ANSM Authorizes Compounded Aprepitant Oral Suspension to Address Emend Shortage

In response to the ongoing unavailability of EMEND 125 mg powder for oral suspension and the impending discontinuation of its commercialization in August, the French National Agency for the Safety of Medicines and Health Products (ANSM) has authorized the provision of a compounded oral aprepitant preparation. This measure aims to ensure continued access to essential antiemetic treatment for pediatric cancer patients undergoing chemotherapy, mitigating the risks associated with nausea and vomiting induced by these therapies.

Background: The Critical Role of Antiemetics in Chemotherapy

Chemotherapy, a cornerstone of cancer treatment, often induces severe side effects, including profound nausea and vomiting. These symptoms can significantly impact a patient’s quality of life, leading to dehydration, malnutrition, poor adherence to treatment, and psychological distress. Aprepitant, the active ingredient in EMEND, is a neurokinin-1 (NK1) receptor antagonist that plays a crucial role in preventing both acute and delayed chemotherapy-induced nausea and vomiting (CINV). It is typically administered in combination with other antiemetic agents, such as 5-HT3 receptor antagonists and corticosteroids, to provide comprehensive protection. The availability of effective antiemetics is therefore paramount for the successful and tolerable delivery of chemotherapy regimens.

The Crisis: EMEND Shortage and Impending Discontinuation

For several months, the French market has been experiencing significant supply chain disruptions affecting EMEND 125 mg powder for oral suspension. Reports indicate widespread shortages in both community pharmacies and hospital settings, creating considerable concern among healthcare professionals and patients alike. Compounding this issue is the announcement that the commercialization of EMEND 125 mg powder for oral suspension is slated for discontinuation in August 2026. This planned cessation of the branded product leaves a critical gap in the therapeutic armamentarium for pediatric CINV prevention.

The initial ANSM response in March 2026 involved several measures to alleviate the shortage, including recommendations for alternative therapeutic strategies and the promotion of existing generic options where available. However, the persistent nature of the shortage and the definitive end of commercial availability necessitated a more robust and immediate solution for the pediatric population.

ANSM’s Solution: Authorized Compounded Aprepitant Oral Suspension

Recognizing the urgent need, the ANSM has now authorized the availability of a compounded oral aprepitant preparation. This magistral preparation, formulated by pharmacists, is designed to serve as a direct replacement for the unavailable EMEND oral suspension.

Key Characteristics of the Magistral Preparation:

• Dosage and Concentration: The compounded preparation is formulated at a concentration of 20 mg/mL of aprepitant. This differs from the original EMEND 125 mg powder for oral suspension, which yields a concentration of 25 mg/mL when reconstituted.
• Presentation: The magistral preparation is supplied in a 16 mL bottle, containing a total of 320 mg of aprepitant.
• Storage: It requires refrigeration to maintain its stability and efficacy.
• Ready-to-Use: The formulation is pre-mixed and ready for immediate administration, simplifying the dispensing process for pharmacists and use for caregivers.

Streamlined Dispensing Without a New Prescription

A critical aspect of the ANSM’s authorization is the provision for pharmacists to dispense the compounded aprepitant preparation without requiring a new prescription from the prescribing physician. This measure is designed to expedite access and minimize administrative burdens on both healthcare providers and patients during this period of supply disruption. If EMEND oral suspension is prescribed and unavailable, the pharmacist is authorized to provide the magistral preparation as a substitute. This pragmatic approach acknowledges the urgency of the situation and prioritizes patient care.

Specific Pediatric Population and Weight-Based Dosing

The magistral preparation of aprepitant is specifically intended for pediatric patients aged 6 months to under 12 years, with a body weight ranging from over 6 kg to less than 41 kg. This precise age and weight limitation is crucial due to the difference in concentration between the original product and the compounded formulation, necessitating careful dose adjustments.

The Importance of the Equivalence Table

Given the disparity in concentration (20 mg/mL for the magistral preparation versus 25 mg/mL for EMEND oral suspension), pharmacists must meticulously adhere to an equivalence table established by the ANSM. This table provides the specific volume of the 20 mg/mL oral suspension to be administered based on the child’s weight, ensuring that the prescribed milligram-per-kilogram dosage is maintained. For example, if a child weighs 10 kg, the table will specify the precise volume of the 20 mg/mL suspension to deliver the equivalent therapeutic dose that would have been achieved with the original formulation. The dosing frequency (over a 3-day period) and the mg/kg dosage remain consistent with the original EMEND prescription.

