An Imported Vial Enters the Chemotherapy Supply
Patients with sarcoma, relapsed testicular cancer, and some lymphomas who are scheduled for ifosfamide may now receive a version of the chemotherapy made for the Chinese market. SteriMax USA is coordinating with the FDA to temporarily import ifosfamide for injection manufactured by Qilu Pharmaceutical, according to a SteriMax letter to health care providers posted by the FDA.
The FDA has not approved the imported product, though the letter says it is made at an FDA-inspected facility. SteriMax and its distributor, GlobalRX, are the only companies authorized to import or distribute it. The step targets a shortage that the latest NCCN survey found at 94% of responding cancer centers in late August.
For families, the change is practical rather than alarming. The drug inside is ifosfamide, but the vials carry Chinese labels covered by English overlabels, must be refrigerated, contain two added ingredients, and may not scan correctly in hospital systems. Those differences put more responsibility on pharmacists and nurses, and they give patients a few new questions worth asking.
Differences Pharmacists Are Being Told to Watch
The imported 1-gram vials contain glycine and mannitol as inactive ingredients, while the FDA-approved version, sold as Ifex, contains none. The two imported lots listed in the letter expire in June 2029.
The imported vials must be refrigerated and protected from light, while the U.S. product is stored at room temperature. The package insert also lists different drug interaction information and different preparation steps. It calls for dissolving the powder in sterile water, diluting it further, and giving it as a slow infusion over at least 30 minutes.
The packaging lacks the serialization data U.S. law uses to trace prescription drugs, and its barcodes may not register accurately on U.S. scanners. The letter tells hospitals to enter the product information manually and to use backup procedures to confirm that each patient receives the correct drug.
Pharmacy Times advised pharmacy teams to pay close attention to the imported product's refrigeration, light protection, ingredient, and handling differences. The FDA has used this approach before. During the 2023 cisplatin shortage, it also allowed temporary imports of an unapproved product from Qilu, Becker's Hospital Review reported.
Supply Timelines Point in Different Directions
MedicalDaily previously reported on the NCCN survey, which described the FDA as planning to allow imports. The Aug. 21 SteriMax letter shows the imports had already been authorized by the time the survey results were released on Sept. 10. The survey also found 71% of centers short on carboplatin, 16% short on cisplatin, and more than half short on BCG for bladder cancer. In addition, 61% of responding centers said they needed pharmacy- and physician-led workarounds to keep every patient on the recommended dose and schedule.
The FDA added ifosfamide injection to its drug shortage list on June 12. The agency has linked the shortage to good manufacturing practice requirements at Baxter, along with rising demand for products from Fresenius Kabi and Hikma. Baxter has said it relies on a contract plant in Germany for the drug. As of early August, Baxter estimated U.S. recovery in September to October. In late August, ASCO warned that some practices had less than a few weeks of inventory and that no direct substitute exists.
European regulators are less optimistic. The European Medicines Agency has said the shortage of Baxter's ifosfamide in Europe is expected to last until the first quarter of 2027, when the manufacturing site should return to full capacity. U.S. and European supply channels differ, so that timeline does not automatically apply here, but it suggests the problem could outlast earlier U.S. estimates.
NCCN Chief Executive Officer Dr. Crystal S. Denlinger said member centers have "developed internal strategies, task forces, and communications plans" to keep patient care and clinical trials on track. She added that the work takes time and attention that could otherwise go toward improving patient care. NCCN belongs to the End Cancer Drug Shortages Coalition, which released policy proposals in May.
Questions Patients and Caregivers Can Bring to the Infusion Center
The people most affected are those already on, or about to start, ifosfamide-based regimens. That includes children and adults with bone and soft tissue sarcomas, patients with relapsed testicular cancer, and some adults with lymphoma, including those receiving the RICE regimen.
Patients can ask whether their scheduled drug is the U.S.-approved product or the imported version, and whether the care team has checked the interaction differences against their other medications. Caregivers can keep a simple log of infusion dates, drug names, and any changes to the plan.
The imported drug carries the same known risks as the U.S. product, including bladder bleeding, kidney damage, lowered blood counts, and confusion or drowsiness from nerve toxicity. Blood in the urine, unusual sleepiness, confusion, fever, or signs of infection during treatment should be reported to the oncology team right away, and severe symptoms need emergency care.
Ifosfamide is routinely given with mesna, a protective drug, and extra fluids to reduce bladder damage. The imported product's insert also calls for mesna and hydration, so that part of care should look familiar.
Patients should not delay, skip, or switch treatment on their own, and they should never buy chemotherapy from online sellers. Because NCCN found that 90% of centers needed repeat prior authorization when a treatment plan changed, asking the clinic's financial counselor to start paperwork early can reduce gaps. Problems with the imported product can be reported to SteriMax or the FDA's MedWatch program.
What happens next depends on whether Baxter's recovery estimate holds and whether the FDA authorizes more imported supply. For now, the imported vials add needed supply, and patients can confirm that their team has addressed the differences.
Key Questions Answered
What changed in the ifosfamide shortage?
The FDA is allowing SteriMax USA to temporarily import an unapproved ifosfamide product made by Qilu Pharmaceutical for the Chinese market, distributed through GlobalRX.
Is the imported ifosfamide safe to use?
It is not FDA-approved, but the letter posted by the FDA says it is made at an FDA-inspected facility. Care teams are told to review its labeling and differences before use.
How is it different from the U.S. version?
It contains glycine and mannitol, needs refrigeration, has Chinese labels with English overlabels, lists different interaction information, and may not scan correctly.
Who is most affected?
People receiving ifosfamide for sarcomas, relapsed testicular cancer, or some lymphomas, including children with certain bone and soft tissue cancers.
When will the shortage end?
As of early August, Baxter estimated U.S. recovery in September to October. European regulators expect the shortage in Europe to last until early 2027.
What should patients ask their care team?
Ask which product you will receive, whether interactions with your other medicines were checked, and whether any schedule change needs new insurance approval.
What symptoms need prompt attention during treatment?
Blood in the urine, confusion, unusual drowsiness, fever, or signs of infection should be reported right away. Severe symptoms need emergency care.
