Veligrotug
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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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Recommended Dosage The recommended dosage of LUMVOA is 10 mg/kg administered by intravenous infusion every three weeks for a total of 5 infusions.
Dose Preparation Step 1: Calculate the dose (mg) and determine the number of vials needed for the 10 mg/kg dosage based on patient weight. Each LUMVOA vial contains 500 mg of veligrotug antibody. Step 2: Use a 250 mL 0.9% Sodium Chloride infusion bag to prepare the diluted solution. To maintain a constant volume in the infusion bag, use a sterile syringe and needle to remove the volume equivalent to the amount of the LUMVOA solution to be placed into the infusion bag.
Discard the withdrawn volume of 0.9% Sodium Chloride. Step 3: Withdraw the required volume from the LUMVOA vial(s) based on the patient's weight (in kg) and transfer into the intravenous bag containing 0.9% Sodium Chloride Solution. Mix the diluted solution by gentle inversion to avoid foaming. Do not shake. LUMVOA does not contain any preservative.
The storage time of the diluted solution in the infusion bag containing 0.9% Sodium Chloride Injection is 4 hours at room temperature 20°C to 25°C (68°F to 77°F) or up to 72 hours under refrigerated conditions at 2°C to 8°C (36°F to 46°F), protected from light. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted solution should be a colorless, clear liquid, and free of visible particles. Discard the solution if any particulate matter or discoloration are observed.
Do not freeze the diluted solution. Discard vial(s) and all unused contents. LUMVOA compatibility with the infusion solution has been demonstrated in the following intravenous administration materials: Intravenous (IV) Bag: polyvinyl chloride (PVC), ethyl vinyl acetate (EVA), polypropylene-styrene-ethylene-butylene-styrene (PP-SEBS), and ethylene-propylene copolymer (polyolefin (PO)).
Inline 0.2- or 0.22-micron filters: polyethersulfone solution filter (PES) and polyvinylidene fluoride air filter (PVDF). Infusion sets: polyvinyl chloride/bis (2-ethylhexyl) phthalate (PVC/DEHP), polyurethane (PUR), and polyethylene (without DEHP).
Administration Instructions Administer the diluted solution intravenously over 45 minutes for the first infusion. If well tolerated, subsequent infusions can be administered over a minimum of 30 minutes. If not well tolerated, the minimum time for subsequent infusions should remain at 45 minutes. Do not administer LUMVOA as an intravenous push or bolus.
LUMVOA should not be infused concomitantly with other agents.
Contraindications
None None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Because inhibiting insulin-like growth factor-1 receptor (IGF-1R) signaling impacts embryonic development and placental development and function, LUMVOA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There is insufficient data with LUMVOA use in pregnant women to inform any drug associated risks for adverse developmental outcomes. Animal reproductive and developmental toxicity studies have not been conducted with LUMVOA. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
LUMVOA should not be used during pregnancy, and appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months after the last dose of LUMVOA. Women of childbearing potential should have a pregnancy test performed by their doctor before starting treatment with LUMVOA. If the patient becomes pregnant during treatment, LUMVOA should be discontinued and the patient advised of the potential risk to the fetus. 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.
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.