Adalimumab (Systemic)

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.

• 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:

• Hypersensitivity to adalimumab or any ingredients in adalimumab.

• 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 cause these illnesses.