An ifosfamide shortage prompts cancer treatment concerns and new importation efforts.
The ongoing ifosfamide shortage is creating concerns for cancer treatment as oncology practices report dwindling supplies of the chemotherapy agent and limited options for substitution. The shortage has become particularly concerning because ifosfamide is used in several treatment regimens, including those with curative intent.
The American Society of Clinical Oncology (ASCO) reported that some practices have less than a few weeks of ifosfamide inventory remaining.1
The FDA added ifosfamide injection to its drug shortage database in June 2026. The current disruption is associated with manufacturing issues affecting Baxter Healthcare, while increased demand has placed additional pressure on products from alternative manufacturers Fresenius Kabi and Hikma Pharmaceuticals.2
ASCO has described the situation as a critical supply disruption and noted there is no direct therapeutic substitute for ifosfamide.1 The shortage, therefore, presents particular concerns for patients whose treatment plans depend on the agent and for institutions attempting to conserve available inventory.
Ifosfamide is an alkylating agent FDA-approved in combination with other antineoplastic agents for adults with malignant germ cell testicular cancer who have previously received at least 2 chemotherapy regimens.3
However, its clinical use extends beyond its FDA-approved indication. Ifosfamide is incorporated into treatment regimens for bone and soft tissue sarcomas, as well as other malignancies.1 Because of these applications, a prolonged shortage could affect patients across multiple disease states.
Pharmacists should closely monitor local ifosfamide inventory and current FDA and ASCO shortage guidance. If imported ifosfamide is used, pharmacy teams should review the product-specific English labeling and comparison information because storage, preparation, administration, excipients, drug-interaction information, and barcode considerations differ from FDA-approved IFEX.
The FDA is working with SteriMax USA Inc to temporarily import an unapproved ifosfamide product manufactured by Qilu Pharmaceutical in China. The imported product is available as a 1-g vial and is being distributed by GlobalRX.4
Although the imported product was manufactured at an FDA-inspected facility, it has not been approved by the FDA for use in the United States.4 Pharmacists should be aware of several differences between the imported product and FDA-approved IFEX.
The imported product contains glycine and mannitol as excipients, whereas FDA-approved IFEX does not. It also has different storage, reconstitution, dilution, administration, and drug-interaction information. The imported product should be refrigerated at 2 °C to 8 °C and protected from light.4
The product also presents medication-safety considerations related to barcode scanning. The imported carton barcode may not register accurately in US scanning systems, and the packaging does not contain serialization information required under the Drug Supply Chain Security Act. Institutions should establish procedures for manually verifying the product before preparation and administration.4
ASCO has directed oncology practices to federal shortage-mitigation guidance that includes strategies for minimizing drug waste.1 Recommended approaches include appropriate dose rounding, vial sharing or aliquoting when permitted and supported by institutional procedures, and coordination between facilities to optimize available inventory.
The federal guidance emphasizes prioritizing patients for whom treatment is highly likely to benefit, particularly when therapy is potentially curative.5 Significant dose reductions or treatment delays solely to conserve supply should not replace individualized clinical decision-making.
For pharmacists, managing the shortage requires close coordination with oncologists, nurses, purchasing teams, and pharmacy operations. Institutions should monitor inventory, identify patients receiving ifosfamide-containing regimens, evaluate opportunities for conservation, and prepare medication-use processes for the imported product if it becomes available at their facility.
The shortage underscores the clinical consequences that can arise when manufacturing disruptions affect essential generic chemotherapy. As US supply remains constrained, pharmacists will play an important role in maintaining safe access to ifosfamide while helping oncology teams make evidence-based decisions about conservation and treatment alternatives.
Pharmacists should review current inventory, identify patients scheduled to receive ifosfamide, and communicate anticipated supply limitations with oncology teams.
Treatment prioritization should consider the intent of therapy and the likelihood of clinical benefit. Pharmacists can also evaluate opportunities to reduce waste through appropriate dose rounding, vial sharing, or aliquoting when permitted by institutional policies and applicable compounding requirements.1,2
Pharmacists should carefully distinguish the temporarily imported Qilu Pharmaceuticals product from FDA-approved IFEX. The imported product has different labeling, excipients, storage requirements, reconstitution and administration instructions, and drug-interaction information. The product also may not scan correctly in US barcode systems.
Pharmacy teams should establish verification procedures and ensure that staff involved in preparation and administration are familiar with the product-specific information.3
Pharmacists should work with the oncology team to evaluate alternatives when available supply cannot support a patient's planned treatment. Because ASCO has noted that there is no direct therapeutic substitute for ifosfamide, alternative regimens should be evaluated based on the patient's cancer type, treatment intent, prior therapy, and available clinical evidence rather than assuming another alkylating agent is interchangeable.1
Pharmacists can help assess differences in efficacy, toxicity, dosing, supportive care, and administration requirements before a regimen is changed.
