Risankizumab

Risankizumab is a prescription medication used for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

• Risankizumab is available under the following different brand names: Skyrizi, risankizumab-rzaa

Adult dosage

Injectable solution

• 75mg/0.83mL (single-dose prefilled syringe)
• 150mg/mL (single-dose prefilled syringe or pen)
• Each syringe/pen has an affixed 27-gauge 0.5-inch needle

Plaque Psoriasis

Adult dosage

• 150 mg SC at Week 0, Week 4, and every 12 weeks thereafter

Psoriatic Arthritis

Adult dosage

• 150 mg SC at Week 0, Week 4, and every 12 weeks thereafter

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Risankizumab include:

• upper respiratory infections,
• headache,
• fatigue,
• injection site reactions (bruising, redness, fluid leakage, bleeding, infection, inflammation, irritation, pain, itching, swelling, warmth), and
• tinea infections (ringworm, athlete’s foot, and jock itch)

Serious side effects of Risankizumab include:

• fever,
• chills,
• sweating,
• body aches,
• shortness of breath,
• cough,
• bloody mucus,
• mouth sores,
• red or swollen gums,
• stomach pain,
• diarrhea,
• increased urination,
• burning while urinating,
• pale skin,
• easy bruising,
• unusual bleeding,
• skin sores from psoriasis,
• rash,
• redness, blisters, itching, burning, cracking, or peeling of the skin,
• changes in skin color,
• fever,
• cough,
• night sweats,
• loss of appetite,
• weight loss, and
• feeling very tired

Rare side effects of Risankizumab include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Risankizumab has severe interactions with no other drugs.
• Risankizumab has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • BCG vaccine live
  • influenza virus vaccine quadrivalent, intranasal
  • measles mumps and rubella vaccine, live
  • measles, mumps, rubella, and varicella vaccine, live
  • rotavirus oral vaccine, live
  • smallpox (vaccinia) vaccine, live
  • typhoid vaccine live
  • varicella virus vaccine live
  • yellow fever vaccine
  • zoster vaccine live
• Risankizumab has moderate interactions with the following drugs:
  • dengue vaccine
  • efgartigimod alfa
  • isavuconazonium sulfate
• Risankizumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• History of serious hypersensitivity reactions to risankizumab or any product excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Risankizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Risankizumab?”

Cautions

• Serious hypersensitivity reactions, including anaphylaxis, reported; if a serious hypersensitivity reaction occurs, discontinue risankizumab and initiate appropriate therapy immediately
• In Phase 3 clinical studies, patients with latent TB were concurrently treated with risankizumab and appropriate TB prophylaxis during the studies, none developed active TB; consider antitubercular therapy before initiating treatment in patients with a history of latent or active TB in whom the course of treatment cannot be confirmed; monitor for signs and symptoms of active TB during and after treatment; do not administer to patients with active TB
• Before initiating therapy, consider completion of all age-appropriate immunizations according to current immunization guidelines; avoid the use of live vaccines in treated patients; no data available on the response to live or inactive vaccines
• Administration of vaccines
  • Avoid the use of live vaccines in patients receiving therapy; medications that interact with the immune system may increase the risk of infection following administration of live vaccines
  • Before initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines; no data are available on the response to live or inactive vaccines
• Infections
  • In clinical studies, infections occurred more frequently in the risankizumab-treated patients compared with placebo
  • Consider risks and benefits of risankizumab in patients with chronic infection or a history of recurrent infection
  • If an infection develops or is not responding to standard therapy, closely monitor and withhold risankizumab until the infection resolves

Pregnancy and Lactation

• There is a pregnancy exposure registry that monitors outcomes in women with plaque psoriasis who become pregnant while receiving therapy; patients should be encouraged to enroll by calling 1- 877-302-2161
• Limited available data with use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome
• Human IgG is known to cross the placental barrier; therefore, risankizumab is transmitted from mother to developing fetus
• Lactation
  • There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production
  • Maternal IgG is known to be present in human milk
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition