Sunday 23 September 2012

Stelara


Pronunciation: US-te-KIN-ue-mab
Generic Name: Ustekinumab
Brand Name: Stelara


Stelara is used for:

Treating certain patients with moderate to severe plaque psoriasis. It may also be used for other conditions as determined by your doctor.


Stelara is a monoclonal antibody. It works by blocking certain substances in the body that affect inflammation and the body's immune system.


Do NOT use Stelara if:


  • you are allergic to any ingredient in Stelara

  • you will be receiving a live vaccine (eg, measles, mumps)

  • you have had a Bacillus Calmette-Guerin (BCG) vaccine within the past year

  • you have a severe infection (eg, sepsis) or any other active infection

Contact your doctor or health care provider right away if any of these apply to you.



Before using Stelara:


Some medical conditions may interact with Stelara. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances, including rubber or latex

  • if you have a history of an infection that keeps coming back, tuberculosis (TB) infection or positive TB skin test, cancer, or a neurological disorder called reversible posterior leukoencephalopathy syndrome (RPLS)

  • if you have immune system problems, you have or a member of your household has recently received a vaccine, or you are scheduled to receive a vaccine or to have surgery

  • if you have open cuts or sores on your body, have flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or are using medicine to treat an infection

  • if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB

  • if you are having phototherapy or you take medicine that may decrease your immune system (eg, cyclosporine)

Some MEDICINES MAY INTERACT with Stelara. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Cyclosporine or warfarin because the risk of their side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Stelara may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Stelara:


Use Stelara as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Stelara comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Stelara refilled.

  • Stelara is usually given as an injection at your doctor's office, hospital, or clinic.

  • Stelara is colorless to light yellow and may contain a few small white particles. Do not use Stelara if it contains other particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Stelara, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Stelara.



Important safety information:


  • Patients should receive a TB skin test before using Stelara. Patients who test positive for TB should begin treatment for TB before starting Stelara. All patients should also be monitored for signs of TB while using Stelara even if their TB test is negative.

  • Serious infections, including tuberculosis, fungal infection, and other types of infections, have occurred in patients using Stelara. Avoid contact with people who have colds or infections. Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin; increased or painful urination; persistent diarrhea or stomach pain).

  • Stelara may increase the risk of developing certain types of cancer. Discuss any questions or concerns with your doctor.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. It is not known if using Stelara for more than 2 years is safe and effective.

  • Tell your doctor or dentist that you take Stelara before you receive any medical or dental care, emergency care, or surgery.

  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Stelara. Talk with your doctor before you or a member of your household receives any vaccine.

  • Do not receive a Bacillus Calmette-Guerin (BCG) vaccine for 1 year before, during, or 1 year after treatment with Stelara.

  • Lab tests, including TB tests, may be performed while you use Stelara. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Stelara should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stelara while you are pregnant. Stelara is found in breast milk. If you are or will be breast-feeding while you use Stelara, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Stelara:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Headache; mild redness at the injection site; mild sore throat; tiredness; upper respiratory infection.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in a mole; confusion; open sore that does not heal; persistent pain, swelling, or redness at the injection site; seizures; severe or persistent headache; signs of infection (eg, fever, chills, or persistent sore throat; cough; muscle aches; shortness of breath; warm, red, or painful skin; increased or painful urination; stomach pain or diarrhea; blood in phlegm; unexplained weight loss); unusual lump or skin growth; unusual tiredness or weakness; vision changes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Stelara side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.


Proper storage of Stelara:

Stelara is usually handled and stored by a health care provider. If you are using Stelara at home, store Stelara as directed by your pharmacist or health care provider. Keep Stelara out of the reach of children and away from pets.


General information:


  • If you have any questions about Stelara, please talk with your doctor, pharmacist, or other health care provider.

  • Stelara is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Stelara. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Stelara resources


  • Stelara Side Effects (in more detail)
  • Stelara Use in Pregnancy & Breastfeeding
  • Stelara Drug Interactions
  • Stelara Support Group
  • 11 Reviews for Stelara - Add your own review/rating


  • Stelara Prescribing Information (FDA)

  • Stelara Consumer Overview

  • Stelara Monograph (AHFS DI)

  • Stelara Advanced Consumer (Micromedex) - Includes Dosage Information

  • Ustekinumab Professional Patient Advice (Wolters Kluwer)



Compare Stelara with other medications


  • Psoriasis

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