Lumvoa

veligrotug · Injection · Intravenous

Prescription (Rx)

Uses

1 INDICATIONS AND USAGE LUMVOA is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. LUMVOA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. ( 1 )

Dosage and administration

10 mg/kg every three weeks for a total of 5 infusions ( 2.1 ) Administer LUMVOA by intravenous infusion over 30 to 45 minutes ( 2.3 ) See full prescribing information for dose preparation and administration instructions ( 2.2 , 2.3 ) 2.1 Recommended Dosage The recommended dosage of LUMVOA is 10 mg/kg administered by intravenous infusion every three weeks for a total of 5 infusions. 2.2 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 Discard the withdrawn volume of 0.9% Sodium Chloride.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). 2.3 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.

Dosage forms and strengths

Injection: 500 mg/10 mL (50 mg/mL) yellowish to brown, slightly opalescent solution in a single-dose vial. Injection: 500 mg/10 mL (50 mg/mL) solution in a single-dose vial ( 3 )

Contraindications

None None ( 4 )

Warnings and precautions

Infusion Reactions : If an infusion reaction occurs, interrupt or slow the rate of infusion and use appropriate medical management ( 5.1 ) Inflammatory Bowel Disease (IBD) : Monitor patients for signs and symptoms of disease, including patients without a history of IBD; discontinue LUMVOA if IBD is suspected ( 5.2 ) Hyperglycemia : Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with LUMVOA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving LUMVOA. Continue monitoring after treatment for patients who experience hyperglycemia while on LUMVOA ( 5.3 ) Hearing Impairment including Hearing Loss : LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patient's hearing before, during, and after treatment with LUMVOA and consider the benefit-risk of treatment with patients ( 5.4 ) 5.1 Infusion Reactions LUMVOA may cause infusion reactions. Infusion reactions have been reported in approximately 9% of patients treated with LUMVOA. Signs and symptoms of infusion-related reactions include transient increases in blood pressure, fever, chills, headache, and fatigue. Infusion reactions may occur during or soon after an infusion. Reported infusion reactions are usually mild or moderate in severity and can usually be successfully managed with corticosteroids, antihistamines, and antipyretics. In patients who experience an infusion reaction, consideration should be given to standard premedication and/or administering infusions at a slower infusion rate. 5.2 Inflammatory Bowel Disease LUMVOA may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients receiving insulin-like growth factor-1 receptor inhibitors without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD, including patients without a history of IBD. If IBD is suspected, discontinue use of LUMVOA. 5.3 Hyperglycemia Hyperglycemia or increased blood glucose may occur in patients treated with LUMVOA. In clinical trials, 12% of patients, of whom one half had pre-existing diabetes or impaired glucose tolerance, experienced hyperglycemia. Hyperglycemic events should be controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with LUMVOA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving LUMVOA. Continue monitoring after treatment for patients who experience hyperglycemia while on LUMVOA. 5.4 Hearing Impairment Including Hearing Loss LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients' hearing before, during, and after treatment with LUMVOA and consider the benefit-risk of treatment with patients.

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [ see Warnings and Precautions ( 5.1 ) ] Inflammatory Bowel Disease [ see Warnings and Precautions ( 5.2 ) ] Hyperglycemia [ see Warnings and Precautions ( 5.3 ) ] Hearing Impairment [ see Warnings and Precautions ( 5.4 ) ] Most common adverse reactions (incidence of 5% or more) are muscle spasms, headache, hearing impairment, hyperglycemia, fatigue, diarrhea, ear discomfort, infusion-related reaction, nausea, nasopharyngitis, blood creatine phosphokinase increased, dry skin, and hypertension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viridian Therapeutics, Inc. at 1-866-321-VRDN (1-866-321-8736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 LUMVOA was evaluated in two randomized, double-masked, placebo-controlled clinical studies (Study 1 [NCT05176639] and Study 2 [NCT06021054]) consisting of 113 patients with active thyroid eye disease (75 received LUMVOA and 38 received placebo) and 188 patients with chronic thyroid eye disease (125 received LUMVOA and 63 received placebo). Patients were treated with LUMVOA 10 mg/kg or placebo given as an intravenous infusion every 3 weeks for a total of 5 infusions. The majority of patients completed 5 infusions (94% of LUMVOA patients and 99% of placebo patients). The most common adverse reactions (≥5%) that occurred at greater incidence in the LUMVOA group than in the control group during the treatment period of Studies 1 and 2 are summarized in Table 1 . In addition, menstrual disorders (amenorrhea, menstruation irregular, dysmenorrhea, menstruation delayed, intermenstrual bleeding, and menstrual disorder) were reported in approximately 29% (24/82) of menstruating women treated with LUMVOA compared to 6% (2/33) of patients treated with placebo in the clinical trials. Table 1: Adverse Reactions Occurring in 5% or More of Patients Treated with LUMVOA and Greater Incidence than Placebo in Study 1 and Study 2 Adverse Reactions LUMVOA N=200 N (%) Placebo N=101 N (%) 1 Hearing impairment includes tinnitus, hypoacusis, deafness, and autophony. 2 Hyperglycemia includes blood glucose increased, glucose tolerance impaired, glycosylated hemoglobin increased, diabetes mellitus, glucose urine present, and impaired fasting glucose. 3 Fatigue includes asthenia. 4 Ear discomfort includes ear feels clogged or blocked, ear plugging, sensation of ear pressure, and ear popping. Muscle spasms 79 (40%) 7 (7%) Headache 34 (17%) 14 (14%) Hearing impairment 1 29 (15%) 6 (6%) Hyperglycemia 2 25 (13%) 5 (5%) Fatigue 3 25 (13%) 11 (11%) Diarrhea 22 (11%) 7 (7%) Ear discomfort 4 19 (10%) 3 (3%) Infusion-related reaction 18 (9%) 2 (2%) Nausea 15 (8%) 6 (6%) Nasopharyngitis 14 (7%) 1 (1%) Blood creatine phosphokinase increased 12 (6%) 1 (1%) Dry skin 12 (6%) 2 (2%) Hypertension 11 (6%) 5 (5%) During the follow-up period, the most common adverse reactions in patients treated with LUMVOA were alopecia and onychoclasis (5%). Immune thrombocytopenia was also reported in one patient.

