site on your body (eg, thigh or stomach area). Clean the injection site with a fresh alcohol wipe and let it dry.
  • Remove the cap or needle cover when you are ready to inject. Inject the full amount of medicine within a few minutes after the cap or cover has been removed.
  • You might have a small amount of blood or liquid at the injection site. Press and hold a dry, clean cotton ball on the injection site for 10 seconds, but do not rub it.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Keep the medicine in its original carton to protect from light. Do not use it if it has been frozen or thawed. If traveling, you may store this medicine at room temperature for up to 14 days. Throw away any unused medicine after 14 days. Do not store this medicine in extreme heat or cold temperatures.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how adalimumab works. Tell your doctor if you are using any of the following:
  • Abatacept, anakinra, azathioprine, cyclosporine, mercaptopurine, rituximab, theophylline
  • Blood thinner (including warfarin)
  • Medicine that weakens the immune system (including a steroid or cancer medicine)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, COPD, heart failure, diabetes, psoriasis, multiple sclerosis, optic neuritis, problems with your immune system, or a history of cancer or Guillain-Barré syndrome. Tell your doctor if you have any type of infection (including hepatitis B or tuberculosis) or an infection that keeps coming back.
• This medicine may cause the following problems:
  • Increased risk for infection
  • Increased risk of certain cancers, including lymphoma or leukemia
  • New or worsening heart failure
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash, or red, scaly patches on the skin
• Change in how much or how often you urinate, painful urination
• Changes in vision
• Chest pain, uneven heartbeat, trouble breathing
• Cough, fever, chills, runny or stuffy nose, sore throat, body aches
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet, joint pain
• Rapid weight gain, swelling in your hands, ankles, lower legs, or feet
• Sores or white patches on your lips, mouth, or throat
• Swollen glands in your neck, underarms, or groin
• Unusual bleeding, bruising, tiredness, weakness, or weight loss

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Headache
• Redness, itching, bruising, bleeding, pain, or swelling where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088