Lumvoa

Lumvoa is an FDA-registered drug product whose active ingredient is VELIGROTUG. It is labelled by Viridian Therapeutics, Inc. taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 85166-001, application BLA761530, label effective 20260629. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing VELIGROTUG are most often described in connection with: thyroid eye, disease regardless, activity duration, usage lumvoa, insulin-like growth, factor- receptor, inhibitor indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 )

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 Discard the withdrawn volume of 0.9% Sodium Chloride.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.

4 CONTRAINDICATIONS None None ( 4 )

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.

What is Lumvoa used 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 disease activity or duration. ( 1 )

Who makes Lumvoa?
Viridian Therapeutics, Inc. is the labeler of record for Lumvoa.

What form does Lumvoa come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Lumvoa prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Lumvoa been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.