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

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

Brand Name(s):

Abrilada, Abrilada Pen

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 in the thighs or stomach.
• A nurse or other health provider will give you this medicine.
• 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.
• Allow this medicine to warm to room temperature for 15 to 30 minutes. Do not warm it in any other way. Do not remove the needle cover while allowing the medicine to reach to room temperature. Remove it before use.
• Check the liquid in the prefilled syringe or pen. It should be clear and colorless to pale brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not shake.
• 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, hard, or scaly, or areas with scars or stretch marks. 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.
• 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 it in its original container. Protect from light. Do not use it if it has been frozen or thawed. If needed (including traveling), you may also store this medicine at room temperature for up to 30 days. Do not store it in extremely cold or hot temperatures. Throw away any unused medicine after 30 days.
• 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 medicines can affect how adalimumab-afzb works. Tell your doctor if you are using any of the following:
  • Abatacept, anakinra, azathioprine, cyclosporine, mercaptopurine, methotrexate, 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, Guillain-Barré syndrome, or a history of cancer. 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 serious infections
  • Increased risk of certain cancers, including skin cancer, lymphoma, or leukemia
  • New or worsening heart failure
  • Lupus-like syndrome
• You will need to have a skin test for tuberculosis (TB) before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or has 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
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet, or joint pain
• Rapid weight gain, swelling in your hands, ankles, lower legs, or feet
• 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
• Nausea, stomach pain
• 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