Safety profile established in the largest prevention trial in HAE1-3
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.1
Injection site reactions were the most common adverse reactions (ARs).1
| Most common ARs (≥10%) observed in the clinical trial1,4* | TAKHZYRO every 2 weeks (n=27) | TAKHZYRO every 4 weeks (n=29) | Placebo (n=41) |
|---|---|---|---|
| Injection site reactions† | 56% | 45% | 34% |
|
52% | 31% | 29% |
|
7% | 7% | 2% |
|
4% | 7% | 0% |
| Upper respiratory infection‡ | 44% | 31% | 32% |
| Headache§ | 33% | 21% | 22% |
| Rash¶ | 4% | 10% | 5% |
| Myalgia | 11% | 0% | 0% |
| Dizziness | 4% | 10% | 0% |
| Diarrhea | 4% | 0% | 5% |
*≥10% in any TAKHZYRO group that also occurred at a higher rate than placebo group.1,4
†Additional injection site reactions included hematoma, hemorrhage, pruritus, swelling, induration, paresthesia, reaction, warmth, edema, and rash.1
‡Includes upper respiratory infection, viral upper respiratory infection.1
§Includes headache, tension headache, sinus headache.1
¶Includes rash, rash maculopapular, rash erythematous.1
No incidence of anaphylaxis in clinical trials.1
Safety data from an interim analysis of the open-label extension study were consistent with safety data from the clinical trial.1
SELECT IMPORTANT SAFETY INFORMATION
Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.
No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.
To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1-800-828-2088, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Lexi
Real TAKHZYRO patient
INDICATION
TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients ≥12 years of age.
IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment.
Adverse Reactions: The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.
Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.
No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.
To report SUSPECTED ADVERSE REACTIONS, contact Dyax Corp., a Takeda company, at 1–800–828–2088, or FDA at 1–800–FDA–1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
References: 1. TAKHZYRO (lanadelumab-flyo) [prescribing information]. Lexington, MA: Shire LLC; 2018. 2. HAEGARDA [prescribing information]. Kankakee, IL: CSL Behring LLC; 2017. 3. CINRYZE [prescribing information]. Lexington, MA: Shire ViroPharma Incorporated; 2018. 4. Banerji A, Riedl MA, Bernstein JA, et al. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121.