HAEGARDA SIDE EFFECTS
- Generic Name: c1 esterase inhibitor subcutaneous [human] injection
- Brand Name: Haegarda
- Drug Class: Immunomodulators
SIDE EFFECTS
Adverse reactions occurring in more than 4% of subjects treated with HAEGARDA were injection site reaction, hypersensitivity, nasopharyngitis and dizziness.
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials o f a drug cannot be directly compared to rates in the clinical trials o f another drug and may not reflect the rates observed in practice.
Of the 90 subjects randomized in the double-blind, placebo-controlled, cross-over study [see Clinical Studies], 86 subjects received at least one dose of HAEGARDA and 86 subjects received at least one dose of placebo (Table 1). A total of 5081 injections of HAEGARDA and placebo were administered over a range of 3 to 19 weeks (median of 16.6 weeks for HAEGARDA; median of 16.3 weeks for placebo).
Table 1: Adverse Reactions in > 4% of Subjects Treated with HAEGARDA
| MedDRA System Organ Class | Adverse Reaction | HAEGARDA | Placebo (N=86) n (%) |
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| 60 IU/kg (N=43) n (%) |
40 IU/kg (N=43) n (%) |
Overall* (N=86) n (%) |
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| General Disorders and Administration Site Conditions | Injection Site Reaction† | 15 (35) | 12 (28) | 27 (31) | 21 (24) |
| Immune System Disorders | Hypersensitivity‡ | 3 (7) | 2 (5) | 5 (6) | 1 (1) |
| Infections and Infestations | Nasopharyngitis | 8(19) | 1(2) | 9(11) | 6(7) |
| Nervous System Disorders | Dizziness | 0(0) | 4(9) | 4(5) | 1(1) |
| N = number of subjects receiving the treatment; n = number of subjects experiencing ≥ 1 event. * Includes subjects who were treated with 40 IU/kg or 60 IU/kg HAEGARDA. † Includes: Injection site bruising, coldness, discharge, erythema, hematoma, hemorrhage, induration, edema, pain, pruritus, rash, reaction, scar, swelling, urticaria, warmth. ‡Includes: hypersensitivity, pruritus, rash, and urticaria. |
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Of the injection site reactions occurring after treatment with HAEGARDA, 95% were of mild intensity and 83% resolved within 1 day after onset.
SRC: NLM .