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ANDEMBRY Garadacimab 200 mg/1.2mL Injection, Solution, 1 syringe — NDC 63833-0925-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ANDEMBRY Garadacimab 200 mg/1.2mL Injection, Solution, 1 syringe — NDC 63833-925-01 (Billing 63833-0925-01)

by CSL · 1 SYRINGE, GLASS in 1 CARTON / 1.2 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of ANDEMBRY Garadacimab 200 mg/1.2mL Injection, Solution from CSL, marketed since Jun 2025 and currently FDA-listed. It is this product's only package size.

NDC 63833-0925-01
🏷️ FDA NDC (as labeled) 63833-925-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63833-925-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63833 labeler · 925 product · 01 package
Package marketed since
Jun 16, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6383392501 9
Medicaid fills, this package
153 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63833-925-01
Product NDC 63833-925
11-digit billing NDC 63833092501
NCPDP billing unit ML — per mL (volume)
RxCUI 2717175, 2717182
UNII 32W6AJL0DY
Application # BLA761367
SPL Set ID 07b0b671-db81-49f0-a402-0c0219db7fa2
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-06-16
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance GARADACIMAB
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 8583203001D520
GCN Seq No 087872
GCN 57898
HICL code 050645
Ingredient (HICL) Garadacimab-Gxii
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A7
Therapeutic class — intermediate (HIC2) Vasoactive Drugs
HIC3 code A7P
Therapeutic class — specific (HIC3) Factor Xii Inhibitors
AHFS code 24:48.12.00
AHFS class Factor Xiia Inhibitors
FDB label name ANDEMBRY 200 MG/1.2 ML AUTOINJ
FDB brand name Andembry Autoinjector
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087872
  • GCN: 57898
  • GPI-14 (Medi-Span): 8583203001D520
  • HICL (First Databank): 050645
  • AHFS class code: 24:48.12.00
  • RxCUI (RxNorm): 2717175
Why two NDCs? The FDA registers this code as 63833-925-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63833-0925-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Drugs used in hereditary angioedema class.

Drug family (ATC) Drugs used in hereditary angioedema
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ANDEMBRY 200 MG/1.2 ML AUTOINJ Ingredient Garadacimab-Gxii

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $47,663.49 $57,196.19 / 1.2 ml
Medicare drug plans payPart D · Q2 2026 $47,699.63 $57,239.55 / 1.2 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63833-0925-01 You're viewing this Main listing 1 SYRINGE, GLASS in 1 CARTON / 1.2 mL in 1 SYRINGE, GLASS 2025-06-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Andembry 200 mg/1.2mLthis 63833-0925-01 CSL 1 syringe — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Jun 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 16, 2025 ⏳ ~10.7 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Andembrygaradacimab-gxii
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJun 16, 2037
Common questions
Is there a biosimilar for ANDEMBRY 200 MG/1.2 ML AUTOINJ?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCSL
FDA applicationBLA761367 (BLA)
Labeler code63833
First marketedJun 2025
Product typeHuman Prescription Drug

More NDCs from CSL labeler code 63833

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 59 words ▾

1 INDICATIONS AND USAGE 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 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION 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 )

2.1Recommended 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.

2.2Preparation 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] .

💊 Dosage Forms and Strengths 78 words ▾

3 DOSAGE 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 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions 9 words ▾

5 WARNINGS AND PRECAUTIONS None. None. ( 5 )

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS 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.

6.1Clinical 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) ] .

🔄 Drug Interactions 94 words ▾

7 DRUG INTERACTIONS 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 )

7.1Drug 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) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation 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.

8.4Pediatric 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.

8.5Geriatric Use O… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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.

🧒 Pediatric Use 132 words ▾

8.4Pediatric 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.

🧓 Geriatric Use 75 words ▾

8.5Geriatric 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) ] .

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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. The inhibition of FXIIa decreases the activation of prekallikrein to kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in HAE attacks, thus reducing the cascade of events leading to an HAE attack.

