UpToDate خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده:
4
September 2025
Hereditary angioedema, prophylaxis : SUBQ: Initial: 400 mg as a single loading dose, followed by 200 mg once monthly.
Missed dose: If a dose is missed, administer dose as soon as possible.
eGFR ≥30 mL/min/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling.
eGFR <30 mL/min/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Garadacimab: Pediatric drug information")
Hereditary angioedema, prophylaxis:
Children ≥12 years and Adolescents: SUBQ: 400 mg once as a single loading dose, followed by maintenance dosing of 200 mg once monthly.
There are no dosage adjustments provided in the manufacturer's labeling. Mild to moderate kidney impairment (eGFR 30 to <90 mL/minute/1.73 m2) does not alter pharmacokinetics; however, the effect of severe impairment (eGFR <30 mL/minute/1.73 m2) is unknown.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
>10%:
Hematologic & oncologic: Prolonged prothrombin time (including increased INR)
Respiratory: Nasopharyngitis
1% to 10%:
Gastrointestinal: Abdominal pain
Hematologic & oncologic: Prolonged partial thromboplastin time
Immunologic: Antibody development
Frequency not defined: Local: Injection-site reaction (including bruising at injection site, erythema at injection site, hematoma at injection site, injection-site pruritus, urticaria at injection site)
There are no contraindications listed in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Auto-injector, Subcutaneous [preservative free]:
Andembry: Garadacimab-gxii 200 mg/1.2 mL (1.2 mL) [contains polysorbate 80]
No
Solution Auto-injector (Andembry Subcutaneous)
200 mg/1.2 mL (per mL): $57,100.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
For SUBQ administration only. Following proper training by a health care provider; autoinjector or prefilled syringes may be self-administered or administered by a caregiver. Prior to administration, allow to come to room temperature for 30 minutes. Do not warm using a heat source (eg, microwave, hot water). Do not shake. Administer in upper arm (caregiver administration only), abdomen (avoiding 2 inches around the navel), or thigh. Administer the 400 mg loading dose as 2 injections of 200 mg, one after another. Rotate injection site with each injection. Do not inject into moles, scars, bruises, or into areas where the skin is red, hard, or injured.
SUBQ: Note: Following proper training by a health care provider, autoinjector or prefilled syringes may be self-administered or administered by a caregiver.
Remove device (prefilled syringe or autoinjector) from refrigerator and allow to sit for 30 minutes at room temperature; do not warm product in any other way. Solution should be clear to slightly opalescent, brownish yellow to yellow. Discard if device is damaged, has cracks, is leaking, has been dropped, or if solution is discolored or contains particles. Do not shake. Administer SUBQ into the thigh or abdomen (avoid 2 cm area around navel). May administer in upper arm if administered by caregiver. Rotate the injection site with each injection. Do not administer into belly button, moles, scars, or bruises, or into areas where the skin is tender, red, hard, or injured.
Autoinjector: Pinch skin and hold firmly until injection is complete. Place autoinjector at a 90° angle and press firmly into skin; the first click means administration has started. Keep skin pinched and autoinjector pressed firmly into skin. The viewing window on the autoinjector will turn yellow as the plunger moves through; a second click will be heard. Keep pressing autoinjector down for an additional 5 seconds after second click to ensure delivery of entire dose; once viewing window has turned yellow and plunger has stopped moving, autoinjector may be removed. Injection may take up to 15 seconds to complete administration. Do not tilt, turn, or remove autoinjector from skin during administration. Release pinched skin and discard autoinjector. Do not rub injection site.
Prefilled syringe: Pinch skin and hold firmly until injection is complete. Insert needle at an angle between 45° and 90°; do not change angle during the injection. Do not hold or push plunger while inserting the needle. Inject medication by firmly pushing the plunger all the way down to ensure delivery of full dose. Remove thumb slowly from plunger; this causes needle to retract. Release pinched skin and remove syringe from injection site. Do not rub injection site. Discard syringe after use.
Hereditary angioedema, prophylaxis: Prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients ≥12 years of age.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Nipocalimab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Rozanolixizumab: May decrease therapeutic effects of Fc Receptor-Binding Agents. Risk C: Monitor
Based on data from animal reproduction studies, garadacimab showed no evidence of fetal harm and had no effects on offspring survival, growth, or development at doses up to ~76 to 100 times the exposure achieved at the maximum recommended human dose of 200 mg once monthly.
Garadacimab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
It is not known if garadacimab is present in breast milk; however, garadacimab is a humanized immunoglobulin G4 monoclonal antibody (IgG4); maternal IgG is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Garadacimab is a fully human monoclonal immunoglobulin G4 antibody against activated factor XII (FXIIa). Inhibition of FXIIa decreases the activation of the plasma kallikrein-kinin system, thereby reducing the overproduction of bradykinin responsible for triggering hereditary angioedema attacks (Craig 2023; manufacturer’s labeling).
Onset: Inhibition of FXIIa-mediated kallikrein activity observed after first dose.
Distribution: Vd: 11.8 L (SD: 5.17 L).
Metabolism: Expected to be metabolized into small peptides by catabolic pathways.
Bioavailability: ~39%.
Half-life elimination: 17.4 days (SD: 3.14 days).
Time to peak: Median: 6 days; Range: 2 to 15 days.
Excretion: Clearance: 0.02 L/hour.
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