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Ilumya

Last reviewed on RxList: 4/4/2018
Ilumya Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/4/2018

Ilumya (tildrakizumab-asmn) injection is an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Common side effects of Ilumya include:

  • upper respiratory infections,
  • injection site reactions (hives, itching, pain, redness, inflammation, swelling, bruising, hematoma, and bleeding), and
  • diarrhea

The recommended dose of Ilumya is 100 mg at Weeks 0, 4, and every twelve weeks thereafter. Ilumya may interact with live vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant or plan to become pregnant before using Ilumya; it is unknown how it would affect a fetus. It is unknown if Ilumya passes into breast milk. Consult your doctor before breastfeeding.

Our Ilumya (tildrakizumab-asmn) Injection 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.

SLIDESHOW

Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Ilumya 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.

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, chills, sweating;
  • skin sores;
  • muscle pain;
  • increased urination, pain or burning when you urinate;
  • stomach pain, diarrhea, weight loss; or
  • cough, shortness of breath, coughing up pink or red mucus.

Common side effects may include:

  • pain, itching, rash, redness, swelling, bruising, or bleeding where the medicine was injected;
  • diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Ilumya (Tildrakizumab-asmn Injection, for Subcutaneous Use)

QUESTION

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

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

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

In clinical trials, a total of 1994 subjects with plaque psoriasis were treated with ILUMYA, of which 1083 subjects were treated with ILUMYA 100 mg. Of these, 672 subjects were exposed for at least 12 months, 587 for 18 months, and 469 for 24 months.

Data from three placebo-controlled trials (Trials 1, 2, and 3) in 705 subjects (mean age 46 years, 71% males, 81% white) were pooled to evaluate the safety of ILUMYA (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 12 weeks [Q12W]) [see Clinical Studies].

Placebo-Controlled Period (Weeks 0-16 Of Trial 1 And Weeks 0-12 Of Trials 2 And 3)

In the placebo-controlled period of Trials 1, 2, and 3 in the 100 mg group, adverse events occurred in 48.2% of subjects in the ILUMYA group compared to 53.8% of subjects in the placebo group. The rates of serious adverse events were 1.4% in the ILUMYA group and 1.7% in the placebo group.

Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the ILUMYA group than in the placebo group.

Table 1: Adverse Reactions Occurring in ≥1% of Subjects in the ILUMYA Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Trials 1, 2, and 3

Adverse Reaction ILUMYA 100 mg
(N=705)
N (%)
Placebo
(N=355)
N (%)
Upper respiratory infections* 98 (14) 41 (12)
Injection site reactions† 24 (3) 7 (2)
Diarrhea 13 (2) 5 (1)
* Upper respiratory infections include nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, and pharyngitis.
† Injection site reactions include injection site urticaria, pruritus, pain, reaction, erythema, inflammation, edema, swelling, bruising, hematoma, and hemorrhage.

During the placebo-controlled period of Trials 1, 2, and 3, adverse reactions that occurred at rates less than 1% but greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity.

Specific Adverse Reactions

Hypersensitivity Reactions

Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials [see WARNINGS AND PRECAUTIONS].

Infections

Infections were slightly more common in the ILUMYA group. The difference in frequency of infections between the ILUMYA group (23%) and the placebo group was less than 1% during the placebo-controlled period. The most common (≥1%) infections were upper respiratory infections. The rates of severe infections for the ILUMYA group and the placebo group were ≤0.3%.

Safety Through Week 52/64

Through Week 52 (Trials 1 and 3) and Week 64 (Trial 2), no new adverse reactions were identified with ILUMYA use and the frequency of the adverse reactions was similar to that observed during the placebo-controlled period.

Immunogenicity

As with all therapeutic proteins there is the 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 incidence of antibodies to tildrakizumab in the studies described below with the incidences of antibodies in other studies or to other products may be misleading.

Up to Week 64, approximately 6.5% of subjects treated with ILUMYA 100 mg developed antibodies to tildrakizumab. Of the subjects who developed antibodies to tildrakizumab, approximately 40% (2.5% of all subjects receiving ILUMYA) had antibodies that were classified as neutralizing. Development of neutralizing antibodies to tildrakizumab was associated with lower serum tildrakizumab concentrations and reduced efficacy.

Read the entire FDA prescribing information for Ilumya (Tildrakizumab-asmn Injection, for Subcutaneous Use)

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

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