Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® (ixekizumab): Överkänslighetsreaktioner vid psoriasis och psoriasisartrit i kliniska prövningar

Ixekizumab är kontraindicerat för patienter med känd allvarlig överkänslighet mot ixekizumab eller något av dess innehållsämnen.

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en-GB

What are the Label Information Related to Hypersensitivity?

Ixekizumab is contraindicated in patients with serious hypersensitivity to the active substance or to any of the excipients.1

Serious hypersensitivity reactions, including some cases of

  • anaphylaxis,
  • angioedema,
  • urticaria
  • and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including
    • widespread urticaria,
    • dyspnea and
    • high antibody titres

have been reported.

If a serious hypersensitivity reaction occurs, administration of ixekizumab should be discontinued immediately and appropriate therapy initiated.1

Postmarketing Data

Rare events consistent with anaphylaxis (estimated as ≥0.01% to <0.1%) have been identified during postmarketing use of ixekizumab. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a relationship to ixekizumab exposure.2

Serious allergic-type events reported have included one or more of the symptoms and signs shown in Examples of Serious Allergic-Type Events With Ixekizumab in Postmarketing Reports.

Examples of Serious Allergic-Type Events With Ixekizumab in Postmarketing Reports2
  • hives
  • skin swelling
  • lip swelling
  • throat swelling
  • difficulty breathing
  • chest tightness
  • difficulty swallowing
  • throat tightness
  • fast heartbeat
  • irregular heartbeat
  • abdominal pain
  • redness of the skin
  • itching
  • low blood pressure

Treatment-Emergent Events of Hypersensitivity

Psoriasis Clinical Trials

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 16 Psoriasis Clinical Trials characterizes nonanaphylactic hypersensitivity events across a broader data set of 15 adult and 1 pediatric psoriasis clinical trials (N=6645 patients accounting for 17,902 PY of ixekizumab exposure through March 19, 2020).3

There were no confirmed cases of anaphylaxis.4

The overall IR of allergic/hypersensitivity reactions across the 16 psoriasis clinical trials was 5.3 per 100 PY.3

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 16 Psoriasis Clinical Trials2

All Ixekizumab Exposures
N=6645
PY=17,902
n (IR)

Patients with ≥1 TEAE nonanaphylactic allergic reactions/hypersensitivity

930 (5.2)

Dermatitis contact

200 (1.1)

Eczema

171 (1.0)

Urticaria

119 (0.7)

Dermatitis

99 (0.6)

Rash

97 (0.5)

Rhinitis allergic

92 (0.5)

Hypersensitivity

34 (0.2)

Conjunctivitis allergic

29 (0.2)

Dermatitis allergic

27 (0.2)

Drug hypersensitivity

27 (0.2)

Dermatitis atopic

25 (0.1)

Drug eruption

17 (0.1)

Hand dermatitis

17 (0.1)

Angioedema

14 (0.1)

Rash pustular

10 (0.1)

Bronchospasm

9 (0.1)

Perioral dermatitis

9 (0.1)

Abbreviations: PY = patient-years; TEAE = treatment-emergent adverse event.

Psoriatic Arthritis Clinical Trials

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Clinical Trials characterizes hypersensitivity events across a broader data set of 4 psoriatic arthritis clinical trials (N=1401 patients accounting for 2247.7 PY of ixekizumab exposure through March 19, 2020).5

There were no confirmed cases of anaphylaxis.6

The overall IR of allergic/hypersensitivity reactions across the 4 psoriatic arthritis clinical trials was 4.5 per 100 PY.5

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Clinical Trials2


All Ixekizumab Exposures
N=1401
PY=2247.7
n (IR)

Patients with ≥1 TEAE nonanaphylactic allergic reactions/hypersensitivity

101 (4.5)

Rash

19 (0.8)

Eczema

15 (0.7)

Drug hypersensitivity

10 (0.4)

Rhinitis allergic

10 (0.4)

Urticaria

6 (0.3)

Dermatitis atopic

5 (0.2)

Dermatitis contact

5 (0.2)

Hypersensitivity

5 (0.2)

Dermatitis

4 (0.2)

Dermatitis allergic

4 (0.2)

Drug eruption

4 (0.2)

Injection-related reaction

4 (0.2)

Angioedema

3 (0.1)

Conjunctivitis allergic

2 (0.1)

Erythema nodosum

2 (0.1)

Rash erythematous

2 (0.1)

Rash maculo-papular

2 (0.1)

Rash pruritic

2 (0.1)

Swelling of face

2 (0.1)

Swelling of eyelid

2 (0.1)

Abbreviations: PY = patient-years; TEAE = treatment-emergent adverse event.

