Adalimumab Injection (patient information)

IMPORTANT WARNING
Adalimumab may increase the chance that you will develop a serious infection, including tuberculosis. You may already be infected with tuberculosis but not have any symptoms of the disease. In this case, adalimumab may make your infection more serious and cause you to develop symptoms. Tell your doctor if you have or have ever had tuberculosis or recurrent infections or have been around someone who has or has ever had tuberculosis. Tell your doctor if you are taking medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf).

Before you begin your treatment, your doctor will perform a skin test to see if you have tuberculosis. If you do have tuberculosis, your doctor will treat this infection with antibiotics before you begin taking adalimumab. If you experience any of the following symptoms, call your doctor immediately: dry cough, weakness, night sweats, fever, and weight loss.

Why this medication is prescribed
Adalimumab is used alone or in combination with other medications (such as methotrexate) to reduce the pain, swelling, and difficulty with daily activities caused by rheumatoid arthritis and to stop the disease from causing further damage to joints. It is only used in patients who have taken other medications to treat their disease and have not gotten better. Adalimumab is in a class of medications called tumor-necrosis factor (TNF) inhibitors. It works by blocking the activity of TNF, a substance in the body that causes swelling and joint damage in rheumatoid arthritis.

How this medication should be used
Adalimumab comes as a solution to inject subcutaneously (under the skin). It is usually injected once every other week, or in some cases, once a week. To help you remember to take adalimumab, mark the days you are scheduled to take it on your calendar. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use adalimumab exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You will receive your first dose of adalimumab in your doctor's office. After that, you can inject adalimumab yourself or have a friend or relative perform the injections. Before you use adalimumab yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.

Adalimumab comes in prefilled syringes. Use each syringe only once and inject all the solution in the syringe. Even if there is still some solution left in the syringe after you inject, do not inject again. Dispose used syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

You can inject adalimumab anywhere on the front of your thighs or stomach except your navel and the area two inches around it. To reduce the chances of soreness or redness, use a different site for each injection.The new injection should be given at least 1 inch away from the previous injection. Keep a list of the places where you have given injections so that you will not inject in these places again. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

To inject adalimumab, follow these steps:


 * 1) Check your pre-filled syringe to be sure it is safe to use. It should be labeled with the correct name of the medication and an expiration date that has not passed and should contain a clear colorless solution. Do not use the syringe if it is expired or if the solution is cloudy or contains flakes.
 * 2) Wash your hands with soap and water and wipe the place on your skin where you will inject adalimumab with an alcohol pad. Move the alcohol pad over the area with a circular motion and do not touch the area again until you give the injection.
 * 3) Hold the syringe with the needle pointing down. Line up the syringe with the drawing of a syringe included with the medication and be sure that the syringe contains 0.8 mL of medication as shown in the drawing. Do not use the syringe if it contains a different amount of medication.
 * 4) Remove the needle cover, but do not touch the needle to your fingers or any surface.
 * 5) Turn the syringe so the needle is pointing up. Slowly push the plunger in to push the air out of the syringe. A small drop of liquid may come out of the syringe, but this will not affect your dose.
 * 6) Gently pinch the cleaned area of skin with one hand and hold it firmly. With the other hand, hold the syringe like a pencil at a 45 degree angle to the skin.
 * 7) Quickly push the needle into the skin, and let go of the skin with the other hand.
 * 8) Pull back on the plunger and check if blood appears in the syringe. If blood appears, pull the syringe out of your skin, discard it properly, and begin the process again with a fresh syringe and a new injection site. If no blood appears in the syringe, proceed with step 9.
 * 9) Slowly push the plunger in until the syringe is empty.
 * 10) Pull the needle out of the skin at the same angle you inserted it.
 * 11) Press a cotton ball over the area for 10 seconds, but do not rub it. It is normal to bleed a little bit at this point. If the area is painful or swollen, cover it with a cold, wet towel.

Adalimumab controls rheumatoid arthritis but does not cure it. Continue to use adalimumab even if you feel well. Do not stop using adalimumab without talking to your doctor.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special Precautions
Before using adalimumab:


 * tell your doctor and pharmacist if you are allergic to adalimumab, mannitol, or any other medications. Also tell your doctor if you or the person who will be helping you inject adalimumab are allergic to latex or rubber.
 * do not use adalimumab if you are using other TNF inhibitors such as etanercept (Enbrel) and infliximab (Remicade) or anakinra (Kineret).
 * tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
 * in addition to the condition mentioned in the IMPORTANT WARNING section, tell your doctor if you have or have ever had numbness or tingling in any part of your body; any disease that affects your nervous system, such as multiple sclerosis; any disease that affects your immune system, such as cancer, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or severe combined immunodeficiency syndrome (SCID); and lupus. Also tell your doctor if you have any infection, including infections that only affect a small part of your body (such as an open sore) and infections that come and go (such as cold sores).
 * tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using adalimumab, call your doctor.
 * if you are having surgery, including dental surgery, tell the doctor or dentist that you are using adalimumab.
 * do not have any vaccinations (e.g., measles or flu shots) without talking to your doctor.

Special dietary instructions
Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose
Inject the missed dose as soon as you remember it. Then inject the next dose on your regularly scheduled day. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

Minor Side Effects
Adalimumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:


 * redness, itching, bruising, pain, or swelling in the place you injected adalimumab
 * stomach pain
 * upset stomach

Severe Side Effects
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:


 * numbness or tingling
 * problems with vision
 * weakness in legs
 * chest pain
 * shortness of breath
 * rash on cheeks or arms that is sensitive to sunlight
 * new joint pain
 * rash
 * hives
 * itching
 * swollen face
 * difficulty breathing or swallowing
 * fever, sore throat, chills, and other signs of infection
 * unusual bruising or bleeding
 * pale skin
 * extreme tiredness or weakness
 * headache
 * dizziness
 * confusion
 * fast heartbeat
 * difficulty falling asleep or staying asleep
 * runny nose
 * coughing
 * back pain
 * difficult or painful urination
 * blood in urine
 * swelling in the neck, underarm, or groin

Adalimumab may increase the risk of developing certain types of cancers including lymphoma (a cancer of the lymph system). People who have had severe rheumatoid arthritis for a long time may have a greater than normal chance of developing these cancers even if they do not use adalimumab. Talk to your doctor about the risks of taking this medication.

Adalimumab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator and protect it from light. Do not freeze it. If you are traveling and need to take adalimumab with you, keep it in a cooler with an ice pack and do not expose it to light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information
Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

 * Humira®