Mediclarum
Medicine guide

Andembry

200 mg/1.2mL · Injection, Solution

  • Prescription only
Active substance
Garadacimab
Made by
CSL

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-06-30

Used for
  • ANDEMBRY is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.
The label’s usual adult dose

Initial loading dose of 400 mg (two 200 mg injections) administered subcutaneously followed by maintenance dosage of 200 mg once monthly.

Full directions ↓
Do not take it if

None. None. ( 4 )

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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.
  • ( 1 )

From the official label · 2025-06-30 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-06-30

Do not take it if

None. None. ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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.
  • The upper arm can also be used if a caregiver administers the subcutaneous injection.
  • Discard the used ANDEMBRY into a sharps disposal container (closed puncture-resistant container).
  • For detailed instructions on the preparation and administration of ANDEMBRY [see Instructions for Use] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

None. None. ( 5 )

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • 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.
  • Data Animal Data In an embryo-fetal development study in pregnant rabbits dosed by the intravenous route every 3 days during the period of organogenesis from gestation days 6 to 18, garadacimab-gxii produced no evidence of fetal harm or maternal toxicity at doses resulting in approximately 100 times the exposure achieved at the MRHD (on an AUC basis with maternal intravenous doses up to 100 mg/kg/dose).
  • In a pre- and post-natal development study in rabbits dosed by the intravenous or subcutaneous route once every 5 days from the end of implantation (Gestation Day 7) to postpartum day 38 (end of the lactation period), 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 (on an AUC basis with a maternal intravenous dose of 100 mg/kg/dose).
  • There was no evidence of maternal toxicity.
  • Garadacimab-gxii crossed the placenta in rabbits.
  • With a maternal dose of 100 mg/kg garadacimab-gxii on gestation day 29, fetal plasma concentrations were 40.8% of maternal concentrations following subcutaneous administration and approximately equivalent following intravenous administration.
  • IN SPECIFIC POPULATIONS
  • 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.
  • Data Animal Data In an embryo-fetal development study in pregnant rabbits dosed by the intravenous route every 3 days during the period of organogenesis from gestation days 6 to 18, garadacimab-gxii produced no evidence of fetal harm or maternal toxicity at doses resulting in approximately 100 times the exposure achieved at the MRHD (on an AUC basis with maternal intravenous doses up to 100 mg/kg/dose).
  • In a pre- and post-natal development study in rabbits dosed by the intravenous or subcutaneous route once every 5 days from the end of implantation (Gestation Day 7) to postpartum day 38 (end of the lactation period), 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 (on an AUC basis with a maternal intravenous dose of 100 mg/kg/dose).
  • There was no evidence of maternal toxicity.
  • Garadacimab-gxii crossed the placenta in rabbits.
  • With a maternal dose of 100 mg/kg garadacimab-gxii on gestation day 29, fetal plasma concentrations were 40.8% of maternal concentrations following subcutaneous administration and approximately equivalent following intravenous administration.
  • 8.2 Lactation Risk Summary There are no data on the presence of garadacimab-gxii or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.
  • Maternal IgG is known to be present in human milk.
  • The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to garadacimab-gxii are unknown.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ANDEMBRY and any potential adverse effects on the breastfed infant from ANDEMBRY or the underlying maternal condition.
  • 8.4 Pediatric Use The safety and effectiveness of ANDEMBRY for prophylaxis to prevent attacks of HAE have been established in pediatric patients aged 12 years and older.
  • Use of ANDEMBRY for this indication is supported by evidence from a total of 6 pediatric patients aged 12 years and older enrolled in VANGUARD who received treatment with ANDEMBRY 400 mg loading dose administered subcutaneously followed by a maintenance dosage of 200 mg subcutaneously every month (n=4) or placebo (n=2).
  • Results of the subgroup analysis for pediatric patients aged 12 years and older were consistent with study results for adult patients [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ].
  • The safety and effectiveness of ANDEMBRY have not been established in pediatric patients younger than 12 years of age.
  • 8.5 Geriatric Use Of the total number of ANDEMBRY-treated patients in the clinical study for prophylaxis to prevent attacks of HAE, 6 (9%) were 65 years of age and older [see Clinical Studies (14) ] .
  • No overall differences in safety or effectiveness of ANDEMBRY have been observed between patients 65 years of age and older and younger adult patients [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Drug Interference with Laboratory Test:
  • ANDEMBRY can prolong activated partial thromboplastin time (aPTT) due to an interaction of garadacimab-gxii with the aPTT assay.
  • ( 7.1 )
  • 7.1 Drug Interference with Laboratory Test Coagulation Tests ANDEMBRY can prolong activated partial thromboplastin time (aPTT) due to an interaction of garadacimab-gxii with the aPTT assay.
  • The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of FXII in the contact system, therefore inhibition of plasma FXIIa by ANDEMBRY can prolong aPTT in this assay [see Adverse Reactions (6.1) ] .

Quoted from the official label, section “Drug Interactions”.

Use in children

  • The safety and effectiveness of ANDEMBRY for prophylaxis to prevent attacks of HAE have been established in pediatric patients aged 12 years and older.
  • Use of ANDEMBRY for this indication is supported by evidence from a total of 6 pediatric patients aged 12 years and older enrolled in VANGUARD who received treatment with ANDEMBRY 400 mg loading dose administered subcutaneously followed by a maintenance dosage of 200 mg subcutaneously every month (n=4) or placebo (n=2).
  • Results of the subgroup analysis for pediatric patients aged 12 years and older were consistent with study results for adult patients [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ].
  • The safety and effectiveness of ANDEMBRY have not been established in pediatric patients younger than 12 years of age.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Of the total number of ANDEMBRY-treated patients in the clinical study for prophylaxis to prevent attacks of HAE, 6 (9%) were 65 years of age and older [see Clinical Studies (14) ] .
  • No overall differences in safety or effectiveness of ANDEMBRY have been observed between patients 65 years of age and older and younger adult patients [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .

