Adalimumab (Injection)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have kidney disease, liver disease, a history of cancer, COPD, congestive heart failure, diabetes, psoriasis, any type of infection (such as hepatitis B or tuberculosis), or an infection that keeps coming back. Tell your doctor if you have multiple sclerosis, optic neuritis, problems with your immune system, or a history of Guillain-Barré syndrome. Also tell your doctor if you are scheduled for any surgery.
• Serious allergic reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; rash; sore throat; or sores, ulcers, or white spots in your mouth or lips.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Call your doctor right away if you have a cough, runny or stuffy nose, headache, fever, chills, weight loss, night sweats, trouble breathing, or unusual tiredness or weakness. These may be signs that you have an infection.
• Check with your doctor right away if you have chest pains, trouble breathing, joint pain, or a rash on your cheeks or arms that is sensitive to the sun. These may be signs of a lupus-like syndrome.
• A small number of people who have used this type of medicine have developed certain types of cancer. Talk with your doctor if you have unusual bleeding, bruising, or weakness; swollen glands in your neck, underarms, or groin; red, scaly patches on your skin; or weight loss.
• Check with your doctor right away if you have chest pain or tightness; decreased urination; unusual tiredness; uneven heartbeat; swelling of your face, fingers, feet, or lower legs; trouble breathing; or weight gain. These may be signs of congestive heart failure.
• You will need to have a skin test for tuberculosis before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive tuberculosis skin test or been exposed to tuberculosis.
• Tell your doctor if you have a latex allergy before you start using this medicine. The needle cover of the syringe is made from a dry natural rubber. This may cause allergic reactions in people who are sensitive to latex.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

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, or red skin rash
• Changes in vision or eye pain
• Chest pain or uneven heartbeat
• Cough, fever, chills, runny or stuffy nose, sore throat, or body aches
• Dark-colored urine or pale stools
• Nausea, vomiting, loss of appetite, or stomach pain
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Pain with urination or a change in how much or how often you urinate
• Red, scaly patches on the skin
• Sores or white patches on your lips, mouth, or throat
• Swelling in your hands, ankles, lower leg, or feet
• Swollen glands in your neck, underarms, or groin
• Trouble breathing
• Unusual bleeding, bruising, tiredness, or weakness
• Yellowing of your skin or the whites of your eyes

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

• Headache
• Mild skin rash
• Redness, itching, bruising, bleeding, pain, or swelling where the shot was given

Introduction

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

Treats symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, and plaque psoriasis.

Brand Name(s)

Humira

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.
• A nurse or other trained health professional 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.
• Use a new needle and syringe each time you inject your medicine.
• Do not use the syringe or pen if the liquid is cloudy, discolored, or has particles floating in it.
• 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.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from light. Keep your medicine and supplies in the original packages until you are ready to use them. If you are traveling, you may store the medicine in a cool carrier with an ice pack.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

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

• This medicine should not be taken together with abatacept (Orencia®), anakinra (Kineret®), certolizumab pegol (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), or infliximab (Remicade®). Also, make sure your doctor knows if you use any medicines that weaken the immune system (such as steroids or cancer medicines).
• Tell your doctor if you also use azathioprine (Imuran®), mercaptopurine (Purinethol®), or rituximab (Rituxan®).
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine. Your child's vaccines need to be current before he or she begins using adalimumab.

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