Use in specific populations

Females of Reproductive Potential: Appropriate forms of contraception should be implemented prior to initiation, during treatment and for 6 months following the last dose of LUMVOA ( 8.3 ) 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. 8.2 Lactation Risk Summary There is no information regarding the presence of LUMVOA in human milk, the effects on the breast-fed infant or the effects on milk production. 8.3 Females and Males of Reproductive Potential Contraception Females Because inhibiting IGF-1R signaling impacts normal embryonic development and placental development and function, LUMVOA may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception prior to initiation, during treatment with LUMVOA and for 6 months after the last dose of LUMVOA. 8.4 Pediatric Use The safety and effectiveness of LUMVOA have not been established in pediatric patients. 8.5 Geriatric Use Of the 301 patients in Study 1 and Study 2, 12% were 65 years of age or older, with a similar proportion of patients 65 years of age or older between treatment groups. No overall differences in safety or effectiveness of LUMVOA have been observed between patients 65 years of age or older and younger adult patients.

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.

Pediatric use

8.4 Pediatric Use The safety and effectiveness of LUMVOA have not been established in pediatric patients.

Geriatric use

8.5 Geriatric Use Of the 301 patients in Study 1 and Study 2, 12% were 65 years of age or older, with a similar proportion of patients 65 years of age or older between treatment groups. No overall differences in safety or effectiveness of LUMVOA have been observed between patients 65 years of age or older and younger adult patients.

Overdosage

No information is available for patients who have received an overdosage.

Description

Veligrotug-vvze, an insulin-like growth factor-1 receptor inhibitor (IGF-1R), is a humanized IgG1ϰ monoclonal antibody produced in Chinese hamster ovary (CHO-K1) cells. It has a molecular weight of approximately 150 kilodaltons. LUMVOA (veligrotug-vvze) injection is supplied as a sterile, preservative-free, yellowish to brown, slightly opalescent solution, and free of visible particles, for intravenous infusion. Each single-dose vial contains 500 mg of veligrotug-vvze, histidine (6.50 mg), L-histidine hydrochloride monohydrate (33.1 mg), methionine (14.9 mg), polysorbate 80 (2.0 mg), sucrose (800 mg), and Water for Injection (quantity sufficient to 10 mL). The final concentration is 50 mg/mL with a pH of 5.5.

Mechanism of action

12.1 Mechanism of Action Veligrotug-vvze's mechanism of action in patients with thyroid eye disease has not been fully characterized. Veligrotug-vvze is a humanized IgG1 monoclonal antibody that binds to IGF-1R and inhibits IGF-1R signaling by blocking ligand-induced receptor autophosphorylation.

How supplied

How Supplied LUMVOA (veligrotug-vvze) injection is a sterile, preservative-free, yellowish to brown, slightly opalescent solution available as follows: Carton containing one 500 mg/10 mL (50 mg/mL) single-dose vial NDC 85166-001-01 Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

Storage

Storage and Handling Store refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. Do not freeze. Do not shake.

Patient information

Embryo-Fetal Toxicity Advise females of reproductive potential that LUMVOA may cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Educate and counsel females of reproductive potential about the need to use effective contraception prior to initiation of, during treatment with LUMVOA and for 6 months after the last dose of LUMVOA. Infusion Reactions Advise patients that LUMVOA may cause infusion reactions that can occur during or soon after an infusion. Instruct patients to recognize the signs and symptoms of infusion reactions and to contact their healthcare provider immediately for signs or symptoms of potential infusion-related reactions. Inflammatory Bowel Disease Advise patients on the risk of inflammatory bowel disease (IBD), including patients with or without a prior diagnosis of IBD. Advise patients to seek medical advice immediately if they experience diarrhea, with or without blood, or rectal bleeding, associated with abdominal pain or cramping/colic, fecal urgency, tenesmus or incontinence. Hyperglycemia Advise patients on the risk of hyperglycemia and, if diabetic, discuss with healthcare provider to adjust glycemic control measures including medications as appropriate. Encourage compliance with glycemic control. Hearing Impairment Including Hearing Loss Advise patients that LUMVOA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Instruct patients to contact their healthcare provider if they experience any signs or symptoms of hearing impairment or any changes in hearing. Manufactured by: Viridian Therapeutics, Inc. 221 Crescent Street, Suite 103A Waltham, MA 02453 U.S. License No. 2377

Label text from the FDA structured product label by Viridian Therapeutics, Inc. (revised Jun 29, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Veligrotug in 1 product

Lumvoa NDC products (1)

NDC	Strength & form	Labeler	Type
85166-001	Veligrotug 50 mg/mL Injection	Viridian Therapeutics, Inc.	BLA

Frequently asked questions

What is Lumvoa used for?

What are the side effects of Lumvoa?

Who makes Lumvoa?

Lumvoa is listed by 1 labeler in the FDA NDC directory, including Viridian Therapeutics, Inc..