Brand Name
Andembry
Generic Name
Garadacimab
View Brand Information FDA approval date: June 16, 2025
Form: Injection
What is Andembry (Garadacimab)?
ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients aged 12 years and older.
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Brand Information
ANDEMBRY (Garadacimab)
1INDICATIONS AND USAGE
ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
2DOSAGE FORMS AND STRENGTHS
Injection: a sterile, preservative-free, slightly opalescent to clear, brownish-yellow to yellow solution available in the following:
- 200 mg/1.2 mL of garadacimab solution in a single-dose prefilled autoinjector
- 200 mg/1.2 mL (167 mg/mL) of garadacimab solution in a single-dose prefilled syringe with needle safety device
3CONTRAINDICATIONS
None.
4WARNINGS AND PRECAUTIONS
None.
5DESCRIPTION
Garadacimab-gxii, an activated Factor XII (FXIIa) inhibitor, is a recombinant, fully human, monoclonal antibody (IgG4/
ANDEMBRY (garadacimab-gxii) injection is a sterile, preservative-free, slightly opalescent to clear, brownish-yellow to yellow solution for subcutaneous use.
Each 1.2 mL prefilled autoinjector or prefilled syringe with needle safety device of ANDEMBRY contains 200 mg of garadacimab-gxii, arginine monohydrochloride (37.9 mg), histidine (3.7 mg), polysorbate 80 (0.24 mg), proline (19.3 mg), and water for injection, USP. The pH is 6.1.
6CLINICAL STUDIES
The efficacy of ANDEMBRY for prophylaxis to prevent hereditary angioedema (HAE) attacks was evaluated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study (VANGUARD [NCT04656418]) of 6 months duration.
VANGUARD enrolled a total of 64 adult and pediatric patients 12 years of age and older with Type I or Type II HAE who experienced at least 2 investigator-confirmed HAE attacks over a 2-month period prior to treatment with ANDEMBRY or placebo. Patients were randomized in a 3:2 ratio (ANDEMBRY:placebo) to receive an initial loading dose of ANDEMBRY 400 mg administered subcutaneously followed by a maintenance dose of 200 mg every month, or matched placebo. Patients were required to discontinue other prophylactic HAE medications prior to entering the study. All patients were allowed to use on-demand medications for the treatment of HAE attacks during the study.
The demographics and baseline characteristics of patients in VANGUARD are provided in Table 3.
The primary endpoint for VANGUARD was the monthly HAE attack rate at 6 months (number of investigator-confirmed HAE attacks per month). As shown in Table 4, the least squares mean for the monthly HAE attack rate was lower with ANDEMBRY compared to placebo.
The monthly rate of HAE attacks requiring on-demand therapy and the monthly rate of moderate or severe HAE attacks were assessed as secondary endpoints in VANGUARD. There was a 91.2% reduction with ANDEMBRY relative to placebo in the monthly rate of HAE attacks requiring on-demand therapy and a 93.6% reduction with ANDEMBRY relative to placebo in the monthly rate of moderate or severe HAE attacks.
Additional secondary endpoints assessed the proportion of patients with a ≥50%, ≥70%, ≥90%, and 100% (attack-free) reduction in monthly HAE attack rate from the first dose through the end of the 6-month treatment period compared to the 2-month period prior to treatment. The proportion of patients with a ≥50%, ≥70%, ≥90%, and 100% reduction was 95%, 92%, 74%, and 62% on ANDEMBRY versus 33%, 17%, 8%, and 0% on placebo, respectively.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
8PRINCIPAL DISPLAY PANEL - 200 mg Autoinjector Label
NDC 63833-925-20
200 mg
ANDEMBRY
200 mg/1.2 mL
Manufactured by:
LOT 0000000000
Read the instructions
41126
9PRINCIPAL DISPLAY PANEL - 200 mg Autoinjector Carton
NDC 63833-925-01
200 mg
ANDEMBRY
200 mg/1.2 mL
CSL Behring
