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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions including anaphylaxis have been reported following use of DAWNZERA. Advise patients to discontinue DAWNZERA and seek immediate medical attention if serious hypersensitivity reactions occur. ( 5.1 ) 5.1 Risk of Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with DAWNZERA [see Adverse Reactions (6.1) ] . If signs and symptoms of serious hypersensitivity reactions occur, discontinue DAWNZERA and institute appropriate therapy.
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; q4wks = every 4 weeks; q8wks = every 8 weeks. * Injection site reactions include: erythema, discoloration, pain, pruritus, induration, bruising, haematoma, hypersensitivity, swelling, reaction, and urticaria. † All injection site reactions were mild, nonserious, and the majority of them resolved without receiving any treatment. Adverse Reaction DAWNZERA Placebo (N=22) 80 mg q4wks (N=45) 80 mg q8wks (N=23) n (%) n (%) n (%) Injection site reactions*† 11 (24) 1 (4) 1 (5) Upper respiratory tract infection 4 (9) 2 (9) 1 (5) Urinary tract infection 4 (9) 2 (9) 0 Abdominal discomfort 3 (7) 0 0 Specific Adverse Reactions Hypersensitivity Reactions, Including Anaphylaxis In clinical trials, hypersensitivity reactions, including anaphylaxis, have occurred. Symptoms included generalized rash, dyspnea, chest pain, and peri-oral swelling. Laboratory Tests Decrease in Platelet Count : DAWNZERA can cause reductions in platelet count. In OASIS-HAE, the mean platelet count at baseline was 266,000/mm 3 for the DAWNZERA 80 mg every 4 weeks group, 265,000/mm 3 for the DAWNZERA 80 mg every 8 weeks group, and 245,000/mm 3 for the placebo group. The mean percent change in platelet count at Week 25 was -9.6% for the DAWNZERA 80 mg every 4 weeks group, -7.9% for the DAWNZERA 80 mg every 8 weeks group, and -1.4% for the placebo group. In OASIS-HAE and 2 other clinical studies no DAWNZERA-treated patient had a platelet count of <50,000/mm 3 , and there were no major bleeding events associated with a low platelet count. Increase in Liver Function Tests : Increases from baseline in liver enzymes (alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase) were observed with DAWNZERA use. The increased levels were generally below 3 times the upper limit of normal and stabilized. Discontinuations due to liver function test increases were infrequent.
adverse reactions table
<table width="85%"><caption>Table 1: Adverse Reactions with DAWNZERA with Incidence ≥5% and More Common than Placebo in Patients with HAE (OASIS-HAE)</caption><tfoot><tr styleCode="First Last"><td colspan="4">N = number of patients; n = number of patients experiencing the event; q4wks = every 4 weeks; q8wks = every 8 weeks. * Injection site reactions include: erythema, discoloration, pain, pruritus, induration, bruising, haematoma, hypersensitivity, swelling, reaction, and urticaria. † All injection site reactions were mild, nonserious, and the majority of them resolved without receiving any treatment. </td></tr></tfoot><tbody><tr valign="bottom"><td rowspan="3" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold"> Adverse Reaction</content></td><td colspan="2" align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">DAWNZERA</content></td><td rowspan="2" align="center" styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">Placebo</content> <content styleCode="bold">(N=22)</content></paragraph></td></tr><tr><td align="center" styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">80 mg q4wks (N=45) </content></paragraph></td><td align="center" styleCode="Botrule Lrule Rrule Toprule"><paragraph><content styleCode="bold">80 mg q8wks (N=23) </content></paragraph></td></tr><tr><td align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">n (%)</content></td><td align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">n (%)</content></td><td align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">n (%)</content></td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Injection site reactions*†</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">11 (24)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">1 (4)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">1 (5)</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Upper respiratory tract infection</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">4 (9)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">2 (9)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">1 (5)</td></tr><tr><td styleCode="Lrule"> Urinary tract infection</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">4 (9)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">2 (9)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">0</td></tr><tr><td styleCode="Botrule Lrule Rrule Toprule"> Abdominal discomfort</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">3 (7)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">0</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">0</td></tr></tbody></table>