How is Lumvoa administered?

Speaker 1 (00:00):
This video will walk you through the steps required to prepare and administer Lumvoa, veligrotug-vvze, intravenous infusions for patients with thyroid eye disease. Please review the important safety information at the end of this video.

Speaker 2 (00:16):
Lumvoa is indicated for the treatment of thyroid eye disease, regardless of thyroid eye disease activity or duration. Lumvoa may cause infusion reactions. Infusion reactions may occur during or soon after an infusion. Please review the important safety information at the end of this video.

Speaker 1 (00:36):
Now, let's review how Lumvoa is supplied. The Lumvoa injection is a sterile, preservative-free, slightly opalescent yellowish to brown solution. Each carton contains one single dose vial of Lumvoa. Each Lumvoa vial contains 10 milliliters of veligrotug drug product at a concentration of 50 milligrams per milliliter of veligrotug antibody.

(01:01):
Now, let's look at proper storage and handling for Lumvoa. Refrigerate Lumvoa at 2 to 8 degrees Celsius or 36 to 46 degrees Fahrenheit in its original carton until time of use to protect it from light. Do not freeze Lumvoa. Do not shake the Lumvoa vial.

(01:25):
Now, let's review the recommended dosing for Lumvoa. Lumvoa is administered via an intravenous infusion every three weeks for five infusions for a total of 12 weeks from start to completion. Dosing for Lumvoa is weight-based. You will need to calculate the dose and the appropriate number of vials needed for the 10 milligrams per kilogram dosage based on your patient's weight.

(01:53):
Ensure you have all the necessary supplies prior to starting administration. A 500 milligram per 10-milliliter vial or vials of Lumvoa; a sterile syringe and needle; a 250-milliliter intravenous infusion bag containing 250 milliliters of 0.9% sodium chloride, USP; and an infusion administration set. Remember to check the seal and expiration dates on Lumvoa vials and infusion bags prior to use. See the full prescribing information for details on compatible materials.

(02:31):
Here's how to prepare the infusion. Use a 250-milliliter 0.9% sodium chloride USP 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 Lumvoa solution to be placed into the infusion bag. Discard the withdrawn volume of 0.9% sodium chloride USP.

(03:00):
Withdraw the required volume from the Lumvoa vials based on the patient's weight in kilograms and transfer into the intravenous bag containing 0.9% sodium chloride solution, USP. Discard vials and all unused contents. Mix the diluted solution by gentle inversion to avoid foaming. Do not shake.

(03:21):
The product does not contain any preservative. The storage time of the diluted solution in the infusion bag is four hours at room temperature, which is 20 to 25 degrees Celsius, or 68 to 77 degrees Fahrenheit, or up to 72 hours under refrigerated conditions at 2 to 8 degrees Celsius or 36 to 46 degrees Fahrenheit protected from light. Do not freeze the diluted solution.

(03:49):
Visually inspect the diluted solution for particulate matter and discoloration prior to administration whenever solution and container permit. If any particulate matter or discoloration are observed, please notify Viridian Therapeutics Incorporated at 1-866-321-VRDN. That's 1-866-321-8736 and discard the solution immediately.

(04:17):
Now, let's look at how to administer Lumvoa infusions. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion. For the first infusion, administer the diluted solution intravenously over 45 minutes. If well-tolerated, subsequent infusions could be administered over a minimum of 30 minutes. If not well-tolerated, the minimum time for subsequent infusions should remain at 45 minutes.

(04:47):
Do not administer Lumvoa as an intravenous push or bolus. Lumvoa should not be infused concomitantly with other agents. In patients who experience an infusion reaction, consideration should be given to standard pre-medication and/or administering infusions at a slower infusion rate. Once the infusion is complete, remove the IV and discard items.

(05:13):
Please review the prescribing information for full dosing and administration considerations. For more information or to review the steps seen in this video, please see the Lumvoa Infusion Guide (PDF) at lumvoahcp.com/resources.

(05:29):
To report suspected adverse reactions, contact Viridian Therapeutics Incorporated toll-free at 1-866-321-VRDN. That's 1-866-321-8736. Or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Speaker 2 (05:51):
Indication. Lumvoa is indicated for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration.

(06:04):
Important safety information. 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.

(06:28):
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 pre-medication and/or administering infusions at a slower infusion rate.

(06:56):
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 one 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.

(07:25):
Hyperglycemia. Hyperglycemia or increased blood glucose may occur in patients treated with Lumvoa. In clinical trials, 12% of patients of whom one have had preexisting 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. Continued monitoring after treatment is recommended for patients who experience hyperglycemia while on Lumvoa.

(08:16):
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.

(08:34):
Most common adverse events. Most common adverse reactions, incidents 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.

(09:00):
Females of reproductive potential. Appropriate forms of contraception should be implemented prior to initiation, during treatment, and for six months following the last dose of Lumvoa. Lumvoa 500 milligrams is an injection for infusion. Please see full prescribing information at www.lumvoahcp.com.