ANDEMBRY Garadacimab 200 mg/1.2mL Injection, Solution, 1 syringe
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Drugs used in hereditary angioedema class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Garadacimab-gxii is used to prevent hereditary angioedema (HAE) attacks (genetic condition causing recurring episodes of painful swelling in the face, limbs, airway and GI tract). Garadacimab-gxii is in a class of medications called monoclonal antibodies. It works by blocking certain substances in the body that are responsible for producing the symptoms of angioedema.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $47,604.78 | $57,125.74 / 1.2 ml |
| Medicare drug plans payPart D · Q2 2026 | $47,699.63 | $57,239.55 / 1.2 ml |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Andembry 200 mg/1.2mLthis 63833-0925-01 | CSL | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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.
🛈 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.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Jun 16, 2037 |
Is there a biosimilar for ANDEMBRY 200 MG/1.2 ML AUTOINJ?
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🗺️ Medicaid utilization & spend
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63833-0925-01 You're viewing this | 1 SYRINGE, GLASS in 1 CARTON (63833-925-01) / 1.2 mL in 1 SYRINGE, GLASS (63833-925-20) | 2025-06-16 | Active |
🧭 About this NDC listing & data coverage
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 |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS None. None. ( 5 )
🤒 Adverse Reactions ▾
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 ▾
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 ▾
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.
8.5 Geriatric Use O…
🤰 Pregnancy ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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).