Garadacimab

Garadacimab-gxii is an inhibitor of activated FXII that binds to the catalytic domain of activated Factor XII (FXIIa and βFXIIa) and inhibits its catalytic activity. FXII is the first factor activated in the contact activation pathway and initiates the inflammatory bradykinin-producing kallikrein-kinin system.

• ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

• None. None.contraindicated

Recommended Dosage : Initial loading dose of 400 mg (two 200 mg injections) administered subcutaneously followed by maintenance dosage of 200 mg once monthly. ( 2.1 ) Subcutaneous use only. ( 2.2 ) Patients may self-administer. See full prescribing information for preparation and administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of ANDEMBRY is an initial loading dose of 400 mg (two injections of 200 mg) administered subcutaneously on the first day of treatment followed by a maintenance dosage of 200 mg administered subcutaneously every month. Missed Dose(s) If a dose of ANDEMBRY is missed, administer the dose as soon as possible. 2.2 Preparation and Administration Instructions for ANDEMBRY Prefilled Autoinjector and Prefilled Syringe with Needle Safety Device For subcutaneous use only. ANDEMBRY is intended for self-administration or administration by a caregiver. Prior to treatment initiation, train patients/caregivers on proper preparation and subcutaneous (SC) administration technique of ANDEMBRY [see Instructions for Use ] . Prior to administration, remove ANDEMBRY from the refrigerator and allow to sit for 30 minutes at room temperature before use. Inspect ANDEMBRY visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ANDEMBRY is a slightly opalescent to clear, brownish-yellow to yellow solution. Administer ANDEMBRY subcutaneously into the thigh or abdomen ensuring to stay 1 inch (2 cm) away from the navel.

None. None. ( 5 )

Most common adverse reactions (incidence ≥ 7%) are nasopharyngitis and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring at 1-866-915-6958 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 ANDEMBRY reflects the exposure in a total of 164 adult and pediatric patients aged 12 years and older with hereditary angioedema (HAE) from a placebo-controlled study, VANGUARD [see Clinical Studies (14) ] , and an open-label clinical study. Among the 164 patients who received at least one dose of ANDEMBRY 200 mg subcutaneously, 153 (93%) patients were exposed for at least one year. The median duration of ANDEMBRY treatment was 2.6 years. The safety data below is based on the 6-month placebo-controlled study (VANGUARD), in which ANDEMBRY 400 mg was administered subcutaneously as a loading dose followed by 200 mg (N=39) every month in patients with HAE. Demographics of the patients in this study are summarized in Clinical Studies [see Clinical Studies (14) ]. The safety of ANDEMBRY was similar across all subgroups of patients, including analysis by age, sex and geographic region. Table 1 provides the most common adverse reactions with ANDEMBRY with incidence ≥7% and more common than placebo.

8.1 Pregnancy Risk Summary There are no available data on ANDEMBRY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies such as garadacimab-gxii are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In an embryo-fetal development study in pregnant rabbits, garadacimab-gxii produced no evidence of fetal harm at doses up to approximately 100 times the exposure achieved at the maximum recommended human dose (MRHD) of 200 mg once monthly. In a pre- and post-natal development study in rabbits, garadacimab-gxii had no effects on survival, growth, or development of F 1 offspring at doses resulting in approximately 76 times the exposure achieved at the MRHD (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

The pharmacokinetics of garadacimab-gxii are provided in Table 2 following subcutaneous administration of a single 200 mg dose to healthy volunteers and are presented as mean (SD), unless otherwise specified.

• Jun 16, 2025BLABLA761367Csl Behring Llc

1. 1Hereditary Angioedema21268%
2. 2Drug Ineffective4113%
3. 3Product Dose Omission Issue3210%
4. 4Stress278.7%
5. 5Abdominal Pain237.4%
6. 6Weight Decreased237.4%
7. 7Weight Increased237.4%
8. 8Product Use Issue227.1%
9. 9Pain206.4%
10. 10Swelling206.4%
11. 11Fatigue196.1%
12. 12Insurance Issue196.1%
13. 13Nausea196.1%
14. 14Malaise185.8%
15. 15Headache175.5%

The 10 most recently updated of 10 ClinicalTrials.gov registrations naming Garadacimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
  Recruiting · Observational · 200 enrolled · CSL Behring
  NCT07001280updated 2026-06-03
• CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
  Completed · Phase 3 · Interventional · 22 enrolled · CSL Behring
  NCT05819775updated 2026-06-02
• Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
  Completed · Phase 3 · Interventional · 171 enrolled · CSL Behring
  NCT04739059updated 2026-06-02
• Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab
  Active not recruiting · Phase 4 · Interventional · 18 enrolled · CSL Behring
  NCT06806657updated 2026-05-14
• Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study
  Available · Expanded access · CSL Behring
  NCT07159464updated 2025-09-08
• Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
  Completed · Phase 2 · Interventional · 81 enrolled · CSL Behring
  NCT05130970updated 2024-12-13
• CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
  Completed · Phase 3 · Interventional · 64 enrolled · CSL Behring
  NCT04656418updated 2023-06-29
• A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults
  Completed · Phase 1 · Interventional · 38 enrolled · CSL Behring
  NCT04580654updated 2022-10-04
• Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
  Completed · Phase 2 · Interventional · 124 enrolled · CSL Behring
  NCT04409509updated 2022-01-24
• A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line
  Withdrawn · Phase 1 · Phase 2 · Interventional · 0 enrolled · CSL Behring
  NCT04281524updated 2020-03-25

Frequently asked questions

How does Garadacimab work?

Garadacimab-gxii is an inhibitor of activated FXII that binds to the catalytic domain of activated Factor XII (FXIIa and βFXIIa) and inhibits its catalytic activity. FXII is the first factor activated in the contact activation pathway and initiates the inflammatory bradykinin-producing kallikrein-kinin system.

What is Garadacimab used for?

According to FDA labeling, Garadacimab carries indications including: ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Garadacimab?

Garadacimab is classified as Drugs used in hereditary angioedema, Kallikrein Inhibitors, Coagulation Factor Alteration, Decreased Bradykinin Production.

What are the brand names for Garadacimab?

Garadacimab is marketed under brand names including Andembry.

What are the contraindications for Garadacimab?

Garadacimab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.