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Stelara

Generic Name: ustekinumab (YOO sti KIN ue mab)
Brand Names: Stelara, Stelara PFS

Medically reviewed: December 4, 2017

What is Stelara?

Stelara (ustekinumab) is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

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

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

Important information

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

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

Serious infections may occur during treatment with Stelara. 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.

Before using this medicine

You should not use Stelara if you are allergic to ustekinumab, 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 Stelara is safe for you, tell your doctor if you have:

  • signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired);

  • a history of chronic infections;

  • new or changing skin lesions;

  • a latex allergy;

  • if you recently received or 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 Stelara 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. This is to track the outcome of the pregnancy and to evaluate any effects of Stelara on the baby.

It is not known whether ustekinumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Stelara is not approved for use by anyone younger than 12 years old.

How should I use Stelara?

Before you start treatment with Stelara, 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.

Stelara 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.

Stelara 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 Stelara. 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 Stelara, you will need frequent blood tests at your doctor's office.

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

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 vials in an upright position.

Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Stelara dosing information

Usual Adult Dose for Psoriasis:

100 kg (220 lbs) or less:
Initial dose: 45 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 45 mg subcutaneously once every 12 weeks

Greater than 100 kg (220 lbs):
Initial dose: 90 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 90 mg subcutaneously once every 12 weeks

Comment:
-In subjects weighing greater than 100 kg, 45 mg was also shown to be effective. However, 90 mg resulted in greater efficacy.

Use: For the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Usual Adult Dose for Psoriatic Arthritis:

Initial dose: 45 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 45 mg subcutaneously once every 12 weeks

For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg (220 lbs):
Initial dose: 90 mg subcutaneously once initially and 4 weeks later
Maintenance dose: 90 mg subcutaneously once every 12 weeks

Use: For the treatment of adult patients (18 years or older) with active psoriatic arthritis. This drug can be used alone or in combination with methotrexate (MTX).

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Stelara 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 Stelara?

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 Stelara. 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 Stelara.

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 this medicine.

Stelara side effects

Get emergency medical help if you have signs of an allergic reaction to Stelara: hives; chest pain, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with Stelara. 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 Stelara side effects may include:

  • cold symptoms such as stuffy nose, sneezing, cough, sore throat;

  • itching;

  • vomiting;

  • vaginal itching or discharge;

  • headache, tiredness; or

  • redness where Stelara 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.

See also: Side effects (in more detail)

What other drugs will affect Stelara?

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.

Further information

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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