Lumvoa (veligrotug-vvze) is filed as IGF-1R monoclonal antibody. The sections below restate public label fields stored for this profile.
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 )
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.
5 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.
4 CONTRAINDICATIONS None None ( 4 )
Muscle spasms (≥5%); Headache (≥5%); Hearing impairment (≥5%); Hyperglycemia (≥5%); Fatigue (≥5%); Diarrhea (≥5%); Ear discomfort (≥5%); Infusion-related reaction (≥5%); Nausea (≥5%); Nasopharyngitis (≥5%); Blood creatine phosphokinase increased (≥5%); Dry skin (≥5%)
6 ADVERSE REACTIONS 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.
2 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.
17 PATIENT COUNSELING 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
According to its FDA label, Lumvoa (veligrotug-vvze) is approved for: 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 d… For medical advice, please talk to your prescriber or pharmacist.
Lumvoa (veligrotug-vvze) belongs to the IGF-1R monoclonal antibody class of medications.
The FDA label lists Lumvoa (veligrotug-vvze) as: 3 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 ); intravenous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Lumvoa. Availability changes as patents expire.
Our ingest of the FDA label for Lumvoa (veligrotug-vvze) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Lumvoa (veligrotug-vvze) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Lumvoa (veligrotug-vvze) as 2026-06-26.
The FDA label lists Viridian Therapeutics, Inc. as a labeler/manufacturer of Lumvoa (veligrotug-vvze). Multiple firms may market generics of the same molecule.
The FDA label states: "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." Follow the packaging insert for the authoritative guidance.
Loading full data from Know Your Drugs Institute…