Uses
What is Sotyktu used for?
Sotyktu (deucravacitinib) is commonly used for moderate to severe plaque psoriasis.
Sotyktu may also be used for other conditions as determined by your healthcare provider.
How does Sotyktu work (mechanism of action)?
Sotyktu blocks a substance in the body called tyrosine kinase 2 (TYK2) from working. TYK2 plays an important role in the process that leads to swelling (inflammation). By blocking TYK2, Sotyktu can reduce the swelling (inflammation) that occurs in certain conditions, such as plaque psoriasis.
How is Sotyktu supplied (dosage forms)?
Sotyktu is available as 6 mg oral tablets that are taken by mouth.
How should I store Sotyktu?
Sotyktu should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Sotyktu?
The most common side effects of Sotyktu are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Acne
- An infection caused by a virus called herpes simplex
- Cold sores in or around the mouth
- Infection in the nose or throat, sore throat, or common cold symptoms
- Sores or swelling on the gums, lips, tongue, cheeks, or roof of the mouth
- Swollen or infected hair follicles (folliculitis), which look like small, red bumps on your skin
There may be other side effects of Sotyktu that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Sotyktu?
While less common, the most serious side effects of Sotyktu are described below, along with what to do if they happen.
Severe Allergic Reactions. Sotyktu may cause allergic reactions, which can be serious. Stop taking Sotyktu and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Cancer. A small number of people who took Sotyktu have developed cancer, including a type of cancer called lymphoma. It is not clear if Sotyktu increases the risk for cancer. Let your healthcare provider know if you or your family has a history of cancer.
Infection. Sotyktu can increase the risk of infections, including serious infections. It can also make current infections worse. Call your healthcare provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Feeling very tired
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
Reactivated Infections. Some types of microbes that cause infections (such as bacteria or viruses) can remain in the body after you recover from that infection. When a microbe stays in the body but does not cause an infection, it is called a “latent” microbe. Sotyktu may increase your risk of reactivating a latent microbe, causing an infection. Before you start treatment with Sotyktu, let your healthcare provider know if you have ever had tuberculosis (TB), hepatitis B, hepatitis C, or any other serious infections.
High Triglyceride Levels. Sotyktu can increase triglyceride levels. High triglyceride levels may cause heart problems. Keep all appointments with your healthcare provider to check your triglyceride levels before and after you start using Sotyktu.
Liver Damage. Liver damage, also called hepatotoxicity, can happen when using Sotyktu. Call your healthcare provider right away if you have any of the following symptoms of liver damage.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine (pee)
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Muscle Problems. Sotyktu can cause muscle problems, including muscle pain, weakness, and tenderness called myopathy. In some people, the muscle may break down (rhabdomyolysis), which can be serious and rarely lead to kidney damage and death. Stop taking Sotyktu and get help right away if you have any of the following symptoms of myopathy or rhabdomyolysis.
- Unexplained muscle pain, weakness, or tenderness
- Low energy levels or feeling easily tired, especially with activity
- Dark-colored urine (pee)
- Fever
- Muscle cramps
- Stomach pain
- Nausea or vomiting
Warnings & Precautions
Who should not use Sotyktu?
Allergies to Ingredients. People who are allergic to any of the following should not take Sotyktu.
- Deucravacitinib
- Sotyktu
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Sotyktu.
What should I know about Sotyktu before using it?
Do not take Sotyktu unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Sotyktu with other people, even if they have the same condition as you. It may harm them.
Keep Sotyktu out of the reach of children.
Do not chew, cut, or crush Sotyktu.
What should I tell my healthcare provider before using Sotyktu?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Sotyktu is right for you.
In particular, make sure that you discuss any of the following.
- Cancer
- Currently smoke or have smoked in the past
- Heart problems, including a past heart attack
- High triglyceride levels
- History of a blood clot or stroke
- History of hepatitis
- Kidney problems
- Liver problems
Risk for Infection. Before starting Sotyktu, it is important to talk to your healthcare provider about any serious infections you have had in the past as well as any infections you have currently. You should also let your healthcare provider know if you have any of the following issues that might increase your chance of having an infection.
- A current infection or any symptoms of an infection
- Have a weak immune system or a history of infections coming back often
- History of tuberculosis (TB)
- Been in close contact with someone who has TB
- Living in, have lived in, or traveled to countries where there is a risk for TB
Vaccines. Let your healthcare provider know if you have recently received or are scheduled to receive any vaccinations. There are certain vaccines (live vaccines) that you should not receive either right before receiving Sotyktu or once you have started using Sotyktu. Your healthcare provider will confirm whether any upcoming vaccinations are safe.
Other Medicines and Supplements. Sotyktu may interact with other medicines and supplements. Before taking Sotyktu, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Sotyktu could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Sotyktu while you are pregnant or trying to get pregnant. If you become pregnant while taking Sotyktu, let your healthcare provider know. You can also report your pregnancy to the manufacturer of Sotyktu by calling 800-721-5072.
Breastfeeding. It is not known if Sotyktu passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Sotyktu while breastfeeding.
How can I get more information about Sotyktu?
For more information about Sotyktu, you can visit the manufacturer’s website at www.sotyktu.com or call them at 888-768-9588.
Interactions
Does Sotyktu interact with foods or drinks?
There are no known interactions between Sotyktu and foods or drinks.
It is unknown if drinking alcohol will affect Sotyktu.
Does Sotyktu interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are taking any medicines that suppress your immune system (immunosuppressants).
This may not be a complete list of medicines that can interact with Sotyktu. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Sotyktu?
If you or someone else has used too much Sotyktu, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Sotyktu?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.