Adalimumab Solution for injection

What is this medicine?

ADALIMUMAB (a dal AYE mu mab) is used to treat rheumatoid and psoriatic arthritis. It is also used to treat ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease

• hepatitis B or history of hepatitis B infection

• immune system problems

• infection or history of infections

• multiple sclerosis

• recently received or scheduled to receive a vaccine

• scheduled to have surgery

• tuberculosis, a positive skin test for tuberculosis or have recently been in close contact with someone who has tuberculosis

• an unusual reaction to adalimumab, other medicines, mannitol, latex, rubber, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

The manufacturer of the medicine offers free information to patients and their health care partners. Call 1—800—448—6472 for more information.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Give the next dose when your next scheduled dose is due. Call your doctor or health care professional if you are not sure how to handle a missed dose.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• abatacept

• anakinra

• etanercept

• infliximab

• live virus vaccines

• rilonacept

This medicine may also interact with the following medications:

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You will be tested for tuberculosis (TB) before you start this medicine. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine. Make sure to finish the full course of TB medicine.

Call your doctor or health care professional if you get a cold or other infection while receiving this medicine. Do not treat yourself. This medicine may decrease your body's ability to fight infection.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• chest pain

• fever, chills, or any other sign of infection

• numbness or tingling

• red, scaly patches or raised bumps on the skin

• swelling of the ankles

• swollen lymph nodes in the neck, underarm, or groin areas

• unexplained weight loss

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• nausea

• redness, itching, swelling, or bruising at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in the original container and in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. The product may be stored in a cool carrier with an ice pack, if needed. Protect from light. Throw away any unused medicine after the expiration date.