Generic Name: ustekinumab (YOO sti KIN ue mab)
Brand names: Stelara, Stelara PFS
What is ustekinumab?
Ustekinumab is an immunosuppressant that reduces the effects of a substance in the body that can cause inflammation.
Ustekinumab is used to treat plaque psoriasis (raised, silvery flaking of the skin) in adults.
Ustekinumab may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about ustekinumab?
You should not use this medication if you are allergic to ustekinumab or if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past year (12 months).
Before using ustekinumab, tell your doctor if you have an active infection, a history of tuberculosis or recurrent infections, high blood pressure, a weak immune system, or if you are receiving phototherapy (light therapy).
Your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Make sure you are current on all vaccines before you start treatment with ustekinumab.
Ustekinumab can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.
Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, swelling or redness, pain or burning when you urinate, blood in your urine, severe stomach pain, changes in your bowel habits, cough with yellow or green mucus, stabbing chest pain, or severe headache with confusion, vision problems, or seizure.
Treatment with ustekinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.
What should I discuss with my health care provider before using ustekinumab?
You should not use this medication if you are allergic to ustekinumab or if you have received a BCG (Bacillus Calmette and Guérin) vaccine within the past year (12 months).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
an active infection;
a history of recurrent infections;
a history of tuberculosis;
high blood pressure;
a weak immune system; or
if you are receiving phototherapy (light therapy).
FDA pregnancy category B. Ustekinumab is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Ustekinumab can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Treatment with ustekinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.
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.
Ustekinumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection.
Ustekinumab injections are usually given every 12 weeks, but your first two injections will be 4 weeks apart. Follow your doctor's instructions.
Ustekinumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.
Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness, mouth sores, swelling or redness, severe stomach pain, cough with mucus, or severe headache. These may be early signs of a severe infection.
To be sure ustekinumab is not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments. You must remain under the care of a doctor while you are receiving ustekinumab.
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 if you think you have received too much of this medicine.
Symptoms of a ustekinumab overdose are not known.
What should I avoid while using ustekinumab?
Avoid injecting this medication into skin that is bruised, red, tender, or hardened.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with 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), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu 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.
Ustekinumab side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
signs of infection such as fever, chills, sore throat, flu symptoms, swollen glands, unusual weakness;
mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
swelling, pain, tenderness, or redness anywhere on your body;
pain or burning when you urinate, blood in your urine;
stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation);
cough with yellow or green mucus;
stabbing chest pain, feeling short of breath; or
severe headache, confusion, vision problems, and/or seizure (convulsions).
Less serious side effects may include:
cold symptoms (runny or stuffy nose, sore throat);
headache, tired feeling;
mild diarrhea; or
mild skin rash or itching.
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.
Ustekinumab Dosing Information
Usual Adult Dose for Psoriasis:
For use in the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy:
Less than 100 kg (220 lbs):
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
In subjects weighing greater than 100 kg, 45 mg was also shown to be effective. However, 90 mg resulted in greater efficacy.
The safety and efficacy of ustekinumab have not been evaluated beyond two years.
What other drugs will affect ustekinumab?
Tell your doctor about all other medications you use, especially:
drugs that weaken your immune system (such as cancer medicine or steroids);
a blood thinner such as warfarin (Coumadin);
cyclosporine (Gengraf, Neoral, Sandimmune);
digoxin (digitalis, Lanoxin, Lanoxicaps);
sirolimus (Rapamune) or tacrolimus (Prograf);
theophylline (Elixophyllin, Theo-24, Uniphyl);
seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or
a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quinidex, Quin-Release Quin-G).
This list is not complete and there may be other drugs that can interact with ustekinumab. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
More ustekinumab resources
- Ustekinumab Side Effects (in more detail)
- Ustekinumab Dosage
- Ustekinumab Use in Pregnancy & Breastfeeding
- Ustekinumab Drug Interactions
- Ustekinumab Support Group
- 11 Reviews for Ustekinumab - Add your own review/rating
- ustekinumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information
- Ustekinumab Professional Patient Advice (Wolters Kluwer)
- Ustekinumab MedFacts Consumer Leaflet (Wolters Kluwer)
- Ustekinumab Monograph (AHFS DI)
- Stelara Prescribing Information (FDA)
- Stelara Consumer Overview
Compare ustekinumab with other medications
- Psoriasis
- Psoriatic Arthritis
Where can I get more information?
- Your doctor or pharmacist can provide more information about ustekinumab.
See also: ustekinumab side effects (in more detail)
No comments:
Post a Comment