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ustekinumab (Stelara, Stelara PFS)

Brand Names: Stelara, Stelara PFS

Generic Name: ustekinumab

What is ustekinumab (Stelara, Stelara PFS)?

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

Ustekinumab is used to treat plaque psoriasis in adults and children who are at least 12 years old. Ustekinumab is also used to treat psoriatic arthritis in adults, and is sometimes given with another medicine called methotrexate.

Ustekinumab is also used in adults 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 are the possible side effects of ustekinumab (Stelara, Stelara PFS)?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; feeling light-headed; 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);
  • new or worsening cough, sudden chest pain, feeling short of breath;
  • pain or burning when you urinate; or
  • severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

Common side effects may include:

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 is the most important information I should know about ustekinumab (Stelara, Stelara PFS)?

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

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

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

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.

Tell your doctor if you have ever had:

  • signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired);
  • chronic infections;
  • new or changing skin lesions;
  • a latex allergy;
  • phototherapy (light therapy);
  • allergy shots; or
  • if you recently received or are scheduled to receive any vaccine.

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.

It is not known whether this medicine will 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 to track the effects of ustekinumab on the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You must remain under the care of a doctor while you are receiving ustekinumab.

Ustekinumab is injected under the skin, or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use ustekinumab if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

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.

Ustekinumab doses are based on weight. Your dose needs may change if you gain or lose weight.

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

You will need frequent medical tests.

Each prefilled syringe or single-use vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store in the refrigerator. Protect from light. Do not freeze and not shake the medicine. Store ustekinumab vials in an upright position.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

QUESTION

Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer

What happens if I miss a dose (Stelara, Stelara PFS)?

Call your doctor for instructions if you miss a dose.

What happens if I overdose (Stelara, Stelara PFS)?

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

What should I avoid while using ustekinumab (Stelara, Stelara PFS)?

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. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, 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 other drugs will affect ustekinumab (Stelara, Stelara PFS)?

Other drugs may affect ustekinumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information (Stelara, Stelara PFS)?

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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Reviewed on 7/24/2019

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