The magistral preparation is supplied with three oral syringes of appropriate volumes to facilitate accurate and safe administration of the calculated dose.

Pharmacist’s Responsibilities and Documentation

When dispensing the compounded aprepitant preparation as a substitute, pharmacists are required to document the substitution on the original prescription. This includes noting the name of the magistral preparation, the quantity dispensed, and the date of dispensing. This ensures proper record-keeping and traceability.

Furthermore, a detailed patient information leaflet is to be provided to parents or caregivers. This leaflet contains essential instructions for administering the oral suspension and includes a critical warning regarding the risk of aspiration (mis-swallowing). Caregivers will be instructed on proper administration techniques to minimize this risk, emphasizing slow and controlled delivery of the medication.

Reimbursement and Cost Considerations

The compounded aprepitant oral suspension is covered by French Social Security. The established reimbursement rate for the 16 mL bottle of the 20 mg/mL preparation is €64.45 (including VAT), as amended by an arrêté dated April 15, 2026. This reimbursement structure aims to ensure that the financial burden on patients and their families is minimized during this period of product unavailability. The price is composed of the cost of the active pharmaceutical ingredient and the compounding fee for the pharmacist, reflecting the specialized nature of preparing magistral formulations.

Chronology of Events and ANSM Actions

• Several Months Prior to March 2026: Increasing reports of significant supply chain tensions for EMEND 125 mg powder for oral suspension emerge.
• March 2026: ANSM issues initial recommendations and alerts regarding EMEND shortages, outlining early mitigation strategies.
• March 2026 (Article Published March 12, 2026): ANSM details previous measures taken to address the EMEND buvable unavailability and alternative solutions.
• April 13, 2026: An arrêté establishes the initial basis for reimbursement of the compounded aprepitant oral suspension.
• April 15, 2026: A subsequent arrêté modifies the reimbursement rate. ANSM publishes a recommendation detailing the modalities for pharmacists to dispense the magistral preparation as a substitute for EMEND oral suspension.
• August 2026: Planned discontinuation of the commercialization of EMEND 125 mg powder for oral suspension.
• Present: ANSM authorizes the immediate availability and dispensing of the compounded aprepitant oral suspension to bridge the therapeutic gap.

Broader Implications and Analysis

The ANSM’s decisive action to authorize a compounded magistral preparation highlights the agency’s commitment to patient access to essential medicines, particularly for vulnerable populations like pediatric cancer patients. The move underscores the flexibility and adaptability of the regulatory framework to respond to unforeseen supply chain crises.

The reliance on magistral preparations, while effective in the short to medium term, also points to the broader challenges within the pharmaceutical supply chain. Factors such as manufacturing complexities, geopolitical influences, and the economic viability of certain drug productions can lead to such shortages. This situation may prompt discussions about strengthening domestic pharmaceutical manufacturing capabilities and diversifying supply sources to prevent future crises.

For pharmacists, this authorization represents an expanded role in patient care, requiring specialized compounding skills and diligent adherence to regulatory guidelines and equivalence protocols. It also emphasizes the crucial communication link between pharmacists, physicians, and patients to ensure seamless transitions in medication therapy.

The focus on a specific pediatric age and weight range underscores the importance of precise dosing in children and the potential risks associated with off-label use or inappropriate substitutions. The provision of detailed instructions and warnings is paramount to ensure patient safety and the effective management of chemotherapy side effects.

Conclusion: Ensuring Continuity of Care

The authorization of a compounded oral aprepitant suspension by the ANSM is a critical intervention to ensure that young cancer patients in France continue to receive vital antiemetic treatment. By enabling pharmacists to dispense this preparation without a new prescription and providing clear guidance on its use, the ANSM is actively mitigating the impact of the EMEND shortage and the impending cessation of its commercial availability. This proactive measure demonstrates a commitment to patient well-being and the continuity of essential cancer care in the face of pharmaceutical supply chain challenges. Healthcare professionals are urged to familiarize themselves with the ANSM’s recommendations and the provided equivalence tables to ensure the safe and effective implementation of this therapeutic solution.