12.2Pharmacodynamics Garadacimab-gxii concentration-dependent inhibition of FXIIa-mediated kallikrein activity was observed in patients with HAE. Inhibition of FXIIa-mediated kallikrein activity was observed after the first dose.

12.3Pharmacokinetics 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. Table 2 Garadacimab-gxii Pharmacokinetics Following Subcutaneous Administration The PK of garadacimab-gxii is similar between healthy volunteers and subjects with HAE Parameter Garadacimab-gxii Abbreviations: AUC = area under the plasma concentration-time curve; CI = confidence interval; C max = maximum plasma concentration; C trough,steady state = trough plasma concentration at steady state; T max = time to peak concentration T max is reported as median (range) and absolute bioavailability is reported as estimate (95% CI) Exposure C max 18.4 (7.23) mcg/mL AUC 0-inf 11470 (4103) mcg∙h/mL C trough,Steady State HAE patients enrolled in the VANGUARD trial , Garadacimab-gxii exposure (based on AUC tau and C max ) following the initial subcutaneous administration of loading dose of 400 mg (2 doses of 200 mg) is 133% of steady-state exposures following 200 mg subcutaneous once monthly.

8.09(4.28) to 8.69 (3.93) mcg /mL Absorption Absolute Bioavailability 39 (34, 43)% T max 6 (2, 15) days Distribution Apparent Volume of Distribution 11.8 (5.17) Liters (L) Elimination Half-Life 17.4 (3.14) days Apparent Clearance 0.02 (0.008) L/h Metabolism Primary Pathway Expected to be metabolized into small peptides by catabolic pathways Specific Populations No clinically significant differences in the pharmacokinetics of garadacimab-gxii were observed based on age (age range: 12 to 73 years), gender, race, body weight (range: 43 to 153 kg), and mild to moderate renal impairment (eGFR 30 to <90 mL/min/1.73 m 2 ).

The effect of severe renal impairment (eGFR <30 mL/min/1.73 m 2 ) on garadacimab-gxii pharmacokinetics is unknown. Pediatric Patients No clinically significant difference in garadacimab-gxii C max and AUC tau was observed between pediatric patients (age range: 12 to 17 years) and adults who received the recommended dosage of garadacimab-gxii (200 mg of garadacimab-gxii once monthly). Drug Interactions No dedicated drug interaction studies have been conducted in humans.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of garadacimab-gxii or other garadacimab products. In VANGUARD, 2.6% (1/39) of patients who received garadacimab-gxii tested positive for anti- garadacimab-antibodies during the 6-month treatment period.

The development of ADA against garadacimab-gxii did not affect pharmacokinetics (PK), safety, or clinical response.

🧬 Mechanism of Action 84 words ▾

12.1Mechanism of Action 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. The inhibition of FXIIa decreases the activation of prekallikrein to kallikrein and the generation of bradykinin, which is associated with inflammation and swelling in HAE attacks, thus reducing the cascade of events leading to an HAE attack.

📦 How Supplied / Storage and Handling 147 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 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).

📦 Storage and Handling 47 words ▾

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).

📋 Description 102 words ▾

11 DESCRIPTION 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.

💬 Information for Patients 144 words ▾

17 PATIENT COUNSELING INFORMATION 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).

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics 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. Table 2 Garadacimab-gxii Pharmacokinetics Following Subcutaneous Administration The PK of garadacimab-gxii is similar between healthy volunteers and subjects with HAE Parameter Garadacimab-gxii Abbreviations: AUC = area under the plasma concentration-time curve; CI = confidence interval; C max = maximum plasma concentration; C trough,steady state = trough plasma concentration at steady state; T max = time to peak concentration T max is reported as median (range) and absolute bioavailability is reported as estimate (95% CI) Exposure C max 18.4 (7.23) mcg/mL AUC 0-inf 11470 (4103) mcg∙h/mL C trough,Steady State HAE patients enrolled in the VANGUARD trial , Garadacimab-gxii exposure (based on AUC tau and C max ) following the initial subcutaneous administration of loading dose of 400 mg (2 doses of 200 mg) is 133% of steady-state exposures following 200 mg subcutaneous once monthly.

