Zolbetuximab
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From MedlinePlus, U.S. National Library of Medicine
Claudin 18.2-directed Cytolytic Antibody
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
Prepare this dose
Your numbers for zolbetuximab. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
Prior to Administration If a patient is experiencing nausea and/or vomiting prior to administration of VYLOY, the symptoms should be resolved to Grade ≤1 before administering the first infusion. Premedication Prior to each infusion of VYLOY, premedicate patients with a combination of antiemetics (e.g., NK-1 receptor blockers and/or 5-HT3 receptor blockers, as well as other drugs as indicated) for the prevention of nausea and vomiting [see Warnings and Precautions].
Preparation Reconstitution
Calculate the recommended dose based on the patient’s body surface area as described in Section 2.3 to determine the total volume and number of vials needed.
Reconstitute each vial of VYLOY to achieve a concentration of 20 mg/mL as follows: o 100 mg vial add 5 mL of Sterile Water for Injection. o 300 mg vial add 15 mL of Sterile Water for Injection.
Slowly add the Sterile Water for Injection into the VYLOY vial, and direct the stream toward the inside wall of the vial. Do not inject directly onto the lyophilized powder.
Slowly swirl each vial until the contents are completely dissolved. Allow the reconstituted vial(s) to settle until the bubbles are gone. Do not shake the vial .
Visually inspect the reconstituted solution for particulate matter and discoloration. The reconstituted solution should be clear to slightly opalescent, colorless to slight yellow and free of visible particles. Discard any vial with visible particles or discoloration.
Store reconstituted vial(s) at room temperature 15°C to 30°C (59°F to 86°F) for up to 5 hours if not used immediately. This product does not contain a preservative . Dilution
Withdraw the required volume of reconstituted VYLOY vial(s) and transfer into an infusion bag containing 0.9% Sodium Chloride Injection, to a final concentration of 5 mg/mL. o The diluted solution of VYLOY is compatible with intravenous infusion bags composed of polyethylene (PE), polypropylene (PP), polyvinyl chloride (PVC) [with either Di(2-ethylhexyl) phthalate (DEHP) or, Trioctyl trimellitate (TOTM) plasticizers], ethylene propylene copolymer, ethylene-vinyl acetate (EVA) copolymer, PP and styrene-ethylene-butylene-styrene copolymer. o The diluted solution of VYLOY is compatible with infusion tubing composed of PE, PVC [with DEHP, TOTM or Di(2-ethylhexyl) terephthalate plasticizers], polybutadiene (PB), or elastomer modified polypropylene with in-line filter membranes composed of polyethersulfone (PES) or polysulfone.
Mix diluted solution by gentle inversion. Do not shake the bag .
Visually inspect the infusion bag for any particulate matter prior to use. The diluted solution should be free of visible particles. Do not use the infusion bag if particulate matter is observed.
Discard any unused portion left in the single-dose vials. Storage of diluted infusion
Store the prepared infusion bag: o At room temperature 15°C to 30°C (59°F to 86°F) for no longer than 6 hours from the end of the preparation of the infusion bag to the completion of the infusion. o Under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 16 hours from the end of the preparation of the infusion bag to the completion of the infusion.
Do not freeze.
Administration
Administer VYLOY as an intravenous infusion only. Do NOT administer as an intravenous push or bolus.
If VYLOY and fluoropyrimidine- and platinum-containing chemotherapy are administered on the same day, VYLOY must be administered first.
No incompatibilities have been observed with o closed system transfer devices composed of PP, PE, stainless steel, silicone (rubber/oil/resin), polyisoprene, PVC with TOTM plasticizer, acrylonitrile-butadiene-styrene (ABS) copolymer, methyl methacrylate-ABS copolymer, thermoplastic elastomer, polytetrafluoroethylene, polycarbonate, PES, acrylic copolymer, polybutylene terephthalate, PB, or EVA copolymer. o central ports composed of silicone rubber, titanium alloy or PVC with TOTM plasticizer.
In-line filters (pore size of 0.2 μm composed of materials listed above) are recommended to be used during administration.
Do NOT co-administer other drugs through the same infusion line.
Immediately administer the infusion as described in Table 2 . To minimize the risk of adverse reactions, begin each infusion at a slower rate for 30 to 60 minutes; if tolerated, gradually increase the rate as described in Table 2 .
If the infusion time exceeds the recommended storage time (6 hours from end of preparation of infusion solution at room temperature or 16 hours from end of preparation of infusion solution under refrigeration), the infusion bag must be discarded and a new infusion bag prepared to continue the infusion. Infusion Rate Recommendations [See table below.]
| Adverse Reaction | SeverityToxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0). | Dose Modification |
| Hypersensitivity or Infusion-related reactions [see Warnings and Precautions (5.1)]. | Grade 2 | |
| Grade 3Follow Grade 2 management for Grade 3 infusion-related nausea and vomiting. or 4 or anaphylaxis |
| VYLOY Dose | Initial Infusion Rate(first 30-60 minutes)In the absence of adverse reactions after 30 to 60 minutes, the infusion rate can be increased to the subsequent infusion rate as tolerated. | Subsequent Infusion Rate | |
| First Dose | 800 mg/m2 | 100 mg/m2/hr | 200-265 mg/m2/hr |
| Subsequent Doses | 600 mg/m2 every 3 weeks | 75 mg/m2/hr | 150-265 mg/m2/hr |
| or | or | or | |
| 400 mg/m2 every 2 weeks | 50 mg/m2/hr | 100-200 mg/m2/hr | |
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data with VYLOY use in pregnant women to inform any drug-associated risks. Embryo-fetal toxicity was not observed in pregnant mice intravenously administered zolbetuximab-clzb [see Data] . VYLOY should only be given to a pregnant woman if the benefit outweighs the potential risk. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Data Animal Data In an embryo-fetal development toxicity study, zolbetuximab-clzb was intravenously administered to pregnant mice during the period of organogenesis and did not result in embryo-fetal toxicity at doses up to 300 mg/kg (approximately 1.9 times the recommended clinical dose based on AUC). Zolbetuximab-clzb crossed the placental barrier resulting in higher fetal serum concentrations on Day 18 of gestation than maternal serum concentrations on Day 16 of gestation.
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
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.