Risankizumab

Generic name: risankizumab [ RIS-an-KIZ-ue-mab ]
Brand names: Skyrizi, Skyrizi Pen
Dosage forms: intravenous solution (rzaa 60 mg/mL), subcutaneous solution (150 mg/mL; rzaa 180 mg/1.2 mL; rzaa 360 mg/2.4 mL)
Drug class: Interleukin inhibitors

Medically reviewed by Drugs.com on Feb 20, 2024. Written by Cerner Multum.

What is risankizumab?

Risankizumab is used alone or in combination in adults to treat moderate to severe plaque psoriasis and active psoriatic arthritis.

Risankizumab is also used in adults to treat Crohn's disease.

Risankizumab may also be used for purposes not listed in this medication guide.

Risankizumab side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, night sweats, chills, sore throat;

• mouth sores, red or swollen gums;

• pale skin, easy bruising, unusual bleeding; or

• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• nausea, vomiting, skin rash; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of risankizumab may include:

• fever, headache, tiredness;

• stomach pain, joint pain, back pain;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• pain and burning when you urinate;

• fungal skin infection;

• low red blood cells (anemia); or

• pain, bruising, swelling, or irritation where the medicine was injected.

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.

Warnings

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems. Before you use risankizumab, your doctor should test you for tuberculosis or other infections.

Before taking this medicine

You should not use risankizumab if you are allergic to it.

Before you start using risankizumab, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores, or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you have or ever had:

• an active, chronic, or recent infection;

• tuberculosis, been exposed to tuberculosis, or if you recently traveled;

• recently received or are scheduled to receive any vaccine; or

• liver disease.

Make sure you are current on all vaccines before you start using risankizumab.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risankizumab on the baby.

It is not known if risankizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using risankizumab.

How should I use risankizumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Before you use risankizumab, your doctor will test you for tuberculosis or other infections.

If you have Crohn's disease, risankizumab is given as an infusion into a vein by a healthcare provider every 4 weeks for the first 3 doses. Later doses are then injected under the skin once every 8 weeks.

If you have plaque psoriasis and psoriatic arthritis, risankizumab is injected under the skin every 4 weeks for the first 2 doses. Later doses are then injected every 12 weeks.

A healthcare provider may give you this injection or teach you how to properly use this medicine by yourself. Ask your doctor or pharmacist if you don't understand how to use a prefilled syringe, an injection pen, or the injector device placed on the body.

A full dose of risankizumab may require more than one injection under the skin. Your healthcare provider will show you where to inject risankizumab. Do not inject into the same place two times in a row. Avoid injecting into skin that is hard, red, bruised, swollen, tender, or affected by psoriasis.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Each injection is for one use only. Throw away after one use, even if there is still medicine left inside. Place it in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Throw away any risankizumab that has been shaken, frozen, or damaged in any way.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

You will need frequent blood tests to check your liver function.

Take the medicine out of the refrigerator and follow the instructions to let it reach room temperature before using the medicine. Do not warm the medicine with hot water, sunlight, or a microwave.

Store the medicine in the original container in the refrigerator. Protect from light and do not freeze.

Risankizumab dosing information

Usual Adult Dose for Psoriatic Arthritis:

150 mg (two 75 mg injections) subcutaneously at Week 0, Week 4, and every 12 weeks thereafter

Comments:
-Evaluate patients for tuberculosis (TB) infection prior to initiating this drug.
-In psoriatic arthritis this drug can be administered alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs).

Use(s):
-For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
-For the treatment of active psoriatic arthritis

Usual Adult Dose for Plaque Psoriasis:

150 mg (two 75 mg injections) subcutaneously at Week 0, Week 4, and every 12 weeks thereafter

Comments:
-Evaluate patients for tuberculosis (TB) infection prior to initiating this drug.
-In psoriatic arthritis this drug can be administered alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs).

Use(s):
-For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
-For the treatment of active psoriatic arthritis

Usual Adult Dose for Crohn's Disease -- Acute:

Induction dose: 600 mg by IV infusion over at least one hour at Week 0, Week 4, and Week 8
Maintenance dose: 180 mg or 360 mg subcutaneously at Week 12, and every 8 weeks thereafter.

Comments:
-Use the lowest effective dosage to maintain therapeutic response.
-Obtain liver enzymes and bilirubin prior to treatment initiation.

Use: Moderately to severely active Crohn's disease

Usual Adult Dose for Crohn's Disease -- Maintenance:

Induction dose: 600 mg by IV infusion over at least one hour at Week 0, Week 4, and Week 8
Maintenance dose: 180 mg or 360 mg subcutaneously at Week 12, and every 8 weeks thereafter.

Comments:
-Use the lowest effective dosage to maintain therapeutic response.
-Obtain liver enzymes and bilirubin prior to treatment initiation.

Use: Moderately to severely active Crohn's disease

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your risankizumab infusion.

Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using risankizumab?

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What other drugs will affect risankizumab?

Other drugs may affect risankizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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