Taltz ® (ixekizumab) injektion

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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.

Ixekizumab Label Information Related to Hypersensitivity

Ixekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients (Sodium citrate, Citric acid Anhydrous, Sodium chloride, Polysorbate 80, Water for injections).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 (estimates ≥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 1 or more of the symptoms and signs shown in Table 1.

Table 1. 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

  • redness of the skin

  • irregular heartbeat

  • low blood pressure

  • abdominal pain

---

  • itching

---

Treatment-Emergent Events of Hypersensitivity

Psoriasis Clinical Trials

Further characterization of non-anaphylactic hypersensitivity events across a broader data set of 14 psoriasis clinical trials including phase 1, 2, and 3 trials (N=6091 patients accounting for 17,499 PYs of ixekizumab exposure), are described in Table 2.2

There were no confirmed cases of anaphylaxis.2

The IR of hypersensitivity across the 14 psoriasis clinical trials was 5.1 per 100 PYs.2

Table 2. Non-Anaphylactic Hypersensitivity Events Reported at an IR ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 14 Psoriasis Clinical Trials2


All Ixekizumab Exposures
N=6091
PY=17,499

Patients with ≥1 TEAE Non-Anaphylactic Allergic Reactions/Hypersensitivity, n (IR)

893 (5.1)

Dermatitis contact

187 (1.1)

Eczema

172 (1.0)

Urticaria

107 (0.6)

Dermatitis

92 (0.5)

Rhinitis allergic

88 (0.5)

Rash

84 (0.5)

Hypersensitivity

34 (0.2)

Conjunctivitis allergic

29 (0.2)

Drug hypersensitivity

27 (0.2)

Dermatitis allergic

25 (0.1)

Rash pustular

24 (0.1)

Dermatitis atopic

23 (0.1)

Drug eruption

17 (0.1)

Hand dermatitis

17 (0.1)

Angioedema

13 (0.1)

Rash generalized

10 (0.1)

Bronchospasm

9 (0.1)

Perioral dermatitis

9 (0.1)

Abbreviations: IR = incidence rate per 100 patient-years; PY = patient-years; TEAE = treatment-emergent adverse event.

Psoriatic Arthritis Clinical Trials

Further characterization of hypersensitivity events across a broader data set of 4 psoriatic arthritis clinical trials (N=1401 patients accounting for 2229 PYs of ixekizumab exposure), are described in Table 3.2

There were no confirmed cases of anaphylaxis.2

The IR of hypersensitivity across the 4 psoriatic arthritis clinical trials was 4.5 per 100 PYs.2

Table 3. Non-Anaphylactic Hypersensitivity Events Reported at an IR ≥0.1 Per 100 Patient-Years in Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Clinical Trials2


All Ixekizumab Exposures
N=1401
PY=2229

Patients with ≥1 TEAE Non-Anaphylactic Allergic Reactions/Hypersensitivity, n (IR)

99 (4.4)

Rash

18 (0.8)

Eczema

15 (0.7)

Drug Hypersensitivity

10 (0.4)

Rhinitis Allergic

10 (0.4)

Urticaria

6 (0.3)

Dermatitis contact

5 (0.2)

Hypersensitivity

5 (0.2)

Dermatitis

4 (0.2)

Dermatitis allergic

4 (0.2)

Dermatitis atopic

4 (0.2)

Drug eruption

4 (0.2)

Injection related reactions

4 (0.2)

Angioedema

3 (0.1)

Conjunctivitis allergic

2 (0.1)

Erythema nodosum

2 (0.1)

Rash erythematous

2 (0.1)

Rash pruritic

2 (0.1)

Swelling face

2 (0.1)

Swelling of eyelid

2 (0.1)

Abbreviations: IR = incidence rate per 100 patient-years; PY = patient-years; TEAE = treatment-emergent adverse event.

Axial Spondyloarthritis Clinical Trials

Using integrated data from the 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 April 2019 from 929 patients (1336.2 PYs), the IR of allergic reaction/hypersensitivity in patients exposed to ixekizumab was 5.5 per 100 PYs. There were no confirmed cases of anaphylaxis.3

The nonanaphylactic hypersensitivity events reported at an IR of at least 0.1 per 100 PYs are listed in Table 4.

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


All Ixekizumab Exposures
N=929
PY=1336.2

Patients with ≥1 TEAE Nonanaphylactic Allergic Reactions/Hypersensitivity, n (IR)

73 (5.5)

Rash

19 (1.4)

Eczema

15 (1.1)

Dermatitis

7 (0.5)

Urticaria

7 (0.5)

Dermatitis allergic

5 (0.4)

Erythema nodosum

3 (0.2)

Rash generalized

3 (0.2)

Rash pustular

3 (0.2)

Dermatitis atopic

2 (0.1)

Drug eruption

2 (0.1)

Erythema multiforme

2 (0.1)

Rash pruritic

2 (0.1)

Angioedema

1 (0.1)

Dermatitis psoriasiform

1 (0.1)

Drug hypersensitivity

1 (0.1)

Face oedema

1 (0.1)

Perioral dermatitis

1 (0.1)

Swelling face

1 (0.1)

Abbreviations: IR = incidence rate per 100 patient-years; PY = patient-years; TEAE = treatment-emergent adverse event.

References

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

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

3. Genovese 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

Glossary

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

axSpA = axial spondyloarthritis

IR = incidence rate

nr-axSpA = nonradiographic axial spondyloarthritis

PY = patient-years

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M07 22


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