8.09(4.28) to 8.69 (3.93) mcg /mL Absorption Absolute Bioavailability 39 (34, 43)% T max 6 (2, 15) days Distribution Apparent Volume of Distribution 11.8 (5.17) Liters (L) Elimination Half-Life 17.4 (3.14) days Apparent Clearance 0.02 (0.008) L/h Metabolism Primary Pathway Expected to be metabolized into small peptides by catabolic pathways Specific Populations No clinically significant differences in the pharmacokinetics of garadacimab-gxii were observed based on age (age range: 12 to 73 years), gender, race, body weight (range: 43 to 153 kg), and mild to moderate renal impairment (eGFR 30 to <90 mL/min/1.73 m 2 ).

The effect of severe renal impairment (eGFR <30 mL/min/1.73 m 2 ) on garadacimab-gxii pharmacokinetics is unknown. Pediatric Patients No clinically significant difference in garadacimab-gxii C max and AUC tau was observed between pediatric patients (age range: 12 to 17 years) and adults who received the recommended dosage of garadacimab-gxii (200 mg of garadacimab-gxii once monthly). Drug Interactions No dedicated drug interaction studies have been conducted in humans.

🧬 Pharmacodynamics 26 words ▾

12.2Pharmacodynamics Garadacimab-gxii concentration-dependent inhibition of FXIIa-mediated kallikrein activity was observed in patients with HAE. Inhibition of FXIIa-mediated kallikrein activity was observed after the first dose.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL 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.

Table 3 Demographics and Baseline Characteristics of Patients in the VANGUARD Trial VANGUARD (N=64) Female, n (%) 38 (59) Race, n (%) Asian 6 (9) Black or African American 1 (2) Native Hawaiian or Pacific Islander 1 (2) White 55 (86) Other 1 (2) Hispanic or Latino, n (%) 3 (5) Mean age, years (SD) 41 (16) ≤ 17 years, n (%) 6 (9) > 17 years, n (%) 58 (91) C1-INH HAE Type 1, n (%) 56 (88) Prior HAE prophylaxis Within 3 months before screening , n (%) 21 (33) Baseline HAE attack rate During 2-month period prior to treatment , n (%) 1 to < 3 attacks 26 (41) ≥ 3 attacks 38 (59) 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. Table 4 Rate of Monthly HAE Attack at 6 Months in VANGUARD Rate of Monthly HAE Attack ANDEMBRY (N=39) Placebo (N=25) Abbreviations: CI=confidence interval; HAE=hereditary angioedema; LS=least squares Note: LS means were obtained from a Poisson model accounting for overdispersion with an offset term for time on treatment and fixed effects for treatment group and HAE attack rate over a 2-month period prior to treatment LS mean (95% CI) 0.22 (0.11, 0.47) 2.07 (1.49, 2.87) Percent reduction relative to placebo (95% CI) 89.2 (75.6, 95.2) P-value Obtained from a two-sided Wilcoxon rank sum test at alpha = 5% < 0.001 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.

🧪 Nonclinical Toxicology 72 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of garadacimab-gxii. Fertility and reproductive performance were unaffected in sexually mature male and female rabbits that received garadacimab-gxii at intravenous doses up to 100 mg/kg once every three days (resulting in exposures in male and female rabbits up to approximately 100 and 80 times the MRHD on an AUC basis).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 69 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of garadacimab-gxii. Fertility and reproductive performance were unaffected in sexually mature male and female rabbits that received garadacimab-gxii at intravenous doses up to 100 mg/kg once every three days (resulting in exposures in male and female rabbits up to approximately 100 and 80 times the MRHD on an AUC basis).

