Refrigerator for storing hemophilia factor

Safely Storing Factor at Home

What you need to know to begin home therapy
Author: Martha Frase

Starting a home-care regimen for hemophilia and other bleeding disorders can be a life-changing experience for families. Self-infusion, prophylactically or in the case of a bleed, is quick, convenient, medically effective and safe—as long as the products and equipment are used correctly. If you’re feeling overwhelmed about beginning home therapy, here’s what you need to know about storing factor products properly.

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“Proper storage is important to ensure the factor product will be effective in preventing or treating bleeding episodes,” says Lisa Bowman, RN, pediatric clinical nurse coordinator at the Indiana Hemophilia & Thrombosis Center in Indianapolis. “Products that have been improperly stored or allowed to expire may become inactive, making them ineffective in treating and preventing bleeding. This could result in a bleed not resolving or the need for more factor, requiring a longer duration of treatment.”

The basic elements provided by most manufacturers are two vials—one with sterile diluents and one with factor powder concentrate—and a mixing device. Fortunately, storing them is a simple matter, as long as you closely follow the manufacturers’ directions, says hematologist Deborah Brown, MD, of Gulf States Hemophilia and Thrombophilia Center in Houston. “Each type of product is different, so you need to check the manufacturers’ instructions for proper storage and shelf life,” she says. “Some are stable at room temperature, but that is a very narrow temperature range. In hotter climates, like here in Houston, it is sometimes hard to maintain a constant temperature in the home.”

Manufacturers typically recommend storing factor products in the refrigerator, although many are stable at room temperature for a limited time. Most recombinant factor VIII products can be stored at room temperature for three months, but you should always check the manufacturer’s instructions. Room-temperature storage recommendations for plasma-derived factor VIII products vary, with Alphanate® stable at room temperature for two months and Humate-P® for up to 24 months. Koate®-DVI may be stored at room temperature for up to six months.

As for the factor IX products, manufacturers also recommend they be stored in the refrigerator. BeneFIX®, a recombinant factor IX product, can be stored at room temperature for up to six months. AlphaNine® SD, a plasma-derived factor IX product, is stable at room temperature for up to one month.

For those who use Stimate® nasal spray, a highly concentrated form of desmopressin acetate, to treat mild hemophilia A or mild to moderate von Willebrand disease, storing the medicine has become more convenient. The nasal spray can now be stored at room temperature for up to six months without compromising stability, making it easier to carry with you. The nasal spray should always be stored in an upright position.

Refrigerator Storage

For some, it may be easier to store factor products in the refrigerator. That way you don’t have to control room temperatures or keep track of how many months the product has been on the shelf.

Pharmacist Vincent Fusaro, RPh, recommends storing factor products in a dedicated refrigerator, if possible. “It’s easier to keep the temperature stable because the door is opened less often than the household fridge,” says Fusaro, president of Positudes pharmacy in Westbury, New York. The pharmacy serves clients who are treated with injectable drugs—primarily individuals with bleeding disorders. Fusaro has severe hemophilia B and has been self-infusing for years.

If a dedicated refrigerator is not doable, Fusaro suggests placing a separate thermometer in the household refrigerator to monitor the temperature. “The best place to store factor is in the center of the fridge—never in the door.”

Brown recommends separating factor products from foods and other refrigerator contents by storing them in a covered container or resealable plastic bag. “Take it out of the cardboard box, which can attract mold,” she says. “Keep the label and instructions with the products if at all possible so you can easily refer to the expiration date and other information.”

Factor products should never be frozen. “Freezing doesn’t affect the factor product itself—it goes through so many processes during manufacturing. If your factor gets cold under other circumstances, it’s not something to worry about,” Bowman says. “But freezing can cause the vials of diluent to crack or even shatter.”

To avoid injecting cold factor, patients often allow the contents to warm up before mixing and using, Brown says. “This prevents that unpleasant cold sensation after injection.” However, once the factor is reconstituted, it must be used within a relatively short period—usually three hours. “In every case, if the product has been subjected to extreme heat, discard it,” Fusaro says.

One of the most common mistakes people make, Bowman says, is letting a refrigerated product come to room temperature and then refrigerating it again. “Products can be stored in the refrigerator, but once they have been at room temperature, they should stay there.” For travel, put refrigerated factor in an insulated bag with an ice pack, she adds.

It’s also important to know what to do with refrigerated factor if the power goes out. Items in refrigerators may stay cold for several hours, provided you don’t open the door to check the temperature. The US Food and Drug Administration has developed guidance in the event of a power outage or expected flood. See “Impact of Severe Weather Conditions on Biological Products.”

Minding Expiration Dates

It’s important to make note of product expiration dates; product stability times vary among brands, Bowman says. “Once the product hits the expiration date, it should be disposed of.” When new factor arrives, she suggests, make note of the expiration date before storing and post the date somewhere easily visible. You can also write a note on your calendar to check dates monthly. It can be helpful to rotate the factor stock in the refrigerator, putting the newest toward the back and using the one in front first, Bowman says.

Finally, always read the instructions when using a new product. If you are unsure of its storage or use, check with your hemophilia treatment center or pharmacist. “If you have any questions or concerns about a product, call the manufacturer,” says Fusaro. “Each of them has a hotline and 800 number.”