INDICATION
TAKHZYRO (lanadelumab-flyo) is indicated for prophylaxis to prevent attacks of
hereditary angioedema (HAE) in patients ≥2 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%) associated with TAKHZYRO were injection site reactions
consisting mainly of pain, erythema, and bruising at the
injection site; upper respiratory infection; headache; rash; dizziness; diarrhea; and
myalgia. 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 <2 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 1-877-TAKEDA-7 (1-877-825-3327), or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing
Information.