📄 Patient Package Insert ~2 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 06/2025 PATIENT INFORMATION ANDEMBRY ® (an-DEM-bree) (garadacimab-gxii) injection, for subcutaneous use Read this Patient Information before you start using ANDEMBRY and each time you get a refill.

There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. What is ANDEMBRY?

ANDEMBRY is a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in children 12 years of age and older. It is not known if ANDEMBRY is safe and effective in children under 12 years of age. Before you use ANDEMBRY, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or planning to become pregnant.

It is not known if ANDEMBRY can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ANDEMBRY passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while using ANDEMBRY.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins and herbal supplements. How should I use ANDEMBRY? See the detailed Instructions for Use that comes with this Patient Information leaflet about the right way to prepare and inject ANDEMBRY.

Use ANDEMBRY exactly as your healthcare provider tells you to use it. ANDEMBRY is given as an injection under your skin (subcutaneous) by you or a caregiver. Your healthcare provider should show you or your caregiver how to prepare and inject your dose of ANDEMBRY before you inject yourself for the first time.

Do not try to inject ANDEMBRY unless you have been trained by your healthcare provider. What are the possible side effects of ANDEMBRY? The most common side effects of ANDEMBRY include: redness, itchiness, and bruising (injection site reactions) stomach (abdominal) pain runny or stuffy nose, sneezing, watery eyes (nasopharyngitis) Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ANDEMBRY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of ANDEMBRY Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ANDEMBRY for a condition for which it is not prescribed.

Do not give ANDEMBRY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ANDEMBRY that is written for healthcare professionals.

What are the ingredients in ANDEMBRY? Active ingredient: garadacimab-gxii Inactive ingredients: arginine monohydrochloride, histidine, polysorbate 80, proline, water for injection. Manufactured for: CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany US License No.

1765 Manufactured by: CSL Behring LLC King of Prussia, PA 19406 US License No. 1767 Distributed by: CSL Behring LLC Kankakee, IL 60901 For Patent information: www.cslbehring.com/products/patents For more information, visit www.ANDEMBRY.com or call 1-866-915-6158.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ANDEMBRY (an-DEM-bree) (garadacimab-gxii) injection, for subcutaneous use Prefilled Autoinjector Important: This autoinjector works differently than other injection devices. Read the Instructions for Use carefully before using it, and each time you get a new autoinjector. There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Children should inject ANDEMBRY under the supervision of an adult. Make sure you have been trained by your healthcare provider before you use this autoinjector for the first time.

Parts of the Autoinjector ( see Figure A ): Continue to the next sections to prepare and perform the injection. Figure A Read the Following Safety Information: Keep the autoinjector in its original carton box until use, to protect it from light. Do not remove the clear autoinjector cap until you are ready to inject.

Do not put the clear autoinjector cap back on the autoinjector after it has been removed because this could start the injection and cause injury. The autoinjector contains 1 dose and is for one time use only. Do not try to reuse the same autoinjector.

Do not use the autoinjector if the expiration date has passed. The autoinjector is for subcutaneous (under the skin) injection only. Do not use the autoinjector if it has dropped, looks damaged, has cracks, or is leaking medicine.

Throw away the autoinjector as described in Step 11 and use a new one. Do not inject through clothing. Do not touch or try to remove the gray needle shield at any time.

Keep ANDEMBRY and all medicines out of reach of children. Contact your healthcare provider if you have any questions. How Should I Store ANDEMBRY?

Store ANDEMBRY autoinjector in a refrigerator, between 36°F to 46°F (2°C to 8°C) in its original carton box until use, to protect it from light. Do not shake Do not freeze. If the autoinjector has been frozen, do not use the autoinjector even if it is thawed.

The refrigerated autoinjector may be used until the expiration date (EXP) printed on the label. Take the autoinjector out of the refrigerator 30 minutes before use, allowing it to reach room temperature. Do not put the autoinjector back in the refrigerator after it has reached room temperature.

