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ustekinumab (cont.)

What should I discuss with my health care provider before using ustekinumab (Stelara, Stelara PFS)?

You should not use this medication if you are allergic to ustekinumab or if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past year (12 months).

To make sure you can safely use ustekinumab, tell your doctor if you have other medical conditions, especially:

  • an active infection;
  • a history of chronic infections;
  • a history of tuberculosis;
  • high blood pressure;
  • a weak immune system;
  • if you are receiving phototherapy (light therapy); or
  • if you have ever received allergy shots or used an Epi-Pen (for severe allergic reaction).

FDA pregnancy category B. Ustekinumab is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Ustekinumab can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Treatment with ustekinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

How should I use ustekinumab (Stelara, Stelara PFS)?

Before you start treatment with ustekinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Ustekinumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection.

Ustekinumab injections are usually given every 12 weeks, but your first two injections will be 4 weeks apart. Follow your doctor's instructions.

Ustekinumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth sores, swelling or redness, severe stomach pain, cough with mucus, or severe headache. These may be early signs of a severe infection.

You must remain under the care of a doctor while you are receiving ustekinumab.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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