TALTZ® (ixekizumab): Common Side Effects

Contraindications

Ixekizumab is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.¹

Warnings and Precautions

Infections: Ixekizumab may increase the risk of infection. Upper respiratory tract infections, oral candidiasis, conjunctivitis, and tinea infections occurred more frequently in the ixekizumab group than in the placebo group. Instruct patients treated with ixekizumab to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue ixekizumab until the infection resolves.¹

Pretreatment Evaluation for TB: Evaluate patients for TB infection prior to initiating treatment with ixekizumab. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering ixekizumab. Consider anti-TB therapy prior to initiating ixekizumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ixekizumab should be monitored closely for signs and symptoms of active TB during and after treatment.¹

Hypersensitivity Reactions: Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%) occurred in the ixekizumab group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in postmarketing use with ixekizumab. If a serious hypersensitivity reaction occurs, discontinue ixekizumab immediately and initiate appropriate therapy.¹

Inflammatory Bowel Disease: Patients treated with ixekizumab may be at increased risk of IBD. In clinical trials, CD and UC, including exacerbations, occurred at a greater frequency in the ixekizumab group than the placebo control group. During ixekizumab treatment, monitor for onset or exacerbation of IBD and if IBD occurs, discontinue ixekizumab and initiate appropriate medical management.¹

Immunizations: Prior to initiating therapy with ixekizumab, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with ixekizumab. No data are available on the response to live vaccines.¹

Adverse Reactions in Ixekizumab Clinical Trials

Most common (≥1%) adverse reactions associated with ixekizumab treatment are

• ISRs

• upper respiratory tract infections

• nausea, and

• tinea infections.¹

Adult Plaque Psoriasis

In the 12-week, placebo-controlled period across the 3 UNCOVER pivotal adult plaque psoriasis clinical trials, AEs occurred in 58% of patients treated with ixekizumab 80 mg Q2W (2.5 per subject-year of follow-up) compared with 47% of the placebo group (2.1 per subject-year of follow-up). Serious adverse events occurred in 2% of the ixekizumab group (0.07 per subject-year of follow-up), and in 2% of the placebo group (0.07 per subject-year of follow-up).¹ 

Adverse reactions reported by >1% of patients treated with ixekizumab 80 mg Q2W (approved dosage regimen through week 12) are listed in Table 1.

Table 1. Adverse Reactions Occurring in ≥1% of the Ixekizumab Group and More Frequently Than the Placebo Group in Phase 3 UNCOVER Clinical Trials Through Week 12¹

Adverse Reactions	IXE Q2Wa N=1167 n (%)	Etanerceptb  N=287 n (%)	Placebo N=791 n (%)
Injection-site reactions	196 (17)	32 (11)	26 (3)
Upper respiratory tract infectionsc	163 (14)	23 (8)	101 (13)
Nausea	23 (2)	1 (<1)	5 (1)
Tinea infections	17 (2)	0	1 (<1)

Abbreviations: IXE= ixekizumab; Q2W = every 2 weeks.
Note: Adverse reactions that occurred at rates <1% in the ixekizumab group and more frequently than in the placebo group during the 12-week induction period included rhinitis, oral candidiasis, urticaria, influenza, conjunctivitis, inflammatory bowel disease, and angioedema.

^a Following 160 mg starting dose of ixekizumab at week 0.

^b US approved etanercept only. UNCOVER-2 and -3 only.

^c Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.

Pediatric Plaque Psoriasis

Overall, the safety profile observed in pediatric patients with plaque psoriasis treated with ixekizumab Q4W is consistent with the safety profile in adult patients with plaque psoriasis with the exception of the frequencies of

• conjunctivitis (2.6%)

• influenza (1.7%), and

• urticaria (1.7%).¹

Psoriatic Arthritis

Overall, the safety profile observed in patients with PsA treated with ixekizumab Q4W is consistent with the safety profile in patients with plaque psoriasis with the exception of the frequencies of influenza (1.3%) and conjunctivitis (1.3%).¹

Ankylosing Spondylitis

Overall, the safety profile observed in patients with AS/r-axSpA treated with ixekizumab 80 mg Q4W is consistent with the safety profile in patients with plaque psoriasis.¹

Non-radiographic Axial Spondyloarthritis

Overall, the safety profile observed in patients with nr-axSpA treated with ixekizumab 80 mg Q4W up to week 16 is consistent with the previous experience of ixekizumab in other indications.¹

Enclosed Prescribing Information

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

References

1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.

Glossary

AE = adverse event

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

CD = Crohn's disease

IBD = inflammatory bowel disease

ISR = injection site reaction

nr-axSpA = nonradiographic axial spondyloarthritis

PsA = psoriatic arthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

TB = tuberculosis

UC = ulcerative colitis