Skyrizi

Skyrizi is a prescription medication used to treat plaque psoriasis, psoriatic arthritis and severe Crohn's disease in adults. 

Skyrizi belongs to a group of drugs called monoclonal antibodies that target specific molecules in the body known to play a role in disease. While the exact causes of plaque psoriasis, psoriatic arthritis and Crohn's disease are unknown, your body may produce too much of a protein called IL-23. IL-23 is one of several proteins that may contribute to excess inflammation inside the body, which can lead to painful, red, itchy, burning plaques on the skin. Skyrizi works by binding to excess IL-23. This can help reduce the inflammation inside the body that leads to these diseases.

This medication is available in an injectable form to be given directly into the skin (subcutaneously).

Common side effects include upper respiratory infections, injection site reactions, and headache. 

Skyrizi is a prescription medicine used to treat:

• moderate to severe plaque psoriasis in adults who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
• active psoriatic arthritis in adults.
• moderate to severe Crohn’s disease in adults.

It is not known if Skyrizi is safe and effective in children under 18 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Skyrizi. See the "Skyrizi Precautions" section.

Liver problems in Crohn’s disease: A person with Crohn’s disease who received Skyrizi by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with Skyrizi if you develop liver problems. Tell your doctor right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.

The most common side effects of Skyrizi in people treated for Crohn’s disease include: upper respiratory infections, injection site reactions, fever, headache, stomach (abdominal) pain, back pain, joint pain, and low red blood cells (anemia).

The most common side effects of Skyrizi in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, feeling tired, fungal skin infections, headache, and injection site reactions.

This is not a complete list of Skyrizi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Additionally, tell your doctor if you are scheduled to take any vaccines or have recently received a vaccine.

Serious side effects have been reported with Skyrizi including the following:

• Infections. Skyrizi may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with Skyrizi and may treat you for TB before you begin treatment with Skyrizi if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with Skyrizi. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

• fever, sweats, or chills
• cough
• shortness of breath
• blood in your mucus (phlegm)
• muscle aches
• warm, red, or painful skin or sores on your body different from your psoriasis
• weight loss
• diarrhea or stomach pain
• burning when you urinate  or urinating more often than normal

Do not take Skyrizi if you are allergic to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Skyrizi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Skyrizi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any of its ingredients
• have an active infection or suspect you may have an infection
• have ever had TB (tuberculosis) or been in contact with someone with TB
• have recently received or are scheduled to receive a vaccination
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Skyrizi. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication. However, the animals did have an increased number of miscarriages. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Skyrizi crosses into human milk. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Skyrizi.

Take Skyrizi exactly as prescribed. 

See the detailed “Instructions for Use” that comes with Skyrizi for information on how to prepare and inject a dose of Skyrizi, and how to properly dispose of used Skyrizi prefilled pens, syringes and cartridges.

This medication is available in an injectable form to be given directly into the skin (subcutaneously). 

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2 doses of Skyrizi at the same time. 

Adults with plaque psoriasis or psoriatic arthritis will receive Skyrizi as an injection under the skin (subcutaneous injection) using the prefilled pen or prefilled syringe.

Adults with Crohn’s disease will receive their starter doses with Skyrizi through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the starter doses, patients will receive Skyrizi as an injection under the skin (subcutaneous injection) using the prefilled cartridge with on-body injector.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

Plaque Psoriasis and Psoriatic Arthritis: The recommended dose is 150 mg (two 75 mg injections) administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

Crohn’s Disease: The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter.

If you take too much Skyrizi, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Skyrizi in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze Skyrizi.
• Do not shake Skyrizi.
• Keep Skyrizi in the original carton to protect it from light.
• Keep Skyrizi and all medicines out of the reach of children.