Axial Spondyloarthritis Clinical Trials

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 4 Axial Spondyloarthritis Clinical Trials characterizes hypersensitivity events across a broader data set of 4 axSpA clinical trials (COAST-V and COAST-W AS/r-axSpA trials, COAST-X nr-axSpA trial, and COAST-Y long-term extension study in patients with axSpA) through March 19, 2020 from 932 patients (1792.2 PY).7

One incident of potential (unconfirmed) anaphylaxis occurred.8

The overall IR of allergic/hypersensitivity reactions across the 4 axSpA clinical trials was 4.8 per 100 PY as of the March 2020 database lock.7

Nonanaphylactic Hypersensitivity Events Reported at an Incidence Rate ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 4 Axial Spondyloarthritis Clinical Trials2


All Ixekizumab Exposures
N=932
PY=1792.2
n (IR)

Patients with ≥1 TEAE nonanaphylactic allergic reactions/hypersensitivity

85 (4.7)

Rash

24 (1.3)

Eczema

17 (0.9)

Dermatitis

10 (0.6)

Urticaria

9 (0.5)

Dermatitis allergic

5 (0.3)

Angioedema

3 (0.2)

Drug eruption

3 (0.2)

Erythema nodosum

3 (0.2)

Dermatitis atopic

2 (0.1)

Drug hypersensitivity

2 (0.1)

Erythema multiforme

2 (0.1)

Rash pruritic

2 (0.1)

Rash pustular

2 (0.1)

Allergic edema

1 (0.1)

Bronchospasm

1 (0.1)

Dermatitis psoriasiform

1 (0.1)

Face edema

1 (0.1)

Hypersensitivity

1 (0.1)

Perioral dermatitis

1 (0.1)

Rash erythematous

1 (0.1)

Rash papulosquamous

1 (0.1)

Skin reaction

1 (0.1)

Swelling of face

1 (0.1)

Swelling of eyelid

1 (0.1)

Abbreviations: PY = patient-years; TEAE = treatment-emergent adverse event.

References

1Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3Griffiths CEM, Reich K, Gooderham M, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis up to 5 years: pooled data from 16 clinical trials. Poster presented at: 29th Annual Meeting of the European Academy of Dermatology and Venereology (EADVirtual); October 29-31, 2020.

4Griffiths CEM, Reich K, Gooderham M, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis up to 5 years: pooled data from 16 clinical trials. Abstract presented at: 29th Annual Meeting of the European Academy of Dermatology and Venereology (EADVirtual); October 29-31, 2020.

5Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Poster presented at: European League Against Rheumatism Virtual Congress; June 2-5, 2021.

6Genovese MC, Mysler E, Tomita T, et al. Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials. Rheumatology (Oxford). Published online May 25, 2020. https://doi.org/10.1093/rheumatology/keaa189

7Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety profile of ixekizumab treatment on patients with axial spondyloarthritis. Poster presented at: American College of Rheumatology/ARP 2020 Annual Scientific Meeting (Virtual); November 5-9, 2020.

8Schwartzman S, Sandoval D, Kronbergs A, et al. Long-term safety profile of ixekizumab treatment on patients with axial spondyloarthritis. Abstract presented at: American College of Rheumatology/ARP 2020 Annual Scientific Meeting (Virtual); November 5-9, 2020.

Glossary

AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis

axSpA = axial spondyloarthritis

IR = incidence rate

nr-axSpA = nonradiographic axial spondyloarthritis

PY = patient-years

Datum fӧr senaste ӧversyn 2020 M07 22


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