Dear Patient:
We take pride in Helping Healthcare Care® and understand your concerns and the importance of providing patients with their immune globulin (IG) product. Since the U.S. Food and Drug Administration (FDA) approved the first intravenous IG (IVIG) product in 1981, IG has experienced a sustained record of near-continuous demand growth. More than 35 years after they were first introduced, demand for IG products continues to grow more than 8 percent a year. In 2018, as it has over each of the past several years, demand for IG products grew by more than 7 million grams. Collectively, IVIG and subcutaneous IG (SCIG) product shipments last year approached 88 million grams.
Even though there are currently 15 IG products available today, this demand growth nevertheless poses two special challenges for IG manufacturers: 1) they must forecast and invest in plasma collection facilities to ensure sufficient additional donor plasma is available to process into IG products, and 2) they must plan, invest and provide adequate lead time to construct and secure regulatory approval to operate new or expanded fractionation (how plasma is manufactured into IG products) and related IG production facilities. To meet these growing demands, IG manufacturers are making great strides to increase production of this lifesaving treatment in order to meet the needs of our most precious patients.
On the CBER-Regulated Products: Current Shortages list, GAMMAGARD LIQUID®, CUVITRU® and Gammaplex® were identified as currently unavailable due to increased demand. “Shortages of drugs and biologics pose a significant public health threat, delaying, and in some cases even denying, critically needed care for patients. Preventing shortages remains a top priority for FDA,” as stated in FDA Facts: Drug Shortages in the United States.
The ASHP (American Society of Health System Pharmacists) drug shortage website lists the following products as in short supply: CUVITRU®, Flebogamma® DIF (5 and 10%), GAMMAGARD LIQUID® , GAMMAKED™, Gamunex®-C, Hizentra®, HYQVIA®, Octagam®, and Privigen®.
While inventory is in short supply on most products, Nufactor may have product on hand to assist patients in this time of short supply. Nufactor is one of four limited distribution pharmacy providers of Cutaquig®, a new 16.5% subcutaneous immune globulin. In addition, Nufactor has access to PANZYGA®, a 10% intravenous immune globulin product. Please contact us at 1.800.323.6832 to see if we may able to help mitigate the current situation for patients with immediate needs.
Unfortunately, we cannot project when or which products will become available. However, through our experience with controlled volume measures, we are doing our best to provide critical-care patients with their lifesaving IG products. With the help of our manufacturing partners and our parent company FFF Enterprises, we will continue to provide you with the latest IG industry and product information.
Please know that patients are very important to us. We sympathize with you and understand the difficulty of having to hear that future treatments with a current brand of IG may not be possible.
Let us work together to find solutions for patients. Please call us at (800) 323-6832
Sincerely,
Patrick M. Schmidt
Chief Executive Officer
FFF Enterprises
Leslie J. Vaughan, R.Ph.
Chief Operations Officer
NuFactor Inc.
