Dawnzera Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Risk of Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.1) ] Most common adverse reactions (incidence ≥ 5%) are injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ionis Pharmaceuticals at 1-833-644-6647 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 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.

The safety of DAWNZERA reflects the exposure in a total of 171 adult and pediatric patients 12 years and older with hereditary angioedema (HAE) from a placebo-controlled trial (OASIS-HAE) [see Clinical Studies (14) ] , and 2 other clinical studies.

The average duration of DAWNZERA treatment exposure across the 3 clinical studies was 14 months.

The safety data below is based on the 24-week multicenter, randomized, double-blind, placebo-controlled trial (OASIS-HAE), in which patients received at least one subcutaneous dose of DAWNZERA 80 mg once every 4 weeks (n=45), DAWNZERA 80 mg once every 8 weeks (n=23), or matching placebo (n=22).

Demographics of the patients in OASIS-HAE are summarized in Clinical Studies [see Clinical Studies (14) ] .

Table 1 provides the most common adverse reactions with DAWNZERA with incidence ≥5% and more common than placebo.

Table 1: Adverse Reactions with DAWNZERA with Incidence ≥5% and More Common than Placebo in Patients with HAE (OASIS-HAE) N = number of patients;

n = number of patients experiencing the event;