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ADALIMUMAB (Systemic)

Some commonly used brand names are:

In the U.S.—

Humira

In Canada—

Humira

Generic name product may be available in the U.S.

Description

Adalimumab (ADD-ah-lim-u-mab) is used to decreased signs, symptoms, and progression of moderately to severely active rheumatoid arthritis. It is also used to treat psoriatic arthritis which is a type of arthritis that causes pain and swelling of the joints and patches of scaly skin on some areas of the body. Psoriatic arthritis is related to the skin condition, psoriasis. Adalimumab can be used in combination with methotrexate or other Disease Modifying Antirheumatic Drugs (DMARDs).

This medicine is available only with your doctor"s prescription, in the following dosage forms:

Parenteral
Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking adalimumab must be weighed against the good it will do. This is a decision you and your doctor will make. For adalimumab, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to adalimumab, rubber or latex. Also tell your doctor and pharmacist if you are allergic to any other substances such as foods, preservatives, or dyes.

Pregnancy—Adalimumab has not been studied in pregnant women. However, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether adalimumab passes into the breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on adalimumab have been done only in adult patients, and there is no specific information comparing the use adalimumab in children with use in other age groups.

Older adults—Elderly people are especially sensitive to the effects of certain drugs. Specific side effects may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of adalimumab. Adalimumab causes more serious infections and malignancies in the elderly.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Anakinra (e.g., Kineret)—Other medicines similar to adalimumab have shown serious adverse effects when used together with anakinra. Use of adalimumab and anakinra together is not recommended.

Immunosuppressive medicines (medicines that make you more at risk for getting serious infections)—Adalimumab has been shown to increase your risk for getting serious infections.

Vaccines—Certain vaccines should not be given at the same time as adalimumab.

Other medical problems—The presence of other medical problems may affect the use of adalimumab. Make sure you tell your doctor if you have any other medical problems, especially:

Heart failure—This medicine may cause heart failure to become worse or for new heart failure symptoms and adverse effects to occur. Caution should be used and your doctor should monitor you carefully.

Infections—This medicine should not be started in patients who have active infections of any type. This medicine may need to be stopped if you develop an infection.

Tuberculosis or
Demyelinating disorders—This medicine may make these medical problems worse.

Proper Use of This Medicine

Dosing—Follow your doctor"s orders or the directions on the label. If your dose is different, do not change it unless your doctor tells you to do so. Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, make sure you clearly understand and carefully follow your doctor"s instructions. Do not change your dose unless your doctor has told you to.

The time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking adalimumab. Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it for a longer time than directed. To do so may increase the chance of unwanted effects.

For injection dosage form:
- For psoriatic arthritis or rheumatoid arthritis:
  - Adults—40 milligrams (mg) given under the skin by injection every other week alone or in combination with methotrexate, glucocorticoids, aspirin, non-steroidal anti-inflammatories (NSAIDS), analgesics, or other disease modifying antirheumatic drugs (DMARDS); or 40 mg given under the skin by injection every week for patients with rheumatoid arthritis who are not taking methotrexate.
  - Children—Use and dose must be determined by your doctor

Missed dose—If you miss a dose of this medicine, take it as soon as possible. Then, take your next dose when your next scheduled dose is due. This will put you back on schedule.

Storage—To store this medicine:

Keep out of the reach of children.
Do not freeze.
Store in the refrigerator.
Store in original carton until time of administration.
Protect from light.
Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly. Your doctor can then decide if you should continue to take it.

Call your doctor immediately if you have signs of tuberculosis or any other infection.

Call your doctor immediately if you have a fever that does not go away and unusual bleeding or bruising.

Do not take other medicines unless they have been discussed with your doctor. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as lymphoma or skin cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

More common

Abdominal fullness; body aches or pain; cough or hoarseness; ear congestion; gaseous abdominal pain; infection; lightheadedness

loss of voice; lower back or side pain; muscle aches and pains; nasal congestion; pain or tenderness around eyes or cheekbones; rapid sometimes shallow breathing; runny nose; shivering; stuffy nose; sunken eyes; thirst; trouble sleeping; warmth on skin; wrinkled skin

Less common

Abdominal pain; abnormal vaginal bleeding or discharge; agitation; anxiety; arm, back, or jaw pain; a sore on the skin of the breast that doesn"t heal; back pain; black, tarry stools; bleeding from gums or nose; blindness; bloating or swelling of face, arms, hands, lower legs, or feet; blood in stool or change in bowel habits; bloody or cloudy urine; blurred vision; broken bones; change in size, shape, or color of an existing mole; change in skin color; chest tightness or heaviness; chest pain; chills; clear or bloody discharge from nipple; cold hands and feet; confusion; constipation; cough; coughing or spitting up blood; decreased urination; decreased vision; depression; difficulty, burning, or painful urination; difficult or frequent urination; difficulty breathing; dimpling of breast skin; dizziness; drowsiness; eye pain; fainting; fast, slow or irregular heartbeat; fever; forgetfulness; frequent urge to urinate; general feeling of illness; hair loss; hallucinations; headache; increased thirst; inverted nipple; irregular breathing; irregular pulse; irritability; itching; light colored stools; loss of appetite; lump in breast or under your arm; lump or swelling in the abdomen; mole that leaks fluid or bleeds; mood or mental changes; muscle cramps or spasms; nausea; new mole; night sweats; no blood pressure or pulse; noisy breathing; numbness or tingling in your arms, legs, or face; pain, redness, or swelling in arms or legs without any injury present; pale skin; persistent non-healing sore on your skin; pink growth; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; raised, firm, bright red patch; rash; redness or swelling of the breast; seizures; sharp back pain just below your ribs; shiny bump on your skin; shortness of breath; skin rash; slurred speech or problems swallowing; sneezing; sore throat; sores, ulcers, or white spots on lips or mouth; spitting up blood; stiff neck; stopping of the heart; sudden high fever or low grade fever for months; sweating; swelling of the face, fingers, feet, or lower legs; swollen glands; swollen neck veins; tightness in chest; tiredness; trouble breathing with activity; trouble thinking; unconsciousness; unexplained bruising or bleeding; unpleasant breath odor; unusual tiredness or weakness; unusual weight gain or loss; visual disturbances; vomiting; vomiting of blood or material that looks like coffee grounds; yellow skin or eyes; wheezing

Frequency not determined—occurred during clinical practice; frequency not known

Pinpoint red spots on skin; unusual bleeding or bruising

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Bladder pain; bleeding; blistering; burning; coldness; discoloration of skin; feeling of pressure; general feeling of discomfort or illness; hives; infection; inflammation; joint pain; large amount of cholesterol in your blood; large amount of fat in your blood; lumps; numbness; pounding in the ears; redness; scarring; soreness; stinging; swelling; tenderness; tingling; ulceration; warmth

Less common

Abnormal healing; decrease in height; difficulty in moving; difficulty in walking; difficulty swallowing; dry mouth; heartburn; indigestion; loss of hearing; loss of strength or energy; menstrual changes; muscle or joint stiffness, tightness, or rigidity; muscle pain or stiffness; muscle pain or weakness; pain in back, ribs, arms, or legs; pain or burning in throat; passing of gas; shakiness in legs, arms, hands, and feet; sores; stomach pain, fullness, or discomfort; swelling or redness in joints; weakness

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 10/22/2003
Revised: 11/03/2005

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Typical mistypes for Humira
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