Supplies needed for your Autoinjector Injection ( see Figure B ): Included in the carton box: 1 Single-dose autoinjector Required supplies but not included in the carton box: 1 Alcohol pad 1 Cotton ball or gauze pad 1 FDA-cleared sharps container or puncture-resistant container for disposal (see Step 11. Disposing of the Autoinjector ) Figure B Preparing for an Injection Do not remove the clear autoinjector cap until immediately before the injection. Step 1.

Let the Autoinjector Reach Room Temperature Remove the autoinjector from the carton box and place it laying down on a clean flat surface. Wait 30 minutes for the medicine to reach room temperature after taking it out of the refrigerator (see Figure C ). Injecting the medicine cold could be uncomfortable.

Do not try to speed up the warming process in any way. For example, do not warm it in a microwave, in hot water, or leave it in direct sunlight. Figure C Step 2.

Check the Expiration Date Check the expiration date on the autoinjector label (see Figure D ). Do not use the autoinjector if the expiration date has passed. If the expiration date has passed, then safely dispose of the autoinjector and get a new one (see Step 11.

Disposing of the Autoinjector ). Figure D Step 3. Inspect the autoinjector and the medicine Check the autoinjector for damage .

Check the medicine through the viewing window of the autoinjector (see Figure E ). It is normal to see air bubbles, do not try to remove the air bubbles . The medicine should be brownish-yellow to yellow and may appear slightly opalescent to clear.

Do not use the autoinjector, safely dispose and get a new one (see Step 11. Disposing of the Autoinjector ) if : The medicine i… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 104 words ▾

PRINCIPAL DISPLAY PANEL - 200 mg Autoinjector Label NDC 63833-925-20 200 mg 1.2 mL ANDEMBRY ® garadacimab-gxii injection 200 mg/1.2 mL For Subcutaneous Use 1 single-dose Prefilled Autoinjector Rx only Manufactured by: CSL Behring LLC King of Prussia, PA 19406 USA US License No. 1767 LOT 0000000000 EXP MMM YYYY Read the instructions before use 41126 PRINCIPAL DISPLAY PANEL - 200 mg Pen Label

PRINCIPAL DISPLAY PANEL - 200 mg Autoinjector Carton NDC 63833-925-01 200 mg 1.2 mL ANDEMBRY ® garadacimab-gxii injection 200 mg/1.2 mL For Subcutaneous Use 1 single-dose Prefilled Autoinjector Rx only CSL Behring PRINCIPAL DISPLAY PANEL - 200 mg Pen Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q1 2026 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
153
Units reimbursed last 4 qtrs
203
Gross reimbursed last 4 qtrs
$9.68M
Avg / prescription
$63,239.79
Avg / unit
$47,710.49
Latest quarter Q1 2026
99Rx
Fee-for-service vs managed care ⓘ
72% FFS 28% MCO
Fee-for-service · 110 Rx Managed care · 43 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 48 units · 0.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 14 units · 0.1 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 40 units · 0.1 per 100k residents CA Utah: no data reported UT Colorado: 56 units · 1.0 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 44 units · 0.2 per 100k residents FL
Units reimbursed · per 100k residents
0.11.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Colorado 1.0 /100k
2 New York 0.2 /100k
3 Florida 0.2 /100k
4 Pennsylvania 0.1 /100k
5 California 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ANDEMBRY (this brand).

Top reported reactions

Hereditary Angioedema344
Stress46
Weight Decreased38
Weight Increased36
Fatigue33
Therapy Interrupted33
Insurance Issue31

Age at onset

Adolescent5
Adult83
Elderly17

Reporter sex

507 reports
Male · 22%
Female · 78%

Serious outcomes

Hospitalization127
Life-threatening27
Death3
Disabling2
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 265 3
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CSL. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CSL is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63833-0892-51 · CSL 63850-0003-01 · Natco →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.