Ustekinumab Generic Name:
Ustekinumab (US-te-KIN-ue-mab)Brand Name:
Ustekinumab 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.
Ustekinumab 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 Ustekinumab if:
- you are allergic to any ingredient in Ustekinumab
- 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 Ustekinumab :
Some medical conditions may interact with Ustekinumab . 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 Ustekinumab . 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 Ustekinumab 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 Ustekinumab :
Use Ustekinumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ustekinumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ustekinumab refilled.
- Ustekinumab is usually given as an injection at your doctor's office, hospital, or clinic.
- Ustekinumab is colorless to light yellow and may contain a few small white particles. Do not use Ustekinumab 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 Ustekinumab , contact your doctor right away.
Ask your health care provider any questions you may have about how to use Ustekinumab .
Important safety information:
- Patients should receive a TB skin test before using Ustekinumab . Patients who test positive for TB should begin treatment for TB before starting Ustekinumab . All patients should also be monitored for signs of TB while using Ustekinumab even if their TB test is negative.
- Serious infections, including tuberculosis, fungal infection, and other types of infections, have occurred in patients using Ustekinumab . 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).
- Ustekinumab 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 Ustekinumab for more than 2 years is safe and effective.
- Tell your doctor or dentist that you take Ustekinumab 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 Ustekinumab . 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 Ustekinumab .
- Lab tests, including TB tests, may be performed while you use Ustekinumab . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Ustekinumab 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 Ustekinumab while you are pregnant. Ustekinumab is found in breast milk. If you are or will be breast-feeding while you use Ustekinumab , check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Ustekinumab :
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
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 Ustekinumab :
Ustekinumab is usually handled and stored by a health care provider. If you are using Ustekinumab at home, store Ustekinumab as directed by your pharmacist or health care provider. Keep Ustekinumab out of the reach of children and away from pets.
- If you have any questions about Ustekinumab , please talk with your doctor, pharmacist, or other health care provider.
- Ustekinumab 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.
This information is a summary only. It does not contain all information about Ustekinumab . 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.
- Ustekinumab Professional Patient Advice (Wolters Kluwer)
- ustekinumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information
- Stelara Prescribing Information (FDA)
- Stelara Consumer Overview