Skyrizi

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/24/2022
Skyrizi Side Effects Center

What Is Skyrizi?

Skyrizi (risankizumab-rzaa) is an interleukin-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

What Are Side Effects of Skyrizi?

Common side effects of Skyrizi include:

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

Call your doctor at once if you have the following serious side effects:

  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
  • low levels of sodium in the body with severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
  • severe nervous system reaction with very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out.

Dosage for Skyrizi

The dose of Skyrizi is 150 mg (two 75 mg injections) administered by subcutaneous injection at Week 0, Week 4 and every 12 weeks thereafter.

What Drugs, Substances, or Supplements Interact with Skyrizi?

Skyrizi may interact with "live" vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Skyrizi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Skyrizi; it is unknown how it would affect a fetus. It is unknown if Skyrizi passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Skyrizi (risankizumab-rzaa) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer
Skyrizi Consumer Information

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

Call your doctor right away if you have signs of infection such as:

  • fever, chills, sweating, body aches;
  • shortness of breath, cough, bloody mucus;
  • mouth sores, red or swollen gums;
  • stomach pain, diarrhea;
  • increased urination, burning when you urinate;
  • pale skin, easy bruising, unusual bleeding;
  • a fungal skin infection--skin sores different from psoriasis, rash or redness, blisters, itching, burning, cracking or peeling, changes in skin color; or
  • signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Further doses may be delayed until your infection clears up.

Common side effects may include:

  • headache;
  • tiredness;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • fungal skin infections; or
  • pain, redness, itching, bruising, swelling, warmth, bleeding, burning, or other skin 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.

Read the entire detailed patient monograph for Skyrizi (Risankizumab-rzaa Injection)

SLIDESHOW

Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Skyrizi Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of labeling:

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Plaque Psoriasis

A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.

Data from placebo-and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group.

Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials.

Table 1.Adverse Drug Reactions Occurring in ≥ 1% of Subjects on SKYRIZI through Week 16

Adverse Drug Reactions SKYRIZI
N = 1306
n (%)
Placebo
N = 300
n (%)
Upper respiratory infectionsa 170 (13.0) 29 (9.7)
Headacheb 46 (3.5) 6 (2.0)
Fatiguec 33 (2.5) 3 (1.0)
Injection site reactionsd 19 (1.5) 3 (1.0)
Tinea infectionse 15 (1.1) 1 (0.3)
a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis
b Includes: headache, tension headache, sinus headache, cervicogenic headache
c Includes: fatigue, asthenia
d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth
e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis

Adverse drug reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.

Specific Adverse Drug Reactions

Infections

In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100 subject-years) compared with 14.7% of the placebo group (56.5 events per 100 subject-years) and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included cellulitis, osteomyelitis, sepsis, and herpes zoster. In Studies PsO-1 and PsO-2, through Week 52, the rate of infections (73.9 events per 100 subject-years) was similar to the rate observed during the first 16 weeks of treatment.

Safety Through Week 52

Through Week 52, no new adverse reactions were identified, and the rates of the adverse reactions were similar to those observed during the first 16 weeks of treatment. During this period, serious infections that led to study discontinuation included pneumonia.

Psoriatic Arthritis

The overall safety profile observed in subjects with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in subjects with plaque psoriasis. Additionally, in the Phase 3 placebo-controlled trials the incidence of hepatic events was higher in the SKYRIZI group (5.4%, 16.7 events per 100 patient years) compared to the placebo group (3.9%, 12.6 events per 100 patient years). Of these, the most common events that were reported more frequently in both the placebo group and the SKYRIZI group were ALT increased (placebo: n=12 (1.7%); SKYRIZI: n=16 (2.3%)), AST increased (placebo: n=9 (1.3%); SKYRIZI: n=13 (1.8%)), and GGT increased (placebo: n=5 (0.7%); SKYRIZI: n=8 (1.1%)). There were no serious hepatic events reported. The incidence of hypersensitivity reactions was higher in the SKYRIZI group (n=16, 2.3%) compared to the placebo group (n=9, 1.3%). In the Phase 3 placebo-controlled trials, hypersensitivity reactions reported at a higher rate in the SKYRIZI group included rash (placebo: n=4 (0.6%); SKYRIZI: n=5 (0.7%), allergic rhinitis (placebo: n=1 (0.1%); SKYRIZI: n=2 (0.3%), and facial swelling (placebo: n=0 (0.0%); SKYRIZI n=1 (0.1%). One case of anaphylaxis was reported in a subject who received SKYRIZI in the Phase 2 clinical trial.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other products, including other risankizumab products, may be misleading.

Plaque Psoriasis

By Week 52, approximately 24% (263/1079) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa. Of the subjects who developed antibodies to risankizumab-rzaa, approximately 57% (14% of all subjects treated with SKYRIZI) had antibodies that were classified as neutralizing. Higher antibody titers in approximately 1% of subjects treated with SKYRIZI were associated with lower risankizumab-rzaa concentrations and reduced clinical response.

Psoriatic Arthritis

By Week 28, approximately 12.1% (79/652) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa. None of the subjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing. Antibodies to risankizumab-rzaa were not associated with changes in clinical response for psoriatic arthritis. A higher proportion of subjects with anti-drug antibodies experienced hypersensitivity reactions (6.3% (5/79)) and injection site reactions (2.5% (2/79)) compared to subjects without anti-drug antibodies (3.8% (22/574) with hypersensitivity reactions and 0.7% (4/574) with injection site reactions). None of these hypersensitivity and injection site reactions led to discontinuation of risankizumab-rzaa.

Postmarketing Experience

The following adverse reactions have been reported during post-approval of SKYRIZI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to SKYRIZI exposure:

  • Skin and subcutaneous tissue disorders: eczema and rash

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Skyrizi (Risankizumab-rzaa Injection)

© Skyrizi Patient Information is supplied by Cerner Multum, Inc. and Skyrizi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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