Changeflow GovPing Drug Safety Melphalan AqVida: Risk of Overdose Due to Highe...
Priority review Notice Added Final

Melphalan AqVida: Risk of Overdose Due to Higher Concentration

Favicon for www.bfarm.de BfArM Drug Safety Communications
Published December 16th, 2025
Detected March 13th, 2026
Email

Summary

The German Federal Institute for Drugs and Medical Devices (BfArM) issued a communication regarding Melphalan AqVida RTD 90 mg/ml, a new formulation with an 18-fold higher concentration than existing melphalan products. This increased concentration poses a potential risk of overdose for patients.

What changed

The Federal Institute for Drugs and Medical Devices (BfArM) in Germany has issued a Direct Healthcare Professional Communication (DHPC) concerning Melphalan AqVida RTD 90 mg/ml. This new formulation is a concentrate for solution for infusion with a concentration of 90 mg/ml, significantly higher than the 5 mg/ml concentration of Alkeran and other standard melphalan formulations. The 18-fold increase in concentration presents a potential risk of overdose for patients.

Healthcare providers administering melphalan hydrochloride must be aware of this higher concentration and implement appropriate measures to prevent medication errors and patient overdose. This includes careful verification of dosage calculations and administration protocols. The communication highlights the critical need for vigilance when transitioning to or using this new product to ensure patient safety.

What to do next

  1. Review and understand the potential overdose risk associated with Melphalan AqVida RTD 90 mg/ml.
  2. Verify dosage calculations and administration protocols for melphalan hydrochloride to prevent medication errors.
  3. Ensure all relevant clinical staff are informed of the higher concentration and associated risks.

Source document (simplified)

Direct Healthcare Professional Communication (DHPC) on melphalan hydrochloride, Melphalan AqVida 90 mg / ml concentrate for solution for infusion: potential risk of overdose due to higher concentration

2025.12.16

Active substance: melphalan hydrochloride

AqVida GmbH in agreement with the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Melphalan AqVida RTD 90 mg / ml is a one-vial melphalan formulation as a concentrate

for solution for infusion with a concentration of 90 mg / ml. Alkeran and other melphalan formulations have a final concentration of 5 mg / ml after reconstitution. Due to the 18-fold higher concentration, the introduction of this new product bears a

potential risk of overdose.

Download DHPC/Information letter, DownloadVeroeffentlichtAmEN

2025.12.16

PDF, 477KB, File does not meet accessibility standards

Classification

Agency
Various
Published
December 16th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Healthcare providers Drug manufacturers
Geographic scope
National (Germany)

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Product Safety

Get Drug Safety alerts

Weekly digest. AI-summarized, no noise.

Free. Unsubscribe anytime.

Get alerts for this source

We'll email you when BfArM Drug Safety Communications publishes new changes.

Free. Unsubscribe anytime.