This medication is used to treat moderate to severe cases of plaque psoriasis. It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that may lead to the overproduction of skin cells and inflammation seen in plaque psoriasis.
Ustekinumab does not cure plaque psoriasis, but it can help lessen the symptoms, including decreasing the amount of painful, itchy, sore patches of thick, red or inflamed skin covered with silvery scales known as plaques. It is not known if using ustekinumab for more than 2 years is safe and effective.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat a certain bowel condition (Crohn's disease).
Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start using ustekinumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, to prevent a serious TB infection you must first be treated for it before you start ustekinumab.
This medication is given by injection under your skin either in the upper arms, buttock, thighs, or abdomen as directed by your doctor. You will receive one dose, followed by a second dose 4 weeks later. Then this medication is given every 3 months.
Dosage is based on your weight, medical condition, and response to treatment.
If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. The solution is normally colorless to light yellow. It may contain a few small white particles of protein. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Do not reuse syringes.
It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Therefore, choose a different injection site with each dose. Do not inject into skin that is irritated, sore, or infected.
Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.
Tell your doctor if your condition does not improve or if it worsens.
Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. Headache, back pain, or sinus/throat pain may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as lung infections, bone/joint infections, skin infections, sinus infections, or bowel/gallbladder infections. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop any signs of an infection, such as worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, cold/flu symptoms, severe stomach pain, or persistent nausea/vomiting. (See also Precautions section.)
Ustekinumab may cause a rare (sometimes fatal) condition called RPLS (reversible posterior leukoencephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (such as confusion).
There is a rare risk of developing cancer (including skin cancer) due to this medication. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, unusual skin changes (including a sore that does not heal or a change in the size/shape/color of a mole), swollen glands, unexplained weight loss.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using ustekinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the needle cover on the prefilled syringe), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Ustekinumab can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Avoid receiving BCG vaccines for one year after completing treatment with ustekinumab. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This drug may pass into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some of the products that may interact with this drug include: live vaccines (such as polio vaccine taken by mouth, flu vaccine inhaled through the nose, BCG).
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as checking for skin cancer) should be performed periodically to monitor your progress or to check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.
Store in the refrigerator. Do not freeze. Keep the product in the original carton to protect from light until the time of use. Discard any unused portion of the vial or syringe.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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