SELARSDI® (ustekinumab-aekn) Injection is a prescription medicine that affects your immune system. SELARSDI can increase your chance of having serious side effects including:
SELARSDI may lower your ability to fight infections and may increase your risk of infections. While taking ustekinumab products, some people have serious infections, that may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.
- Your healthcare provider should check you for TB before starting SELARSDI and watch you closely for signs and symptoms of TB during treatment with SELARSDI.
- If your healthcare provider feels that you are at risk for TB, you may be treated for TB before and during treatment with SELARSDI.
- Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with SELARSDI.
You should not start taking SELARSDI if you have any kind of infection unless your healthcare provider says it is okay.
- think you have an infection or have symptoms of an infection such as:
- fever, sweats, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection or have any open cuts.
- get a lot of infections or have infections that keep coming back.
- have TB, or have been in close contact with someone with TB.
After starting SELARSDI, call your healthcare provider right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications. SELARSDI can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take SELARSDI may also be more likely to get these infections.
SELARSDI may decrease the activity of your immune system and increase your risk for certain types of cancers. Tell your healthcare provider if you have ever had any type of cancers. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving ustekinumab products. During your treatment with SELARSDI, tell your healthcare provider if you have any new skin growths.
Serious allergic reactions can occur. Stop using SELARSDI and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue or throat, chest tightness, or skin rash.
Cases of lung inflammation have happened in some people who receive ustekinumab products and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with SELARSDI.
- have any of the conditions or symptoms listed in the section "What is the most important information I should know about SELARSDI?"
- ever had an allergic reaction to ustekinumab products or any of the ingredients in SELARSDI. Ask your doctor if you are not sure.
- have recently received or are scheduled to receive an immunization (vaccine). People who are being treated with SELARSDI should avoid receiving live vaccines. Tell your healthcare provider if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems. You should avoid receiving the BCG vaccine during the one year before receiving SELARSDI or one year after you stop receiving SELARSDI.
- have any new or changing lesions within psoriasis areas or on normal skin.
- are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with SELARSDI. SELARSDI may also increase your risk of having an allergic reaction to an allergy shot.
- receive or have received phototherapy for your psoriasis.
- are pregnant or plan to become pregnant. It is not known if SELARSDI can harm your unborn baby. You and your healthcare provider should decide if you will receive SELARSDI.
- are breastfeeding or plan to breastfeed. SELARSDI can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive SELARSDI.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
- Use SELARSDI exactly as your healthcare provider tells you to. The healthcare provider will determine the right dose of SELARSDI, the amount for each injection, and how often it should be given. Be sure to keep all scheduled follow-up appointments.
- SELARSDI is intended for use under the guidance and supervision of your healthcare provider. In children it is recommended that SELARSDI be administered by a healthcare provider. If a healthcare provider decides that you or a caregiver may give your injections of SELARSDI at home, you or a caregiver should receive training on the right way to prepare and inject SELARSDI. Do not try to inject SELARSDI until you have been shown how to inject SELARSDI by a healthcare provider.
Common side effects of SELARSDI include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, influenza, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain and joint pain.
These are not all of the possible side effects with SELARSDI. Call your doctor for medical advice about side effects. Ask your doctor or pharmacist for more information.
