APP Pharmaceuticals releasing more preservative-free methotrexate

Continuing to work with FDA to ease the ongoing shortage of injectable methotrexate, APP Pharmaceuticals this week released another 10,000 vials of preservative-free methotrexate (Methotrexate Injection), a drug used in the treatment of pediatric oncology and hematology. 

FDA approved Methotrexate Injection in February. Earlier this month, the Schaumberg, Ill.-based company released 35,000 vials of the sterile injectable chemotherapeutic product.  It expects to release another 10,000 vials by the end of the month, an APP spokesman said.

Scott Meacham, executive vice president and chief commercial officer of APP, said the company benefits from the cooperative efforts with the FDA toward solving drug shortages. 

“APP has repeatedly demonstrated that it can meet the challenges of critical drug shortages and the company was able to easily collaborate with the FDA to obtain expedited approval of preservative-free Methotrexate Injection,” Meacham told
Drug Topics.

Meacham said that after FDA approval, “we quickly adapted our manufacturing schedule in order to produce more doses, so that we are able to get this critically needed drug to clinicians across the United States. ”

For pediatric oncologist Carl Lenarsky, MD, director of the Dallas/Fort Worth-area Pediatric Hematology and Oncology of Texas, release of the preservative-free drug is very good news.

“It just now has gotten to the point where we were beginning to ration our supply. We have been able to give out the drug but we were just a few weeks away from coming down to zero supply,” Lenarsky said.

Lenarsky explained that treatment in pediatric cancers such as “leukemia and certain types of bone cancer” requires therapy with a non-preservative methotrexate injectable, as the antimicrobial preservative benzyl alcohol is known to cause illness in children.

“We inject a high-dose methotrexate directly into the nervous system via the spinal cord to prevent the cancer from going to the brain, so it is essential we use preservative-free methotrexate,” he said.

Each year there are 3,000 children diagnosed with acute lymphoblastic leukemia, which Lenarsky said projects to “9,000 or 10,000 patients who are on the therapy at any given time, and, as the treatment typically lasts 3 years, that’s a lot of patients who would have been denied proper therapy.” 

The current FDA boxed warning says that “methotrexate formulations and diluents containing preservatives must not be used for intrathecal or high-dose methotrexate therapy.”