ustekinumab

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Pronunciation: YOO sti KIN ue mab

Brand: Stelara, Stelara PFS

What is the most important information I should know about ustekinumab?

You should not use this medicine if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

What is ustekinumab?

Ustekinumab is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

Ustekinumab is used in adults to treat plaque psoriasis or psoriatic arthritis. Ustekinumab is sometimes given with another medicine called methotrexate.

Ustekinumab is also used to treat moderate to severe Crohn's disease after other medicines have been tried without success.

Ustekinumab may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before using ustekinumab?

You should not use ustekinumab if you are allergic to it, or if you have:

  • active tuberculosis; or
  • if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure ustekinumab is safe for you, tell your doctor if you have:

  • signs of infection (fever, chills, cough, muscle aches, diarrhea, pain when you urinate, feeling very tired);
  • a history of chronic infections;
  • a latex allergy;
  • warmth, redness, or sores on your skin;
  • if you are scheduled to receive any vaccine;
  • if you have ever received phototherapy (light therapy); or
  • if you have ever received allergy shots.

Some people using ustekinumab have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of ustekinumab on the baby.

Ustekinumab can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ustekinumab is not approved for use by anyone younger than 18 years old.

How should I use ustekinumab?

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

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ustekinumab is injected under the skin, or into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Ustekinumab is usually given every 12 weeks, but your first two injections will be 4 weeks apart. For Crohn's disease, your first dose may be given by IV injection. Follow your doctor's dosing instructions very carefully.

Tell your doctor if you have any changes in weight. Ustekinumab doses are based on weight, and any changes may affect the dose.

Your care provider will show you the best places on your body to inject ustekinumab. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Avoid injecting the medicine into skin that is red, bruised, swollen, or tender.

Call your doctor if you have any signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling constantly tired.

While using ustekinumab, you will need frequent blood tests at your doctor's office.

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

Each prefilled syringe or single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store in the refrigerator, do not freeze. Protect from light. Store the ustekinumab vials in an upright position.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your ustekinumab injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using ustekinumab?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using ustekinumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

BCG vaccine should not be given for at least 1 year after you receive your last dose of ustekinumab.

Non-live vaccines (including flu shots) may not work as well during your treatment, and may not fully protect you from disease. Make sure you are current on all vaccines before you begin treatment with ustekinumab.

What are the possible side effects of ustekinumab?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with ustekinumab. Call your doctor right away if you have signs of infection such as: fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood.

Also call your doctor at once if you have:

  • a mole that has changed in size or color;
  • swelling, pain, warmth, or redness anywhere on your body;
  • stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);
  • pain or burning when you urinate;
  • stabbing chest pain, wheezing, cough with yellow or green mucus; or
  • severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

Common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, cough, sore throat;
  • itching;
  • vomiting;
  • headache;
  • vaginal itching or discharge;
  • mild tiredness; or
  • redness where ustekinumab was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ustekinumab?

Other drugs may interact with ustekinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about ustekinumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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