Pharmacy News

Ixekizumab Approved for Treatment of Plaque Psoriasis

Kate Traynor

BETHESDA, MD 23 Mar 2016— FDA and Eli Lilly & Co. on March 22 announced the approval of ixekizumab injection for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Eli Lilly and Co. will market the biologic, an interleukin-17A antagonist, as Taltz. The company expects the product to be available during the second quarter of this year.

Labeling (PDF) for ixekizumab recommends initiating therapy with a 160-mg dose, administered as two 80-mg subcutaneous injections, during week 0. Patients should then receive an 80-mg dose during weeks 2, 4, 6, 8, 10, and 12 of therapy, followed by 80 mg every four weeks.

Ixekizumab treatment may increase the risk of tuberculosis (TB) and other infections. These risks are emphasized in the FDA-required Medication Guide (PDF) for patients.

According to the Medication Guide and the labeling, patients should be evaluated for TB infection before ixekizumab treatment is initiated, and they should be monitored for signs and symptoms of TB during and after treatment with ixekizumab.

Ixekizumab should not be administered to patients with active TB infection. Patients with latent TB infection should be treated for that condition before starting treatment with ixekizumab.

The labeling also recommends that healthcare providers consider administering all age-appropriate vaccinations for a patient before initiating ixekizumab therapy.

The most frequently reported adverse events associated with ixekizumab therapy in clinical studies were injection-site reactions, upper respiratory tract infection, nausea, and ringworm.

Severe adverse events reported in clinical trials included urticaria, angioedema, and other hypersensitivity reactions and new-onset or worsening inflammatory bowel disorders. The labeling states that ixekizumab therapy should be immediately discontinued if a serious hypersensitivity reaction occurs during treatment.

Ixekizumab will be supplied in 80-mg single-dose autoinjectors or prefilled syringes in cartons of one, two, or three devices each that should be refrigerated at 2–8 °C and protected from light until use.


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