Adalimumab (Injection)

Introduction

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

Treats symptoms of rheumatoid arthritis (RA) and slows the joint damage caused by RA. This medicine also treats juvenile idiopathic arthritis in children 4 to 17 years of age, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and plaque psoriasis.

Brand Name(s)

There may be other brand names for this medicine.

Humira

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to adalimumab.

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.
  • 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. Your doctor might ask you to sign some forms to show that you understand this information.
  • This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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.
  • 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 anakinra (Kineret®). Also, make sure your doctor knows if you are using any medicines that weaken the immune system (such as steroids or cancer medicines).
  • 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.

Warnings While Using This Medicine

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have kidney disease, liver disease, a history of cancer, congestive heart failure, diabetes, psoriasis, or any type of infection, including hepatitis B, tuberculosis, or an infection that keeps coming back. Tell your doctor if you have multiple sclerosis, problems with your immune system, or a history of Guillain-Barré syndrome. Also tell your doctor if you are scheduled for any surgery.
  • This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis is life-threatening and requires immediate medical attention. Stop using this medicine and check with your doctor right away if you or your child have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you receive the medicine.
  • Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you or your child have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in your mouth or lips; or unusual tiredness or weakness.
  • You or your child will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test or been exposed to tuberculosis.
  • 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 or your child start to have a persistent cough, weight loss, night sweats, shortness of breath, fever, chills, unusual tiredness or weakness, or flu-like symptoms such as a runny or stuffy nose, headache, or feeling generally ill. These may be signs that you have an infection.
  • Some people who have used this medicine developed lupus-like symptoms during treatment and got better after this medicine was stopped. Make sure your doctor knows if you or your child start having chest pains, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.
  • A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (such as leukemia). Some patients also developed a rare type of cancer called lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness; swollen lymph nodes in the neck, underarms, or groin; or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
  • Check with your doctor right away if you or your child have more than one of these symptoms: chest pain; decreased urine output; dilated neck veins; extreme fatigue; irregular breathing; irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; tightness in the chest; trouble with breathing; weight gain; or wheezing. These may be signs of a heart condition called congestive heart failure (CHF).
  • Some people who have used this medicine developed lupus-like symptoms during treatment and got better after the medicine was stopped. Make sure your doctor knows if you or your child start having chest pains, shortness of breath, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.
  • The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using this medicine.
  • 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.
  • Bone pain.
  • Chest pain, fast or uneven heartbeat.
  • Cold or flu symptoms such as a runny or stuffy nose, sore throat, or body aches.
  • Dry mouth, increased thirst, or muscle cramps.
  • Fever, chills, a cough that does not go away, or unexplained weight loss.
  • Nausea, vomiting, loss of appetite, or pain in your upper stomach.
  • Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
  • Pain in your lower leg (calf).
  • Pain with urination or a change in how much or how often you urinate.
  • Raised bumps on the skin filled with pus.
  • Red, black, or tarry stools, or dark urine.
  • Red, scaly patches on the skin.
  • Shortness of breath, cold sweats, and bluish-colored skin.
  • Sores or white patches on your lips, mouth, or throat.
  • Swelling in your hands, ankles, or feet.
  • Swollen lymph nodes in the neck, underarms, or groin.
  • Unusual bleeding, bruising, weakness, or pale skin.
  • Yellowing of your skin or the whites of your eyes.

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

  • Back pain or joint pain.
  • Changes in vision.
  • Headache.
  • Mild skin rash.
  • 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

Review Date: 2011-02-04 Reviewed By: Keywords: ,
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