Garetosmab
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation and Administration Instructions Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PASATRU is a clear to slightly opalescent, colorless to pale yellow solution. Discard the vial if the solution is cloudy, discolored, or contains particulate matter.
Each vial is intended for one-time use only. Do not shake the vial. Withdraw the required volume from the vial(s) of PASATRU and transfer into an intravenous infusion bag [polyvinyl chloride (PVC), polyolefin (PO), or ethyl vinyl acetate (EVA)] containing a minimum of 50 mL and a maximum of 100 mL of 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 0.9 mg/mL to 25 mg/mL.
Mix the diluted solution by gentle inversion. Do not shake the solution. Discard any unused portion left in the vial. Storage of Infusion Solution Use diluted PASATRU immediately. If not used immediately, store the diluted solution refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours or at room temperature up to 25°C (77°F) for no more than 16 hours from the time of preparation to the start of infusion.
Do not freeze the diluted solution. Administration If refrigerated, allow the diluted solution to come to room temperature prior to administration. Administer PASATRU diluted solution by intravenous infusion over 60 minutes using an infusion set constructed of PVC, polyethylene (PE)-lined PVC, or polyurethane (PU). A sterile, in-line or add-on, 0.2-micron to 5-micron polyethersulfone (PES) or polyamide (PA) filter is recommended.
PASATRU should be administered using an infusion pump to control the rate of infusion. Upon completion of the PASATRU infusion, flush the infusion line with an adequate volume of sterile 5% Dextrose Injection, USP to ensure that the entire contents of the infusion bag are administered. Do not mix other drugs with PASATRU or administer other drugs concomitantly via the same infusion line.
Contraindications
4 CONTRAINDICATIONS PASATRU is contraindicated during pregnancy. PASATRU can cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ] . Pregnancy. ( 4 , 5.1 , 8.1 , 8.3 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for garetosmab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary PASATRU is contraindicated for use during pregnancy. Based on its mechanism of action and data from animal reproduction studies, PASATRU can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on PASATRU during pregnancy to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Although there are no data on PASATRU exposure during pregnancy, monoclonal antibodies can be actively transported across the placenta.
Inhibition of activin A signaling by PASATRU during pregnancy may adversely affect embryogenesis and fetal organogenesis, including development of the reproductive system (see Clinical Considerations ) . In an enhanced pre- and post-natal developmental (ePPND) toxicity study, intravenous administration of garetosmab-grts to pregnant cynomolgus monkeys resulted in developmental toxicity, including post-natal malformations, neurobehavioral deficits, and infant mortality at exposures equivalent to or higher than those in patients at the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively ( see Data ).
If pregnancy occurs during treatment with PASATRU, discontinue treatment immediately, and advise the patient to contact their healthcare provider. The background risk of major birth defects and miscarriage for the indicated population 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.
Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, it is expected that PASATRU may be present in infants exposed in utero. The potential clinical impact of PASATRU exposure in infants exposed in utero should be considered. Data Animal Data In an ePPND toxicity study, pregnant cynomolgus monkeys were administered intravenous doses of garetosmab-grts 5 mg/kg or 50 mg/kg once weekly beginning from gestation day 20 through delivery, with no evidence of maternal toxicity at either dose level.
An increased incidence of post-natal malformations, including neurological deficiencies and testes malformations, were observed in offspring at 5 mg/kg/week (approximately equivalent to or 4 times the recommended human doses of…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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