Nanaz Amini, PharmD, RPh, MS, advises healthcare professionals on the proper storage and administration of T-VEC for appropriate patients with melanoma.
Nanaz Amini, PharmD, RPh, MS: This drug needs to be kept between -70°C and -90°C. Large academic institutions, larger clinics, tend to always keep the drug at -70°C to -90°C, so that’s not an issue. But for smaller practices, it’s still not a detriment of not being able to use it because the drug is shipped in a very nice container. It is actually a fluorescent green/yellow color. It reminds you of the 1980s. It’s a big box that comes with dry ice, and that container—they’ve done stability studies—keeps a temperature at -70°C to -90°C for 96 hours. And there’s an expiration date that is written on the outside. So, if it is ordered properly, they can use that as storage.
In addition, the manufacturer has a program where they have, basically, portable freezers that they can loan. I don’t know the specifics because we don’t use that. I don’t know the information, but basically, you can contract with them and they can provide that to you. It’s a smaller freezer, but in order for you not to have to purchase and then obviously maintain it, because when you have the -70°C to -90°C temperatures, you’ve got to have preventative maintenance and calibrations done annually in order to assure that the drug is kept at the proper temperature.
In addition to that, when you get the drug, you have 60 seconds to move it from the container that it comes in into where you’re going to store it—unless you’re going to store it in the container that it comes in. You have 60 seconds to take it out and to visually just check to make sure the right product came and that everything is OK. Then you can close it again, but you have 60 seconds.
In that 60 seconds, obviously, you want to check the drug that you’ve received—the expiration date, the name on there, the dosage you ordered, and the compounds. Each of them are in individual vials—they’re single-use vials. The lower dosage color is a light green, and the higher dosage is color-coded with a royal blue. So, you can do a quick spot check.
And how the container comes, if you open it, there’s a silver foil that you remove. And over that, there’s like a little cricket box. There’s dry ice. You remove that, and under that are the boxes of Imlygic that it comes in. And usually, 4 boxes will fit in 1 of those containers. And then, you can do a quick check and put it back. So, you want to make sure of its expiration date and that what you’ve ordered is correct. Also, before you even open it, make sure that what you received came in is still good in the sense of the expiration hours that you have in the container. So, those are the things you’re checking for.
Usually what happens, at least for our clinic, is that the patient is seen in a room, and it is determined what lesions are going to be injected and how many lesions are going to be injected. And from there, we determine how much the patient is going to get. So, the maximum volume that a patient can get at any time, at any clinic visits, is 4 mL, based on lesion size.
Basically, when you determine what volume you’re going to use, each vial is 1 amount, and you can get a maximum of 4 mL at any treatment time. So, you would thaw out each of the vials that you’re going to need, in the individual box that it comes in, for a half an hour. We do this under the hood in our practice. After a half an hour, you would prepare each of the amounts that you need. There is a little diagram which is in the insert that you can use to refer to. It’s specific that if it’s less than 0.5 cm, you’re going to inject .1 mL; between 0.5 cm and 1.5 cm, you’re going to give 0.5 mL; between 1.5 cm to 2.5 cm you give 1 mL; between 2.5 cm to 5 cm, you give 2 mL; and anything above that you give all 4 mL into the 1 lesion. So, you would prepare it accordingly. There is a form that is provided, and you can actually mark all the lesions. It’s helpful to know what to do at subsequent treatments, and you would give the volume necessary. So, you’d prepare 1 mL or 0.5 mL, depending on the lesion size. But, if it’s anything below that and you’re going to use 0.1 mL, from my personal experience, it’s better to draw 0.5 mL and then change out needles for each lesion that you’re going to inject. And usually, you want to draw up with an 18- to 26-gauge needle. And then for injection, it’s 22- to 26-gauge.