Quoted from the official label, section “Geriatric Use”.

Side effects

  • 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.
  • Table 1 Adverse Reactions with ANDEMBRY with Incidence ≥7% and More Common than Placebo in Patients with HAE (VANGUARD) Adverse Reactions ANDEMBRY (N=39) Placebo (N=25) n (%) n (%) Nasopharyngitis Consists of nasopharyngitis, rhinitis, and upper respiratory infections 8 (21) 3 (12) Abdominal Pain Consists of abdominal pain and abdominal pain lower 3 (8) 0 Specific Adverse Reaction(s):
  • Injection Site Reactions In VANGUARD and an open-label clinical study, which included 57 patients who rolled over from VANGUARD, 164 patients with HAE received ANDEMBRY 200 mg subcutaneously every month.
  • Injection site reactions (e.g., injection site bruising, injection site erythema, injection site hematoma, injection site pruritus, injection site urticaria) were reported in 23 (14%) patients.
  • Laboratory Abnormalities:
  • Prolonged Coagulation Tests (aPTT and PT) In the VANGUARD trial, the incidence of prolonged activated partial thromboplastin time (aPTT), defined as >1.4×ULN, was 3 (8%) patients in the ANDEMBRY group compared to 0 patients in the placebo group.
  • Additionally, the incidence of prolonged prothrombin time (PT) or international normalized ratio (INR), defined as >1.3× ULN, was 6 (15%) patients in the ANDEMBRY group compared to 1 (4%) patient in the placebo group.
  • None of the increases in aPTT, PT and INR were associated with bleeding events [see Drug Interactions (7.1) ] .

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Administration Instructions Instruct patients that ANDEMBRY is for subcutaneous use and intended for self-administration or administration by caregiver.
  • Instruct patients and/or caregivers on the proper preparation and subcutaneous administration techniques of ANDEMBRY [see Dosage and Administration (2.2) and Instructions for Use ] .
  • Instruct patients and/or caregivers to administer ANDEMBRY subcutaneously into the upper arm, thigh or abdomen ensuring to stay 1 inch (2 cm) away from the navel [see Dosage and Administration (2.2) ] .
  • Instruct patients or caregivers in proper disposal technique for prefilled autoinjector or prefilled syringe with needle safety device and advise them not to reuse these items.
  • Instruct patients to dispose of the prefilled autoinjector or prefilled syringe with needle safety device in a sharps disposal container (closed puncture-resistant container).

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • 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 Injection:
  • 200 mg/1.2 mL solution in single-dose prefilled autoinjector ( 3 ) 200 mg/1.2 mL (167 mg/mL) solution in single-dose prefilled syringe with needle safety device ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • How Supplied ANDEMBRY (garadacimab-gxii) injection is a ready-to-use, slightly opalescent to clear, brownish-yellow to yellow solution in the following presentations, supplied in single-dose prefilled autoinjector or prefilled syringe with needle safety device.
  • Table 5 provides the available presentations and strengths of ANDEMBRY.
  • Table 5 Presentations and Strengths for ANDEMBRY Presentation Strength Unit Count NDC (Device) NDC (Carton) Prefilled autoinjector 200 mg/1.2 mL 1 63833-925-20 63833-925-01 Prefilled syringe with needle safety device 200 mg/1.2 mL (167 mg/mL) 1 63833-920-20 63833-920-01 Each single-dose prefilled autoinjector or prefilled syringe with needle safety device is supplied in a carton.
  • Storage and Handling Do not freeze.
  • Do not shake.
  • Keep the prefilled autoinjector and prefilled syringe with needle safety device in the original carton to protect from light.
  • Store the prefilled autoinjector and prefilled syringe with needle safety device refrigerated at 36°F to 46°F (2°C - 8°C).

Quoted from the official label, section “How Supplied”.

How to store it

  • Do not freeze.
  • Do not shake.
  • Keep the prefilled autoinjector and prefilled syringe with needle safety device in the original carton to protect from light.
  • Store the prefilled autoinjector and prefilled syringe with needle safety device refrigerated at 36°F to 46°F (2°C - 8°C).

Quoted from the official label, section “Storage and Handling”.

What is in it

  • Garadacimab-gxii, an activated Factor XII (FXIIa) inhibitor, is a recombinant, fully human, monoclonal antibody (IgG4/ λ -light chain) produced in Chinese Hamster Ovary (CHO) cells.
  • Based on the amino acid sequence, the molecular weight of garadacimab-gxii is approximately 148 kDa.
  • 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.

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (1)

SpainNo exact match for this strength and form

Every strength and form (1)

CanadaNo exact match for this strength and form

Every strength and form (2)

NetherlandsNo exact match for this strength and form

Every strength and form (2)

Details

Made byCSL
Active substanceGaradacimab
Strength200 mg/1.2mL
FormInjection, Solution
RouteSubcutaneous
Packs1 SYRINGE, GLASS in 1 CARTON / 1.2 mL in 1 SYRINGE, GLASS
NDC63833-925

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page